Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes automated image processing functions like segmentation and thickness calculation, but it does not explicitly mention the use of AI or ML algorithms for these tasks. The comparison to a reference database is a standard statistical method, not necessarily indicative of AI/ML.

Therapeutic

No
The device is described as an imaging and diagnostic tool for viewing and measuring ocular structures to aid in diagnosis, documentation, and management of ocular health and diseases. It does not provide treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The DRI OCT Triton is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "non-contact, highresolution, tomographic and bio-microscopic imaging systems that merge optical coherence tomography (OCT) and fundus camera into a single device." This indicates it is a hardware device with integrated software for image processing and analysis.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Topcon DRI OCT Triton is an in vivo imaging device. It directly images structures within the living eye using light (OCT and fundus photography). It does not analyze samples taken from the body.
Intended Use: The intended use clearly states "in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures... as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population." This describes a diagnostic imaging tool used directly on the patient, not a test performed on a sample.

Therefore, the device falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Topcon DRI OCT Triton is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.

The DRI OCT Triton is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.

It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the human retina to a database of known normal subjects. The DRI OCT Triton is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

Product codes

OBO, HKI

Device Description

The DRI OCT Triton ("Triton") and the DRI OCT Triton (plus)") are non-contact, high-resolution, tomographic and bio-microscopic imaging systems that merge optical coherence tomography (OCT) and fundus camera into a single device. Triton and Triton (plus) employ the swept source OCT (SS-OCT) technology. Both can take anterior OCT images in addition to fundus OCT images. The fundus camera, in both Triton and Triton (plus), includes color imaging, red-free imaging, and infrared light imaging (hereinafter, IR imaging) capabilities for fundus observation. The Triton (plus) has fluorescein angiography (FA), and fundus autofluorescence angiography (FAF) imaging function in addition to all fundus functions for Triton.

The fundus photographs and OCT images are captured by different system components of this device, which enables Triton to capture an OCT image and a fundus image sequentially. It allows in vivo viewing, axial cross sectional, and three dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures. It also has a reference database for posterior ocular measurements of normal subjects, which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head and the macula.

Captured images are transferred from the device to an off-the-shelf personal computer (PC) via LAN cable, where the dedicated software for this device is installed. The transferred data is then automatically processed with analysis functions such as the automatic retinal layers segmentation, the automatic thickness calculation with several grids, the optic disc analysis and comparison with a reference database of eyes free of ocular pathology, and is finally automatically saved to the PC. It allows the user to manually adjust the automated retinal layer segmentation results and optic disc analysis results.

Accessories include the power cord, chin-rest paper sheet, monitor cleaner, LAN cable; chin-rest paper pins, external fixation target, dust cover accessory case, user manual, unpacking and analysis software DVD.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT), Fundus Camera (Color imaging, Red-free imaging, Infrared light imaging, Fluorescein angiography (FA), Fundus autofluorescence angiography (FAF))

Anatomical Site

Retina, surrounding parts of the eye, posterior ocular structures (retinal nerve fiber layer, macula, optic disc), anterior ocular structures, cornea, angle

Indicated Patient Age Range

Adult population (age>=18)

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Agreement and Precision Study:
A prospective comparative clinical study was conducted at a single U.S. clinical site.
Participants, with and without eye disease, had OCT images and fundus photographs obtained using both Triton and Maestro devices.
Major eligibility criteria included participants age≥18 with: 1) normal eyes (excluding glaucomatous optic nerve damage), 2) Glaucomatous optic nerve damage, based on pattern deviation and Glaucoma hemi-field test or damage based on optic disc or retinal nerve fiber layer structural abnormalities (excluding other ocular pathology), and 3) Retinal pathology diagnosis (excluding glaucoma or any other ocular pathology).
Participants were randomized for the selection of study eye, operator order and device order.
There were 13 planned scans during a single session, for all subject groups, per subject, per device (3 scans per 3D Wide, 3D Macula and 3D Disc scans; 1 scan per Radial cornea and angle scans; 1 per macula fundus and optic disc fundus photographs). The total number of planned scans for a subject was 78 (39 for each device).
While the precision analysis utilized all acceptable scans for all measurement types, all other analysis utilized the first acceptable photograph of each scan type of each device from all study eyes.
The image quality of the fundus photographs, and the image quality of anterior and posterior OCT B scans were graded by two masked independent experts on a scale based on the quality and clarity of the images.
Quality assurance procedures were instituted to produce a consistent system for assessing, saving and processing study images.

Reference Database Study:
A prospective, multicenter study was conducted at six U.S. clinical sites.
Subjects without eye disease had OCT images obtained with the Triton device.
Major eligibility criteria included participants age≥18 presenting at the site with normal eyes bilaterally (excluding glaucomatous optic nerve damage, based on pattern deviation or Glaucoma hemi-field test).
One eye of each subject was randomly selected and measured with the study device.
Subjects were enrolled with a wide range of ethnicities including Asian, Hispanic/Latino, African-American, and others. The number of subjects within each age group (18-30, 31-40, 41-50, 51-60, 61-70 and 70+ years) was evenly distributed.
There were nine scans taken during a single session, for each subject (3 scans per 3D Wide 12x9, 3D Macula 7x7, and 3D Disc 6x6 scans). The first accepted scan of each scan parameter from each eligible subject was included in the analysis.

Fundus Autofluorescence and Fluorescein Angiography Image Quality Evaluation Study:
A prospective clinical study was conducted at one clinical site, located in the United States.
Major inclusion criteria included age (≥18 years) and medical need to undergo dye injection for FA imaging. Major exclusion criteria included ocular motility dysfunction.
Subjects were randomized for device order.
FA images were captured in two time intervals after the intravenous fluorescein dye injection.
The FAF and FA images that met the image acceptance criteria were graded by two masked independent graders in a blinded and randomized fashion.
The agreement analysis of FA and FAF photograph image quality for eyes with retinal pathologies was based on a 5-point scale, where a "1" indicated that the photograph was insufficient for any interpretation, and "5" represented an excellent photograph.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Agreement and Precision Study:

Study Type: Prospective comparative clinical study.
Sample Size: Not explicitly stated for each group, but total participants (N=76) comprising Normal (N=25), Retinal (N=26), and Glaucoma (N=25) eye populations were enrolled.
Key Results:
- Agreement Analysis (against Maestro): Measurements obtained with the Triton device were mathematically similar, statistically consistent with, and clinically useful compared to the Maestro device. Limits of Agreement (LOA) were provided for various retinal and optic disc parameters (Full Retinal Thickness, Ganglion Cell + IPL Thickness, Ganglion Cell Complex Thickness, Retinal Nerve Fiber Layer Thickness, Optic Disc measurements). Detailed tables (Table 2 to Table 11) show means, standard deviations, differences, 95% CI for mean difference, and 95% LOA.
- Image Quality Evaluation (Fundus Photographs): Two masked independent experts graded images on a 5-point scale (1=insufficient, 5=excellent). Over 95% of photographs were considered clinically useful (grade 3 or above) by both experts. Response rates (Triton grades equal to or better than Maestro grades) ranged between 65.4% and 96%. Total agreement between graders for Triton photographs ranged from 28% to 68%, and for Maestro photographs from 28% to 64%.
- Image Quality Evaluation (Anterior B Scan): B scans were graded on a 4-point scale (0=failure, 3=good). Nearly all images (all Triton and 74 out of 76 Maestro images) were graded as fair or good. Response rates (Triton grades equal to or better than Maestro grades) ranged between 92% and 100%. Total agreement between graders was generally higher for Triton images (72% - 100%) compared to Maestro images (48% - 80%).
- Image Quality Evaluation (Posterior B Scan): Graded using the same 4-point scale. All grades were good or fair. Response rates (Triton grades equal to or better than Maestro grades) ranged between 84.6% and 100%. Agreement between graders was similar for both devices, ranging from 64% to 96% for Triton and 68% to 96% for Maestro. 34% of images differed by one grade but were still considered clinically useful (grades 2 or higher by both).
- Precision Analysis (Repeatability and Reproducibility): Detailed tables (Table 12 to Table 26) show mean, SD, repeatability limit (ratio), repeatability CV%, reproducibility SD, reproducibility limit (ratio), and reproducibility CV% for various measurements (Full Retinal Thickness, Ganglion Cell + IPL Thickness, Ganglion Cell Complex Thickness, Retinal Nerve Fiber Layer Thickness, Optic Disc measurements) across normal, retinal disease, and glaucoma eye populations for both Triton and Maestro devices.

Reference Database Study:

Study Type: Prospective, multicenter clinical study.
Sample Size: The total number of evaluable eyes was 410.
Key Results: Collected measurements for normal eyes for full retinal thickness, retinal nerve fiber layer thickness, ganglion cell layer plus the IPL layer thickness, ganglion cell complex, and optic disc, in addition to TSNIT circle profile measurements. The 1st, 5th, 95th, and 99th percentile were estimated by quantile regression to establish reference limits for quantitative comparison of measured parameters to a database of known normal subjects. Demographic data for the reference database (Total N=410) is provided in Table 27. Median, mean (SD), 95% CI, Min, and Max values for Full Retinal Thickness, Ganglion Cell + IPL Thickness, Ganglion Cell Complex Thickness, Retinal Nerve Fiber Layer Thickness, and Optic Disc measurements for the Triton device are summarized in Tables 28-32.

Fundus Autofluorescence and Fluorescein Angiography Image Quality Evaluation Study:

Study Type: Prospective clinical study.
Sample Size: Not explicitly stated.
Key Results: Comparison of FAF and FA photographs between DRI OCT Triton (plus) and TRC-50DX. Majority of FAF and FA images were graded as good or excellent. Response rates (Triton grades equal to or better than TRC-50DX grades) ranged between 85.2% and 94.9%. Triton had higher rates of agreement across FAF and FA images (68.3% - 73.2%) compared to TRC-50DX (56% - 61.7%).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found. The document reports agreement and precision metrics (95% LOA, coefficient of variation, repeatability and reproducibility limits), as well as image quality grading.

Predicate Device(s)

Topcon 3D OCT-1 Maestro (#K161509, #K170164)

Reference Device(s)

Topcon TRC-50DX Retinal Camera (#K123101)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 19, 2018

Topcon Corporation % Zvi Ladin, Ph.D. Principal Boston MedTech Advisors Inc. 990 Washington Street, Suite #204 Dedham, MA 02026

Re: K173119

Trade/Device Name: DRI OCT Triton Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI Dated: December 18, 2017 Received: December 20, 2017

Dear Zvi Ladin, Ph.D .:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K173119

Device Name DRI OCT Triton

Indications for Use (Describe)

The Topcon DRI OCT Triton is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.

The DRI OCT Triton is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.

It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the human retina to a database of known normal subjects. The DRI OCT Triton is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Topcon Corporation DRI OCT Triton and Triton (plus)

Submitter Information:

| Applicant: | Topcon Corporation
75-1 Hasunuma-cho, Itabashi-ku
Tokyo, Japan 174-8580 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | (201) 599-5533 |
| Fax: | (201) 599-5248 |
| Contact Person: | Charles Reisman
Vice President of Research and Development
Topcon Healthcare Solutions, Inc.
111 Bauer Drive
Oakland, NJ 07436
1 (201) 599-5283 |
| Date Prepared: | January 17, 2018 |
| Subject Device: | |
| Device Name: | DRI OCT Triton and Triton (plus) |
| Common Name: | Optical Coherence Tomography |
| Classification Name: | Ophthalmoscope |
| Regulation: | Class II, 21 C.F.R. § 886.1570 |
| Product Code(s): | OBO, HKI |
| Predicate Device(s): | |

Primary Predicate: Topcon 3D OCT-1 Maestro (#K161509, #K170164)

Secondary Predicate: Topcon TRC-50DX Retinal Camera (#K123101)

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Indications for Use:

The Topcon DRI OCT Triton is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.

The DRI OCT Triton is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.

It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The DRI OCT Triton is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

Device Description:

The DRI OCT Triton ("Triton") and the DRI OCT Triton (plus)") are non-contact, highresolution, tomographic and bio-microscopic imaging systems that merge optical coherence tomography (OCT) and fundus camera into a single device. Triton and Triton (plus) employ the swept source OCT (SS-OCT) technology. Both can take anterior OCT images in addition to fundus OCT images. The fundus camera, in both Triton and Triton (plus), includes color imaging, red-free imaging, and infrared light imaging (hereinafter, IR imaging) capabilities for fundus observation. The Triton (plus) has fluorescein angiography (FA), and fundus autofluorescence angiography (FAF) imaging function in addition to all fundus functions for Triton.

The fundus photographs and OCT images are captured by different system components of this device, which enables Triton to capture an OCT image and a fundus image sequentially. It allows in vivo viewing, axial cross sectional, and three dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures. It also has a reference database for posterior ocular measurements of normal subjects, which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head and the macula.

Captured images are transferred from the device to an off-the-shelf personal computer (PC) via LAN cable, where the dedicated software for this device is installed. The transferred data is then automatically processed with analysis functions such as the automatic retinal layers segmentation, the automatic thickness calculation with several grids, the optic disc analysis and comparison with a reference database of eyes free of ocular pathology, and is finally automatically saved to the PC. It allows the user to manually adjust the automated retinal layer segmentation results and optic disc analysis results.

Accessories include the power cord, chin-rest paper sheet, monitor cleaner, LAN cable; chin-rest paper pins, external fixation target, dust cover accessory case, user manual, unpacking and analysis software DVD.

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Substantial Equivalence

Triton is substantially equivalent to Topcon's 3D OCT-1 Maestro (#K161509, #K170164, "Maestro") cleared on 7/28/2016 and 3/3/2017 correspondingly. The secondary predicate device is Topcon's TRC-50DX Retinal Camera (#K123101) cleared on 6/5/2013. Triton's indications for use are identical to those of the Maestro device.

Both Triton and Maestro have the same technological characteristics of an optical coherence tomography (OCT) device and a fundus imaging device in a single system. Triton and Maestro are non-contact, high resolution tomographic and biomicroscopic imaging systems that include cameras for both OCT and fundus imaging. These devices can capture fundus OCT and color fundus images sequentially and can capture anterior segment OCT images. Both devices include a reference database tool, used as an aid in the detection and management of the same series of ocular diseases claimed in the indications for use.

Triton incorporates a swept-source (SS) light source to divide wavelengths temporally, while the Maestro incorporates a superluminescent diode (SLD) light source and a splitter to divide wavelengths spatially. Though the methods used to divide wavelengths are different, both are based on optical interference principles, and both spectral domain and swept-source OCT are generally thought to fall under the umbrella classification of Fourier Domain OCT.

Both systems are non-contact, ophthalmic diagnostic devices using infrared to visible light. Triton has a higher scan speed, a higher resolution of 3D scans and additional scan patterns compared to Maestro. There are slight differences in the axial resolutions, center wavelength and bandwidths of the light sources of both devices.

Triton and Maestro have the same technological characteristics regarding the fundus camera function, except for FA/FAF. Both devices employ an Infrared (IR) Light Emitting Diode (LED) for observation light source, a Xenon flash for photographing light source and a complementary metaloxide semiconductor (CMOS) for camera. Both Triton (plus) and TRC-50DX Retina Camera provide FA/FAF functionality. While Triton (plus) employs an IR LED for observation light source, TRC-50DX employs a Halogen lamp. Both devices employ a Xenon flash for photographing light source. For camera, Triton (plus) employs a CMOS while TRC-50DX employs a charge-coupled device (CCD). The minor differences between the candidate and predicate devices in technological implementation or performance do not raise new or different questions of safety or effectiveness.

Performance Data

Performance bench testing has been conducted on Triton to demonstrate substantial equivalence to the predicate devices. A list of testing conducted is as follows:

. Axial and Transversal Resolutions
. Trueness and Precision for Axial and Transversal Directions

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Testing to Consensus Standards for Ophthalmic Devices .
- ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods - O Part1: General requirements applicable to all ophthalmic instruments, 2006
- ISO 10940, Ophthalmic instruments Fundus cameras, 2009 O
- ISO 15004-2, Ophthalmic instruments Fundamental requirements and test methods - O Part 2: Light hazard protection, 2007
. Electrical Safety
- AAMI/ANSI ES 60601-1, Medical Electrical Equipment Part1: General requirements for O Safety and essential performance, 2005/(R)2012 and A1:2012, C1:2009 /(R) 2012 and A2:2010/(R)2012
Electromagnetic Compatibility
- IEC 60601-1-2, Medical electrical equipment Part1-2: General requirements for Safety o and essential performance - Collateral standard : Electromagnetic compatibility -Requirements and tests, 2007
Software Verification and Validation Testing .
- Software verification and validation testing were conducted and documentation was O provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- The software for this device was considered as 'Moderate Level of Concern' since a O failure or latent flaw in the software could result in an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.

Biocompatibility of materials used in the patient contacting components were already evaluated and established in company's predicate device submissions.

Clinical Data

Topcon conducted two clinical studies to demonstrate substantial equivalence of the investigational Triton device to the predicate devices, 3D OCT-1 Maestro (#K161509, #K170164) and TRC-50DX Retinal Camera (#K123101). An agreement and precision study was conducted at a single clinical site to determine precision (repeatability and reproducibility) and agreement with the predicate Maestro device. A second single-site study was performed to compare the performance of the Triton (plus) and TRC-50DX for FA/FAF imaging. These two studies were performed independently and in parallel. A third multi-center clinical study was performed to collect OCT data in order to establish a reference database for measurement comparisons.

Agreement and Precision Study

Topcon conducted a prospective comparative clinical study, at a U.S. clinical site, to compare the agreement and precision between Triton and Maestro. Participants, with and without eye disease, had OCT images and fundus photographs obtained using both Triton and Maestro devices. The studies included five main analyses: 1) precision analysis, 2) agreement analysis, 3) fundus photograph evaluation, 4) anterior segment image evaluation, and 5) posterior B scan image quality evaluation. The agreement and precision study compared the full retinal thickness, retinal nerve fiber

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layer thickness, Ganglion cell layer plus the IPL layer thickness, Ganglion cell complex thickness, and the optic disc measurements. In addition, the study estimated the precision of the small and large super pixel grid and the TSNIT circle profile measurements of the Triton.

Participants were randomized for the selection of study eye, operator order and device order. There were 13 planned scans during a single session, for all subject groups, per subject, per device (3 scans per 3D Wide, 3D Macula and 3D Disc scans; 1 scan per Radial cornea and angle scans; 1 per macula fundus and optic disc fundus photographs). The total number of planned scans for a subject was 78 (39 for each device). While the precision analysis utilized all acceptable scans for all measurement types, all other analysis utilized the first acceptable photograph of each scan type of each device from all study eyes. The image quality of the fundus photographs, and the image quality of anterior and posterior OCT B scans were graded by two masked independent experts on a scale based on the quality and clarity of the images. Quality assurance procedures were instituted to produce a consistent system for assessing, saving and processing study images.

Major eligibility criteria included participants age≥18 with: 1) normal eyes (excluding glaucomatous optic nerve damage), 2) Glaucomatous optic nerve damage, based on pattern deviation and Glaucoma hemi-field test or damage based on optic disc or retinal nerve fiber layer structural abnormalities (excluding other ocular pathology), and 3) Retinal pathology diagnosis (excluding glaucoma or any other ocular pathology).

Agreement between Triton and Maestro was evaluated by the 95% LOA, Bland-Altman plots, and the Deming regression for each subject population. The analysis of precision used a two-way random-effect ANOVA model to estimate the repeatability and reproducibility limits, and coefficient of variation of each scan parameter by subject population and study device. Image clarity analysis, for both fundus photographs and anterior and posterior OCT B scans, calculated the percentage of subjects whose Triton grades were equal to or better than their Maestro grades by photograph type and subject population, and the percentage of total inter-grader agreement by photograph type, subject population and study device with exact 95% confidence interval.

The rate of rejected scans for image quality reasons was in the range of 1% - 20%, and was similar for both the Triton and Maestro images. For each of the measurement types, image or scan type and size, and subject eye category, the measurements obtained with the Triton device as compared to the Maestro device were mathematically similar, statistically consistent with, and clinically useful in the assessment of normal and diseased eyes. In sum, the agreement results were expected based on minor differences in axial resolution, validated software and algorithm updates, and a minor difference in the pixel calibration factor between devices. Software and algorithm updates included improved fovea detection, ILM and RPE segmentation, artifact removal and cup map refinement. In addition, the Triton device uses a factory determined pixel calibration factor that is used for thickness calculations. The Maestro device uses a standard, average value for pixel measurements, while each Triton device relies on a device specific pixel size value. These results demonstrate that the Topcon DRI OCT Triton is substantially equivalent to the predicate device Topcon 3D OCT-1 Maestro (#K161509, # K170164).

