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iVue ® with Corneal Epithelial Thickness Mapping (ETM) Software Optovue Traditional 510(k) Premarket Notification 510(k) SUMMARY (per 21 CFR §807.92) iVue Model 100 with Corneal Epithelial Thickness Mapping I. GENERAL INFORMATION Submitter: Optovue, Inc. 2800 Bayview Drive Fremont, CA 94538 Est. Registration No.: 3005950902 Contact Person: Thomas Navarro, RAC Advisor, Regulatory and Quality Affairs Direct: (510) 897-1728 Fax: (510) 651-2516 Email: [email protected] Date Summary Prepared: November 23, 2016 II. SUBJECT DEVICE Trade Name: iVue ® Model 100 Common Name: Optical Coherence Tomography (OCT) Classification Name: Ophthalmoscope, AC-powered Device Classification: Class II (21 CFR§ 886.1570) Product Code: HLI (ophthalmoscope, ac-powered) Subsequent Product Code: OBO (tomography, optical coherence) III. PREDICATE DEVICE Company: Optovue, Inc. Device: iVue ® with Normative Database (K121739) Cleared: 510(k) K121739 on 18-January-2013

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iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

510(k) SUMMARY

(per 21 CFR §807.92)

iVue Model 100 with Corneal Epithelial Thickness Mapping

I. GENERAL INFORMATION

Submitter: Optovue, Inc.

2800 Bayview Drive

Fremont, CA 94538

Est. Registration No.: 3005950902

Contact Person: Thomas Navarro, RAC

Advisor, Regulatory and Quality Affairs

Direct: (510) 897-1728

Fax: (510) 651-2516

Email: [email protected]

Date Summary Prepared: November 23, 2016

II. SUBJECT DEVICE

Trade Name: iVue® Model 100

Common Name: Optical Coherence Tomography (OCT)

Classification Name: Ophthalmoscope, AC-powered

Device Classification: Class II (21 CFR§ 886.1570)

Product Code: HLI (ophthalmoscope, ac-powered)

Subsequent Product Code: OBO (tomography, optical coherence)

III. PREDICATE DEVICE

Company: Optovue, Inc.

Device: iVue® with Normative Database (K121739)

Cleared: 510(k) K121739 on 18-January-2013

iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

IV. DEVICE DESCRIPTION

Introduction

The iVue is used to capture, store, display and print spectral domain-optical coherence

tomography (SD-OCT) images of the posterior and anterior structure of the eye. The device

software includes a Normative Database (NDB), consisting of OCT data from a range of known

normal subjects that can be used to compare a new patient’s measurements in relation to the

normal distribution.

iVue is a computer controlled ophthalmic imaging system using either a laptop computer or “all-

in-one” computer (where the computer is integrated into the monitor). For laptop systems there

are two control box options 110 vs 230 volts. They interface between the motor column and the

medical power supply for the computer.

iVue System Key Functional Components

The iVue system contains the following hardware components:

Scanner Head: the scanner is the main component of the iVue system. It is used to view

and scan the patient’s eye, collect the OCT signal, and send it to the computer for

processing.

Computer: the system computer, either a laptop or All-in-One (AIO, which includes the

computer and monitor in one unit), is approved for medical use. It supports scanner

operation and processes, stores and displays exam data through the application software.

The searchable iVue database stores and organizes patient and exam data.

Control Box: the control box supports operation of the scanner and contains the backup

hard disk.

Joystick and Chinrest Assembly: the joystick moves the scanner left and right, forward

and back, and align it with the patient’s eye to capture the scan.

Footswitch (optional): the footswitch provides another way to capture scans, including

auto-adjustment, capture and saving.

Motorized Table (optional): a motorized table is optional. Customers may order the table in

two input voltages of 120V or 230V.

Cornea Adapter Module: the cornea lens adapter is attached to the front of the instrument

to enable the iVue to image the cornea and anterior chamber of the eye.

iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

iVue Device Characteristics

The device scans a patient’s eye and uses a low coherence interferometer to measure the

reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of

sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic

devices. The patient will rest their head on the forehead and chin rest while the operator uses

joystick to align the device to patient’s eye. The computer has a graphic user interface for

acquiring and analyzing the image.

iVue also has a cornea lens adapter, which can be attached to the front of the instrument to enable

the iVue to image the cornea and anterior chamber of the eye. This lens adapter is called the

Corneal Anterior Module, or “CAM.”

