Title: device on general population AtCor~· XCEL 510 CLINICAL... · DHF Doc. No.: Doc. Control No.: 101394 Rev.: 2.0 Page: 1 Of 21 CPWV-5-096 Introduction The clinical performance

AtCor~· MEDICAL 'Y"

Title : Clinical Performance Testing & Validation of SphygmoCor XCEL PWA/PWV

device on general population

DHF Doc. No.:

Doc. Control No.: 101394 Rev.: 2.0 Page: 1 Of 21 CPWV-5-096

Introduction The clinical performance testing of the new Cuff PWA/PWV XCEL device consisted of validating the device's clinical outputs on a general population by aiming to show equivalence with the previously FDA-cleared SphygmoCor CvMS (K080670} predicate. The tests and the analysis involved a measure of equivalence between the XCEL and the predicate device. Both devices have 2 main functions:

1} pulse wave analysis (PWA} function, which calculates aortic central pressure parameters from a peripheral pulse, and

2} pulse wave velocity (PWV} function, that calculate the pulse velocity between the carotid and femoral arterial pulses.

The clinical performance test setting composed of having the two devices (XCEL & the

predicate} measuring PWA & PWV on the same subject. The minimum number of subjects

aimed for was 30, distributed among three age groups. The analysis will be composed of

statistical tests to measure the equivalence between the results of the two devices.

The study was carried out at the: Australian School of Advanced Medicine, Macquarie University, Australia. The Principal Investigator was: Alberto Avolio, Professor, Australian School of Advanced Medicine, Macquarie University. Australia.

Central Pressure waveform Analysis PWA

1- Predicate & Investigational Devices i. Predicate Device (K080670): SphygmoCor EM3 module and CVMS V9.0

The device estimates central aortic pressure waveform from radial

tonometer pressure signal using a general transfer function .

ii. Investigational Device: SphygmoCor XCEL

The device estimate central aortic pressure waveform from brachial cuff

signal using a general transfer function .

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MEDICAL 'Y Doc. Control No.: 101394 Rev.: 2.0

2- Protocol

2.1 Set Up

Tonometer

SphygmoCor CvMS V9

DHF Doc. No.:

Page: 2 Of 21 CPWV-5-096

Figure 1: PWA test setup for investigational (XCEL) and predicate (CvMS) devices

2.2 Procedure a. Record Subject's height and weight b. Subject rest in supine position for at least 5 minutes. c. Measure Brachial SP and DP Using SunTech NIBP module d. Perform SphygmoCor XCEL which will inflate the cuff to 10 mmHg below an

individual's diastolic blood pressure for optimum recording of the brachial volume displacement waveform.

e. Perform radial tonometry based assessment of aortic waveform parameters using SphygmoCor CvMS. Using the calibration in step c.

f. Randomly alternate between steps (d) & (e) three times g. Compare central PWA parameters of both devices using linear regression

analysis, Bland-Aitman plots.

AtCor MJ:· MEDICAL 'V'

3- Subjects

Title : Clinical Performance Testing & Validation of SphygmoCor XCEL PWA/PWV


DHF Doc. No.:


30 Subjects (14 Female, aged 44±20 years with range of 22 to 79 years) distributed equally between 3 Age groups: <30 years (N=10, 6F); 30 to 60 years (N=12, SF); above 60 years (N=8, 3F).

Characteristics of the group were: heart rate 49-90 bpm, brachial systolic pressure 95-155 mmHg, brachial diastolic pressure 64-106 mmHg, height 156-194 em, weight 44-92 kg. The following groups were not included: Subjects with pacemakers, under 18 years of age, Individuals not in sinus rhythm, Known significant carotid or femoral artery stenosis, and Impalpable arterial pulse at site of measurement.

4- Statistics

The following four statistical procedures were used to compare the two different

methodologies. These statistics were requested by the FDA during Pre-IDE discussions

(1080005) for the predicate device clearance and were subsequently accepted during

the 510(k) submission (K080670) for the predicate device. Given the same type of

parameters are being measured; we believe they are appropriate statistical

measurements. They are:

i) Pearson's coefficient (r): the univariate correlation and regression analyses

between measured values were conducted . The coefficient is an assessment of

the degree of agreement between the two methodologies. The higher the

correlation coefficient (r) the more agreement of the tested parameter between

the two devices.

ii) Mean difference: the relative or absolute differences within each pair of

measures were plotted against the mean of the pair (Biand-Aitman Plot). In this

step, an estimation of the agreement between the two methodologies was

represented by plotting the mean difference and the double standard deviation

of the difference. The lower the mean difference, the more agreement of the

tested parameter between the two devices.

iii) t-test (p): to examine the significance of the difference between the tested

parameter values of the two devices. Based on statistical theory, the p value

produced by that test should be higher than 0.05 to accept the hypothesis that

tested parameter of the two devices are significantly similar.