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| | Normal
(N=25) | Retinal
(N=26) | Glaucoma
(N=25) | Total
(N=76) |
|-------------------------------------|------------------|-------------------|--------------------|-----------------|
| Age (years) | | | | |
| n | 25 | 26 | 25 | 76 |
| Mean (SD) | 42.7 (14.7) | 67.2 (11.3) | 67.6 (10.4) | 59.3 (16.8) |
| Median | 40.0 | 67.0 | 68.0 | 62.0 |
| Age group, n (%) | | | | |
| Normal Eyes (N = 25) | | | | | |
| Central Fovea | 252.783 (25.344) | 252.039 (27.524) | 0.744 (6.219) | -1.824, 3.311 | -11.695, 13.182 |
| Inner Superior | 318.430 (15.531) | 321.084 (16.041) | -2.653 (4.541) | -4.527, -0.779 | -11.734, 6.428 |
| Inner Nasal | 319.948 (16.716) | 321.864 (16.700) | -1.916 (4.247) | -3.669, -0.163 | -10.410, 6.578 |
| Inner Inferior | 313.842 (17.074) | 315.470 (17.704) | -1.628 (4.207) | -3.365, 0.108 | -10.043, 6.786 |
| Inner Temporal | 303.981 (17.133) | 305.390 (17.280) | -1.409 (4.432) | -3.238, 0.420 | -10.272, 7.454 |
| Outer Superior | 273.314 (15.440) | 276.887 (16.315) | -3.573 (3.436) | -4.992, -2.155 | -10.446, 3.300 |
| Outer Nasal | 289.616 (18.592) | 291.432 (18.750) | -1.815 (3.269) | -3.165, -0.466 | -8.354, 4.723 |
| Outer Inferior | 263.023 (17.675) | 265.177 (18.321) | -2.154 (3.584) | -3.633, -0.675 | -9.322, 5.014 |
| Outer Temporal | 257.459 (14.410) | 258.748 (15.657) | -1.288 (3.567) | -2.761, 0.184 | -8.423, 5.847 |
| Retinal Eyes (N = 26) | | | | | |
| Central Fovea | 287.357 (69.085) | 289.860 (71.068) | -2.503 (5.865) | -4.872, -0.134 | -14.233, 9.227 |
| Inner Superior | 319.017 (37.733) | 323.572 (40.551) | -4.555 (4.739) | -6.469, -2.640 | -14.034, 4.924 |
| Inner Nasal | 321.600 (34.510) | 325.010 (36.073) | -3.409 (4.412) | -5.191, -1.627 | -12.233, 5.414 |
| Inner Inferior | 315.722 (36.594) | 319.435 (37.898) | -3.712 (5.135) | -5.786, -1.638 | -13.982, 6.557 |
| Inner Temporal | 310.943 (40.324) | 315.846 (43.195) | -4.903 (6.001) | -7.327, -2.479 | -16.905, 7.100 |
| Outer Superior | 273.324 (25.716) | 277.460 (26.634) | -4.136 (3.377) | -5.500, -2.772 | -10.890, 2.618 |
| Outer Nasal | 285.318 (22.409) | 288.067 (22.352) | -2.748 (4.608) | -4.609, -0.887 | -11.964, 6.468 |
| Outer Inferior | 260.377 (25.022) | 265.861 (26.674) | -5.485 (7.538) | -8.529, -2.440 | -20.561, 9.592 |
| Outer Temporal | 256.704 (25.894) | 259.992 (26.967) | -3.287 (4.373) | -5.054, -1.521 | -12.033, 5.458 |
| Glaucoma Eyes (N = 25) | | | | | |
| Central Fovea | 243.749 (16.276) | 245.544 (18.331) | -1.795 (4.937) | -3.833, 0.243 | -11.670, 8.079 |
| Inner Superior | 286.105 (25.967) | 289.968 (28.053) | -3.864 (3.917) | -5.480, -2.247 | -11.698, 3.971 |
| Inner Nasal | 292.276 (17.609) | 296.114 (19.647) | -3.838 (4.251) | -5.592, -2.083 | -12.339, 4.664 |
| Inner Inferior | 284.798 (19.193) | 287.965 (20.269) | -3.167 (3.223) | -4.498, -1.837 | -9.613, 3.279 |
| Inner Temporal | 278.046 (15.855) | 281.840 (17.968) | -3.794 (4.544) | -5.670, -1.919 | -12.881, 5.293 |
| Outer Superior | 245.268 (17.305) | 248.721 (17.825) | -3.453 (3.861) | -5.047, -1.860 | -11.174, 4.268 |
| Outer Nasal | 259.902 (18.908) | 261.922 (19.747) | -2.021 (3.102) | -3.301, -0.740 | -8.225, 4.184 |
| Outer Inferior | 234.349 (15.412) | 237.959 (16.762) | -3.610 (2.900) | -4.807, -2.412 | -9.410, 2.191 |
| Outer Temporal | 235.496 (13.765) | 238.046 (14.187) | -2.550 (2.886) | -3.741, -1.359 | -8.323, 3.223 |
| | | | | 95% CI for | 95% LOA |
| Eye Population | Triton | Maestro | Difference | Mean | for Mean |
| Measurement | Mean (SD) | Mean (SD) | Mean (SD) | Difference | Difference |
| Normal Eyes (N = 25) | | | | | |
| Central Fovea | | 253.285 (25.739) 254.889 (27.233) | -1.604 (5.824) | -4.008, 0.801 | -13.253, 10.045 |
| Inner Superior | | 318.049 (15.025) 319.785 (15.322) | -1.736 (4.501) | -3.594, 0.122 | -10.738, 7.266 |
| Inner Nasal | | 320.078 (15.970) 321.635 (15.551) | -1.557 (4.414) | -3.379, 0.265 | -10.385, 7.271 |
| Inner Inferior | | 313.766 (16.641) 315.520 (16.579) | -1.754 (3.272) | -3.105, -0.403 | -8.298, 4.790 |
| Inner Temporal | | 304.453 (16.725) 306.027 (16.434) | -1.574 (4.205) | -3.310, 0.162 | -9.984, 6.837 |
| Outer Superior | 273.720 (14.840) | 276.277 (16.733) | -2.557 (3.362) | -3.945, -1.169 | -9.281, 4.168 |
| Outer Nasal | 290.864 (18.051) | 292.204 (18.195) | -1.340 (2.915) | -2.544, -0.137 | -7.170, 4.489 |
| Outer Inferior | 263.360 (17.043) | 264.814 (17.018) | -1.453 (2.954) | -2.673, -0.234 | -7.361, 4.455 |
| Outer Temporal | | 259.225 (14.143) 261.355 (14.541) | -2.130 (2.523) | -3.171, -1.088 | -7.176, 2.917 |
| | | | | | |
| Retinal Eyes (N = 26) | | | | | |
| Central Fovea | | 280.446 (64.997) 284.317 (65.981) | -3.871 (7.183) | -6.904, -0.838 | -18.236, 10.494 |
| Inner Superior | | 318.230 (39.994) 321.523 (39.990) | -3.293 (4.144) | -5.043, -1.543 | -11.581, 4.995 |
| Inner Nasal | | 320.276 (33.435) 323.884 (34.829) | -3.608 (4.875) | -5.666, -1.549 | -13.358, 6.142 |
| Inner Inferior | | 311.013 (35.923) 313.798 (36.435) | -2.786 (8.796) | -6.500, 0.928 | -20.378, 14.806 |
| Inner Temporal | | 304.876 (36.082) 307.938 (34.603) | -3.063 (6.983) | -6.011, -0.114 | -17.029, 10.904 |
| Outer Superior | | 272.455 (24.283) 275.740 (25.617) | -3.285 (3.760) | -4.873, -1.698 | -10.806, 4.235 |
| Outer Nasal | | 287.367 (21.331) 290.301 (23.553) | -2.935 (5.042) | -5.064, -0.806 | -13.018, 7.149 |
| Outer Inferior | 258.478 (23.809) | 261.797 (23.770) | -3.319 (8.331) | -6.836, 0.199 | -19.980, 13.343 |
| Outer Temporal | | 254.986 (25.005) 258.137 (24.698) | -3.151 (4.885) | -5.214, -1.088 | -12.922, 6.620 |
| | | | | | |
| Glaucoma Eyes (N = 25) | | | | | |
| Central Fovea | | 244.176 (17.544) 246.496 (17.721) | -2.320 (4.084) | -4.045, -0.595 | -10.489, 5.849 |
| Inner Superior | | 289.698 (16.230) 292.570 (16.785) | -2.871 (2.271) | -3.830, -1.912 | -7.413, 1.670 |
| Inner Nasal | 293.856 (17.489) | 296.396 (17.516) | -2.540 (3.067) | -3.835, -1.245 | -8.674, 3.594 |
| Inner Inferior | 284.328 (19.942) | 287.300 (19.458) | -2.972 (2.628) | -4.081, -1.862 | -8.228, 2.285 |
| Inner Temporal | 279.409 (17.073) | 282.387 (17.201) | -2.977 (2.872) | -4.190, -1.765 | -8.721, 2.766 |
| Outer Superior | 247.638 (14.386) | 250.155 (14.277) | -2.517 (2.431) | -3.544, -1.491 | -7.379, 2.345 |
| Outer Nasal | 261.083 (19.262) | 262.721 (19.460) | -1.638 (1.956) | -2.464, -0.812 | -5.551, 2.275 |
| Outer Inferior | | 234.086 (15.662) 236.015 (16.030) | -1.930 (1.765) | -2.675, -1.184 | -5.460, 1.600 |
| Outer Temporal | | 237.022 (14.366) 239.752 (14.588) | -2.730 (2.454) | -3.766, -1.694 | -7.638, 2.178 |
| | | | | | |
| | | | | 95% CI for | 95% LOA |
| Eye Population | Triton | Maestro | Difference | Mean | for Mean |
| Measurement | Mean (SD) | Mean (SD) | Mean (SD) | Difference | Difference |
| Normal Eyes (N = 25) | | | | | |
| Superior | 69.757 (5.703) | 72.561 (6.120) | -2.804 (1.492) | -3.419, -2.188 | -5.787, 0.179 |
| Superior Nasal | 74.469 (6.416) | 76.502 (6.824) | -2.032 (1.110) | -2.491, -1.574 | -4.252, 0.188 |
| Superior Temporal | 71.439 (4.766) | 72.628 (5.265) | -1.188 (1.238) | -1.699, -0.677 | -3.664, 1.287 |
| Inferior | 67.243 (6.226) | 69.742 (6.391) | -2.499 (1.242) | -3.011, -1.986 | -4.982, -0.016 |
| Inferior Nasal | 72.865 (6.786) | 74.972 (6.456) | -2.107 (0.833) | -2.451, -1.763 | -3.773, -0.441 |
| Inferior Temporal | 72.590 (6.395) | 73.938 (6.854) | -1.348 (1.238) | -1.859, -0.837 | -3.825, 1.129 |
| Average | 71.400 (5.756) | 73.396 (6.009) | -1.996 (0.782) | -2.319, -1.673 | -3.561, -0.431 |
| Retinal Eyes (N = 26) | | | | | |
| Superior | 66.450 (6.763) | 68.726 (7.568) | -2.276 (1.761) | -2.987, -1.565 | -5.797, 1.245 |
| Superior Nasal | 69.626 (6.088) | 71.558 (6.736) | -1.932 (1.806) | -2.661, -1.202 | -5.543, 1.680 |
| Superior Temporal | 72.453 (9.902) | 72.956 (10.478) | -0.503 (3.274) | -1.826, 0.819 | -7.052, 6.046 |
| Inferior | 64.326 (8.379) | 67.005 (8.407) | -2.680 (2.866) | -3.837, -1.522 | -8.411, 3.052 |
| Inferior Nasal | 69.661 (7.339) | 71.394 (8.164) | -1.733 (2.014) | -2.547, -0.920 | -5.762, 2.295 |
| Inferior Temporal | 73.395 (12.134) | 74.294 (12.198) | -0.899 (2.057) | -1.730, -0.068 | -5.014, 3.216 |
| Average | 69.331 (7.602) | 71.008 (8.053) | -1.677 (1.185) | -2.156, -1.198 | -4.047, 0.693 |
| Glaucoma Eyes (N = 25) | | | | | |
| Superior | 55.622 (8.631) | 56.998 (9.443) | -1.376 (1.457) | -1.978, -0.775 | -4.290, 1.538 |
| Superior Nasal | 59.672 (9.750) | 60.888 (10.400) | -1.216 (1.360) | -1.777, -0.654 | -3.935, 1.504 |
| Superior Temporal | 61.115 (6.586) | 61.802 (7.074) | -0.687 (1.624) | -1.357, -0.016 | -3.935, 2.561 |
| Inferior | 53.388 (6.721) | 55.223 (7.183) | -1.835 (2.017) | -2.668, -1.003 | -5.869, 2.198 |
| Inferior Nasal | 58.004 (9.676) | 59.361 (9.861) | -1.356 (1.564) | -2.002, -0.711 | -4.485, 1.772 |
| Inferior Temporal | 60.408 (7.330) | 60.734 (7.618) | -0.326 (1.820) | -1.077, 0.426 | -3.966, 3.314 |
| Average | 58.036 (7.172) | 59.192 (7.566) | -1.156 (1.045) | -1.587, -0.725 | -3.246, 0.934 |

N is the number of eyes with measurements from both devices.

Difference = Triton - Maestro

95% confidence interval (CI) for mean difference is based on t-distribution.

10

Table 3. Limits of Agreement between Triton 12x9 Wide and Maestro 12x9 Wide: Full Retinal Thickness (mm) Agreement Analysis Population

N is the number of eyes with measurements from both devices.

Difference = Triton - Maestro

95% confidence interval (CI) for mean difference is based on t-distribution.

11

Table 4. Limits of Agreement between Triton 7x7 Macula and Maestro 6x6 Macula: Ganglion Cell + IPL Thickness (mm) Agreement Analysis Population

N is the number of eyes with measurements from both devices.

Difference = Triton - Maestro

95% confidence interval (CI) for mean difference is based on t-distribution.

12

| | Eye Population Measurement | Triton
Mean (SD) | Maestro
Mean (SD) | Difference
Mean (SD) | 95% CI for
Mean
Difference | 95% LOA
for Mean
Difference |
|------------------------|--------------- | Normal Eyes (N = 25) | | | Superior | | Superior Nasal | | Superior Temporal | | Inferior | | Inferior Nasal | | Inferior Temporal | | Average | Retinal Eyes (N = 26) | | | Superior | | Superior Nasal | | Superior Temporal | | Inferior | | Inferior Nasal | | Inferior Temporal | | Average | Glaucoma Eyes (N = 25) | | | Superior | | Superior Nasal | | Superior Temporal | | Inferior | | Inferior Nasal | | Inferior Temporal | | Average
----------------|---------------------|----------------------|-------------------------|----------------------------------|-----------------------------------|
| | | | | |
| 70.391 (5.561) | 72.198 (5.957) | -1.807 (0.985) | -2.214, -1.401 | -3.777, 0.162 |
| 74.646 (6.561) | 76.435 (6.870) | -1.789 (0.952) | -2.182, -1.396 | -3.692, 0.115 |
| 70.918 (5.407) | 72.358 (5.815) | -1.440 (0.861) | -1.796, -1.084 | -3.163, 0.283 |
| 67.660 (6.299) | 69.411 (6.190) | -1.751 (1.165) | -2.232, -1.270 | -4.081, 0.580 |
| 73.210 (6.506) | 75.078 (6.668) | -1.868 (0.954) | -2.262, -1.475 | -3.777, 0.040 |
| 72.144 (6.457) | 74.028 (6.788) | -1.884 (1.004) | -2.298, -1.469 | -3.892, 0.125 |
| 71.500 (5.857) | 73.256 (6.103) | -1.756 (0.593) | -2.001, -1.511 | -2.942, -0.570 |
| | | | | |
| 67.840 (6.751) | 69.305 (7.067) | -1.466 (2.789) | -2.643, -0.288 | -7.043, 4.112 |
| 72.020 (7.167) | 74.356 (9.542) | -2.336 (4.571) | -4.266, -0.406 | -11.478, 6.806 |
| 69.399 (10.325) | 70.473 (9.534) | -1.073 (2.257) | -2.026, -0.120 | -5.587, 3.440 |
| 64.227 (8.273) | 65.463 (8.917) | -1.235 (4.215) | -3.015, 0.545 | -9.666, 7.195 |
| 71.283 (7.734) | 72.863 (8.840) | -1.580 (2.246) | -2.529, -0.632 | -6.072, 2.911 |
| 70.758 (10.839) | 72.162 (11.077) | -1.404 (3.130) | -2.726, -0.083 | -7.664, 4.855 |
| 69.254 (7.667) | 70.779 (7.956) | -1.525 (0.999) | -1.947, -1.103 | -3.523, 0.473 |
| | | | | |
| 56.588 (8.355) | 57.728 (8.866) | -1.140 (1.125) | -1.615, -0.665 | -3.390, 1.110 |
| 60.501 (9.182) | 61.990 (9.248) | -1.488 (0.719) | -1.792, -1.185 | -2.926, -0.050 |
| 58.203 (8.942) | 58.782 (9.913) | -0.579 (1.360) | -1.153, -0.005 | -3.299, 2.141 |
| 52.420 (8.545) | 53.430 (8.592) | -1.010 (0.815) | -1.355, -0.666 | -2.641, 0.620 |
| 57.940 (10.485) | 59.125 (10.909) | -1.185 (0.881) | -1.557, -0.813 | -2.947, 0.577 |
| 55.950 (10.765) | 56.580 (11.330) | -0.630 (1.422) | -1.231, -0.030 | -3.475, 2.214 |
| 56.938 (8.605) | 57.946 (9.013) | -1.008 (0.752) | -1.326, -0.691 | -2.513, 0.496 |

Table 5. Limits of Agreement between Triton 12x9 Wide and Maestro 12x9 Wide: Ganglion Cell + IPL Thickness (mm) Agreement Analysis Population

N is the number of eyes with measurements from both devices.

Difference = Triton - Maestro

95% confidence interval (CI) for mean difference is based on t-distribution.

13

| Eye Population
Measurement | Triton
Mean (SD) | Maestro
Mean (SD) | Difference
Mean (SD) | 95% CI for
Mean
Difference | 95% LOA
for Mean
Difference |
|-------------------------------|---------------------|----------------------|-------------------------|----------------------------------|-----------------------------------|
| Normal Eyes (N = 25) | | | | | |
| Superior | 107.598 (7.933) | 108.494 (7.993) | -0.896 (1.449) | -1.494, -0.298 | -3.793, 2.001 |
| Superior Nasal | 118.699 (8.723) | 119.427 (9.142) | -0.728 (1.396) | -1.304, -0.152 | -3.520, 2.064 |
| Superior Temporal | 93.898 (6.339) | 94.378 (6.634) | -0.480 (1.420) | -1.066, 0.106 | -3.321, 2.361 |
| Inferior | 106.720 (9.040) | 107.329 (9.340) | -0.609 (1.426) | -1.198, -0.021 | -3.461, 2.243 |
| Inferior Nasal | 119.495 (10.193) | 120.126 (10.434) | -0.631 (1.290) | -1.163, -0.099 | -3.210, 1.948 |
| Inferior Temporal | 97.209 (7.588) | 97.493 (8.034) | -0.284 (1.738) | -1.001, 0.433 | -3.760, 3.192 |
| Average | 107.268 (7.828) | 107.884 (8.129) | -0.616 (1.116) | -1.077, -0.155 | -2.847, 1.615 |
| Retinal Eyes (N = 26) | | | | | |
| Superior | 113.072 (19.742) | 113.830 (20.513) | -0.758 (1.803) | -1.486, -0.030 | -4.363, 2.848 |
| Superior Nasal | 121.294 (17.619) | 121.730 (17.969) | -0.436 (2.076) | -1.275, 0.402 | -4.588, 3.715 |
| Superior Temporal | 99.000 (15.413) | 99.509 (15.809) | -0.509 (1.879) | -1.268, 0.250 | -4.268, 3.249 |
| Inferior | 108.175 (17.234) | 109.512 (18.970) | -1.337 (4.332) | -3.086, 0.413 | -10.001, 7.328 |
| Inferior Nasal | 122.721 (18.189) | 122.751 (20.334) | -0.030 (3.392) | -1.400, 1.340 | -6.814, 6.754 |
| Inferior Temporal | 99.976 (17.182) | 100.722 (17.411) | -0.745 (2.251) | -1.655, 0.164 | -5.248, 3.757 |
| Average | 110.715 (16.225) | 111.373 (17.188) | -0.658 (1.845) | -1.403, 0.087 | -4.347, 3.032 |
| Glaucoma Eyes (N = 25) | | | | | |
| Superior | 86.832 (15.742) | 86.720 (15.991) | 0.111 (1.280) | -0.417, 0.640 | -2.449, 2.671 |
| Superior Nasal | 97.626 (17.241) | 97.097 (17.399) | 0.529 (2.786) | -0.621, 1.679 | -5.043, 6.101 |
| Superior Temporal | 78.534 (11.797) | 78.363 (12.093) | 0.172 (1.240) | -0.340, 0.683 | -2.308, 2.651 |
| Inferior | 83.838 (14.596) | 83.881 (15.292) | -0.044 (1.303) | -0.581, 0.494 | -2.649, 2.562 |
| Inferior Nasal | 96.685 (18.388) | 96.327 (19.027) | 0.358 (1.736) | -0.358, 1.074 | -3.113, 3.829 |
| Inferior Temporal | 77.714 (13.157) | 77.519 (13.613) | 0.195 (0.920) | -0.185, 0.575 | -1.646, 2.036 |
| Average | 86.876 (13.385) | 86.680 (13.651) | 0.196 (1.078) | -0.249, 0.641 | -1.959, 2.351 |

Table 6. Limits of Agreement between Triton 7x7 Macula and Maestro 6x6 Macula: Ganglion Cell Complex Thickness (mm) Agreement Analysis Population

N is the number of eyes with measurements from both devices.