The iVue device uses two light sources for illumination. A near-infrared (but still visible) LED is

used for illumination during alignment to the patient’s eye with a central wavelength in the 735-

850nm range. A superluminescent diode (SLD) is used to illuminate the retina using a wavelength

of 840nm.

The subject iVue device with ETM software measures the epithelial cell layer. The device scans

the patient’s eye using a low coherence interferometer to measure the reflectivity of the corneal

tissue. The cross-sectional corneal image is composed of a sequence of A-scans. The computer

has a graphic user interface for acquiring and analyzing the image. The iVue ETM software

modification also expands the pachymetry scan pattern for corneal epithelial measurements,

automates segmentation for the posterior boundary, provides a thickness map for the central 6

mm diameter, and generates reports and associated data.

The iVue device has a chin rest and forehead rest that come into contact with the patient’s skin.

The chin rest and forehead rest can be cleaned with a disinfectant, such as a wipe with an isopropyl

alcohol pad or with another germicide using a clean cloth. The iVue is intended to be used in

clinical settings such as a hospital, eye clinic or doctor’s exam room.

V. PROPOSED INDICATIONS FOR USE

The iVue® is a non-contact, high resolution tomographic imaging device. It is intended for in-vivo

imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and

posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex

(GCC), optic disc, cornea, corneal epithelia, corneal stroma and anterior chamber of the eye. With

the integrated normative database, the iVue with Normative Database is a quantitative tool for the

comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc

measurements to a database of known normal subjects. The iVue is indicated for use as a device

to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult

population.

iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE

PREDICATE DEVICE

Both the predicate iVue device and subject iVue with corneal ETM software are used to capture

spectral domain-optical coherence tomography (SD-OCT) images of the eye. The predicate iVue

device with Normative Database (NDB) was previously verified for performance and

functionality to assure conformance to the requirements for its intended use.

At a high level, both devices are based on the following same technological elements:

Scanner Head: used to view and capture scans of the patient’s eye

Computer: supports scanner operation and processes, stores and displays exam data

Normative Database (NDB): consisting of OCT data that can be used to compare a new

patient’s measurements in relation to the normal distribution

The following technological differences exist between the subject and predicate devices:

Corneal Epithelial Thickness Mapping (ETM): used to provide the pachymetry maps and

the corneal epithelial thickness maps

Automatic Segmentation: for the posterior boundary of the epithelial layer to generate

ETM thickness maps

Software-generated Reports: to include corneal epithelial thickness maps and associated

data

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence

determination.

Software Validation

The subject iVue device has the additional corneal ETM software module. Software

documentation complies with the determination of a “moderate” Level of Concern device. Device

software was verified and validated to support the proposed indications for use according to IEC

62304:2006 Medical device software – Software life cycle processes and FDA’s General

Principles of Software Validation; Final Guidance for Industry and FDA Staff.

The iVue software version 2016.2 with corneal ETM software is the final version incorporated

into this 510(k) premarket notification. The iVue with ETM software provides a corneal thickness

(pachymetry) map, and the corneal epithelial thickness map (ETM) for the central 6mm diameter.

The new software version consists of modifying the cornea pachymetry scan pattern for ETM

scan, adding automatic segmentation for the posterior boundary of the epithelial layer to generate

iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

ETM thickness maps, and updating software-generated reports to include corneal epithelial

thickness map and associated data.

Scan Reports

Corneal Pachymetry & Epithelium Report

The “Corneal Pachymetry & Epithelium Report” has been expanded to include an OCT image

and a map showing Pachymetry and Epithelial thickness; alternately, a map showing the thickness

of the Stroma is also available. A “Cornea Pachymetry & Epithelial Change Analysis” shows

thickness measurements from all patient visits.

Cornea Pachymetry/Lens Fitting Scan

The Cornea Pachymetry scan has improved functionality for “lens fitting”. The Lens Fitting

Report maps the clearance space between the posterior surface of the scleral lens and the anterior

surface of the cornea.