AtCor~· Title: Clinical Performance Testing & Validation of SphygmoCor XCEL PWA/PWV


MEDICAL "V"" DHF Doc. No.:

Page:4 Of 21 Doc. Control No.: 101394 Rev.: 2.0 CPWV-5-096

iv) Concordance Correlation Coefficient (CCC): to assess the degree to which pairs

of observations fell on the 45° line through the origin . Similar tor, the higher the

CCC, the more identical are the tested parameters between the two devices.

5- Acceptance Criteria

i) Pearson's coefficient (r) >0.7 for all tested PWA parameters.

ii) Mean difference: the relative differences of tested parameters (SEVR, ED, and HR) to

the average of the predicate device should be <10%. While the absolute difference of a

parameter in mmHg (SP, DP, DP, PP, AP and MAP) should be< 5mmHg (and less than

8mmHg in SD). The absolute difference of other parameters such as Alx and Alx at 75

should be < 10% given that Alx is a relative measurement. The absolute difference in

SphygmoCor reference age should be< 5 years.

iii) t-test (p) > 0.05 for all tested PWA parameters.

iv) Concordance Correlation Coefficient (CCC)> 0. 7 for all tested PWA parameters.

AtCor MJ:· MEDICAL "Y'

6- Results

Title: Clinical Performance Testing & Validation of SphygmoCor XCEL PWA/PWV


DHF Doc. No.:

Doc. Control No.: 101394 Rev. : 2.0 Page: 5 Of 21 CPWV-5-096

AtCor MJ:· Title: Clinica l Performance Testing & Validation of SphygmoCor XCEL PWA/PWV

device on general popu lation

OHF Doc. No.: MED I CAL Y" Doc. Control No. : 101394 Rev.: 2.0 Page: 6 Of 21

PWA Parameters (units)

Centra SP (mmHg)

Central DP (mmHg)

CentraiPP (mmHg)

Central AP (mmHg)

Central Alx (%)

Central Alx at 75 (%)

PP Amplilicaffon (%)

SEVR(%)

ED (ms)

HR (bpm)

MAP(mmHg)

SphygmoCor Ref Age(yr)

Actual Value

Acceptance Criteria

Pass/Fail

Actual Value

Acceptance Criteria

Pass/Fail

Actual Value

Acceptance Criteria

Pass/Fail

Actual Value

Acceptance Criteria

Pass/Fail

Actual Value

Acceptance Criteria

Pass/Fail

Actual Value

Acceptance Criteria

Pass/Fail

Actual Value

Acceptance Criteria

Pass/Fail

Actual Value

Acceptance Criteria

Pass/Fail

Actual Value

Acceptance Criteria

Pass/Fail

Actual Value

Acceptance Criteria

Pass/Fail

Actual Value

Acceptance Criteria

Pass/Fail

Actual Value

Acceptance Criteria

Pass/Fail

CPWV-5-096

SphygmoCor SphygmoCor Correlation CvMs XCEL R

CCC"

Average Average

106 106 0.99 0.99

>0.7 >0.7

Pass Pass

76 76 0.99 0.99

>0.7 >0.7

Pass Pass

30 30 0.99 0.99

>0.7 >0.7

Pass Pass

4.2 I 3.7 0.95 0.93

>0.7 >0.7

Pass Pass

10.7 7.7 0.93 0.88

>0.7 >0.7

Pass Pass

7.2 4.2 0.91 0.88

>0.7 >0.7

Pass Pass

153 149 0.96 0.94

>0.7 >0.7

Pass Pass

173 163 0.91 0.9

>0.7 >0.7

Pass Pass

300 307 0.86 0.86

>0.7 >0.7

Pass Pass

68 68 0.95 0.94

>0.7 >0.7

Pass Pass

89 88 0.99 0.98

>0.7 >0.7

Pass Pass

35 35 0.95 0.87

>0.7 >0.7

Pass Pass

T test (p value)'

0.15

>0.05

Pass

0.88

>0.05

Pass

0.85

>0.05

Pass

0.73

>0.05

Pass

0.5

>0.05

Pass

0.48

>0.05

Pass

0.43

>0.05

Pass

0.14

>0.05

Pass

0.26

>0.05

Pass

0.77

>0.05

Pass

0.66

>0.05

Pass

0.92

>0.05

Pass

Average Diff (! SO)