Difference = Triton - Maestro

95% confidence interval (CI) for mean difference is based on t-distribution.

14

				95% CI for		95% LOA
Eye Population
Measurement	Triton
Mean (SD)	Maestro
Mean (SD)	Difference
Mean (SD)	Mean
Difference	for Mean
Difference
Normal Eyes (N = 25)
Superior	107.536 (7.455)	107.604 (8.219)	-0.068 (1.815)	-0.818, 0.681	-3.698, 3.561
Superior Nasal	119.298 (8.820)	119.394 (9.268)	-0.095 (1.486)	-0.709, 0.518	-3.067, 2.876
Superior Temporal	94.647 (6.099)	94.778 (6.761)	-0.132 (1.215)	-0.633, 0.370	-2.562, 2.299
Inferior	106.996 (8.794)	106.672 (8.999)	0.324 (1.295)	-0.211, 0.858	-2.267, 2.915
Inferior Nasal	119.679 (9.927)	119.590 (10.396)	0.089 (1.282)	-0.440, 0.618	-2.474, 2.652
Inferior Temporal	97.922 (7.219)	98.334 (7.825)	-0.412 (1.309)	-0.952, 0.129	-3.030, 2.206
Average	107.688 (7.626)	107.732 (8.138)	-0.044 (1.158)	-0.522, 0.434	-2.361, 2.273
Retinal Eyes (N = 26)
Superior	112.223 (16.563)	111.426 (17.341)	0.797 (2.185)	-0.126, 1.720	-3.573, 5.167
Superior Nasal	121.542 (16.285)	121.510 (17.564)	0.032 (2.408)	-0.984, 1.049	-4.784, 4.849
Superior Temporal	97.254 (13.954)	96.840 (13.564)	0.415 (2.660)	-0.709, 1.538	-4.905, 5.735
Inferior	108.042 (13.646)	107.501 (15.138)	0.540 (5.328)	-1.710, 2.790	-10.117, 11.197
Inferior Nasal	121.860 (15.448)	121.037 (15.073)	0.824 (2.150)	-0.084, 1.732	-3.476, 5.123
Inferior Temporal	99.482 (14.282)	99.227 (15.210)	0.255 (3.842)	-1.367, 1.877	-7.430, 7.940
Average	110.075 (13.985)	109.600 (14.167)	0.475 (1.732)	-0.256, 1.206	-2.988, 3.938
Glaucoma Eyes (N = 25)
Superior	88.431 (13.569)	88.082 (13.039)	0.349 (1.287)	-0.195, 0.892	-2.226, 2.923
Superior Nasal	99.618 (15.248)	99.090 (15.198)	0.527 (1.184)	0.028, 1.027	-1.841, 2.896
Superior Temporal	79.828 (11.212)	79.573 (11.597)	0.255 (1.152)	-0.232, 0.741	-2.050, 2.559
Inferior	83.691 (15.095)	82.823 (14.813)	0.868 (1.080)	0.412, 1.324	-1.292, 3.028
Inferior Nasal	96.578 (19.085)	95.675 (18.998)	0.903 (1.141)	0.421, 1.385	-1.380, 3.186
Inferior Temporal	77.887 (13.907)	77.543 (14.068)	0.344 (1.296)	-0.204, 0.891	-2.248, 2.936
Average	87.675 (13.555)	87.138 (13.399)	0.537 (0.791)	0.204, 0.871	-1.044, 2.119
Eye Population	Measurement	Triton
Mean (SD)	Maestro
Mean (SD)	Difference
Mean (SD)	95% CI for
Mean
Difference	95% LOA
for Mean
Difference
Normal Eyes (N = 25)	C/D Vertical	0.458 (0.195)	0.454 (0.231)	0.004 (0.110)	-0.041, 0.049	-0.216, 0.224
	C/D Area	0.249 (0.156)	0.255 (0.189)	-0.006 (0.118)	-0.055, 0.043	-0.243, 0.231
	Disc Area (mm2)	1.754 (0.407)	2.038 (0.415)	-0.285 (0.145)	-0.345, -0.225	-0.575, 0.006
	Cup Area (mm2)	0.466 (0.341)	0.537 (0.416)	-0.072 (0.211)	-0.159, 0.015	-0.494, 0.350
	Rim Area (mm2)	1.287 (0.302)	1.502 (0.426)	-0.215 (0.277)	-0.329, -0.100	-0.769, 0.340
	Cup Volume
(mm³)	0.083 (0.079)	0.089 (0.084)	-0.006 (0.008)	-0.009, -0.003	-0.022, 0.010
	Rim Volume (mm³)	0.235 (0.102)	0.288 (0.145)	-0.053 (0.069)	-0.082, -0.025	-0.191, 0.084
	Linear C/D Ratio	0.459 (0.202)	0.453 (0.227)	0.006 (0.090)	-0.031, 0.043	-0.174, 0.186
Retinal Eyes (N = 26)	C/D Vertical	0.527 (0.230)	0.498 (0.212)	0.029 (0.036)	0.014, 0.044	-0.044, 0.102
	C/D Area	0.305 (0.169)	0.280 (0.155)	0.025 (0.024)	0.016, 0.035	-0.023, 0.073
	Disc Area (mm2)	1.763 (0.361)	2.003 (0.434)	-0.240 (0.214)	-0.326, -0.154	-0.668, 0.188
	Cup Area (mm2)	0.549 (0.359)	0.562 (0.365)	-0.013 (0.042)	-0.030, 0.004	-0.097, 0.072
	Rim Area (mm2)	1.214 (0.334)	1.442 (0.434)	-0.228 (0.198)	-0.308, -0.148	-0.625, 0.168
	Cup Volume
(mm³)	0.095 (0.084)	0.100 (0.087)	-0.005 (0.008)	-0.008, -0.002	-0.021, 0.011
	Rim Volume (mm³)	0.213 (0.131)	0.258 (0.172)	-0.045 (0.055)	-0.067, -0.023	-0.156, 0.066
	Linear C/D Ratio	0.508 (0.219)	0.488 (0.210)	0.021 (0.019)	0.013, 0.029	-0.018, 0.060
Glaucoma Eyes (N = 25)	C/D Vertical	0.861 (0.097)	0.823 (0.094)	0.038 (0.052)	0.016, 0.060	-0.066, 0.142
	C/D Area	0.688 (0.175)	0.623 (0.168)	0.064 (0.055)	0.042, 0.087	-0.046, 0.175
	Disc Area (mm2)	1.796 (0.378)	2.044 (0.473)	-0.247 (0.165)	-0.315, -0.179	-0.576, 0.082
	Cup Area (mm2)	1.247 (0.459)	1.297 (0.524)	-0.050 (0.114)	-0.097, -0.003	-0.277, 0.177
	Rim Area (mm2)	0.549 (0.306)	0.748 (0.332)	-0.198 (0.146)	-0.259, -0.138	-0.491, 0.094
	Cup Volume
(mm³)	0.351 (0.212)	0.360 (0.218)	-0.010 (0.057)	-0.033, 0.014	-0.124, 0.104
	Rim Volume (mm³)	0.053 (0.046)	0.071 (0.054)	-0.018 (0.020)	-0.026, -0.010	-0.059, 0.023
	Linear C/D Ratio	0.822 (0.116)	0.781 (0.113)	0.041 (0.035)	0.026, 0.055	-0.030, 0.111
Eye Population
Measurement	Triton
Mean (SD)	Maestro
Mean (SD)	Difference
Mean (SD)	95% CI for
Mean
Difference	95% LOA
for Mean
Difference
Normal Eyes (N = 25)
C/D Vertical	0.476 (0.208)	0.453 (0.199)	0.023 (0.047)	0.003, 0.042	-0.072, 0.118
C/D Area	0.254 (0.166)	0.232 (0.160)	0.022 (0.020)	0.014, 0.030	-0.017, 0.061
Disc Area (mm²)	1.923 (0.411)	2.232 (0.370)	-0.308 (0.168)	-0.378, -0.239	-0.644, 0.027
Cup Area (mm²)	0.518 (0.393)	0.540 (0.410)	-0.022 (0.047)	-0.042, -0.003	-0.116, 0.071
Rim Area (mm²)	1.406 (0.327)	1.693 (0.375)	-0.287 (0.175)	-0.360, -0.215	-0.638, 0.063
Cup Volume
(mm³)	0.086 (0.086)	0.092 (0.091)	-0.006 (0.013)	-0.012, -0.001	-0.032, 0.019
Rim Volume (mm³)	0.261 (0.123)	0.324 (0.157)	-0.063 (0.058)	-0.087, -0.039	-0.178, 0.053
Linear C/D Ratio	0.463 (0.205)	0.440 (0.205)	0.024 (0.022)	0.014, 0.033	-0.021, 0.068
Retinal Eyes (N = 26)
C/D Vertical	0.525 (0.232)	0.510 (0.205)	0.015 (0.058)	-0.008, 0.039	-0.101, 0.131
C/D Area	0.294 (0.169)	0.272 (0.153)	0.022 (0.027)	0.011, 0.033	-0.032, 0.077
Disc Area (mm²)	1.923 (0.376)	2.222 (0.442)	-0.298 (0.148)	-0.358, -0.239	-0.595, -0.002
Cup Area (mm²)	0.577 (0.382)	0.612 (0.395)	-0.035 (0.040)	-0.051, -0.019	-0.115, 0.045
Rim Area (mm²)	1.347 (0.371)	1.609 (0.438)	-0.262 (0.154)	-0.325, -0.200	-0.570, 0.046
Cup Volume
(mm³)	0.094 (0.088)	0.103 (0.094)	-0.010 (0.012)	-0.015, -0.005	-0.034, 0.015
Rim Volume (mm³)	0.242 (0.149)	0.290 (0.181)	-0.048 (0.044)	-0.066, -0.031	-0.137, 0.040
Linear C/D Ratio	0.498 (0.219)	0.485 (0.193)	0.013 (0.047)	-0.006, 0.032	-0.080, 0.106
Glaucoma Eyes (N = 25)
C/D Vertical	0.855 (0.119)	0.816 (0.105)	0.038 (0.057)	0.015, 0.062	-0.075, 0.152
C/D Area	0.679 (0.191)	0.624 (0.184)	0.056 (0.052)	0.034, 0.077	-0.049, 0.160
Disc Area (mm²)	1.958 (0.384)	2.225 (0.562)	-0.267 (0.247)	-0.369, -0.165	-0.760, 0.226
Cup Area (mm²)	1.338 (0.498)	1.390 (0.541)	-0.051 (0.086)	-0.087, -0.016	-0.223, 0.121
Rim Area (mm²)	0.620 (0.382)	0.836 (0.444)	-0.216 (0.212)	-0.303, -0.128	-0.640, 0.209
Cup Volume
(mm³)	0.359 (0.223)	0.375 (0.236)	-0.016 (0.025)	-0.026, -0.005	-0.065, 0.034
Rim Volume (mm³)	0.063 (0.061)	0.087 (0.078)	-0.024 (0.035)	-0.038, -0.010	-0.094, 0.046
Linear C/D Ratio	0.814 (0.132)	0.780 (0.126)	0.034 (0.034)	0.020, 0.048	-0.034, 0.102
Eye Population
Measurement	Triton
Mean (SD)	Maestro
Mean (SD)	Difference
Mean (SD)	95% CI for
Mean
Difference	95% LOA
for Mean
Difference
Normal Eyes (N = 25)
Average	105.171 (10.641)	105.988 (11.016)	-0.817 (1.341)	-1.370, -0.263	-3.499, 1.865
Superior Quadrant	128.772 (16.413)	130.712 (17.175)	-1.940 (3.498)	-3.384, -0.496	-8.936, 5.056
Nasal Quadrant	86.666 (15.590)	84.632 (15.599)	2.034 (3.442)	0.613, 3.455	-4.851, 8.918
Inferior Quadrant	137.382 (18.034)	140.049 (18.778)	-2.667 (3.141)	-3.963, -1.370	-8.949, 3.615
Temporal
Quadrant	67.763 (11.057)	68.887 (12.430)	-1.124 (3.112)	-2.409, 0.160	-7.348, 5.099
12-Sector - T	56.555 (9.167)	57.592 (10.271)	-1.037 (2.600)	-2.110, 0.036	-6.236, 4.163
12-Sector - TS	80.670 (13.210)	82.116 (14.824)	-1.446 (3.994)	-3.094, 0.203	-9.433, 6.542
12-Sector - ST	135.753 (23.322)	137.138 (22.846)	-1.385 (5.559)	-3.680, 0.909	-12.503, 9.733
12-Sector - S	130.320 (29.968)	133.122 (31.334)	-2.802 (6.408)	-5.447, -0.157	-15.617, 10.014
12-Sector - SN	120.430 (24.561)	121.726 (24.006)	-1.295 (6.023)	-3.781, 1.191	-13.341, 10.750
12-Sector - NS	106.190 (21.212)	104.049 (21.605)	2.142 (6.032)	-0.348, 4.631	-9.922, 14.206
12-Sector - N	68.901 (13.540)	66.560 (12.047)	2.341 (3.369)	0.950, 3.731	-4.396, 9.078
12-Sector - NI	84.982 (16.951)	83.355 (17.139)	1.627 (4.641)	-0.288, 3.543	-7.655, 10.909
12-Sector - IN	123.131 (28.022)	125.184 (27.116)	-2.054 (5.219)	-4.208, 0.101	-12.491, 8.384
12-Sector - I	151.904 (24.673)	155.778 (25.809)	-3.874 (5.944)	-6.327, -1.421	-15.761, 8.013
12-Sector - IT	137.190 (25.698)	139.116 (26.460)	-1.926 (6.892)	-4.771, 0.918	-15.710, 11.857
12-Sector - TI	66.050 (14.161)	66.879 (15.433)	-0.829 (3.908)	-2.442, 0.784	-8.644, 6.986

Retinal Eyes (N = 26)
Average	100.435 (17.661)	100.430 (15.504)	0.005 (4.542)	-1.829, 1.840	-9.079, 9.089
Superior Quadrant	115.893 (26.424)	117.700 (22.481)	-1.807 (12.122)	-6.703, 3.089	-26.050, 22.437
Nasal Quadrant	79.862 (18.809)	77.393 (16.593)	2.469 (3.966)	0.867, 4.071	-5.464, 10.402
Inferior Quadrant	126.865 (27.458)	128.233 (23.241)	-1.368 (8.174)	-4.670, 1.933	-17.716, 14.979
Temporal
Quadrant	79.017 (13.687)	78.399 (14.980)	0.618 (5.460)	-1.587, 2.824	-10.302, 11.539
12-Sector - T	68.023 (13.965)	66.158 (14.830)	1.865 (7.680)	-1.237, 4.967	-13.494, 17.224
12-Sector - TS	96.645 (19.772)	96.904 (20.124)	-0.260 (4.793)	-2.196, 1.676	-9.846, 9.326
12-Sector - ST	130.406 (24.977)	133.053 (23.804)	-2.648 (8.696)	-6.160, 0.865	-20.040, 14.744
12-Sector - S	110.586 (39.114)	112.312 (33.024)	-1.726 (17.118)	-8.640, 5.189	-35.963, 32.511
12-Sector - SN	106.680 (27.637)	107.807 (22.876)	-1.128 (14.292)	-6.900, 4.645	-29.711, 27.456
12-Sector - NS	96.660 (22.892)	93.253 (20.543)	3.407 (5.571)	1.156, 5.657	-7.735, 14.548
12-Sector - N	67.715 (16.876)	65.670 (16.091)	2.044 (2.831)	0.901, 3.188	-3.617, 7.705
12-Sector - NI	75.138 (20.824)	73.229 (17.150)	1.908 (8.323)	-1.453, 5.270	-14.738, 18.555
12-Sector - IN	103.739 (30.167)	102.947 (23.195)	0.792 (13.453)	-4.641, 6.226	-26.114, 27.698
12-Sector - I	138.697 (36.060)	140.203 (33.132)	-1.507 (9.879)	-5.497, 2.483	-21.264, 18.251
12-Sector - IT	138.181 (28.232)	141.444 (25.715)	-3.263 (8.790)	-6.813, 0.287	-20.842, 14.316
12-Sector - TI	72.435 (11.994)	72.117 (14.157)	0.318 (7.489)	-2.707, 3.343	-14.660, 15.296
				95% Cl for	95% LOA
Eye Population	Triton	Maestro	Difference	Mean	for Mean
Measurement	Mean (SD)	Mean (SD)	Mean (SD)	Difference	Difference
Average	75.239 (16.078)	73.710 (16.200)	1.528 (2.546)	0.477, 2.579	-3.564, 6.621
Superior Quadrant	88.304 (20.229)	86.330 (20.180)	1.975 (5.862)	-0.445, 4.394	-9.748, 13.698
Nasal Quadrant	61.433 (13.876)	59.520 (12.802)	1.913 (3.943)	0.285, 3.541	-5.974, 9.800
Inferior Quadrant	92.212 (27.030)	91.191 (27.473)	1.021 (3.818)	-0.555, 2.597	-6.616, 8.658
Temporal
Quadrant	59.038 (16.687)	57.782 (17.115)	1.256 (1.328)	0.708, 1.804	-1.399, 3.911
12-Sector - T	51.982 (12.679)	50.962 (13.564)	1.020 (1.978)	0.204, 1.837	-2.936, 4.977
12-Sector - TS	67.155 (22.260)	65.123 (21.840)	2.032 (2.820)	0.868, 3.196	-3.608, 7.672
12-Sector - ST	95.830 (30.338)	94.912 (28.697)	0.918 (6.753)	-1.869, 3.706	-12.588, 14.425
12-Sector - S	89.571 (26.762)	88.121 (28.353)	1.450 (10.658)	-2.949, 5.849	-19.866, 22.766
12-Sector - SN	79.480 (20.953)	75.993 (21.640)	3.488 (10.123)	-0.691, 7.666	-16.759, 23.734
12-Sector - NS	70.668 (16.907)	67.967 (16.928)	2.700 (5.434)	0.457, 4.944	-8.168, 13.569
12-Sector - N	53.123 (12.757)	51.976 (11.143)	1.147 (6.414)	-1.500, 3.795	-11.681, 13.975
12-Sector - NI	60.577 (16.930)	58.564 (15.905)	2.013 (3.398)	0.610, 3.415	-4.783, 8.809
12-Sector - IN	76.783 (25.112)	76.852 (26.862)	-0.070 (4.936)	-2.107, 1.968	-9.941, 9.802
12-Sector - I	102.504 (34.978)	101.589 (33.331)	0.915 (7.116)	-2.022, 3.852	-13.317, 15.146
12-Sector - IT	97.296 (35.771)	95.094 (40.387)	2.202 (7.800)	-1.017, 5.422	-13.397, 17.802
12-Sector - TI	58.015 (18.706)	57.283 (20.613)	0.732 (3.828)	-0.848, 2.312	-6.923, 8.387
Eye Population
Measurement	Triton
Mean (SD)	Maestro
Mean (SD)	Difference
Mean (SD)	95% CI for
Mean
Difference	95% LOA
for Mean
Difference
Normal Eyes (N = 25)
Average	107.354 (11.015)	108.169 (11.566)	-0.814 (1.908)	-1.602, -0.027	-4.630, 3.001
Superior Quadrant	130.096 (17.098)	131.482 (20.499)	-1.386 (7.274)	-4.389, 1.616	-15.935, 13.162
Nasal Quadrant	88.743 (15.978)	88.482 (15.462)	0.261 (3.208)	-1.063, 1.585	-6.154, 6.676
Inferior Quadrant	139.378 (17.855)	140.770 (17.669)	-1.392 (3.707)	-2.923, 0.138	-8.807, 6.022
Temporal
Quadrant	71.185 (11.286)	71.876 (12.218)	-0.691 (2.626)	-1.775, 0.393	-5.942, 4.560
12-Sector - T	60.930 (9.436)	60.679 (9.919)	0.252 (2.984)	-0.980, 1.483	-5.716, 6.219
12-Sector - TS	83.732 (13.893)	85.200 (15.400)	-1.468 (3.863)	-3.063, 0.126	-9.194, 6.257
12-Sector - ST	135.459 (21.305)	135.347 (20.653)	0.112 (4.739)	-1.844, 2.069	-9.366, 9.590
12-Sector - S	131.586 (31.448)	132.920 (33.696)	-1.334 (8.921)	-5.017, 2.348	-19.177, 16.508
12-Sector - SN	123.160 (25.442)	126.225 (29.338)	-3.064 (13.800)	-8.761, 2.632	-30.665, 24.536
12-Sector - NS	107.792 (22.235)	108.904 (21.782)	-1.112 (5.186)	-3.253, 1.028	-11.484, 9.259
12-Sector - N	71.100 (13.089)	70.450 (13.262)	0.650 (2.948)	-0.567, 1.867	-5.247, 6.547
12-Sector - NI	87.380 (17.264)	86.082 (16.425)	1.298 (5.874)	-1.126, 3.723	-10.451, 13.047
12-Sector - IN	126.187 (29.784)	127.289 (26.679)	-1.102 (7.030)	-4.004, 1.800	-15.163, 12.958
12-Sector-1	153.376 (23.110)	155.705 (24.597)	-2.329 (5.984)	-4.799, 0.141	-14.297, 9.639
12-Sector - IT	138.362 (24.574)	139.548 (25.863)	-1.185 (6.934)	-4.047, 1.677	-15.052, 12.682
12-Sector - TI	68.938 (13.733)	69.716 (15.192)	-0.779 (3.352)	-2.163, 0.605	-7.484, 5.926