Cornea Angle Scan

The Cornea Angle scan has been improved to visualize the “landing zones” of lenses, nasal,

temporal, inferior and superior. The angle scan line is perpendicular to where the lens contacts

the sclera. For convenience, multiple (4) images can be selected to display on a single page.

3D Fundus En Face

The 3D Fundus En Face scan option improves usability by offering an NFL thickness map

window to visualize the nerve fiber over the superior and inferior arches.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the iVue device and complies with the IEC

60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.

Clinical Evaluation

Two (2) clinical studies were conducted to demonstrate substantial equivalence:

Clinical Study for Repeatability and Reproducibility of Corneal Epithelial Mapping with iVue®

SD-OCT

The objective of this clinical study was to evaluate the repeatability and reproducibility of the

iVue ETM scan for the corneal thickness (pachymetry), the epithelial thickness, and the stromal

thickness mapping in normal subjects and corneal patients with iVue SD-OCT ETM software

based on a crossed-study design and crossed random-effects ANOVA model.

A heterogeneous population of qualified study subjects was evaluated and included the Normal

Subjects group (12 subjects), and the Corneal Patients group further stratified to target 12 contact

lens patients, 12 post-refractive surgery patients, 12 dry eye patients, and 14 keratoconus patients.

iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

The study inclusion criteria required subject who were 18 years of age or older, able to provide

consent, and were willing to complete the required examinations. In addition, subjects were

qualified based on a history or clinical diagnosis of one or more of the following conditions:

Dry eye patients with no history of refractive surgery

Contact lens patients without complications, refractive surgery or dry eye

Post-laser refractive surgery patients with 1 month post-surgery without complications

Keratoconus patients with a clinical diagnosis of keratoconus in the study eye

The study exclusion criteria excluded those with the inability to complete the required SD-OCT

scans (e.g., unable to fixate due to poor vision).

Based on a crossed-study design, each study subject was imaged with all three iVue/operator

pairs, and within each iVue/operator pair, at least three ETM scans were acquired with the

operator realigning the instrument on the study eye for each scan acquisition. To ensure

realignment for each scan, the operator asked test subject to sit back after a scan acquisition and

then reposition for the next scan.

The repeatability and reproducibility of the ETM scan are assessed for all zonal thickness

parameters and the summary statistics parameters displayed on screen for the corneal thickness

(pachymetry), the epithelial thickness, and the stromal thickness.

For qualified scans, the operators reviewed the thickness maps for obvious segmentation error

and reviewed the individual corneal meridian images to verify segmentation for erroneous maps.

Segmentation edit tools were used to perform manual correction and then the epithelial map was

reprocessed. Noticeable segmentation errors were manually corrected by the operator and marked

for “Manual Correction” in the case report form. Scans with manual correction qualified for R&R

data analysis.

Reproducibility Standard Deviation (SD)

Reproducibility SD across Normal and Corneal Patients (pooled) groups and different map zones

are summarized in Tables 1A, 1B and 1C for pachymetry, epithelial thickness and stromal

measurements respectively.

Reproducibility SD - Pachemetry

Area

2 mm zone 2 to 5 mm zone 5 to 6 mm zone

Normal group

mean

2.2

3.5 5.1

min 2.3 3.5

max 5.1 7.7

Corneal Patients group

mean

3.6

4.6 6.6

min 3.7 5.0

max 5.8 8.8

Table 1A: Reproducibility SD for pachymetry measurements

iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

Reproducibility SD -Epithelial

Area

2 mm zone 2 to 5 mm zone 5 to 6 mm zone

Normal group

mean

0.9

1.1 1.2

min 0.9 1.0

max 1.3 1.5

Corneal Patients group

mean

1.2

1.4 1.7

min 1.4 1.6

max 1.5 1.9

Table 1B: Reproducibility SD for epithelial thickness measurements

Reproducibility SD -Stromal

Area

2 mm zone 2 to 5 mm zone 5 to 6 mm zone

Normal group

mean

2.0

3.3 4.9

min 2.1 3.3

max 4.9 7.6

Corneal Patients group

mean

3.1

4.4 6.6

min 3.3 5.0

max 5.6 9.0

Table 1C: Reproducibility SD for stromal thickness measurements

Reproducibility Coefficient of Variance (COV)

Reproducibility COV Normal and Corneal Patients (pooled) groups and different map zones are

summarized in Tables 2A, 2B and 2C for pachymetry, epithelial thickness and stromal

measurements respectively.