Abs/Rel#

0.51(:!:, 1.8) Abs

<5 (<8)mmHg

Pass

0.02( :!:_ 0.72) Abs

<5 (<8)mmHg

Pass

0. 5(:~_1 . 5) Abs

<5(<8)mmHg

Pass

-0.85( :!:_ 1.9) Abs

<5 (<8)mmHg

Pass

-3.5( :!:_ 7.5) Abs

< 10%

Pass

-3.5(:!: 7.5) Abs

< 10%

Pass

4.1(:!:_6.6) Abs

< 10%

Pass

-6.0(:!: 6 5) Rei

< 10%

Pass

2.3(:!:_4.4) Rei

< 10%

Pass

-0.15(:!:_4.9) Rei

< 10%

Pass

-1 .2(:!:_ 1.5) A bs

<5(<8)mmHg

Pass

-0.2( :!:_ 6.1) Abs

<5 years

Pass

SP IS systolic pressure, DP IS d1astol1c pressure, PP IS pulse pressure, AP IS the augmented pressure, Alx 1s the augmentatiOn mdex, Alx at 75 is Alx at heart rate of 75 beats per minutes, SEVR is subendocardial viability ratio, ED is ejection duration, parameters

HR is heart rate in beats per minutes (bpm) , MAP is mean arterial pressure, SphygmoCor and SphygmoCor Ref Age is the refrence age based on SphygmoCor PWA parameters of heaffhy population. • p value higher than 0.05 indicate that the parameter betv.een the devices is not statistically different. •• CCC is Concordance Correlaffon Coefficient that measure the correlation inrefrence to unity line. # Abs!Rel Absloute or relative difference to the average in % respectively

AtCor MJ:· MEDICAL "V'



Doc. No.:

Doc. Control No. : 101394 Rev.: 2.0 Page : 7 Of 21 CPWV-5-096

Plots: The following is regression and Bland Altman plots of each central PWA parameters.

160

..: 140 u >< :; 120 u 0

~ 100 > .s:: Q.

"' 80

60

60 80

120

100 .... w u

80 >< :; u 60 0 E !1!! 40 .s:: Q.

"' 20

0

0 20

70

60 .... ::l so >< :; 40 u 0 E 30 .. >

-g_ 20

"' 10

0

0 10

C_SP (mmHg)

100 120

SphygmoCor CvMS

C_DP (mmHg)

40 60

SphygmoCor CvMS

C_PP (mmHg)

20 30 40

SphygmoCor CvMS

y = 0.9292x + 7.8778

80

R' = 0.9877

140 160

y = 0.9786x + 1.6477 R2 = 0.9941

100 120

y = 0.9254x + 2.7101 R' = 0.9838

so 60 70

CSP (mmHg) 25

20

15

10 . ., . \t ·h ••• •••••••• Q 0

·5 60 70 80 90 100 110 120 •• 130 140 . 150

-10

-15

-20

-25 Ave

COP (mmHg) 10

• 60 ~~· •• 100 .

~ 0 -2 0 20 40

-4

-6

-8

-10 Ave

CPP (mmHg) 20

1S

10

5 • ~!·~ :t:

' 0 0 • 20 . 40 • 60 0 10 +so -s

-10

-15

-20 Ave

160

120

70

AtCor~· MEDICAL Y"

AP (mmHg) 20.00

15.00

• 10.00

..... w 5.00 u X

-5 6 10 • --10.00

Sphy

Alx (%) 50.00

40.00

30.00

20.00 ..... w 10.00 • u .. X

• -20 .10

~2Cll00 • -30.00

Sphy

Title : Clinical Performance Testing & Validat ion of SphygmoCor XCEL PWA/PWV

device on general populat ion

Doc. Control No.: 101394

•

y = 1.1452x- 1.1997 R2 = 0 .9003

•

15 20

y = 1.2425x- 5.5446 R' = 0.8599

• • • ••

20 30 40

Rev.: 2.0

:; 0 -30

DHF Doc. No.:


AP (mmHg) 30

20

10 '

-20

-30

60

40

20

••• 0 -lt • + 10 • -20

• -40

-60

Ave

• • 10

Alx (%)

~·~r~·

Ave

••• • ~5

• 20

20

~ .. ..... 30 40

AtCor MJ:· Title: Clinical Performance Testing & Validation of SphygmoCor XCEL PWA/PWV


MEDICAL "Y' Doc. Control No. : 101394

~ 1.5 X

.§ 0 E !l2

.<;

~ 0.5

0

0

ul u "'20

• • •

0.5

Alx @75 (%) y = 1.1825x · 4.3256

R' = 0.8318

40.00

30.00

20.00

10.00 • .. ~.00. • 0 + 10

• -20.00

-30.00

-40.00 Sphy

PPAmp

SphygmoCor CvMS

• 20 30

y = 0.804x + 0.2594 R2 = 0.925

1.5

Rev.: 2.0

40

!E c

!E c ·30

0.3

0.2

0.1

0

-0. 1

-0.2

-0.3


Alx @75 (%) 60

40

20

... •!.• + 20 30

-40

-60 Ave

PPAmp

•• • ••• t . • • • • 1.' • 1.4 • • + 1.t ·~-8 • .•: ..

Ave

40

..... w 1.1 )(

l5 1.1 0 E .. > .s:; c.