Retinal Eyes (N = 26)
Average	101.483 (18.437)	100.567 (17.514)	0.916 (3.584)	-0.531, 2.364	-6.251, 8.083
Superior Quadrant	117.027 (23.434)	116.987 (21.533)	0.040 (10.090)	-4.036, 4.115	-20.139, 20.219
Nasal Quadrant	81.328 (19.988)	78.570 (18.803)	2.758 (4.512)	0.936, 4.581	-6.266, 11.782
Inferior Quadrant	126.324 (29.867)	126.047 (31.537)	0.277 (6.126)	-2.198, 2.751	-11.975, 12.528
Temporal
Quadrant	81.147 (13.619)	80.771 (13.617)	0.376 (3.045)	-0.854, 1.605	-5.713, 6.465
12-Sector - T	70.817 (11.701)	69.671 (12.591)	1.146 (3.818)	-0.396, 2.688	-6.489, 8.781
12-Sector - TS	98.327 (18.655)	98.862 (18.728)	-0.535 (4.284)	-2.265, 1.196	-9.102, 8.033
12-Sector - ST	131.285 (22.930)	132.223 (22.664)	-0.938 (11.287)	-5.497, 3.620	-23.512, 21.635
12-Sector - S	111.873 (33.165)	112.355 (31.226)	-0.482 (15.060)	-6.565, 5.601	-30.602, 29.638
12-Sector - SN	108.051 (25.327)	106.500 (23.645)	1.551 (10.750)	-2.791, 5.893	-19.950, 23.051
12-Sector - NS	96.147 (26.152)	93.692 (23.966)	2.455 (9.044)	-1.198, 6.108	-15.634, 20.543
12-Sector - N	71.181 (16.450)	68.018 (16.055)	3.163 (3.780)	1.636, 4.689	-4.396, 10.722
12-Sector - NI	76.690 (20.512)	74.092 (19.829)	2.598 (5.243)	0.480, 4.715	-7.889, 13.084
12-Sector - IN	105.134 (29.867)	101.650 (30.308)	3.483 (8.076)	0.221, 6.745	-12.669, 19.636
12-Sector - I	138.033 (37.295)	138.178 (38.677)	-0.145 (9.222)	-3.870, 3.580	-18.590, 18.300
12-Sector - IT	135.828 (32.544)	138.310 (34.948)	-2.482 (9.851)	-6.461, 1.497	-22.184, 17.219
12-Sector - TI	74.327 (15.359)	73.764 (16,108)	0.562 (5.924)	-1.831, 2.955	-11.286, 12.411
				95% Cl for	95% LOA
Eye Population	Triton	Maestro	Difference	Mean	for Mean
Measurement	Mean (SD)	Mean (SD)	Mean (SD)	Difference	Difference
Average	75.922 (16.232)	74.327 (16.764)	1.594 (2.491)	0.566, 2.622	-3.387, 6.575
Superior Quadrant	87.176 (21.723)	85.305 (22.301)	1.871 (4.917)	-0.159, 3.901	-7.964, 11.706
Nasal Quadrant	63.545 (12.881)	60.888 (14.002)	2.657 (5.273)	0.480, 4.834	-7.890, 13.204
Inferior Quadrant	91.852 (27.651)	90.576 (26.655)	1.275 (5.822)	-1.128, 3.679	-10.369, 12.920
Temporal
Quadrant	61.036 (16.731)	60.584 (17.475)	0.452 (2.725)	-0.673, 1.577	-4.998, 5.902
12-Sector - T	55.343 (13.456)	53.978 (13.430)	1.365 (2.598)	0.292, 2.437	-3.832, 6.562
12-Sector - TS	68.714 (21.816)	67.882 (23.312)	0.832 (4.834)	-1.163, 2.827	-8.836, 10.500
12-Sector - ST	95.236 (29.815)	95.524 (29.402)	-0.288 (7.453)	-3.365, 2.789	-15.194, 14.618
12-Sector - S	87.299 (27.281)	85.454 (29.440)	1.845 (7.227)	-1.138, 4.828	-12.608, 16.298
12-Sector - SN	79.082 (23.146)	74.832 (24.032)	4.250 (7.595)	1.115, 7.385	-10.941, 19.441
12-Sector - NS	71.338 (15.840)	67.757 (20.494)	3.581 (10.783)	-0.870, 8.032	-17.986, 25.148
12-Sector - N	55.734 (10.833)	53.993 (10.984)	1.740 (3.783)	0.179, 3.302	-5.826, 9.307
12-Sector - NI	63.469 (16.602)	61.000 (15.838)	2.469 (5.866)	0.048, 4.890	-9.262, 14.200
12-Sector - IN	78.248 (26.112)	77.536 (26.737)	0.713 (7.721)	-2.474, 3.900	-14.730, 16.156
12-Sector - I	102.256 (34.631)	99.734 (34.025)	2.522 (9.935)	-1.579, 6.623	-17.347, 22.391
12-Sector - IT	95.183 (35.802)	94.271 (36.536)	0.912 (7.374)	-2.132, 3.956	-13.836, 15.660
12-Sector - Tl	59.019 (18.529)	59.911 (20.885)	-0.892 (4.240)	-2.642, 0.858	-9.371, 7.587

Table 7. Limits of Agreement between Triton 12x9 Wide and Maestro 12x9 Wide: Ganglion Cell Complex Thickness (mm) Agreement Analysis Population

N is the number of eyes with measurements from both devices.

Difference = Triton - Maestro

95% confidence interval (CI) for mean difference is based on t-distribution.

15

Table 8. Limits of Agreement between Triton 6x6 Disc and Maestro 6x6 Disc: Optic Disc Agreement Analysis Population

N is the number of eyes with measurements from both devices.

Difference = Triton - Maestro

95% confidence interval (CI) for mean difference is based on t-distribution.

16

Table 9. Limits of Agreement between Triton 12x9 Wide and Maestro 12x9 Wide: Optic Disc Agreement Analysis Population

N is the number of eyes with measurements from both devices.

Difference = Triton - Maestro

95% confidence interval (CI) for mean difference is based on t-distribution.

17

Table 10. Limits of Agreement between Triton 6x6 Disc and Maestro 6x6 Disc: Retinal Nerve Fiber Layer Thickness (mm) Agreement Analysis Population

Glaucoma Eyes (N = 25)

18

T=Temporal; S=Superior; N=Nasal; I=Inferior

N is the number of eyes with measurements from both devices.

Difference = Triton - Maestro

95% confidence interval (CI) for mean difference is based on t-distribution.

19

Table 11. Limits of Agreement between Triton 12x9 Wide and Maestro 12x9 Wide: Retinal Nerve Fiber Layer Thickness (mm) Agreement Analysis Population

Glaucoma Eyes (N = 25)

20

T=Temporal; S=Superior; N=Nasal; I=Inferior

N is the number of eyes with measurements from both devices.

Difference = Triton - Maestro

95% confidence interval (CI) for mean difference is based on t-distribution.

95% limits of agreement (LOA) = mean difference +/- 2 x difference SD

Fundus Photograph Evaluation

An agreement analysis of fundus photograph image quality between the Triton and Maestro was performed for normal, retinal, and glaucoma eyes. Fundus photographs were graded on a 5-point scale, where a "1" indicated that the photograph was insufficient for any interpretation, "2" indicated that the photograph was insufficient for full interpretation, "3" represented an adequate photograph, "4" characterized a good photograph and "5" represented an excellent photograph. Grades of 1-2 represented images that provided no or little information to aid clinical decision making, whereas grades 3-5 indicated images which provided sufficient information for clinical judgment with various degrees of artifacts. Thus, images scoring 3 or above can be considered clinically useful.

Majority of the photographs were graded as good or excellent by both graders. The response rates (i.e., percentage of subjects whose Triton grades were equal to or better than their Maestro grades) ranged between 65.4% and 96%. Furthermore, the total agreement between graders for the Triton and Maestro fundus photograph grades ranged between 28% and 68% among the Triton photographs, and between 28% and 64% among Maestro photographs.

21

There were a total of 304 color fundus images evaluated by both graders in this study. Two-hundred and eighty nine (289) (95.1%) and 303 (99.7%) images received grade 3 or higher by graders 1 and 2, respectively. Importantly, over 95% of the photographs were considered clinically useful by both experts. Since this type of evaluation is subjective, the company performed a further analysis on image quality grades that differed by 1 point, as this difference is not considered significantly different when both graders' scores are 3 or above or 2 or below.

The images were categorized into two groups based on the grade differences where group 1 included images where the grades were off by at most one point between the graders and group 2 consisted of images that had a grade difference larger than 1 point between graders. Notably, the majority of images were in group 1 (n=291 (95.7%); 146 Triton and 145 Maestro).

Among all images (i.e., across groups 1 and 2), 14 images were considered clinically useful by one grader (grade 3 or above) and partial/not useful by the other grader (grade 2 or below). This was only a small fraction (4.6%) of all of the fundus photographs evaluated. Therefore, it is reasonable to conclude that the two graders generally agreed on the clinical utility of majority of the images.

Agreement Analysis of Anterior B Scan Image Quality

An agreement analysis of image quality of anterior corneal and anterior angle scans was performed for normal, retinal, and glaucoma eyes, respectively. B scans were graded on a 4-point scale, where "0" indicated a failure, "1" represented a poor image, "2" characterized a fair image and "3" represented a good image. Nearly all of the images (all Triton and 74 out of 76 Maestro images) were graded as fair or good by both graders. Notably, the response rates (i.e., percentage of subjects whose Triton grades were equal to or better than their Maestro grades) ranged between 92% and 100%.

Furthermore, the total agreement between graders was generally higher for Triton images (72% -100%) compared to Maestro images (48% - 80%).

Agreement Analysis of Posterior B Scan Image Quality

An agreement analysis of posterior B scan quality was also performed for normal, retinal, and glaucoma eyes, respectively. The posterior B scan images were graded using the same 4-point scale as the anterior B scan images. Similar to the previous sections, all of the grades were good or fair by both graders. Notably, the response rates (i.e., percentage of subjects whose Triton grades were equal to or better than their Maestro grades) ranged between 84.6% and 100%.

Agreement between graders was similar between the Triton and Maestro images, ranging between 64% and 96% among the Triton scans, and between 68% and 96% among Maestro scans. 34% of the images differed by one grade. These images all received grades of 2 or higher by both graders and can therefore be considered clinically useful.

22

| Device

Measurement	Mean	SD	Repeatability		SD	Reproducibility
			Limit (Ratio)	CV%		Limit (Ratio)	CV%
Triton 12x9 3D Wide
Central Fovea	252.59	1.324	3.708 (0.378)	0.524	1.678	4.699 (0.420)	0.664
Inner Superior	317.88	0.882	2.470 (0.486)	0.278	1.621	4.539 (0.648)	0.510
Inner Nasal	319.99	0.658	1.844 (0.367)	0.206	1.501	4.202 (0.582)	0.469
Inner Inferior	313.56	0.708	1.982 (0.297)	0.226	1.474	4.126 (0.480)	0.470
Inner Temporal	304.26	0.669	1.873 (0.371)	0.220	1.447	4.051 (0.556)	0.475
Outer Superior	273.69	1.065	2.982 (0.729)	0.389	1.579	4.420 (0.802)	0.577
Outer Nasal	290.85	0.687	1.923 (0.646)	0.236	1.462	4.094 (0.869)	0.503
Outer Inferior	263.16	0.816	2.285 (0.655)	0.310	1.422	3.982 (0.810)	0.540
Outer Temporal	259.08	0.713	1.995 (0.690)	0.275	1.379	3.861 (0.918)	0.532
Triton 7x7 3D Macula
Central Fovea	252.63	1.003	2.809 (0.486)	0.397	1.535	4.298 (0.587)	0.608
Inner Superior	318.34	0.833	2.334 (0.480)	0.262	1.457	4.080 (0.629)	0.458
Inner Nasal	319.64	0.996	2.788 (0.646)	0.311	1.835	5.137 (0.830)	0.574
Inner Inferior	313.69	0.970	2.717 (0.573)	0.309	1.762	4.934 (0.750)	0.562
Inner Temporal	303.77	0.992	2.776 (0.620)	0.326	1.877	5.254 (0.932)	0.618
Outer Superior	273.55	0.971	2.718 (0.614)	0.355	1.545	4.325 (0.660)	0.565
Outer Nasal	289.79	0.609	1.706 (0.576)	0.210	1.395	3.905 (0.845)	0.481
Outer Inferior	262.96	0.984	2.755 (0.889)	0.374	1.702	4.765 (0.971)	0.647
Outer Temporal	257.36	0.994	2.784 (0.827)	0.386	1.653	4.629 (0.902)	0.642
Maestro 12x9 3D Wide
Central Fovea	253.28	3.508	9.822	1.385	3.999	11.198	1.579
Inner Superior	319.05	1.814	5.080	0.569	2.501	7.002	0.784
Inner Nasal	320.63	1.793	5.019	0.559	2.579	7.222	0.804
Inner Inferior	314.57	2.387	6.684	0.759	3.071	8.598	0.976
Inner Temporal	304.92	1.801	5.042	0.591	2.603	7.289	0.854
Outer Superior	275.89	1.461	4.091	0.530	1.970	5.515	0.714
Outer Nasal	291.56	1.063	2.978	0.365	1.683	4.713	0.577
Outer Inferior	264.28	1.247	3.491	0.472	1.756	4.916	0.664
Outer Temporal	260.87	1.033	2.892	0.396	1.501	4.204	0.576
Maestro 6x6 3D Macula
Central Fovea	251.10	2.063	5.777	0.822	2.615	7.321	1.041
Inner Superior	320.29	1.736	4.862	0.542	2.316	6.484	0.723
Device
Measurement	Mean	SD	Repeatability		Reproducibility
			Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
N=25
Inner Nasal	321.16	1.540	4.313	0.480	2.212	6.192	0.689
Inner Inferior	314.86	1.694	4.742	0.538	2.349	6.576	0.746
Inner Temporal	304.67	1.598	4.475	0.525	2.012	5.635	0.661
Outer Superior	275.81	1.580	4.423	0.573	2.341	6.555	0.849
Outer Nasal	290.89	1.058	2.962	0.364	1.649	4.618	0.567
Outer Inferior	264.49	1.107	3.098	0.418	1.753	4.909	0.663
Outer Temporal	258.04	1.203	3.369	0.466	1.832	5.130	0.710
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance
and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility limit = 2.8 x Reproducibility SD Repeatability
CV% = (Repeatability SD)/Intercept x 100%

Table 12: Full Retinal Thickness – Normal Eyes Repeatability and Reproducibility

Page 20 of 60

23

Reproducibility CV% = (Reproducibility SD)/Intercept x 100%

Ratio is relative to Maestro

	N=26
	Repeatability			Reproducibility
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Triton 12x9 3D Wide
Central Fovea	280.33	1.744	4.883 (0.383)	0.622	3.278	9.179 (0.638)	1.169
Inner Superior	317.80	1.730	4.844 (0.848)	0.544	2.241	6.275 (0.920)	0.705
Inner Nasal	320.34	1.091	3.055 (0.492)	0.341	2.548	7.134 (0.874)	0.795
Inner Inferior	311.02	2.080	5.825 (0.499)	0.669	2.966	8.304 (0.635)	0.954
Inner Temporal	304.94	1.111	3.110 (0.285)	0.364	1.989	5.568 (0.423)	0.652
Outer Superior	271.85	1.351	3.782 (0.698)	0.497	2.347	6.571 (0.816)	0.863
Outer Nasal	287.08	0.850	2.379 (0.263)	0.296	1.671	4.678 (0.508)	0.582
Outer Inferior	258.50	1.584	4.434 (0.516)	0.613	2.420	6.777 (0.617)	0.936
Outer Temporal	254.49	0.958	2.681 (0.346)	0.376	1.822	5.102 (0.585)	0.716
Triton 7x7 3D Macula
Central Fovea	287.46	2.306	6.457 (0.579)	0.802	2.513	7.037 (0.573)	0.874
Inner Superior	319.75	1.223	3.425 (0.692)	0.383	2.691	7.536 (1.063)	0.842

Table 13: Full Retinal Thickness - Retinal Disease Eyes Repeatability and Reproducibility

24

N=26
Device
Measurement	Mean	Repeatability				Reproducibility
		SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Inner Nasal	321.74	1.503	4.208 (0.871)	0.467	2.356	6.596 (0.846)	0.732
Inner Inferior	314.69	2.706	7.577 (0.755)	0.860	2.948	8.255 (0.651)	0.937
Inner Temporal	310.48	1.427	3.995 (0.701)	0.460	2.338	6.548 (0.721)	0.753
Outer Superior	273.46	1.414	3.960 (0.767)	0.517	2.057	5.760 (0.804)	0.752
Outer Nasal	285.76	1.581	4.426 (0.801)	0.553	2.046	5.728 (0.785)	0.716
Outer Inferior	260.01	1.580	4.425 (0.582)	0.608	1.982	5.549 (0.499)	0.762
Outer Temporal	256.36	1.827	5.115 (0.795)	0.713	2.134	5.976 (0.816)	0.832
Maestro 12x9 3D Wide
Central Fovea	283.84	4.551	12.744	1.603	5.136	14.381	1.810
Inner Superior	321.04	2.039	5.710	0.635	2.436	6.821	0.759
Inner Nasal	322.71	2.220	6.215	0.688	2.917	8.167	0.904
Inner Inferior	313.47	4.172	11.682	1.331	4.670	13.075	1.490
Inner Temporal	308.35	3.900	10.919	1.265	4.704	13.170	1.525
Outer Superior	275.47	1.936	5.420	0.703	2.876	8.054	1.044
Outer Nasal	289.01	3.226	9.033	1.116	3.290	9.211	1.138
Outer Inferior	261.73	3.069	8.593	1.173	3.925	10.990	1.500
Outer Temporal	258.43	2.768	7.749	1.071	3.115	8.722	1.205
Maestro 6x6 3D Macula
Central Fovea	289.94	3.981	11.147	1.373	4.389	12.289	1.514
Inner Superior	323.40	1.767	4.947	0.546	2.532	7.091	0.783
Inner Nasal	324.67	1.725	4.829	0.531	2.784	7.796	0.858
Inner Inferior	318.98	3.583	10.031	1.123	4.529	12.681	1.420
Inner Temporal	315.77	2.035	5.697	0.644	3.244	9.083	1.027
Outer Superior	276.69	1.843	5.162	0.666	2.560	7.168	0.925
Outer Nasal	287.87	1.974	5.528	0.686	2.605	7.295	0.905
Outer Inferior	265.57	2.716	7.606	1.023	3.968	11.110	1.494
Outer Temporal	259.89	2.298	6.434	0.884	2.617	7.327	1.007
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.