COV - Pachymetry

Area

2 mm zone 2 to 5 mm zone 5 to 6 mm zone

Normal group

mean

0.4%

0.6% 0.9%

min 0.4% 0.6%

max 0.9% 1.3%

Corneal Patients group

mean

0.7%

0.9% 1.2%

min 0.7% 0.9%

max 1.0% 1.5%

Table 2A: Reproducibility COV for pachymetry measurements

iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

COV - Epithelial

Area

2 mm zone 2 to 5 mm zone 5 to 6 mm zone

Normal group

mean

1.8%

2.1% 2.4%

min 1.6% 1.8%

max 2.5% 2.9%

Corneal Patients group mean

2.4%

2.7% 3.3%

min 2.6% 2.9%

max 2.8% 3.6%

Table 2B: Reproducibility COV for epithelial thickness measurements

COV Stromal

Area

2 mm zone 2 to 5 mm zone 5 to 6 mm zone

Normal group

mean

0.4%

0.7% 0.9%

min 0.4% 0.7%

max 0.9% 1.4%

Corneal Patients group

mean

0.7%

0.9% 1.3%

min 0.7% 1.0%

max 1.1% 1.7%

Table 2C: Reproducibility COV for stromal thickness measurements

Reproducibility Limits

Reproducibility limits Normal and Corneal Patients (pooled) groups and different map zones are

summarized in Tables 3A, 3B and 3C for pachymetry, epithelial thickness and stromal

measurements correspondingly.

Reproducibility - pachymetry

Area

2 mm zone 2 to 5 mm zone 5 to 6 mm zone

Normal group

mean

6.0

9.7 14.0

min 6.4 9.8

max 14.2 21.3

Corneal Patients group

mean

10.0

12.8 18.4

min 10.2 14.0

max 16.0 24.4

Table 3A: Reproducibility limits for pachymetry measurements

iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

Reproducibility - epithelial

Area

2 mm zone 2 to 5 mm zone 5 to 6 mm zone

Normal group

mean

2.6

3.1 3.4

min 2.4 2.7

max 3.5 4.0

Corneal Patients group

mean

3.4

3.9 4.8

min 3.8 4.3

max 4.1 5.3

Table 3B: Reproducibility limits for epithelial thickness measurements

Reproducibility - stromal

Area

2 mm zone 2 to 5 mm zone 5 to 6 mm zone

Normal group

mean

5.4

9.2 13.6

min 5.8 9.3

max 13.7 21.1

Corneal Patients group

mean

8.5

12.1 18.2

min 9.1 13.9

max 15.6 25.0

Table 3C: Reproducibility limits for stromal thickness measurements

Overall, the study showed good repeatability and reproducibility for all study groups, all map

zones, and for all 3 parameters evaluated – pachymetry, epithelial, and stromal thickness.

Clinical Study for Accuracy of Corneal Epithelial Mapping with iVue® SD-OCT

The objective of this clinical study was to evaluate the accuracy of the corneal mapping, including

the corneal (i.e., pachymetry), corneal epithelial, and the corneal stromal thickness, in normal

subjects and corneal patients with the iVue SD-OCT ETM software based on the agreement with

manual measurements by qualified graders. The agreement was evaluated based on the combined

group of all qualified normal subjects and corneal patients.

The study inclusion criteria required subject who were 18 years of age or older, able to provide

consent, and were willing to complete the required examinations.

The study exclusion criteria excluded those potential subject who had a history of laser refractive

surgery or cataract surgery, those who used soft or hard contact lens in the past 3 months, had

blepharitis and/or meibomitis, or had a history or current diagnosis of dry eye or other corneal

pathologies, including keratoconus and corneal scar, etc. Exclusion criteria also excluded those

iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

with the inability to complete the required SD-OCT scans (e.g., unable to fixate due to poor

vision).

The study data were collected at three separate clinical study sites. One eye per study subject was

included in the study. All scans from a given study subject were acquired in one visit.