VI

AtCor~· Title: Clinical Performance Testing & Validation of SphygmoCor XCE L PWA/PWV

device on general populat ion

MEDICAL Y'" Doc. Control No.: 101394

250

..... 200 w 1.1 )(

5 150 1.1 0

~ 100 .s:; c. VI so

0 0 so

410

360

g 310 )(

8 260 0 E 210 .. > -a 160

VI

110

60

60 110

100

80

60

40

20

0

0 20

SEVR (%)

•

100 1SO

SphygmoCor CvMS

ED (ms)

160 210 260

SphygmoCor CvMS

y; 0.8922x + 8.3451

310

R' ; 0.828

200 250

V; 0.7293x + 88.245 R' ; 0 .7429

360 410

HR (bpm) y; 0.9897x + 0.5384

R'; 0 .8949

40

~~ ~··

60 80

SphygmoCor CvMS

100

DHF Doc. No.:

Rev.: 2.0 Page: 10 Of 21 CPWV-5-096

SEVR (%) 40

30 • 20

10 •

;.f. \!; 0

20ft so 100 -10 • •• -20 • • • • • 4\ -30

-40 Ave

ED (ms) 80

60

40 . ··~ . • 20

\!; • ....... 0 • 0 ~ f 200 250 350 .

-20 • -40

-60

-80 Ave

HR (bpm) 20

15

10

•

1 • • • \!; 0 • ......... . • •• 0 40 50 ~ # 70 80 90

-5 • • • -10

-15

-20 Ave

250 •

400

100

140

uj 120 u X

5 '5 100 E ... > .s: a. 80 VI

60

AtCor MJ:· Title: Clini ca l Performance Testing & Val idat ion of SphygmoCor XCEL PWA/PWV


DHF Doc. No.: MEDICAL "Y'

Doc. Control No.: 101394 Rev.: 2.0 Page: 11 Of 21

60

MAP (mmHg) y = 0.9522x + 3.0446

R2 = 0.9822

80

90

80

70

60

uj 50

~ 40

30

20

10

0

50

40

30

20

10

!t 0 0 -10 0

-20

-30

·40

-50

100 120 140

SphygmoCor CvMS

y = 0.9803x + 0.4514

Ref Age (Yr) R' = o .9028

20 40

Sphy

• ••

60

•

Ref Age (Years)

. ~ ~ ... 20 • 40

•

Ave

• •• • • • 60 • 80

80

CPWV-5-096

MAP (mmHg) 15

10

!t

~ · 0 o r .. ... . • ~ + 100 • uo 60 70 120 130 •• • -5 •

-10

·15 Ave

100

100

140

AtCor MS:"' MEDICAL "V"

Conclusion




The SphygmoCor XCEL showed statistically significant equivalence with the previously

FDA-cleared SphygmoCor CvMS {K080670) predicate based on the stringent statistical

methods applied between measurements taken between the two devices. All PWA

parameter comparisons demonstrated high correlation and low average difference

between the two devices. Subsequently these two devices are clinically equivalent for

PWA measurements.

..

AtCor Title: Data Set from PWA Clinical Evaluation comparing SphygmoCor CvMS to SphygmoCor XCEL

MEDICAL Doc. Control No.: 1 01392 Rev.: 1.0 Page: 1 Of 13

The following table is the data set obtained from a study titled :

Copyright © 2008 AtCor Medical Ply Limited. Commercial In Confidence.

SphygmoCor® is a Registered Trademark of AtCor Medical Ply Ltd

Clinical Validation & Evaluation of new SphygmoCor Cuff PWA/PWV XCEL device on general Population. Macquarie University Study Report. Date: March 12, 2012. Authors: Alberto Avolio , Professor, Australian School of Advanced Medicine Macquarie University. Mark Butlin, PhD. Lecturer. Australian School of Advanced Medicine Macquarie University

Measurement rejection (MR) criteria were: 1) The device indicated the measurement was not acceptable according to the criteria set in the protocol (see study report above) 2) The measurement was an outlier

0 -~

@f,l~~ IC~M~ 'iS

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,_ - ...

AtCor 4(J· ntle: Data Set from PWA Clinical Evaluation comparing SphygmoCor CvMS to SphygmoCor XCEL Copyright © 2008 AtCor Medical Pty Limited. Commercial In Confidence.