Mean = Intercept of the ANOVA model

Repeatability SD = Square root of the residual variance

Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance and the residual variance

Repeatability limit = 2.8 x Repeatability SD Reproducibility limit = 2.8 x Reproducibility SD Repeatability CV% = (Repeatability SD)/Intercept x 100%

Reproducibility CV% = (Reproducibility SD)/Intercept x 100%

Ratio is relative to Maestro

25

		N=25
		Repeatability				Reproducibility
Device	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Triton 12x9 3D Wide
Central Fovea	243.46	1.336	3.740 (0.547)	0.549	1.723	4.825 (0.595)	0.708
Inner Superior	289.35	0.639	1.790 (0.532)	0.221	1.261	3.531 (0.695)	0.436
Inner Nasal	293.46	0.517	1.447 (0.377)	0.176	1.330	3.725 (0.734)	0.453
Inner Inferior	284.12	0.682	1.909 (0.425)	0.240	1.196	3.348 (0.578)	0.421
Inner Temporal	279.25	0.651	1.822 (0.484)	0.233	1.414	3.960 (0.817)	0.507
Outer Superior	247.48	0.781	2.187 (0.593)	0.316	1.164	3.260 (0.648)	0.470
Outer Nasal	260.96	0.628	1.759 (0.786)	0.241	1.240	3.471 (1.055)	0.475
Outer Inferior	234.09	0.709	1.986 (0.769)	0.303	1.164	3.259 (0.932)	0.497
Outer Temporal	236.77	0.627	1.755 (0.646)	0.265	1.225	3.430 (0.874)	0.517
Triton 7x7 3D Macula
Central Fovea	242.89	1.168	3.270 (0.964)	0.481	1.837	5.145 (0.837)	0.757
Inner Superior	285.91	0.741	2.075 (0.689)	0.259	1.394	3.902 (0.738)	0.487
Inner Nasal	291.98	1.093	3.059 (1.193)	0.374	1.701	4.763 (0.915)	0.583
Inner Inferior	284.67	0.787	2.204 (0.750)	0.277	1.448	4.054 (0.750)	0.509
Inner Temporal	278.01	0.939	2.630 (0.888)	0.338	1.670	4.677 (0.933)	0.601
Outer Superior	245.09	1.723	4.825 (1.647)	0.703	1.870	5.235 (1.171)	0.763
Outer Nasal	259.83	0.620	1.735 (0.707)	0.238	1.249	3.496 (0.852)	0.481
Outer Inferior	234.38	0.953	2.667 (0.886)	0.406	1.479	4.141 (0.947)	0.631
Outer Temporal	235.39	0.734	2.054 (0.950)	0.312	1.307	3.658 (0.954)	0.555
Maestro 12x9 3D Wide
Central Fovea	245.56	2.443	6.840	0.995	2.895	8.106	1.179
Inner Superior	292.28	1.201	3.362	0.411	1.814	5.080	0.621
Inner Nasal	295.99	1.371	3.838	0.463	1.813	5.075	0.612
Inner Inferior	286.72	1.605	4.493	0.560	2.068	5.791	0.721
Inner Temporal	282.13	1.345	3.765	0.477	1.732	4.849	0.614
Outer Superior	250.04	1.317	3.687	0.527	1.796	5.028	0.718
Outer Nasal	262.55	0.799	2.238	0.304	1.175	3.291	0.448
Outer Inferior	235.74	0.922	2.583	0.391	1.249	3.496	0.530
Outer Temporal	239.35	0.971	2.718	0.406	1.402	3.925	0.586
Maestro 6x6 3D Macula
Central Fovea	245.22	1.212	3.393	0.494	2.196	6.150	0.896
Inner Superior	289.35	1.075	3.010	0.372	1.889	5.289	0.653
Inner Nasal	295.42	0.916	2.565	0.310	1.858	5.203	0.629
Inner Inferior	287.51	1.050	2.939	0.365	1.931	5.407	0.672
N=25
Repeatability				Reproducibility
Device	Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Inner Temporal	281.56	1.058	2.963	0.376	1.791	5.015	0.636
Outer Superior	248.27	1.046	2.929	0.421	1.597	4.470	0.643
Outer Nasal	261.64	0.876	2.453	0.335	1.465	4.102	0.560
Outer Inferior	237.05	1.075	3.011	0.454	1.562	4.374	0.659
Outer Temporal	237.44	0.772	2.163	0.325	1.370	3.835	0.577
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance
and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility
limit = 2.8 x Reproducibility SD Repeatability CV% =
(Repeatability SD)/Intercept x 100%
Reproducibility CV% = (Reproducibility SD)/Intercept x 100%
Ratio is relative to Maestro

Table 14: Full Retinal Thickness - Glaucoma Eyes Repeatability and Reproducibility

Page 23 of 60

26

| Device

Measurement	Mean	SD	Repeatability			Reproducibility
			Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
N=25
Triton 12x9 3D Wide
Superior	70.43	0.533	1.491 (0.835)	0.756	0.670	1.875 (0.961)	0.951
Superior Nasal	74.84	0.402	1.125 (0.787)	0.537	0.488	1.365 (0.798)	0.651
Superior Temporal	70.78	0.492	1.378 (0.954)	0.695	0.593	1.659 (0.988)	0.837
Inferior	67.82	0.406	1.135 (0.709)	0.598	0.466	1.304 (0.609)	0.687
Inferior Nasal	73.32	0.361	1.010 (0.632)	0.492	0.442	1.239 (0.650)	0.603
Inferior Temporal	72.25	0.495	1.386 (0.910)	0.685	0.575	1.610 (0.933)	0.796
Average	71.58	0.268	0.749 (1.235)	0.374	0.339	0.950 (1.019)	0.474
Triton 7x7 3D Macula
Superior	69.96	0.430	1.204 (0.824)	0.615	0.600	1.681 (0.991)	0.858
Superior Nasal	74.62	0.375	1.051 (0.794)	0.503	0.485	1.358 (0.926)	0.650
Superior Temporal	71.62	0.589	1.650 (1.029)	0.823	0.700	1.961 (1.123)	0.978
Inferior	67.36	0.452	1.266 (0.926)	0.671	0.621	1.739 (0.879)	0.922
Inferior Nasal	73.02	0.467	1.308 (1.103)	0.640	0.591	1.656 (1.005)	0.810

Table 15: Ganglion Cell + IPL - Normal Eyes Repeatability and Reproducibility

27

Inferior Temporal	72.86	0.657	1.839 (1.353)	0.902	0.761	2.131 (1.217)	1.045
Average	71.58	0.227	0.635 (0.907)	0.317	0.388	1.087 (1.015)	0.543
Maestro 12x9 3D Wide
Superior	72.13	0.638	1.787	0.885	0.697	1.952	0.966
Superior Nasal	76.50	0.511	1.430	0.667	0.611	1.711	0.799
Superior Temporal	72.44	0.516	1.445	0.712	0.600	1.679	0.828
Inferior	69.15	0.572	1.601	0.827	0.765	2.142	1.106
Inferior Nasal	74.89	0.571	1.599	0.763	0.680	1.905	0.908
Inferior Temporal	73.92	0.544	1.522	0.736	0.616	1.725	0.833
Average	73.17	0.217	0.607	0.296	0.333	0.932	0.455
Maestro 6x6 3D Macula
Superior	72.21	0.522	1.461	0.723	0.606	1.697	0.839
Superior Nasal	76.41	0.473	1.324	0.619	0.524	1.467	0.686
Superior Temporal	72.53	0.573	1.604	0.790	0.623	1.745	0.859
Inferior	69.60	0.488	1.367	0.701	0.707	1.980	1.016
Inferior Nasal	74.89	0.424	1.186	0.566	0.588	1.648	0.786
Inferior Temporal	74.05	0.485	1.359	0.655	0.625	1.751	0.845
Average	73.30	0.250	0.700	0.341	0.383	1.071	0.522
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance
and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility limit = 2.8 x Reproducibility SD Repeatability
CV% = (Repeatability SD)/Intercept x 100%
Reproducibility CV% = (Reproducibility SD)/Intercept x 100%
Ratio is relative to Maestro

Table 16: Ganglion Cell + IPL - Retinal Disease Eyes Repeatability and Reproducibility

	N=26
		Repeatability			Reproducibility
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Triton 12x9 3D Wide
Superior	67.77	1.374	3.846 (0.799)	2.027	1.624	4.548 (0.798)	2.397
Superior Nasal	72.16	1.088	3.046 (0.442)	1.508	1.108	3.103 (0.432)	1.536
Superior Temporal	68.94	1.817	5.089 (0.765)	2.636	2.243	6.281 (0.944)	3.254
Inferior	64.28	1.074	3.007 (0.575)	1.671	1.324	3.706 (0.625)	2.059
Inferior Nasal	71.26	1.019	2.854 (0.710)	1.430	1.244	3.483 (0.803)	1.746
Inferior Temporal	70.87	1.301	3.644 (0.795)	1.836	1.361	3.810 (0.630)	1.920

28

		N=26
		Repeatability
Reproducibility
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Average	69.21	0.547	1.532 (0.698)	0.790	0.732	2.049 (0.872)	1.057

Triton 7x7 3D Macula
Superior	66.83	0.996	2.789 (0.994)	1.490	1.251	3.503 (0.889)	1.872
Superior Nasal	70.15	1.036	2.901 (0.860)	1.477	1.207	3.379 (0.768)	1.720
Superior Temporal	72.16	1.370	3.836 (1.025)	1.899	1.660	4.648 (0.967)	2.300
Inferior	64.20	0.965	2.703 (0.742)	1.504	1.065	2.982 (0.553)	1.659
Inferior Nasal	69.54	1.063	2.976 (0.905)	1.528	1.096	3.068 (0.758)	1.575
Inferior Temporal	73.32	0.835	2.338 (0.694)	1.139	1.069	2.994 (0.719)	1.459
Average	69.38	0.499	1.397 (0.942)	0.719	0.578	1.619 (0.920)	0.833

Maestro 12x9 3D Wide
Superior	റ്റു. 55	1.719	4.813	2.471	2.037	5.702	2.928
Superior Nasal	73.91	2.461	6.890	3.329	2.564	7.180	3.469
Superior Temporal	70.61	2.375	6.651	3.364	2.375	6.651	3.364
Inferior	65.72	1.868	5.229	2.842	2.118	5.930	3.223
Inferior Nasal	72.78	1.436	4.021	1.973	1.550	4.340	2.130
Inferior Temporal	72.59	1.637	4.584	2.255	2.159	6.045	2.974
Average	70.84	0.784	2.195	1.106	0.839	2.349	1.184

Maestro 6x6 3D Macula
Superior	68.47	1.002	2.805	1.463	1.407	3.940	2.055
Superior Nasal	71.44	1.205	3.375	1.687	1.570	4.397	2.198
Superior Temporal	72.98	1.336	3.741	1.831	1.717	4.808	2.353
Inferior	66.85	1.300	3.640	1.945	1.927	5.397	2.883
Inferior Nasal	71.33	1.174	3.289	1.646	1.446	4.048	2.027
Inferior Temporal	74.89	1.203	3.368	1.606	1.488	4.166	1.987
Average	70.99	0.530	1.483	0.746	0.629	1.760	0.886
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance
and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility limit = 2.8 x Reproducibility SD Repeatability
CV% = (Repeatability SD)/Intercept x 100%
Reproducibility CV% = (Reproducibility SD)/Intercept x 100%
Ratio is relative to Maestro

29

| | | Repeatability
Reproducibility | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|----------------------------------|---------------|-------|-------|---------------|-------|
| Device | | | | | | | |
| Measurement | Mean | SD | Limit (Ratio) | CV% | SD | Limit (Ratio) | CV% |
| Triton 12x9 3D Wide | | | | | | | |
| Superior | 56.47 | 0.892 | 2.496 (0.779) | 1.579 | 1.002 | 2.806 (0.757) | 1.774 |
| Superior Nasal | 60.62 | 0.454 | 1.272 (0.656) | 0.749 | 0.531 | 1.487 (0.730) | 0.876 |
| Superior Temporal | 58.02 | 0.754 | 2.112 (0.567) | 1.300 | 0.860 | 2.408 (0.591) | 1.482 |
| Inferior | 52.63 | 0.597 | 1.671 (0.620) | 1.134 | 0.656 | 1.837 (0.602) | 1.246 |
| Inferior Nasal | 57.96 | 0.572 | 1.601 (0.619) | 0.986 | 0.628 | 1.758 (0.665) | 1.083 |
| Inferior Temporal | 55.91 | 0.936 | 2.621 (0.438) | 1.674 | 1.109 | 3.106 (0.459) | 1.984 |
| Average | 56.94 | 0.354 | 0.990 (0.459) | 0.621 | 0.460 | 1.288 (0.522) | 0.808 |
| | | | | | | | |
| Triton 7x7 3D Macula | | | | | | | |
| Superior | 55.58 | 0.514 | 1.439 (0.847) | 0.925 | 0.652 | 1.826 (0.993) | 1.173 |
| Superior Nasal | 59.67 | 0.419 | 1.172 (0.991) | 0.702 | 0.495 | 1.386 (0.939) | 0.830 |
| Superior Temporal | 61.24 | 0.829 | 2.320 (1.117) | 1.353 | 0.868 | 2.429 (1.091) | 1.417 |
| Inferior | 53.45 | 0.544 | 1.522 (0.650) | 1.017 | 0.717 | 2.008 (0.816) | 1.342 |
| Inferior Nasal | 58.12 | 0.641 | 1.794 (0.902) | 1.102 | 0.756 | 2.116 (0.955) | 1.300 |
| Inferior Temporal | 60.85 | 0.825 | 2.309 (1.135) | 1.355 | 1.013 | 2.836 (1.138) | 1.664 |
| Average | 58.16 | 0.300 | 0.840 (0.848) | 0.516 | 0.419 | 1.173 (0.947) | 0.720 |
| | | | | | | | |
| Maestro 12x9 3D Wide | | | | | | | |
| Superior | 57.55 | 1.145 | 3.205 | 1.989 | 1.323 | 3.704 | 2.299 |
| Superior Nasal | 62.01 | 0.693 | 1.939 | 1.117 | 0.727 | 2.036 | 1.173 |
| Superior Temporal | 58.60 | 1.331 | 3.727 | 2.271 | 1.456 | 4.076 | 2.484 |
| Inferior | 53.37 | 0.963 | 2.696 | 1.804 | 1.090 | 3.052 | 2.043 |
| Inferior Nasal | 59.08 | 0.923 | 2.584 | 1.562 | 0.944 | 2.644 | 1.598 |
| Inferior Temporal | 56.34 | 2.136 | 5.981 | 3.791 | 2.418 | 6.771 | 4.292 |
| Average | 57.83 | 0.771 | 2.158 | 1.333 | 0.881 | 2.468 | 1.524 |
| | | | | | | | |
| Maestro 6x6 3D Macula | | | | | | | |
| Superior | 57.21 | 0.607 | 1.699 | 1.061 | 0.657 | 1.839 | 1.148 |
| Superior Nasal | 61.02 | 0.423 | 1.183 | 0.692 | 0.528 | 1.477 | 0.864 |
| Superior Temporal | 61.74 | 0.742 | 2.078 | 1.202 | 0.795 | 2.226 | 1.288 |
| Inferior | 54.91 | 0.836 | 2.342 | 1.523 | 0.879 | 2.462 | 1.601 |
| Inferior Nasal | 59.39 | 0.710 | 1.989 | 1.196 | 0.792 | 2.216 | 1.333 |
| Inferior Temporal | 60.86 | 0.727 | 2.035 | 1.194 | 0.890 | 2.492 | 1.463 |
| Average | 59.21 | 0.353 | 0.990 | 0.597 | 0.443 | 1.239 | 0.747 |
| All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model | | | | | | | |

Table 17: Ganglion Cell + IPL - Glaucoma Eyes Repeatability and Reproducibility

30

	N=25
		Repeatability			Reproducibility
Device	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Measurement
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance
and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility limit = 2.8 x Reproducibility SD Repeatability
CV% = (Repeatability SD)/Intercept x 100%
Reproducibility CV% = (Reproducibility SD)/Intercept x 100%
Ratio is relative to Maestro

Table 18: Ganglion Cell Complex Thickness - Normal Eyes Repeatability and Reproducibility

	N=25
Device
Measurement	Mean	SD	Repeatability
Limit (Ratio)	CV%	SD	Reproducibility
Limit (Ratio)	CV%
Triton 12x9 3D Wide
Superior	107.53	0.733	2.053 (0.976)	0.682	0.850	2.381 (0.819)	0.791
Superior Nasal	119.49	0.611	1.711 (0.904)	0.511	0.805	2.253 (0.776)	0.673
Superior Temporal	94.52	0.565	1.583 (1.090)	0.598	0.771	2.159 (1.132)	0.816
Inferior	106.94	0.598	1.673 (0.875)	0.559	0.785	2.198 (0.938)	0.734
Inferior Nasal	119.67	0.548	1.534 (0.820)	0.458	0.787	2.205 (0.929)	0.658
Inferior Temporal	97.88	0.542	1.518 (0.885)	0.554	0.818	2.290 (1.129)	0.836
Average	107.68	0.445	1.247 (0.988)	0.413	0.640	1.792 (1.060)	0.594
Triton 7x7 3D Macula
Superior	107.79	0.683	1.913 (1.069)	0.634	0.875	2.449 (1.048)	0.811
Superior Nasal	118.85	0.498	1.395 (0.839)	0.419	0.674	1.887 (0.857)	0.567
Superior Temporal	93.99	0.723	2.024 (1.129)	0.769	0.933	2.612 (1.121)	0.993
Inferior	106.91	0.677	1.894 (1.023)	0.633	0.918	2.570 (1.112)	0.859
Inferior Nasal	119.68	0.660	1.849 (1.068)	0.552	0.803	2.249 (0.997)	0.671
Inferior Temporal	97.37	0.733	2.051 (1.095)	0.752	1.014	2.840 (1.083)	1.042
Average	107.43	0.461	1.292 (1.050)	0.430	0.654	1.830 (1.164)	0.608
Maestro 12x9 3D Wide
Superior	107.56	0.751	2.104	0.699	1.038	2.905	0.965
Superior Nasal	119.41	0.676	1.893	0.566	1.037	2.905	0.869
Superior Temporal	94.90	0.519	1.453	0.547	0.681	1.908	0.718
Inferior	106.60	0.683	1.912	0.641	0.837	2.343	0.785
Inferior Nasal	119.63	0.668	1.871	0.558	0.847	2.372	0.708
Inferior Temporal	98.30	0.612	1.714	0.623	0.724	2.028	0.737

31

Average	107.74	0.451	1.262	0.418	0.604	1.692	0.561
Maestro 6x6 3D Macula
Superior	108.45	0.639	1.790	0.589	0.834	2.336	0.769
Superior Nasal	119.43	0.594	1.662	0.497	0.786	2.201	0.658
Superior Temporal	94.34	0.640	1.792	0.679	0.832	2.330	0.882
Inferior	107.32	0.662	1.853	0.616	0.826	2.312	0.769
Inferior Nasal	120.13	0.618	1.731	0.515	0.806	2.257	0.671
Inferior Temporal	97.66	0.669	1.874	0.685	0.937	2.623	0.959
Average	107.91	0.439	1.230	0.407	0.562	1.572	0.520
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance
and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility limit = 2.8 x Reproducibility SD Repeatability
CV% = (Repeatability SD)/Intercept x 100%
Reproducibility CV% = (Reproducibility SD)/Intercept x 100%
Ratio is relative to Maestro