One scan of sufficient image quality was required per study eye. If scan quality issue was observed

during scan acquisition by the operator, he/she could take up to two additional scans in attempt to

obtain a scan of sufficient quality. Study site operators evaluated scan quality and determined

whether a scan met image quality criteria and documented scan quality observations in the case

report form.

Manual image grading was performed by 3 qualified graders from the Optovue clinical team.

Each grader performed manual measurements for all ETM scans included in the grading data set.

Three randomized grading orders were generated and each grader was assigned one randomized

grading order to follow. The graders were masked to each other’s results throughout the grading

process.

Distribution of Study Measurements

The distributions of the corneal epithelial thickness, stroma thickness, and corneal thickness

(pachymetry) are based on software output for the combined group using simple descriptive

statistics such as the mean, median, standard deviation (stdev), 1st and 3rd quartiles (Q1 and Q3),

and range (min, max).

Corneal Epithelial Thickness

The distributions of the corneal epithelial thickness based on software output for the 17 zonal

parameters are provided in Tables 4.1 (below) for the Combined Group.

min Q1 median mean Q3 max stdev

C_2__Epi 36.9 49.5 53.3 53.3 57.9 68.1 6.0

T_2_5__Epi 41.2 49.0 53.3 53.0 57.4 67.7 5.8

ST_2_5__Epi 39.9 49.3 52.9 53.5 57.3 68.1 5.5

S_2_5__Epi 37.9 50.6 53.5 53.5 56.8 67.9 5.4

SN_2_5__Epi 38.0 50.0 53.6 53.9 57.1 66.4 5.4

N_2_5__Epi 41.1 51.0 53.7 54.1 57.6 67.5 5.1

IN_2_5__Epi 44.7 51.7 54.0 54.9 58.5 69.0 5.2

I_2_5__Epi 41.8 50.7 54.1 54.7 58.0 69.6 5.6

IT_2_5__Epi 41.4 49.0 53.3 53.8 57.9 71.0 5.9

T_5_6__Epi 42.4 50.6 53.0 53.2 55.8 66.6 4.4

ST_5_6__Epi 37.0 50.7 53.4 53.4 55.8 67.4 4.5

S_5_6__Epi 35.8 50.8 52.8 53.1 55.6 64.2 4.5

SN_5_6__Epi 41.4 51.8 54.1 54.3 56.7 64.7 4.4

N_5_6__Epi 43.0 52.1 54.3 54.8 57.8 66.3 4.4

IN_5_6__Epi 44.2 52.5 54.6 55.6 58.1 69.3 4.7

I_5_6__Epi 44.7 51.7 54.7 55.3 58.6 67.0 5.0

IT_5_6__Epi 42.6 51.5 54.1 54.3 57.1 69.9 4.5

Combined (n= 87 subjects)

iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

Corneal Stroma Thickness

The distributions of the corneal stroma thickness based on software output for the 17 zonal

parameters are provided in Table 4.2 (below) for the Combined Group.

min Q1 median mean Q3 max stdev

C_2__Stroma 309.1 433.2 458.3 451.4 480.1 556.4 46.4

T_2_5__Stroma 358.3 449.2 466.2 466.1 490.1 563.1 39.8

ST_2_5__Stroma 385.0 465.7 482.6 485.1 506.8 582.1 38.6

S_2_5__Stroma 390.6 476.6 492.4 497.5 518.6 591.7 39.0

SN_2_5__Stroma 379.6 474.4 489.0 493.8 516.6 592.0 39.6

N_2_5__Stroma 359.6 462.0 478.7 480.4 507.0 585.0 41.1

IN_2_5__Stroma 349.7 451.0 468.4 468.8 493.0 578.7 42.2

I_2_5__Stroma 345.2 442.3 459.6 460.4 488.6 570.3 42.7

IT_2_5__Stroma 328.6 437.2 458.5 457.5 484.2 558.6 42.7

T_5_6__Stroma 378.9 470.9 485.1 490.2 511.8 591.4 38.2

ST_5_6__Stroma 439.2 498.4 514.8 520.2 541.3 623.3 37.1

S_5_6__Stroma 460.8 513.9 537.5 538.4 560.4 646.3 38.8

SN_5_6__Stroma 442.2 507.7 524.4 530.9 550.8 648.7 37.7

N_5_6__Stroma 406.2 488.4 505.6 510.3 533.5 612.5 37.6

IN_5_6__Stroma 396.0 472.2 493.5 496.5 517.5 600.7 37.6

I_5_6__Stroma 383.4 463.3 483.6 487.7 511.9 589.6 38.9

IT_5_6__Stroma 352.3 461.3 477.6 480.4 502.6 583.0 39.3

Combined (n= 87 subjects)