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1) Central Aortic SP{_mmHg) MR- Measurement rejected • SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA NM- No measurement taken

Patient 1s 2na 3ra

Mean (mmHg) 1s 2na 3ra

Mean (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) -

P01 123 127 126 125 124 124 126 125 ' I

P02 101 97 97 98 101 101 100 101 P05 145 147 147 146 MR 142 143 143 P06 98 97 97 97 99 99 98 99 P07 113 110 113 112 114 111 112 112 P08 94 95 93 94 94 94 94 94 P09 89 89 89 89 89 88 89 89 P10 93 93 93 93 95 96 96 96 P12 93 95 94 94 93 95 95 94 P13 105 102 103 103 104 102 ..J OJ .. ~.., .. - ..,.,. 103 ~·..: P14 100 100 100 100 101 101 1:)11 · . . , •

.M ·.., l- . ~; i ~ 4' . ""'IE 1-Q.L . P15 86 86 87 86 89 89 ~8~w!_.a, ,..;l._~A!,) P16 94 95 94 94 94 95 95 95 P17 110 110 109 110 112 111 112 112 P18 88 88 88 88 90 90 89 90 P20 84 83 84 84 84 84 84 84 P21 86 87 87 87 87 88 86 87 P22 93 92 92 92 95 95 95 95 P23 108 109 109 109 109 109 110 109 P25 116 116 117 116 118 117 114 116 P26 123 123 122 123 123 124 123 123 P27 104 104 NM 104 104 104 NM 104 P11 101 99 101 100 103 103 102 103 P24 95 94 94 94 94 94 94 94 P29 MR 134 134 134 133 133 133 133 P30 119 117 121 119 121 120 121 121 P32 120 119 117 119 120 120 120 120 P34 125 127 127 126 123 122 122 122 P35 113 113 111 112 116 116 116 116 P36 128 128 127 128 124 125 125 125

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2) Central Aortic DP (mmHg) MR - Measurement rejected • SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA r

NM- No measurement taken

Patient 1s 2nu 3ra

Mean (mmHg) 1St 2nu 3ru

Mean (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg)

P01 88 88 88 88 87 87 88 87 P02 73 73 73 73 73 73 74 73 P05 107 107 108 107 MR 106 106 106 P06 77 77 77 77 77 77 76 77 P07 78 78 78 78 77 79 78 78 P08 74 74 75 74 74 74 73 74 P09 68 68 68 68 68 67 68 68 P10 71 71 71 71 72 72 72 72 P12 69 70 70 70 69 69 69 69 P13 80 80 80 80 79 79 79 79 P14 73 73 73 73 73 73 NM 73 P15 65 66 66 66 66 66 66 66 P16 73 73 73 73 72 73 73 73 P17 85 84 83 84 85 84 85 85 P18 67 67 67 67 68 68 67 68 P20 68 67 68 68 68 68 68 68 P21 67 67 67 67 67 67 67 67 P22 69 68 68 68 69 68 69 69 P23 79 80 79 79 78 78 79 78 P25 81 80 81 81 81 81 81 81 P26 93 93 93 93 93 93 94 93 P27 72 72 NM 72 72 72 NM 72 P11 77 77 76 77 76 78 78 77 P24 73 73 73 73 73 73 73 73 P29 MR 88 88 88 88 87 87 87 P30 82 82 82 82 84 84 85 84 P32 73 73 73 73 73 74 73 73 P34 76 77 77 77 76 76 76 76 P35 72 72 71 72 72 72 72 72 P36 68 72 68 69 70 69 67 69

--

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3) Central Aortic PP (mmHg) MR - Measurement rejected • SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA NM - No measurement taken

Patient 15 2na 3ra

Mean (mmHg) 151 2na 3ra


P01 35 39 38 37 37 37 38 37 P02 28 24 24 25 28 28 26 27 P05 38 40 39 39 MR 36 37 37 P06 21 20 20 20 22 22 22 22 PO? 35 32 35 34 37 32 34 34 P08 20 21 18 20 20 20 21 20 P09 21 21 21 21 21 21 21 21 P10 22 22 22 22 23 24 24 24 P12 24 25 24 24 24 26 26 25 P13 25 22 23 23 25 23 24 24 P14 27 27 27 27 28 28 NM 28 P15 21 20 21 21 23 23 22 23 P16 21 22 21 21 22 22 22 22 P17 25 26 26 26 27 27 27 27 P18 21 21 21 21 22 22 22 22 P20 16 16 16 16 16 16 16 16 P21 19 20 20 20 20 21 19 20 P22 24 24 24 24 26 27 26 26 P23 29 29 30 29 31 31 31 31 P25 35 36 36 36 37 36 33 35 P26 30 30 29 30 30 31 29 30 P27 32 32 NM 32 32 32 NM 32 P11 24 22 25 24 27 25 24 25 P24 22 21 21 21 21 21 21 21 P29 MR 46 46 46 45 46 46 46 P30 37 35 39 37 37 36 36 36 P32 47 46 44 46 47 46 47 47 P34 49 50 50 50 47 46 46 46 P35 41 41 40 41 44 44 44 44 P36 60 56 59 58 54 56 58 56

. '

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4) Central Aortic AP (mmHg)

• SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA ~

MR- Measurement rejected "' NM - No measurement taken

Patient 1s 2na 3ru

Mean (mmHg) 1s 2nu 3ru


P01 2 5 4 3.7 4 4 5 4.3

P02 1 -2 -1 -0.7 1 1 1 1.0

P05 12 13 13 12.7 MR 9 10 9.5 P06 1 0 1 0.7 3 3 3 3.0 PO? 10 7 10 9.0 10 6 8 8.0 P08 2 2 0 1.3 2 3 3 2.7 P09 2 2 1 1.7 0 -1 0 -0.3 P10 -2 -2 -1 -1.7 1 1 1 1.0 P12 3 5 4 4.0 2 4 4 3.3 P13 6 4 5 5.0 6 4 5 5.0 P14 -3 -1 -1 -1.7 -1 0 NM -0.5 P15 0 1 1 0.7 4 3 3 3.3 P16 2 2 1 1.7 1 3 3 2.3 P17 -3 -2 -4 -3.0 -1 0 -1 -0.7 P18 -1 0 -2 -1.0 0 0 -1 -0.3 P20 -3 -2 -2 -2.3 0 0 0 0.0 P21 1 1 1 1.0 2 3 1 2.0 P22 1 0 1 0.7 2 3 3 2.7 P23 -4 -1 -4 -3.0 -1 -1 1 -0.3 P25 9 9 10 9.3 11 10 7 9.3 P26 5 4 3 4.0 4 5 4 4.3 P27 9 9 NM 9.0 8 8 NM 8.0 P11 -1 -1 1 -0.3 3 3 2 2.7 P24 2 1 2 1.7 1 2 1 1.3 P29 MR 14 14 14.0 10 11 10 10.3 P30 5 4 7 5.3 4 3 4 3.7 P32 15 15 12 14.0 11 12 11 11.3 P34 14 16 12 14.0 9 8 9 8.7 P35 13 13 9 11.7 15 15 16 15.3 P36 19 12 16 15.7 9 11 10 10.0

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5) Central Aortic Alx (%)

• SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA " MR- Measurement rejected NM - No measurement taken

Patient 1s 2no 3ro

Mean (mmHg) 1s 2no 3ru


P01 4 13 11 9.3 10 10 14 11.3 P02 3 -9 -3 -3.0 3 3 2 2.7 P05 31 34 33 32.7 MR 25 26 25.5 P06 7 2 5 4.7 12 12 11 11.7 PO? 27 21 28 25.3 27 17 22 22.0 P08 8 11 2 7.0 11 13 14 12.7 P09 7 7 6 6.7 0 -5 0 -1.7 P10 -8 -8 -6 -7.3 5 4 5 4.7 P12 11 20 17 16.0 9 16 16 13.7 P13 26 18 21 21.7 23 19 21 21.0 P14 -12 -3 -4 -6.3 -4 1 NM -1.5 P15 0 3 6 3.0 15 15 13 14.3 P16 9 10 7 8.7 6 13 13 10.7 P17 -12 -9 -14 -11.7 -2 -1 -3 -2.0 P18 -3 -1 -8 -4.0 1 2 -6 -1.0 P20 -20 -15 -11 -15.3 1 -1 1 0.3

P21 3 7 5 5.0 11 12 7 10.0 P22 6 -1 3 2.7 7 10 10 9.0 P23 -13 -2 -15 -10.0 -3 -4 2 -1.7 P25 24 26 28 26.0 29 28 21 26.0 P26 16 15 12 14.3 14 17 13 14.7 P27 28 28 NM 28.0 26 26 NM 26.0 P11 -4 -4 5 -1.0 12 11 8 10.3 P24 12 5 9 8.7 7 9 6 7.3 P29 MR 31 31 31.0 21 23 22 22.0 P30 15 10 19 14.7 11 9 12 10.7 P32 31 32 27 30.0 25 26 24 25.0 P34 28 31 25 28.0 20 18 19 19.0 P35 31 33 23 29.0 35 33 37 35.0 P36 31 22 26 26.3 16 19 18 17.7

AtCor 41fJ· m1e: Data Set from PWA Clinical Evaluation comparing SphygmoCor CvMS to SphygmoCor XCEL Copylight © 2008 AtCor Medical Pty Limited. Commercial In Confidence.

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6) Central Aortic Alx at 75 (%) MR - Measurement rejected • SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA NM- No measurement taken

Patient 1s 2no 3ra

Mean {mmHg) 1s 2no 3ru

Mean {mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg)