N=26
	Repeatability			Reproducibility
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Triton 12x9 3D Wide
Superior	111.84	1.191	3.334 (0.358)	1.065	1.623	4.546 (0.486)	1.452
Superior Nasal	121.50	0.972	2.722 (0.588)	0.800	1.281	3.588 (0.763)	1.055
Superior Temporal	97.08	0.783	2.192 (0.494)	0.806	1.121	3.138 (0.678)	1.155
Inferior	108.10	0.988	2.767 (0.417)	0.914	1.308	3.662 (0.539)	1.210
Inferior Nasal	121.86	0.863	2.417 (0.635)	0.708	1.144	3.203 (0.752)	0.939
Inferior Temporal	99.58	0.793	2.222 (0.467)	0.797	1.179	3.301 (0.606)	1.184
Average	110.00	0.558	1.562 (0.503)	0.507	0.949	2.658 (0.837)	0.863
Triton 7x7 3D Macula
Superior	113.26	1.257	3.519 (1.071)	1.110	1.433	4.014 (1.150)	1.266
Superior Nasal	121.49	1.051	2.943 (1.110)	0.865	1.207	3.381 (1.044)	0.994
Superior Temporal	98.87	1.049	2.938 (1.027)	1.061	1.231	3.448 (0.968)	1.245
Inferior	107.98	1.099	3.078 (0.570)	1.018	1.264	3.539 (0.560)	1.170
N=26
Device	Measurement	Repeatability				Reproducibility
		Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
	Inferior Nasal	122.86	1.402	3.925 (1.107)	1.141	1.465	4.103 (1.079)	1.193
	Inferior Temporal	99.92	0.990	2.772 (1.040)	0.991	1.125	3.151 (0.773)	1.126
	Average	110.74	0.895	2.506 (1.221)	0.808	0.985	2.759 (1.130)	0.890
Maestro 12x9 3D Wide	Superior	111.53	3.321	9.300	2.978	3.339	9.350	2.994
	Superior Nasal	121.29	1.652	4.626	1.362	1.680	4.705	1.385
	Superior Temporal	97.38	1.584	4.435	1.626	1.654	4.631	1.698
	Inferior	107.44	2.371	6.638	2.207	2.426	6.794	2.258
	Inferior Nasal	121.19	1.359	3.806	1.122	1.521	4.258	1.255
	Inferior Temporal	99.42	1.698	4.753	1.707	1.947	5.452	1.958
	Average	109.71	1.109	3.104	1.010	1.134	3.175	1.034
Maestro 6x6 3D Macula	Superior	113.61	1.173	3.285	1.033	1.247	3.490	1.097
	Superior Nasal	121.98	0.947	2.651	0.776	1.157	3.239	0.948
	Superior Temporal	99.53	1.022	2.860	1.026	1.272	3.563	1.278
	Inferior	109.50	1.929	5.400	1.761	2.256	6.318	2.061
	Inferior Nasal	122.82	1.266	3.545	1.031	1.357	3.801	1.105
	Inferior Temporal	100.82	0.952	2.665	0.944	1.455	4.075	1.444
	Average	111.40	0.733	2.053	0.658	0.872	2.443	0.783
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance
and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility
limit = 2.8 x Reproducibility SD Repeatability CV% =
(Repeatability SD)/Intercept x 100%
Reproducibility CV% = (Reproducibility SD)/Intercept x 100%
Ratio is relative to Maestro
Device
Measurement	Mean	SD	Repeatability
Limit (Ratio)	CV%	SD	Reproducibility
Limit (Ratio)	CV%
Triton 12x9 3D Wide
Superior	88.57	0.562	1.574 (0.758)	0.635	0.669	1.873 (0.764)	0.755
Superior Nasal	99.75	0.575	1.609 (0.942)	0.576	0.716	2.006 (0.894)	0.718
Superior Temporal	79.84	0.516	1.444 (0.784)	0.646	0.728	2.037 (1.069)	0.911
Inferior	83.89	0.543	1.521 (0.752)	0.647	0.687	1.922 (0.849)	0.818
Inferior Nasal	96.57	0.563	1.578 (0.867)	0.583	0.723	2.026 (0.847)	0.749
Inferior Temporal	78.07	0.526	1.472 (0.785)	0.673	0.783	2.191 (1.029)	1.002
Average	87.79	0.380	1.065 (0.917)	0.433	0.568	1.590 (1.138)	0.647
Triton 7x7 3D Macula
Superior	86.95	0.568	1.591 (0.845)	0.653	0.659	1.844 (0.785)	0.757
Superior Nasal	97.69	0.641	1.795 (0.768)	0.656	0.827	2.314 (0.763)	0.846
Superior Temporal	78.60	0.555	1.555 (0.980)	0.707	0.699	1.958 (1.097)	0.890
Inferior	84.05	0.560	1.569 (0.788)	0.667	0.785	2.197 (0.953)	0.934
Inferior Nasal	96.81	0.551	1.541 (0.718)	0.569	0.822	2.301 (0.896)	0.849
Inferior Temporal	77.95	0.526	1.472 (1.039)	0.674	0.743	2.081 (1.127)	0.953
Average	87.01	0.356	0.998 (0.869)	0.410	0.571	1.599 (1.061)	0.656
Maestro 12x9 3D Wide
Superior	88.16	0.742	2.077	0.841	0.876	2.453	0.993
Superior Nasal	99.17	0.610	1.707	0.615	0.801	2.243	0.808
Superior Temporal	79.70	0.658	1.842	0.825	0.681	1.906	0.854
Inferior	83.04	0.722	2.023	0.870	0.809	2.265	0.974
Inferior Nasal	95.79	0.650	1.820	0.679	0.854	2.392	0.892
Inferior Temporal	77.64	0.669	1.874	0.862	0.761	2.130	0.980
Average	87.26	0.415	1.162	0.475	0.499	1.397	0.572
Maestro 6x6 3D Macula
Superior	86.72	0.672	1.882	0.775	0.839	2.349	0.968
Superior Nasal	97.45	0.835	2.338	0.857	1.084	3.035	1.112
Superior Temporal	78.45	0.567	1.588	0.723	0.637	1.784	0.812
Inferior	83.75	0.711	1.992	0.849	0.823	2.305	0.983
Inferior Nasal	96.34	0.766	2.146	0.796	0.918	2.570	0.953
Inferior Temporal	77.53	0.506	1.416	0.653	0.659	1.846	0.850
Average	86.73	0.410	1.149	0.473	0.538	1.508	0.621
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model

Table 19: Ganglion Cell Complex Thickness - Retinal Disease Eyes Repeatability and Reproducibility

32

|Ratio is relative to Maestro

33

Table 20: Ganglion Cell Complex Thickness - Glaucoma Eyes Repeatability and Reproducibility

34

		N=25
Device
Measurement	Mean	Repeatability		Reproducibility
		SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance
and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
Reproducibility CV% = (Reproducibility SD)/Intercept x 100%
Ratio is relative to Maestro

Table 21: Retinal Nerve Fiber Layer - Normal Eyes Repeatability and Reproducibility

		N=25
			Repeatability			Reproducibility
Device	Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Triton 12x9 3D Wide	Average	107.44	0.938	2.626 (0.718)	0.873	1.123	3.146 (0.815)	1.046
	Superior Quadrant	130.51	2.945	8.246 (0.751)	2.257	3.123	8.744 (0.739)	2.393
	Nasal Quadrant	89.22	1.730	4.845 (0.845)	1.940	2.128	5.960 (0.930)	2.386
	Inferior Quadrant	138.76	2.238	6.265 (0.825)	1.613	2.313	6.476 (0.757)	1.667
	Temporal
Quadrant	71.27	1.026	2.872 (0.860)	1.439	1.392	3.897 (1.066)	1.953
	12-Sector - T	60.67	1.087	3.043 (0.757)	1.791	1.402	3.926 (0.854)	2.311
	12-Sector - TS	84.33	1.808	5.061 (0.933)	2.143	2.068	5.790 (0.950)	2.452
	12-Sector - ST	136.50	3.515	9.842 (0.914)	2.575	3.976	11.132 (0.925)	2.913
	12-Sector - S	131.83	4.887	13.684 (0.775)	3.707	5.123	14.343 (0.767)	3.886
	12-Sector - SN	123.16	4.486	12.561 (0.671)	3.642	4.661	13.051 (0.648)	3.785
	12-Sector - NS	107.10	3.628	10.160 (0.894)	3.388	4.080	11.423 (0.854)	3.809
	12-Sector - N	71.92	1.417	3.967 (0.619)	1.970	1.873	5.244 (0.783)	2.604
	12-Sector - NI	88.58	2.843	7.961 (0.913)	3.210	3.522	9.862 (1.011)	3.976
	12-Sector - IN	126.13	4.001	11.204 (0.860)	3.172	4.179	11.701 (0.856)	3.313
	12-Sector - I	153.34	3.467	9.708 (0.776)	2.261	3.943	11.040 (0.740)	2.571
	12-Sector - IT	136.73	3.984	11.154 (0.922)	2.913	4.711	13.189 (1.077)	3.445
	12-Sector - TI	68.82	1.603	4.489 (0.839)	2.330	2.232	6.249 (1.009)	3.243
Triton 6x6 3D Disc	Average	105.82	0.759	2.125 (0.951)	0.717	1.025	2.871 (0.991)	0.969
	Superior Quadrant	129.81	2.136	5.980 (0.843)	1.645	2.369	6.634 (0.921)	1.825
	Nasal Quadrant	87.61	1.397	3.913 (0.951)	1.595	1.726	4.833 (0.966)	1.970
	Inferior Quadrant	137.96	1.440	4.033 (0.701)	1.044	1.793	5.022 (0.757)	1.300
		N=25
		Repeatability			Reproducibility
Device	Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
	Temporal
Quadrant	67.87	0.776	2.174 (0.736)	1.144	1.079	3.020 (0.818)	1.589
	12-Sector - T	56.90	0.889	2.490 (0.817)	1.563	1.232	3.451 (0.934)	2.166
	12-Sector - TS	80.92	1.443	4.040 (0.768)	1.783	1.948	5.455 (0.889)	2.407
	12-Sector - ST	136.02	3.001	8.402 (0.910)	2.206	3.779	10.581 (1.029)	2.778
	12-Sector - S	132.54	4.288	12.007 (0.923)	3.236	4.390	12.292 (0.918)	3.312
	12-Sector - SN	120.97	3.326	9.314 (0.885)	2.750	3.705	10.374 (0.917)	3.063
	12-Sector - NS	107.39	3.027	8.476 (0.950)	2.819	3.535	9.898 (0.990)	3.292
	12-Sector - N	69.36	1.187	3.323 (0.798)	1.711	1.541	4.314 (0.919)	2.221
	12-Sector - NI	86.06	2.174	6.089 (0.927)	2.527	2.825	7.911 (1.057)	3.283
	12-Sector - IN	123.84	2.726	7.633 (0.705)	2.201	3.087	8.644 (0.747)	2.493
	12-Sector - I	152.70	2.897	8.112 (0.784)	1.897	3.321	9.300 (0.772)	2.175
	12-Sector - IT	137.33	2.859	8.006 (0.715)	2.082	3.685	10.318 (0.834)	2.683
	12-Sector - TI	65.80	1.531	4.287 (0.871)	2.327	1.858	5.201 (0.768)	2.823
Maestro 12x9 3D Wide
	Average	107.58	1.307	3.659	1.215	1.379	3.860	1.282
	Superior Quadrant	131.04	3.921	10.978	2.992	4.225	11.829	3.224
	Nasal Quadrant	87.61	2.047	5.733	2.337	2.290	6.411	2.613
	Inferior Quadrant	139.40	2.713	7.597	1.946	3.056	8.557	2.192
	Temporal
Quadrant	72.27	1.193	3.340	1.651	1.305	3.654	1.806
	12-Sector - T	60.86	1.436	4.022	2.360	1.642	4.597	2.698
	12-Sector - TS	85.98	1.937	5.423	2.253	2.178	6.097	2.533
	12-Sector - ST	137.50	3.847	10.772	2.798	4.298	12.034	3.126
	12-Sector - S	131.95	6.302	17.647	4.776	6.679	18.702	5.062
	12-Sector - SN	123.73	6.687	18.724	5.405	7.188	20.127	5.810
	12-Sector - NS	106.26	4.060	11.367	3.821	4.778	13.378	4.496
	12-Sector - N	70.34	2.290	6.413	3.256	2.392	6.696	3.400
	12-Sector - NI	86.22	3.113	8.715	3.610	3.482	9.751	4.039
	12-Sector - IN	124.95	4.654	13.032	3.725	4.882	13.671	3.908
	12-Sector - I	154.05	4.465	12.503	2.899	5.329	14.920	3.459
	12-Sector - IT	139.26	4.319	12.093	3.101	4.372	12.241	3.139
	12-Sector - TI	69.99	1.911	5.351	2.731	2.211	6.191	3.159
Maestro 6x6 3D Disc
	Average	106.01	0.798	2.235	0.753	1.035	2.898	0.976
	Superior Quadrant	130.21	2.535	7.098	1.947	2.572	7.202	1.975
	Nasal Quadrant	85.06	1.470	4.115	1.728	1.787	5.003	2.101
	Inferior Quadrant	139.89	2.054	5.750	1.468	2.368	6.630	1.693
			N=25
		Repeatability		Reproducibility
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Temporal
Quadrant	68.86	1.055	2.954	1.532	1.319	3.693	1.916
12-Sector - T	57.63	1.088	3.046	1.888	1.319	3.693	2.289
12-Sector - TS	82.12	1.878	5.257	2.286	2.190	6.133	2.667
12-Sector - ST	136.56	3.298	9.233	2.415	3.673	10.286	2.690
12-Sector - S	132.41	4.646	13.008	3.509	4.785	13.397	3.614
12-Sector - SN	121.51	3.757	10.520	3.092	4.041	11.315	3.326
12-Sector - NS	104.42	3.187	8.924	3.052	3.572	10.001	3.421
12-Sector - N	67.30	1.487	4.164	2.210	1.676	4.694	2.491
12-Sector - NI	83.41	2.346	6.569	2.813	2.673	7.484	3.205
12-Sector - IN	124.83	3.864	10.820	3.095	4.133	11.573	3.311
12-Sector - I	155.70	3.695	10.345	2.373	4.302	12.045	2.763
12-Sector - IT	139.12	3.999	11.198	2.875	4.417	12.369	3.175
12-Sector - TI	66.79	1.759	4.924	2.633	2.419	6.774	3.622

35

36

T=Temporal; S=Superior; N=Nasal; I=Inferior

All statistics are estimated from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Mean = Intercept of the ANOVA model

Repeatability SD = Square root of the residual variance

Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance and the residual variance

Repeatability limit = 2.8 x Repeatability SD Reproducibility

limit = 2.8 x Reproducibility SD Repeatability CV% =

(Repeatability SD)/Intercept x 100%

Reproducibility CV% = (Reproducibility SD)/Intercept x 100%

Ratio is relative to Maestro

		N=26
		Repeatability			Reproducibility
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Triton 12x9 3D Wide
Average	101.41	1.100	3.079 (0.420)	1.084	1.439	4.028 (0.545)	1.419
Superior Quadrant	116.77	3.005	8.415 (0.616)	2.574	3.176	8.893 (0.649)	2.720
Nasal Quadrant	81.02	1.917	5.368 (0.717)	2.366	2.653	7.428 (0.968)	3.274
Inferior Quadrant	126.43	2.485	6.957 (0.487)	1.965	2.752	7.705 (0.537)	2.177
Temporal
Quadrant	81.36	1.809	5.066 (0.537)	2.224	1.958	5.482 (0.581)	2.406
		N=26
		Repeatability
Reproducibility
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
12-Sector - T	71.03	1.890	5.292 (0.494)	2.661	2.514	7.039 (0.658)	3.539
12-Sector - TS	98.53	2.308	6.462 (0.717)	2.342	2.439	6.828 (0.734)	2.475
12-Sector - ST	131.12	4.239	11.868 (0.740)	3.233	4.427	12.396 (0.770)	3.376
12-Sector - S	111.69	5.450	15.260 (0.803)	4.880	5.450	15.260 (0.743)	4.880
12-Sector - SN	107.53	3.987	11.163 (0.622)	3.707	5.351	14.983 (0.835)	4.976
12-Sector - NS	95.74	4.631	12.966 (0.890)	4.837	5.455	15.274 (0.952)	5.698
12-Sector - N	70.82	1.599	4.477 (0.536)	2.258	2.350	6.579 (0.787)	3.318
12-Sector - NI	76.50	2.216	6.206 (0.699)	2.897	2.948	8.255 (0.856)	3.854
12-Sector - IN	104.52	3.140	8.791 (0.530)	3.004	3.552	9.946 (0.597)	3.398
12-Sector - I	137.61	4.522	12.662 (0.589)	3.286	4.779	13.382 (0.622)	3.473
12-Sector - IT	137.25	4.501	12.603 (0.620)	3.280	5.313	14.876 (0.732)	3.871
12-Sector - Tl	74.52	2.743	7.679 (0.524)	3.680	3.661	10.252 (0.699)	4.913

Triton 6x6 3D Disc
Average	100.73	1.579	4.420 (0.895)	1.567	1.866	5.224 (1.028)	1.852
Superior Quadrant	116.44	3.425	9.589 (0.678)	2.941	3.599	10.076 (0.698)	3.090
Nasal Quadrant	79.96	1.817	5.088 (0.749)	2.272	2.450	6.859 (0.974)	3.064
Inferior Quadrant	127.22	4.049	11.337 (0.941)	3.182	4.161	11.650 (0.945)	3.270
Temporal
Quadrant	79.27	1.347	3.772 (0.551)	1.700	1.735	4.858 (0.647)	2.189
12-Sector - T	68.15	1.904	5.330 (0.526)	2.793	2.497	6.991 (0.583)	3.663
12-Sector - TS	96.81	1.954	5.470 (0.815)	2.018	2.398	6.714 (0.882)	2.477
12-Sector - ST	131.38	3.851	10.782 (0.852)	2.931	4.251	11.903 (0.810)	3.236
12-Sector - S	110.70	7.410	20.749 (0.873)	6.694	7.689	21.530 (0.906)	6.946
12-Sector - SN	107.27	4.304	12.051 (0.771)	4.012	4.713	13.197 (0.823)	4.394
12-Sector - NS	96.61	3.411	9.551 (0.919)	3.531	3.819	10.693 (0.809)	3.953
12-Sector - N	67.88	1.845	5.167 (1.022)	2.719	2.095	5.866 (1.098)	3.087
12-Sector - NI	75.41	3.099	8.678 (0.842)	4.110	4.060	11.368 (1.093)	5.384
12-Sector - IN	103.82	3.886	10.881 (0.824)	3.743	4.651	13.022 (0.771)	4.480
12-Sector - I	138.72	6.677	18.696 (0.849)	4.813	6.687	18.725 (0.849)	4.821
12-Sector - IT	139.14	5.606	15.696 (1.072)	4.029	5.799	16.236 (1.109)	4.167
12-Sector - TI	72.83	2.793	7.820 (0.701)	3.834	3.377	9.455 (0.845)	4.636

Maestro 12x9 3D Wide
Average	101.02	2.618	7.329	2.591	2.637	7.384	2.611
Superior Quadrant	117.10	4.876	13.653	4.164	4.894	13.704	4.180
Nasal Quadrant	78.46	2.675	7.490	3.409	2.741	7.676	3.494
Inferior Quadrant	127.34	5.106	14.296	4.010	5.123	14.343	4.023
Temporal
Quadrant	81.15	3.370	9.436	4.153	3.370	9.436	4.153
		N=26
		Repeatability				Reproducibility
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
12-Sector - T	69.97	3.823	10.705	5.464	3.823	10.705	5.464
12-Sector - TS	98.99	3.220	9.017	3.253	3.321	9.300	3.355
12-Sector - ST	131.92	5.724	16.029	4.339	5.748	16.095	4.358
12-Sector - S	112.37	6.785	18.998	6.038	7.336	20.541	6.529
12-Sector - SN	107.06	6.411	17.950	5.988	6.411	17.950	5.988
12-Sector - NS	93.05	5.200	14.560	5.589	5.727	16.037	6.155
12-Sector - N	68.28	2.985	8.358	4.372	2.985	8.358	4.372
12-Sector - NI	74.12	3.169	8.873	4.275	3.446	9.649	4.649
12-Sector - IN	103.50	5.921	16.579	5.721	5.948	16.654	5.747
12-Sector - I	139.76	7.683	21.513	5.497	7.683	21.513	5.497
12-Sector - IT	138.73	7.262	20.333	5.235	7.262	20.333	5.235
12-Sector - TI	74.51	5.236	14.660	7.027	5.236	14.660	7.027

Maestro 6x6 3D Disc
Average	100.68	1.764	4.939	1.752	1.816	5.084	1.804
Superior Quadrant	117.19	5.052	14.147	4.311	5.157	14.440	4.400
Nasal Quadrant	77.59	2.425	6.789	3.125	2.516	7.044	3.242
Inferior Quadrant	128.78	4.304	12.051	3.342	4.401	12.322	3.417
Temporal
Quadrant	79.12	2.444	6.842	3.088	2.682	7.510	3.390
12-Sector - T	67.83	3.619	10.134	5.336	4.282	11.988	6.313
12-Sector - TS	97.26	2.396	6.710	2.464	2.718	7.612	2.795
12-Sector - ST	132.79	4.517	12.647	3.402	5.250	14.699	3.953
12-Sector - S	111.97	8.483	23.754	7.577	8.483	23.754	7.577
12-Sector - SN	106.86	5.579	15.622	5.221	5.728	16.037	5.360
12-Sector - NS	93.08	3.712	10.393	3.988	4.722	13.222	5.073
12-Sector - N	66.07	1.806	5.056	2.733	1.908	5.341	2.887
12-Sector - NI	73.64	3.680	10.305	4.998	3.713	10.397	5.042
12-Sector - IN	104.21	4.718	13.209	4.527	6.030	16.883	5.786
12-Sector - I	141.54	7.867	22.027	5.558	7.877	22.056	5.565
12-Sector - IT	140.45	5.228	14.637	3.722	5.228	14.637	3.722
12-Sector - TI	72.29	3.986	11.160	5.514	3.995	11.185	5.526

Table 22: Retinal Nerve Fiber Layer - Retinal Disease Eyes Repeatability and Reproducibility

37

38

39

		N=26
		Repeatability			Reproducibility
Device	Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
T=Temporal; S=Superior; N=Nasal; I=Inferior
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance
and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility
limit = 2.8 x Reproducibility SD Repeatability CV% =
(Repeatability SD)/Intercept x 100%
Reproducibility CV% = (Reproducibility SD)/Intercept x 100%
Ratio is relative to Maestro