Corneal Thickness (Pachymetry)

The distributions of the corneal thickness (pachymetry) based on software output for the 17 zonal

parameters are provided in Table 4.3 (below) for the Combined Group.

min Q1 median mean Q3 max stdev

C_2__Pachy 356.6 484.5 508.8 504.7 532.3 611.6 46.4

T_2_5__Pachy 402.9 499.9 520.7 519.2 542.7 617.9 40.1

ST_2_5__Pachy 432.7 515.5 536.6 538.6 558.0 637.3 38.7

S_2_5__Pachy 449.1 526.6 544.1 551.1 570.6 646.8 38.9

SN_2_5__Pachy 435.5 522.9 541.4 547.6 568.6 645.8 39.4

N_2_5__Pachy 414.8 515.5 531.8 534.5 559.8 640.4 40.9

IN_2_5__Pachy 404.9 503.9 523.9 523.7 547.6 634.8 41.5

I_2_5__Pachy 398.3 496.3 515.5 515.1 541.4 626.2 41.9

IT_2_5__Pachy 382.6 492.3 511.5 511.2 537.6 614.5 42.3

T_5_6__Pachy 441.4 522.6 542.1 543.4 565.0 647.0 38.4

ST_5_6__Pachy 482.0 551.4 569.3 573.6 593.5 678.3 37.4

S_5_6__Pachy 513.6 564.9 587.5 591.5 612.4 697.5 38.7

SN_5_6__Pachy 494.2 559.8 579.6 585.2 606.0 699.7 37.9

N_5_6__Pachy 460.7 540.9 562.1 565.0 586.6 667.6 37.7

IN_5_6__Pachy 453.6 526.1 549.8 552.1 570.7 656.0 37.4

I_5_6__Pachy 443.6 518.2 540.7 543.0 567.9 645.7 38.8

IT_5_6__Pachy 410.0 514.8 536.7 534.7 557.7 638.0 39.4

Combined (n= 87 subjects)

iVue® with Corneal Epithelial Thickness Mapping (ETM) Software

Optovue Traditional 510(k) Premarket Notification

Limits of Agreement (see Section: Performance Testing – Clinical)

The limits of agreement of the corneal thickness mapping between the software output and manual

measurements are provided for the Combined Group, and, for additional information, also for the

5 sub-groups (Normal, Contact Lens, Dry Eye, Post-LRS, and KCN) respectively.

The Bland-Altman plots for the agreement between software output and manual measurement are

provided for the Combined Group and the 5 sub-groups. The Bland-Altman plot is a scatter plot

of the difference between the software-based and manual methods, using manual measurements

as reference as represented by the horizontal axis. Reference lines were added to the plot including

that at mean differences and the upper and lower limits of agreement (LOA).

Deming regression analysis and Scatter plots for the corneal epithelial thickness between the

software output and the manual measurements are provided for the Combined Group and the 5

sub-groups. Deming regression analysis on corneal epithelial thickness for the Combined Group

is also provided, including intercept, confidence intervals (CI) of intercept, slope, and confidence

intervals (CI) of slope.

Summary

Overall, the clinical data and analyses demonstrate agreement of the automated corneal epithelial

thickness segmentation algorithm to qualified, independent, masked graders performing manual

corneal epithelial thickness segmentation.

VIII. CONCLUSIONS

The conclusions drawn from the non-clinical validation tests (software, electrical safety, and EMC)

demonstrate that the iVue subject device with corneal ETM software is as safe, as effective, and

performs as well as or better than the legally marketed iVue predicate device identified in this 510(k)

premarket notification.

We also believe that these study results achieved the clinical objectives and that the performance

of the iVue device is characterized sufficiently to help the Agency make a determination of

substantial equivalence. The cumulative performance testing data indicate the iVue as safe and

effective as applicable in the proposed labeling.