P01 0 8 7 5.0 5 8 12 8.3 P02 0 -14 -6 -6.7 -5 1 -4 -2.7 P05 24 29 29 27.3 MR 20 18 19.0 P06 6 1 5 4.0 9 10 12 10.3 PO? 25 18 26 23.0 25 16 19 20.0 P08 -4 -2 -8 -4.7 0 2 2 1.3 P09 10 10 10 10.0 2 0 8 3.3 P10 -14 -12 -13 -13.0 1 -1 1 0.3 P12 17 28 26 23.7 13 20 21 18.0 P13 21 13 17 17.0 20 14 20 18.0 P14 -18 -9 -9 -12.0 -8 -5 NM -6.5 P15 -9 -5 -2 -5.3 9 8 10 9.0 P16 5 6 4 5.0 3 10 9 7.3 P17 -14 -12 -17 -14.3 -6 -4 -7 -5.7 P18 -7 -8 -12 -9.0 -2 -2 -11 -5.0 P20 -22 -17 -12 -17.0 -1 -3 -2 -2.0 P21 -5 -1 -4 -3.3 1 6 1 2.7 P22 2 -2 -5 -1.7 1 6 6 4.3 P23 -13 3 -11 -7.0 -2 3 4 1.7 P25 18 19 23 20.0 23 22 15 20.0 P26 16 16 15 15.7 20 19 20 19.7 P27 21 21 NM 21.0 17 17 NM 17.0 P11 -1 -3 5 0.3 12 15 13 13.3 P24 10 5 7 7.3 7 9 6 7.3 P29 MR 25 25 25.0 15 16 13 14.7 P30 16 11 18 15.0 8 8 11 9.0 P32 21 22 20 21.0 15 16 16 15.7 P34 20 24 17 20.3 12 10 11 11.0 P35 25 25 16 22.0 27 26 29 27.3 P36 33 23 28 28.0 18 20 19 19.0

AtCor · · Title: Data Set from PWA Clinical Evaluation comparing SphygmoCor CvMS to SphygmoCor XCEL Copyright © 2008 AtCor Medical Pty Limited. Commercial In Confidence.

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7) PP Amplificattion (%)

• SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA u

MR- Measurement rejected NM - No measurement taken I

Patient 1s 2na 3ra

Mean (mmHg) 1 Sl 2nu 3ra



~-

AtCor 41fJ· mte: Data Set from PWA Clinical Evaluation comparing SphygmoCor CvMS to SphygmoCor XCEL Copyright© 2008 AICor Medical Ply Limited. Commercial In Confidence.

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Doc. Control No.: 101392 Rev.: 1.0 of AtCor Medical Ply Ltd

8) SEVR (%) MR - Measurement rejected • SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA "" NM- No measurement taken

Patient 1s 2no 3ro




AtCor .,;· m1e: Data Set from PWA Clinical Evaluation comparing SphygmoCor CvMS to SphygmoCor XCEL Copyright © 2008 AtCor Medical Pty Limited. Commercial In Confidence.

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SphygmoCor® is a Registered Trademark Doc. Control No.: 101392 Rev.: 1.0 of AtCor Medical Pty Ltd

9) ED (ms)

• SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA c MR- Measurement rejected NM- No measurement taken , I

Patient • 1s 2na 3ra

Mean (mmHg) 1s 2nd 3rd



AtCor · · m1e: Data Set from PWA Clinical Evaluation comparing SphygmoCor CvMS to SphygmoCor XCEL Copyright© 2008 AtCor Medical Ply Limited. Commercial In Confidence.

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SphygmoCor® is a Registered Trademark Doc. Control No.: 101392 Rev.: 1.0 of AtCor Medical Ply Ltd

10) HR (bpm) MR - Measurement rejected • SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA NM- No measurement taken

Patient 1s 2no 3ru

Mean (mmHg) 1s 2no 3ro

Mean (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) measurement (mmHg) -


-

AtCor .:;· m1e: Data Set from PWA Clinical Evaluation comparing SphygmoCor CvMS to SphygmoCor XCEL Copyright © 2008 AtCor Medical Ply Limited. Commercial In Confidence.

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SphygmoCor1!l is a Registered Trademark Doc.ControiNo.: 101392 Rev.: 1.0 of AtCor Medical Pty Ltd

11) MAP (mmHg) MR- Measurement rejected • SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA

I NM- No measurement taken

Patient 1s 2nu 3ra

Mean (mmHg) 1 Sl 2nu 3ru


P01 104 106 106 105 101 102 103 102 P02 86 82 84 84 83 84 84 84 P05 123 124 125 124 MR 117 120 119 P06 87 87 88 87 86 86 87 86 P07 93 92 94 93 92 91 91 91 P08 84 84 84 84 81 81 80 81 P09 79 79 80 79 77 78 77 77 P10 81 81 82 81 81 81 82 81 P12 82 84 83 83 80 82 81 81 P13 92 91 91 91 89 89 90 89 P14 85 85 85 85 84 84 NM 84 P15 74 75 76 75 74 74 74 74 P16 83 83 83 83 81 83 83 82

I P17 96 95 93 95 94 95 95 95 P18 77 77 77 77 76 76 76 76 P20 75 74 76 75 75 75 74 75 P21 76 77 76 76 74 75 74 74 P22 80 80 79 80 78 78 79 78 P23 92 95 94 94 92 93 95 93 P25 98 96 97 97 94 94 93 94 P26 107 108 107 107 106 107 106 106 P27 86 86 NM 86 85 85 NM 85 P11 89 87 88 88 88 89 88 88 P24 84 83 83 83 82 82 82 82 P29 MR 103 103 103 104 103 102 103 P30 97 96 98 97 98 98 99 98 P32 90 88 87 88 89 89 89 89 P34 94 98 97 96 92 92 92 92 P35 88 89 86 88 88 88 88 88 P36 89 90 94 91 91 91 91 91

-.'