		N=25
		Repeatability		Reproducibility
Device	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Measurement
Triton 12x9 3D Wide
Average	76.10	1.058	2.962 (0.730)	1.390	1.217	3.408 (0.711)	1.599
Superior Quadrant	87.49	2.281	6.387 (0.668)	2.607	2.571	7.199 (0.714)	2.939
Nasal Quadrant	63.67	1.825	5.109 (0.587)	2.866	2.196	6.148 (0.601)	3.449
Inferior Quadrant	91.99	2.318	6.490 (0.782)	2.520	2.512	7.032 (0.773)	2.730
Temporal
Quadrant	61.22	1.065	2.983 (0.879)	1.740	1.295	3.626 (0.983)	2.115
12-Sector - T	55.37	1.177	3.296 (0.773)	2.126	1.303	3.649 (0.792)	2.353
12-Sector - TS	68.95	1.610	4.507 (0.803)	2.335	1.828	5.119 (0.886)	2.652
12-Sector - ST	96.33	3.315	9.282 (0.755)	3.441	3.818	10.689 (0.869)	3.963
12-Sector - S	87.49	3.846	10.768 (0.674)	4.395	4.058	11.361 (0.678)	4.638
12-Sector - SN	78.68	3.792	10.616 (0.739)	4.819	4.619	12.933 (0.783)	5.871
12-Sector - NS	71.04	3.610	10.109 (0.601)	5.083	4.007	11.218 (0.540)	5.640
12-Sector - N	56.46	1.999	5.598 (0.693)	3.541	2.503	7.009 (0.868)	4.434
12-Sector - NI	63.52	2.299	6.436 (0.636)	3.619	2.505	7.014 (0.541)	3.943
12-Sector - IN	78.62	2.765	7.741 (0.580)	3.517	3.148	8.814 (0.653)	4.004
12-Sector - I	101.72	4.394	12.302 (1.010)	4.319	4.603	12.889 (0.837)	4.525
12-Sector - IT	95.66	3.763	10.536 (0.939)	3.933	3.764	10.540 (0.843)	3.935
12-Sector - TI	59.34	1.786	5.000 (0.932)	3.009	2.137	5.983 (0.940)	3.601

Table 23: Retinal Nerve Fiber Layer - Glaucoma Eyes Repeatability and Reproducibility

40

| Device

Measurement	Mean	SD	Repeatability		Reproducibility		CV%
			Limit (Ratio)	CV%	SD	Limit (Ratio)
N=25
Triton 6x6 3D Disc
Average	75.34	1.001	2.802 (0.822)	1.328	1.262	3.535 (0.945)	1.676
Superior Quadrant	88.72	2.556	7.157 (1.053)	2.881	2.825	7.911 (1.096)	3.184
Nasal Quadrant	61.27	1.668	4.670 (0.680)	2.722	1.932	5.410 (0.661)	3.154
Inferior Quadrant	92.36	1.857	5.199 (0.687)	2.010	2.106	5.896 (0.774)	2.280
Temporal
Quadrant	59.03	0.901	2.524 (0.650)	1.527	1.076	3.013 (0.720)	1.823
12-Sector - T	52.00	1.136	3.182 (0.806)	2.185	1.311	3.670 (0.810)	2.521
12-Sector - TS	66.89	1.421	3.980 (0.760)	2.125	1.747	4.891 (0.886)	2.612
12-Sector - ST	96.98	3.473	9.724 (1.077)	3.581	3.976	11.132 (1.017)	4.100
12-Sector - S	89.31	5.133	14.374 (1.191)	5.748	5.169	14.474 (1.199)	5.788
12-Sector - SN	79.89	3.933	11.013 (0.949)	4.923	4.317	12.088 (0.961)	5.404
12-Sector - NS	70.52	3.238	9.068 (0.769)	4.592	4.457	12.479 (0.886)	6.321
12-Sector - N	52.54	1.749	4.896 (0.479)	3.328	1.780	4.985 (0.473)	3.388
12-Sector - NI	60.73	1.912	5.353 (0.834)	3.148	2.130	5.965 (0.719)	3.507
12-Sector - IN	77.13	2.751	7.702 (0.957)	3.566	3.023	8.465 (0.940)	3.919
12-Sector - I	102.34	3.593	10.062 (0.791)	3.511	3.940	11.031 (0.789)	3.849
12-Sector - IT	97.58	2.671	7.479 (0.619)	2.737	3.027	8.477 (0.697)	3.102
12-Sector - TI	58.20	1.623	4.543 (0.641)	2.788	1.860	5.208 (0.630)	3.196
Maestro 12x9 3D Wide
Average	74.59	1.450	4.060	1.944	1.712	4.795	2.296
Superior Quadrant	85.81	3.413	9.557	3.978	3.599	10.078	4.195
Nasal Quadrant	60.82	3.107	8.700	5.108	3.653	10.229	6.006
Inferior Quadrant	90.95	2.966	8.304	3.261	3.251	9.103	3.574
Temporal
Quadrant	60.80	1.212	3.395	1.994	1.317	3.687	2.166
12-Sector - T	54.44	1.523	4.263	2.797	1.646	4.609	3.024
12-Sector - TS	68.62	2.004	5.613	2.921	2.064	5.778	3.007
12-Sector - ST	96.98	4.391	12.294	4.527	4.391	12.294	4.527
12-Sector - S	85.28	5.703	15.968	6.688	5.984	16.756	7.018
12-Sector - SN	75.16	5.134	14.374	6.830	5.897	16.512	7.846
12-Sector - NS	67.20	6.009	16.826	8.942	7.414	20.760	11.033
12-Sector - N	53.93	2.884	8.076	5.348	2.884	8.076	5.348
12-Sector - NI	61.39	3.616	10.126	5.891	4.630	12.963	7.541
12-Sector - IN	77.63	4.768	13.351	6.142	4.818	13.490	6.206
12-Sector - I	100.02	4.349	12.177	4.348	5.501	15.403	5.500
12-Sector - IT	95.12	4.005	11.215	4.211	4.464	12.498	4.693
12-Sector - TI	59.35	1.916	5.365	3.228	2.272	6.361	3.828

41

	N=25
	Repeatability		Reproducibility
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%

Maestro 6x6 3D Disc
Average	73.96	1.217	3.407	1.645	1.336	3.740	1.806
Superior Quadrant	86.75	2.427	6.797	2.798	2.578	7.218	2.972
Nasal Quadrant	59.53	2.454	6.872	4.123	2.924	8.187	4.912
Inferior Quadrant	91.40	2.701	7.563	2.955	2.721	7.619	2.977
Temporal
Quadrant	58.14	1.386	3.880	2.383	1.494	4.183	2.570
12-Sector - T	51.37	1.410	3.949	2.746	1.619	4.533	3.152
12-Sector - TS	66.02	1.870	5.235	2.832	1.972	5.522	2.987
12-Sector - ST	96.07	3.225	9.031	3.358	3.911	10.951	4.071
12-Sector - S	86.73	4.312	12.073	4.971	4.312	12.073	4.971
12-Sector - SN	77.43	4.146	11.607	5.354	4.493	12.581	5.803
12-Sector - NS	68.19	4.214	11.798	6.179	5.033	14.092	7.381
12-Sector - N	51.18	3.651	10.223	7.133	3.760	10.528	7.346
12-Sector - NI	59.15	2.293	6.420	3.876	2.962	8.293	5.007
12-Sector - IN	77.06	2.874	8.047	3.729	3.215	9.002	4.172
12-Sector - I	101.85	4.542	12.717	4.460	4.993	13.981	4.903
12-Sector - IT	95.32	4.317	12.088	4.529	4.341	12.154	4.554
12-Sector - TI	57.06	2.532	7.089	4.437	2.955	8.273	5.178

T=Temporal; S=Superior; N=Nasal; I=Inferior

All statistics are estimated from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

perator/device, eye and interaction between operator/device
Mean: Interest of the ANOVA model

Mean = Intercept of the ANOVA model

Repeatability SD = Square root of the residual variance

Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance and the residual variance

Repeatability limit = 2.8 x Repeatability SD Reproducibility

limit = 2.8 x Reproducibility SD Repeatability CV% =

(Repeatability SD)/Intercept x 100%

Reproducibility CV% = (Reproducibility SD)/Intercept x 100%

Ratio is relative to Maestro

42

	N=25
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Triton 12x9 3D Wide
C/D Vertical	0.47	0.022	0.063 (0.600)	4.787	0.027	0.075 (0.716)	5.714
C/D Area	0.25	0.009	0.026 (0.786)	3.723	0.012	0.033 (0.906)	4.666
Disc Area	1.91	0.059	0.166 (0.938)	3.105	0.062	0.173 (0.727)	3.236
Cup Area	0.51	0.020	0.057 (0.849)	4.001	0.025	0.069 (1.006)	4.851
Rim Area	1.40	0.056	0.157 (0.907)	3.998	0.059	0.166 (0.734)	4.228
Cup Volume	0.09	0.005	0.015 (1.120)	6.183	0.006	0.016 (0.986)	6.845
Rim Volume	0.26	0.013	0.037 (0.809)	5.107	0.015	0.042 (0.721)	5.765
Linear C/D Ratio	0.46	0.011	0.030 (0.638)	2.301	0.014	0.038 (0.817)	2.948
Triton 6x6 3D Disc
C/D Vertical	0.46	0.019	0.054 (0.415)	4.174	0.026	0.074 (0.570)	5.757
C/D Area	0.25	0.007	0.021 (0.180)	2.958	0.010	0.028 (0.241)	4.014
Disc Area	1.75	0.034	0.094 (0.546)	1.919	0.049	0.137 (0.687)	2.803
Cup Area	0.47	0.011	0.030 (0.142)	2.306	0.013	0.036 (0.171)	2.768
Rim Area	1.28	0.031	0.088 (0.336)	2.438	0.045	0.125 (0.445)	3.490
Cup Volume	0.08	0.004	0.010 (0.891)	4.259	0.004	0.012 (1.028)	5.332
Rim Volume	0.23	0.008	0.022 (0.401)	3.370	0.010	0.029 (0.498)	4.410
Linear C/D Ratio	0.46	0.011	0.030 (0.308)	2.358	0.017	0.047 (0.477)	3.665
Maestro 12x9 3D Wide
C/D Vertical	0.45	0.037	0.104	8.217	0.037	0.104	8.217
C/D Area	0.23	0.012	0.033	5.067	0.013	0.036	5.507
Disc Area	2.20	0.063	0.177	2.873	0.085	0.238	3.868
Cup Area	0.54	0.024	0.067	4.493	0.025	0.069	4.594
Rim Area	1.66	0.062	0.173	3.707	0.081	0.226	4.841
Cup Volume	0.09	0.005	0.013	5.191	0.006	0.017	6.523
Rim Volume	0.32	0.016	0.046	5.169	0.021	0.058	6.546
Linear C/D Ratio	0.44	0.017	0.046	3.739	0.017	0.046	3.740
Maestro 6x6 3D Disc
C/D Vertical	0.44	0.046	0.129	10.576	0.046	0.130	10.619
C/D Area	0.23	0.041	0.115	17.581	0.041	0.116	17.810
Disc Area	2.03	0.061	0.172	3.026	0.071	0.200	3.515
Cup Area	0.49	0.075	0.211	15.290	0.076	0.212	15.307
Rim Area	1.54	0.093	0.261	6.053	0.101	0.282	6.548
Cup Volume	0.09	0.004	0.011	4.507	0.004	0.012	4.889
Rim Volume	0.29	0.020	0.055	6.660	0.021	0.058	7.025
		N=25
		Repeatability			Reproducibility
Device	Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Linear C/D Ratio	0.44	0.035	0.098	7.961	0.035	0.098	8.000
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance
and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
Reproducibility CV% = (Reproducibility SD)/Intercept x 100%
Ratio is relative to Maestro

Table 24: Optic Disc - Normal Eyes Repeatability and Reproducibility

Page 40 of 60

43

Device	Measurement	Repeatability			Reproducibility
		Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Triton 12x9 3D Wide	C/D Vertical	0.53	0.019	0.054 (0.421)	3.679	0.020	0.057 (0.439)	3.862
	C/D Area	0.30	0.011	0.030 (0.518)	3.604	0.012	0.032 (0.558)	3.909
	Disc Area	1.90	0.059	0.165 (0.748)	3.106	0.068	0.192 (0.709)	3.606
	Cup Area	0.57	0.023	0.064 (0.502)	3.968	0.024	0.067 (0.513)	4.182
	Rim Area	1.32	0.052	0.145 (0.638)	3.900	0.060	0.168 (0.704)	4.546
	Cup Volume	0.09	0.004	0.012 (0.699)	4.438	0.005	0.013 (0.756)	5.052
	Rim Volume	0.24	0.010	0.027 (0.586)	4.106	0.012	0.034 (0.678)	5.082
	Linear C/D Ratio	0.50	0.009	0.025 (0.281)	1.755	0.010	0.028 (0.291)	1.964
Triton 6x6 3D Disc	C/D Vertical	0.52	0.017	0.048 (0.912)	3.287	0.018	0.049 (0.870)	3.362
	C/D Area	0.30	0.010	0.027 (1.016)	3.195	0.010	0.029 (0.927)	3.411
	Disc Area	1.76	0.041	0.114 (0.617)	2.306	0.047	0.131 (0.667)	2.665
	Cup Area	0.54	0.019	0.053 (0.914)	3.508	0.020	0.055 (0.792)	3.650
	Rim Area	1.22	0.038	0.107 (0.629)	3.120	0.042	0.118 (0.667)	3.452
	Cup Volume	0.09	0.004	0.012 (0.802)	4.626	0.005	0.013 (0.794)	4.836
	Rim Volume	0.21	0.008	0.022 (0.616)	3.743	0.010	0.028 (0.701)	4.599
	Linear C/D Ratio	0.51	0.008	0.023 (0.934)	1.651	0.009	0.024 (0.845)	1.708

Table 25: Optic Disc - Retinal Disease Eyes Repeatability and Reproducibility

44

Maestro 12x9 3D Wide
C/D Vertical	0.51	0.046	0.129	9.006	0.046	0.130	9.071
C/D Area	0.27	0.021	0.058	7.673	0.021	0.058	7.728
Disc Area	2.22	0.079	0.221	3.546	0.096	0.270	4.341
Cup Area	0.60	0.045	0.127	7.504	0.047	0.131	7.733
Rim Area	1.62	0.081	0.227	5.006	0.085	0.239	5.285
Cup Volume	0.10	0.006	0.017	5.873	0.006	0.018	6.183
Rim Volume	0.29	0.017	0.047	5.741	0.018	0.050	6.146
Linear C/D Ratio	0.48	0.031	0.088	6.484	0.034	0.095	7.014

Maestro 6x6 3D Disc
C/D Vertical	0.50	0.019	0.053	3.772	0.020	0.057	4.048
C/D Area	0.28	0.009	0.026	3.410	0.011	0.031	3.992
Disc Area	2.00	0.066	0.184	3.293	0.070	0.197	3.515
Cup Area	0.56	0.021	0.058	3.710	0.025	0.070	4.453
Rim Area	1.44	0.060	0.169	4.200	0.063	0.177	4.384
Cup Volume	0.10	0.005	0.015	5.438	0.006	0.016	5.748
Rim Volume	0.26	0.013	0.036	5.042	0.014	0.039	5.448
Linear C/D Ratio	0.48	0.009	0.025	1.842	0.010	0.029	2.104
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance
and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility
limit = 2.8 x Reproducibility SD Repeatability CV% =
(Repeatability SD)/Intercept x 100%
Reproducibility CV% = (Reproducibility SD)/Intercept x 100%
Ratio is relative to Maestro

			Table 26: Optic Disc - Glaucoma Eyes Repeatability and Reproducibility

		N=25
	Repeatability		Reproducibility
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Triton 12x9 3D Wide
C/D Vertical	0.86	0.023	0.063 (0.688)	2.626	0.028	0.079 (0.857)	3.273
C/D Area	0.68	0.013	0.038 (0.631)	1.980	0.024	0.067 (0.881)	3.508
Disc Area	1.94	0.052	0.145 (0.608)	2.662	0.067	0.189 (0.711)	3.474
Cup Area	1.33	0.034	0.094 (0.611)	2.531	0.041	0.114 (0.621)	3.045
N=25
		Repeatability			Reproducibility
Device	Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
	Rim Area	0.61	0.038	0.107 (0.587)	6.260	0.057	0.159 (0.766)	9.355
	Cup Volume	0.36	0.009	0.025 (0.484)	2.493	0.010	0.028 (0.544)	2.813
	Rim Volume	0.06	0.006	0.016 (0.582)	8.936	0.008	0.021 (0.759)	12.188
	Linear C/D Ratio	0.82	0.008	0.024 (0.593)	1.035	0.015	0.043 (0.891)	1.882
Triton 6x6 3D Disc	C/D Vertical	0.86	0.023	0.063 (0.817)	2.626	0.023	0.063 (0.751)	2.626
	C/D Area	0.68	0.018	0.051 (0.820)	2.679	0.018	0.052 (0.768)	2.721
	Disc Area	1.80	0.048	0.135 (0.677)	2.667	0.054	0.152 (0.710)	3.005
	Cup Area	1.24	0.036	0.102 (0.730)	2.927	0.037	0.103 (0.668)	2.961
	Rim Area	0.56	0.034	0.096 (0.580)	6.101	0.039	0.109 (0.628)	6.936
	Cup Volume	0.35	0.012	0.033 (0.567)	3.333	0.012	0.033 (0.485)	3.366
	Rim Volume	0.05	0.005	0.014 (0.746)	9.661	0.006	0.016 (0.739)	10.513
	Linear C/D Ratio	0.82	0.013	0.036 (0.831)	1.574	0.013	0.036 (0.755)	1.574
Maestro 12x9 3D Wide	C/D Vertical	0.82	0.033	0.092	3.980	0.033	0.092	3.984
	C/D Area	0.63	0.021	0.060	3.378	0.027	0.076	4.283
	Disc Area	2.19	0.085	0.238	3.880	0.095	0.265	4.328
	Cup Area	1.39	0.055	0.154	3.981	0.065	0.183	4.711
	Rim Area	0.80	0.065	0.182	8.074	0.074	0.208	9.251
	Cup Volume	0.38	0.019	0.052	4.940	0.019	0.052	4.953
	Rim Volume	0.08	0.010	0.027	11.557	0.010	0.028	12.077
	Linear C/D Ratio	0.79	0.014	0.040	1.811	0.017	0.048	2.190
Maestro 6x6 3D Disc	C/D Vertical	0.82	0.028	0.077	3.344	0.030	0.084	3.639
	C/D Area	0.63	0.022	0.062	3.539	0.024	0.067	3.838
	Disc Area	2.03	0.071	0.199	3.508	0.076	0.214	3.764
	Cup Area	1.29	0.050	0.139	3.852	0.055	0.154	4.261
	Rim Area	0.74	0.059	0.166	8.040	0.062	0.174	8.429
	Cup Volume	0.37	0.021	0.058	5.630	0.024	0.068	6.646
	Rim Volume	0.07	0.007	0.019	9.784	0.008	0.021	10.740
	Linear C/D Ratio	0.78	0.015	0.043	1.975	0.017	0.048	2.173

45

46

		N=25
		Repeatability		Reproducibility
Device
Measurement	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
All statistics are estimated from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance and the residual variance
Repeatability limit = 2.8 x Repeatability SD Reproducibility
limit = 2.8 x Reproducibility SD Repeatability CV% = (Repeatability SD)/Intercept x 100%
Reproducibility CV% = (Reproducibility SD)/Intercept x 100%
Ratio is relative to Maestro

Reference Database

Topcon conducted a prospective, multicenter study at six U.S. clinical sites, in which subjects without eye disease had OCT images obtained with the Triton device. The study collected measurements of normal eyes for full retinal thickness, retinal nerve fiber layer thickness, ganglion cell layer plus the IPL layer thickness, ganglion cell complex and the optic disc in addition to TSNIT circle profile measurements. The reference limits at the 1st, 95th and 99th percentile points established thresholds to provide for the quantitative comparison of the retinal nerve fiber layer, optic nerve head and the macula in the human retina to a database of known normal subjects.

Major eligibility criteria included participants age≥18 presenting at the site with normal eyes bilaterally (excluding glaucomatous optic nerve damage, based on pattern deviation or Glaucoma hemi-field test).

One eye of each subject was randomly selected and measured with the study device. Subjects were enrolled with a wide range of ethnicities including Asian, Hispanic/Latino, African-American, and others. The number of subjects within each age group (18-30, 31-40, 41-50, 51-60, 61-70 and 70+ years) was evenly distributed. The total number of evaluable eyes was 410.

There were nine scans taken during a single session, for each subject (3 scans per 3D Wide 12x9, 3D Macula 7x7, and 3D Disc 6x6 scans). The first accepted scan of each scan parameter from each eligible subject was included in the analysis. The 1st, 5th, 95th and 99th percentile were estimated by quantile regression. Age and/or disc area were used as the regression covariates for the scan parameters.