AtCor 41f1· Title: Data Set from PWA Clinical Evaluation comparing SphygmoCor CvMS to SphygmoCor XCEL Copyright© 2008 AtCor Medical Pty Limited. Commercial In Confidence.

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Doc. Control No.: 1 0 1392 Rev.: 1.0 of AtCor Medical Pty Ltd

12) SphygmoCor Reference Age (years) MR- Measurement rejected • SphygmoCor CvMS-PWA • SphygmoCor XCEL PWA - ~~r..:g)~{: . ,... NM - No measurement taken

..,..

Patient 1s 2na 3ra




'

l·o

Patient ID Sex AGE HEIGHT WEIGHT BODY_MASS_INDEX PSP PDP

POl MALE 32 183 91 27.17 132 77

P02 MALE 32 194 75 19.93 131 82

P05 MALE 48 167 92 32.99 151 106

P06 MALE 30 176 63 20.34 110 76

P07 MALE 62 167 75 26.89 122 77

P08 FEMALE 26 165 69 25.34 103 74

P09 FEMALE 36 156 44 18.08 103 67

PlO FEMALE 27 160 63 24.61 109 70

P12 FEMALE 35 166 57 20.69 106 68

P13 MALE 27 171 64 21.89 111 79

P14 MALE 24 190 87 24.1 119 71

P15 FEMALE 27 165 60 22.04 99 65

P16 FEMALE 28 169 63 22.06 106 72

P17 MALE 45 177 53 16.92 130 83

P18 FEMALE 27 179 60 18.73 104 66

P20 FEMALE 29 178 66 20.83 95 67

P21 MALE 25 185 82 23.96 98 66

P22 FEMALE 32 164 56 20.82 109 68

P23 MALE 22 181 86 26.25 131 78

P25 MALE 63 181 81 24.72 124 80

P26 FEMALE 57 166 73 26.49 136 92

P27 FEMALE 34 170 55 19.03 112 71

P11 MALE 34 174 71 23.45 116 76

P24 MALE 37 181 75 22.89 106 72

P29 FEMALE 67 167 69 24.74 144 87

P30 MALE 69 175 92 30.04 137 82

P32 FEMALE 77 174 70 23.12 129 73

P34 MALE 79 172 60 20.28 135 76

P35 FEMALE 68 156 60 24.65 122 71

P36 MALE 79 165 75 27.55 145 67

P37 MALE 77 181 75 22.89 126 67

Average 43.70968 172.7419 69.74194 23.3383871 119.3871 75.03226

std 19.54003 9.266311 12.25824 3.54883652 15.30071 8.810917

Max 79 194 92 32.99 151 106

Min 22 156 44 16.92 95 65

ID Gender Age (years) Height (em) Weight (kg) BMI SBP DBP MAP

POl M 32 183 91 27.17 143 86 101 P02 M 32 194 75 19.93 116 72 83 P05 M 48 167 92 32.99 151 106 120 P06 M 30 176 63 20.34 110 76 86 P07 M 62 167 75 26.89 122 77 92 P08 F 26 165 69 25.34 103 74 81 P09 F 36 156 44 18.08 103 67 77 PlO F 27 160 63 24.61 109 70 81 P12 F 35 166 57 20.69 106 68 80 P13 M 27 171 64 21.89 111 79 89 P14 M 24 190 87 24.1 119 71 84 P15 F 27 165 60 22.04 99 65 74 P16 F 28 169 63 22.06 106 72 81 P17 M 45 177 53 16.92 130 83 94 P18 F 27 179 60 18.73 104 66 76 P20 F 29 178 66 20.83 95 67 75 P21 M 25 185 82 23.96 98 66 74 P22 F 32 164 56 20.82 109 68 78 P23 M 22 181 86 26.25 131 78 92 P25 M 63 181 81 24.72 124 80 94 P26 F 57 166 73 26.49 136 92 106 P27 F 34 170 55 19.03 112 71 85 Pll M 34 174 71 23.45 116 76 88 P24 M 37 181 75 22.89 106 72 82 P29 F 67 167 69 24.74 144 87 104 P30 M 69 175 92 30.04 137 82 98 P32 F 77 174 70 23.12 129 73 89 P34 M 79 172 60 20.28 135 76 92 P35 F 68 156 60 24.65 122 71 88 P36 M 79 165 75 27.55 145 67 91

Documents

Title: device on general population AtCor~· XCEL 510 CLINICAL... · DHF Doc. No.: Doc. Control No.: 101394 Rev.: 2.0 Page: 1 Of 21 CPWV-5-096 Introduction The clinical performance