47

| | Total
(N=410) |
|----------------------------------|------------------|
| Age (years) | |
| Mean (SD) | 48.6 (16.7) |
| 95% CI | 46.9, 50.2 |
| Median | 49.0 |
| Min, Max | 18, 90 |
| Age group, n (%) | |
| 18-30 years | 76 (19) |
| 31-40 years | 73 (18) |
| 41-50 years | 73 (18) |
| 51-60 years | 69 (17) |
| 61-70 years | 69 (17) |
| 70+ years | 50 (12) |
| Gender, n (%) | |
| Male | 194 (47) |
| Female | 216 (53) |
| Ethnicity, n (%) | |
| Hispanic or Latino | 73 (18) |
| Not Hispanic and not Latino | 337 (82) |
| Race, n (%) | |
| American Indian/Alaska Native | 5 (1) |
| Asian | 32 (8) |
| Black/African American | 92 (22) |
| Native Hawaiian/Pacific Islander | 12 (3) |
| White | 236 (58) |
| Other | 48 (12) |
| Disc Area of 12x9 Wide (mm²) | |
| n | 409 |
| Mean (SD) | 1.940 (0.365) |
| 95% CI | 1.904, 1.975 |
| Median | 1.920 |
| Min, Max | 1.11, 3.30 |

Table 27: Triton Reference Database Demographic Data

48

Disc Area of 6x6 Disc (mm²)
n	409
Mean (SD)	1.810 (0.365)
95% Cl	1.775, 1.846
Median	1.780
Min, Max	1.03, 3.29

49

| | Triton
12x9 3D Wide
(N=410) | Triton
7x7 3D Macula
(N=410) |
|----------------|-----------------------------------|------------------------------------|
| Measurement | | |
| Central Fovea | | |
| n | 409 | 404 |
| Mean (SD) | 239.861 (20.973) | 239.619 (21.156) |
| 95% CI | 237.822, 241.899 | 237.550, 241.688 |
| Median | 240.990 | 240.530 |
| Inner Superior | | |
| n | 409 | 404 |
| Mean (SD) | 310.489 (16.778) | 310.623 (16.869) |
| 95% CI | 308.858, 312.119 | 308.973, 312.273 |
| Median | 310.840 | 310.735 |
| Inner Nasal | | |
| n | 409 | 404 |
| Mean (SD) | 311.643 (16.657) | 311.166 (16.863) |
| 95% CI | 310.024, 313.262 | 309.516, 312.815 |
| Median | 312.650 | 311.750 |
| Inner Inferior | | |
| n | 409 | 404 |
| Mean (SD) | 307.438 (16.220) | 307.577 (16.342) |
| 95% CI | 305.862, 309.015 | 305.979, 309.176 |
| Median | 308.450 | 308.045 |
| Inner Temporal | | |
| n | 409 | 404 |
| Mean (SD) | 299.177 (15.373) | 298.357 (15.624) |
| 95% CI | 297.682, 300.671 | 296.829, 299.885 |
| Median | 299.580 | 298.325 |
| Outer Superior | | |
| n | 409 | 404 |
| Mean (SD) | 270.110 (14.968) | 269.368 (14.701) |
| 95% CI | 268.655, 271.565 | 267.930, 270.806 |
| Median | 270.440 | 269.445 |
| Outer Nasal | | |
| n | 409 | 404 |
| Mean (SD) | 285.007 (17.111) | 284.056 (16.950) |
| 95% CI | 283.344, 286.670 | 282.398, 285.713 |
| Median | 286.730 | 285.210 |
| Outer Inferior | | |
| n | 409 | 404 |
| Mean (SD) | 258.388 (14.515) | 257.808 (14.539) |
| 95% CI | 256.977, 259.798 | 256.386, 259.230 |
| | Triton
12x9 3D Wide
(N=410) | Triton
7x7 3D Macula
(N=410) |
| Measurement | | |
| Median | 259.490 | 258.135 |
| Outer Temporal | | |
| n | 409 | 404 |
| Mean (SD) | 254.954 (14.098) | 253.040 (14.019) |
| 95% CI | 253.583, 256.324 | 251.669, 254.411 |
| Median | 254.800 | 253.260 |

50

Table 29: Ganglion Cell + IPL Thickness (μm) – Summary

| Measurement | Triton
12x9 3D Wide
(N=410) | Triton
7x7 3D Macula
(N=410) |
|-------------------|-----------------------------------|------------------------------------|
| Superior | | |
| n | 405 | 405 |
| Mean (SD) | 69.999 (5.880) | 69.376 (5.883) |
| 95% CI | 69.424, 70.573 | 68.801, 69.950 |
| Median | 70.340 | 69.410 |
| Superior Nasal | | |
| n | 405 | 405 |
| Mean (SD) | 73.710 (6.554) | 73.450 (6.527) |
| 95% CI | 73.070, 74.350 | 72.812, 74.087 |
| Median | 74.290 | 73.830 |
| Superior Temporal | | |
| n | 405 | 405 |
| Mean (SD) | 70.733 (5.880) | 71.758 (5.591) |
| 95% CI | 70.158, 71.307 | 71.212, 72.305 |
| Median | 70.750 | 71.840 |
| Inferior | | |
| n | 405 | 405 |
| Mean (SD) | 66.977 (5.744) | 66.362 (5.717) |
| 95% CI | 66.416, 67.538 | 65.803, 66.920 |
| Median | 66.970 | 66.350 |
| Inferior Nasal | | |
| n | 405 | 405 |
| Mean (SD) | 72.128 (6.542) | 71.944 (6.655) |
| 95% CI | 71.489, 72.767 | 71.294, 72.594 |
| Median | 72.610 | 72.450 |
| Inferior Temporal | | |
| n | 405 | 405 |

51

| | Triton
12x9 3D Wide
(N=410) | Triton
7x7 3D Macula
(N=410) |
|-------------|-----------------------------------|------------------------------------|
| Measurement | | |
| Mean (SD) | 71.830 (5.878) | 72.422 (5.739) |
| 95% CI | 71.256, 72.405 | 71.862, 72.983 |
| Median | 71.500 | 72.440 |
| Average | | |
| n | 405 | 405 |
| Mean (SD) | 70.899 (5.757) | 70.888 (5.676) |
| 95% CI | 70.336, 71.461 | 70.334, 71.443 |
| Median | 71.000 | 71.100 |

Table 30: Ganglion Cell Complex Thickness (µm) – Summary

	Triton	Triton
	12x9 3D Wide	7x7 3D Macula
Measurement	(N=410)	(N=410)
Superior
n	409	405
Mean (SD)	107.927 (8.769)	107.835 (8.751)
95% Cl	107.075, 108.780	106.981, 108.690
Median	108.490	108.370
Superior Nasal
n	409	405
Mean (SD)	118.673 (9.691)	118.020 (9.572)
95% Cl	117.731, 119.615	117.085, 118.955
Median	119.180	118.830
Superior Temporal
n	409	405
Mean (SD)	94.841 (6.880)	94.053 (6.879)
95% Cl	94.172, 95.509	93.381, 94.725
Median	94.820	94.100
Inferior
n	409	405
Mean (SD)	105.945 (8.230)	106.024 (8.412)
95% Cl	105.145, 106.745	105.202, 106.845
Median	106.010	106.160
Inferior Nasal
n	409	405
Mean (SD)	118.695 (10.398)	118.652 (10.373)
95% Cl	117.684, 119.705	117.638, 119.665
Median	119.200	119.050

52

| | Triton
12x9 3D Wide
(N=410) | Triton
7x7 3D Macula
(N=410) |
|-------------------|-----------------------------------|------------------------------------|
| Measurement | | |
| Inferior Temporal | | |
| n | 409 | 405 |
| Mean (SD) | 97.502 (6.865) | 96.949 (6.941) |
| 95% CI | 96.834, 98.169 | 96.271, 97.627 |
| Median | 97.590 | 96.930 |
| Average | | |
| n | 409 | 405 |
| Mean (SD) | 107.267 (7.943) | 106.927 (7.949) |
| 95% CI | 106.495, 108.040 | 106.151, 107.704 |
| Median | 108.000 | 107.500 |

Table 31: Retinal Nerve Fiber Layer Thickness (µm) – Summary

	Triton	Triton
	12x9 3D Wide	6x6 3D Disc
Measurement	(N=410)	(N=410)
Average
n	409	409
Mean (SD)	106.350 (10.537)	105.090 (10.355)
95% Cl	105.326, 107.374	104.083, 106.096
Median	106.930	105.760
Superior Quadrant
n	409	409
Mean (SD)	129.044 (17.862)	128.791 (17.250)
95% Cl	127.307, 130.780	127.115, 130.468
Median	129.700	129.980
Nasal Quadrant
n	409	409
Mean (SD)	81.275 (14.747)	80.765 (15.603)
95% Cl	79.841, 82.708	79.249, 82.282
Median	81.370	80.910
Inferior Quadrant
n	409	409
Mean (SD)	138.281 (16.785)	136.952 (16.692)
95% Cl	136.650, 139.913	135.330, 138.575
Median	137.570	136.650
Temporal Quadrant
n	409	409
Mean (SD)	76.778 (11.877)	73.838 (11.875)
Measurement	Triton
12x9 3D Wide
(N=410)	Triton
6x6 3D Disc
(N=410)
95% CI	75.624, 77.933	72.683, 74.992
Median	75.790	72.900
12-Sector - T
n	409	409
Mean (SD)	65.195 (9.237)	61.842 (9.494)
95% CI	64.297, 66.093	60.919, 62.764
Median	65.080	61.090
12-Sector - TS
n	409	409
Mean (SD)	91.576 (16.825)	88.503 (16.547)
95% CI	89.941, 93.212	86.895, 90.112
Median	90.570	86.800
12-Sector - ST
n	409	409
Mean (SD)	138.155 (23.883)	137.967 (24.893)
95% CI	135.834, 140.477	135.547, 140.386
Median	137.430	138.580
12-Sector - S
n	409	409
Mean (SD)	128.377 (27.937)	128.435 (28.389)
95% CI	125.662, 131.093	125.676, 131.195
Median	126.500	127.980
12-Sector - SN
n	409	409
Mean (SD)	120.613 (23.571)	119.982 (23.321)
95% CI	118.322, 122.904	117.715, 122.248
Median	119.940	118.690
12-Sector - NS
n	409	409
Mean (SD)	97.187 (20.967)	98.756 (22.579)
95% CI	95.149, 99.225	96.562, 100.951
Median	97.210	99.510
12-Sector - N
n	409	409
Mean (SD)	68.029 (13.016)	65.882 (13.710)
95% CI	66.764, 69.294	64.549, 67.214
Median	66.520	64.060
12-Sector - NI
n	409	409
Measurement	Triton
12x9 3D Wide
(N=410)	Triton
6x6 3D Disc
(N=410)
Mean (SD)	78.595 (16.965)	77.690 (17.639)
95% CI	76.946, 80.244	75.976, 79.405
Median	78.430	76.930
12-Sector - IN
n	409	409
Mean (SD)	119.511 (25.625)	117.930 (26.191)
95% CI	117.020, 122.002	115.384, 120.476
Median	117.350	114.990
12-Sector - I
n	409	409
Mean (SD)	154.790 (26.388)	152.367 (26.543)
95% CI	152.225, 157.355	149.787, 154.947
Median	154.290	152.870
12-Sector - IT
n	409	409
Mean (SD)	140.556 (25.934)	140.585 (27.175)
95% CI	138.035, 143.077	137.944, 143.227
Median	140.350	142.530
12-Sector - TI
n	409	409
Mean (SD)	73.560 (13.949)	71.178 (14.284)
95% CI	72.204, 74.916	69.790, 72.566
Median	72.240	70.080
T=Temporal; S=Superior; N=Nasal; I=Inferior

53

54

Table 32: Optic Disc – Summary

| Measurement | Triton
12x9 3D Wide
(N=410) | Triton
6x6 3D Disc
(N=410) |
|------------------|-----------------------------------|----------------------------------|
| C/D Vertical | | |
| n | 409 | 409 |
| Mean (SD) | 0.506 (0.210) | 0.501 (0.198) |
| 95% Cl | 0.486, 0.527 | 0.482, 0.520 |
| Median | 0.560 | 0.550 |
| C/D Area | | |
| n | 409 | 409 |
| Mean (SD) | 0.306 (0.183) | 0.305 (0.174) |
| 95% Cl | 0.288, 0.323 | 0.288, 0.322 |
| | Triton
12x9 3D Wide
(N=410) | Triton
6x6 3D Disc
(N=410) |
| Measurement | | |
| Median | 0.310 | 0.310 |
| Disc Area (mm²) | | |
| n | 409 | 409 |
| Mean (SD) | 1.940 (0.365) | 1.810 (0.365) |
| 95% CI | 1.904, 1.975 | 1.775, 1.846 |
| Median | 1.920 | 1.780 |
| Cup Area (mm²) | | |
| n | 409 | 409 |
| Mean (SD) | 0.620 (0.433) | 0.580 (0.396) |
| 95% CI | 0.578, 0.662 | 0.542, 0.619 |
| Median | 0.600 | 0.550 |
| Rim Area (mm²) | | |
| n | 409 | 409 |
| Mean (SD) | 1.319 (0.346) | 1.230 (0.301) |
| 95% CI | 1.286, 1.353 | 1.201, 1.259 |
| Median | 1.290 | 1.200 |
| Cup Volume (mm³) | | |
| n | 409 | 409 |
| Mean (SD) | 0.117 (0.122) | 0.115 (0.116) |
| 95% CI | 0.106, 0.129 | 0.104, 0.126 |
| Median | 0.080 | 0.080 |
| Rim Volume (mm³) | | |
| n | 409 | 409 |
| Mean (SD) | 0.237 (0.126) | 0.214 (0.104) |
| 95% CI | 0.224, 0.249 | 0.204, 0.224 |
| Median | 0.210 | 0.190 |
| Linear C/D Ratio | | |
| n | 409 | 409 |
| Mean (SD) | 0.510 (0.212) | 0.513 (0.204) |
| 95% CI | 0.490, 0.531 | 0.494, 0.533 |
| Median | 0.560 | 0.560 |

55

Fundus Autofluorescence and Fluorescein Angiography Image Quality Evaluation Study

A prospective clinical study was conducted at one clinical site, located in the United States, The predicate device used in the study was the TRC-50DX, cleared for fundus autofluorescence (FAF) and fluorescein angiography (FA) uses (K123101). The objectives of this study were to compare the

56

image quality of the fundus autofluorescence (FAF) and the fluorescein angiography (FA) photographs between DRI OCT Triton (plus) and TRC-50DX retinal camera.

Major inclusion criteria included age (≥18 years) and medical need to undergo dye injection for FA imaging. Major exclusion criteria included ocular motility dysfunction. Subjects were randomized for device order. FA images were captured in two time intervals after the intravenous fluorescein dye injection. The FAF and FA images that met the image acceptance criteria were graded by two masked independent graders in a blinded and randomized fashion. The agreement analysis of FA and FAF photograph image quality for eyes with retinal pathologies was based on a 5-point scale, where a "1" indicated that the photograph was insufficient for any interpretation, and "5" represented an excellent photograph.

Majority of the FAF and FA images were graded as good or excellent by both graders. The response rates (i.e., percentage of subjects whose Triton grades were equal to or better than the corresponding TRC-50DX grades) favorably ranged between 85.2% - 94.9%, confirming that the subject Triton device performed at least as well as the predicate TRC-50DX device. Notably, the Triton device had higher rates of agreement across FAF and FA images (68.3% - 73.2%) as compared to the TRC-50DX (56% - 61.7%).

There were no adverse events in any of the clinical studies.

Conclusion

Based on the intended use/indications for use, the technological characteristics described above, and the safety and effectiveness demonstrated in the clinical trials, the subject device is substantially equivalent to the predicate devices.

57

Substantial Equivalence Comparison Table

Applicant	TOPCON	TOPCON
Device Name	DRI OCT Triton	3D OCT-1 Maestro
	DRI OCT Triton (plus)
510k Number	K173119	K161509
		K170164
Product Code	ово, нкі	ово, нкі
Regulation number	21CFR§886.1570	21CFR§886.1570
Indications for Use	The Topcon DRI OCT Triton is a non-contact, high
resolution tomographic and biomicroscopic imaging device
that incorporates a digital camera for photographing,
displaying and storing the data of the retina and
surrounding parts of the eye to be examined under
Mydriatic and non-Mydriatic conditions.
The DRI OCT Triton is indicated for in vivo viewing, axial
cross sectional, and three-dimensional imaging and
measurement of posterior ocular structures, including
retina, retinal nerve fiber layer, macula and optic disc as
well as imaging of anterior ocular structures.
It also includes a Reference Database for posterior ocular
measurements which provide for the quantitative
comparison of retinal nerve fiber layer, optic nerve head,
and the macula in the human retina to a database of known
normal subjects. The DRI OCT Triton is indicated for use
as a diagnostic device to aid in the diagnosis,
documentation and management of ocular health and
diseases in the adult population.	The Topcon 3D OCT-1 Maestro is a non-contact, high
resolution tomographic and biomicroscopic imaging device
that incorporates a digital camera for photographing,
displaying and storing the data of the retina and surrounding
parts of the eye to be examined under Mydriatic and non-
Mydriatic conditions.
The 3D OCT-1 Maestro is indicated for in vivo viewing, axial
cross sectional, and three-dimensional imaging and
measurement of posterior ocular structures, including retina,
retinal nerve fiber layer, macula and optic disc as well as
imaging of anterior ocular structures.
It also includes a Reference Database for posterior ocular
measurements which provide for the quantitative
comparison of retinal nerve fiber layer, optic nerve head,
and the macula in the human retina to a database of known
normal subjects. The 3D OCT-1 Maestro is indicated for use
as a diagnostic device to aid in the diagnosis,
documentation and management of ocular health and
diseases in the adult population.
Applicant	TOPCON	TOPCON
Device Name	DRI OCT Triton	3D OCT-1 Maestro
	DRI OCT Triton (plus)
510k Number	K173119	K161509
		K170164
Technological	OCT:	OCT:
Characteristics	Optical coherence tomography is employed to obtain cross-
sectional images of the fundus and the anterior segment of
the eye.	Optical coherence tomography is employed to obtain cross-
sectional images of the fundus and the anterior segment of
the eye.
	Fundus Camera (Triton):	Fundus Camera:
	A Xenon flash and a CMOS camera are employed to obtain
fundus/anterior Color/digital red-free images.	A Xenon flash and a CMOS camera are employed to obtain
fundus/anterior Color/digital red-free images.
	Fundus Camera (Triton (plus)):
	A Xenon flash and a CMOS camera are employed to obtain
fundus/anterior Color/digital red-free/FA/FAF images.
OCT
Light Source	Swept source OCT (SS-OCT) using a wavelength swept
laser with a center wavelength 1050 nm.	Spectral domain OCT (SD-OCT) using a superluminescent
diode (SLD) with a center wavelength 840 nm.
Measurement scan	3D 12x9 mm (Wide)	3D 12x9 mm (Wide)
	3D 7x7 mm (Macula)	3D 6x6 mm (Macula)
	3D 6x6 mm (Disc)	3D 6x6 mm (Disc)

58

59

Analysis	For posterior:	For posterior:
	- Full retinal thickness

Ganglion cell plus Inner plexiform layer (GCL+) thickness
Ganglion cell complex (GCL++) thickness
Retinal nerve fiber layer (RNFL) thickness | - Full retinal thickness
Ganglion cell plus Inner plexiform layer (GCL+) thickness
Ganglion cell complex (GCL++) thickness
Retinal nerve fiber layer (RNFL) thickness |
| | - Optic disc analysis | - Optic disc analysis |
| | 1. DA (Disc area) | 1. DA (Disc area) |
| | 2. RA (Rim area) | 2. RA (Rim area) |
| | 3. CV (Cup volume) | 3. CV (Cup volume) |
| | 4. LCDR (Linear Cup Disc ratio) | 4. LCDR (Linear Cup Disc ratio) |
| | 5. VCDR (Vertical Cup Disc ratio) | 5. VCDR (Vertical Cup Disc ratio) |
| | 6. CA (Cup area) | 6. CA (Cup area) |
| | 7. RV (Rim volume) | 7. RV (Rim volume) |
| | 8. CDR (Cup Disc ratio) | 8. CDR (Cup Disc ratio) |
| | 9. Optic disc diameter (vertical direction) | 9. Optic disc diameter (vertical direction) |
| | 10. Optic disc diameter (horizontal direction) | 10. Optic disc diameter (horizontal direction) |
| | Software and algorithm updates included improved fovea detection, ILM and RPE segmentation, artifact removal and cup map refinement. | |
| | For anterior: | For anterior: |
| | NA | NA |

Fundus Camera
Observation	Light source	Light source

60

Applicant	TOPCON	TOPCON
Device Name	DRI OCT Triton
DRI OCT Triton (plus)	3D OCT-1 Maestro
510k Number	K173119	K161509
K170164
	- IR LED
Camera

CMOS camera (0.3M pixels) | - IR LED
Camera
CMOS camera (0.3M pixels) |
| Applicant | TOPCON | TOPCON |
| Device Name | DRI OCT Triton (plus) | TRC-50DX |
| 510k Number | K173119 | K123101 |
| Product Code | OBO, HKI | HKI |
| Regulation number | 21CFR§886.1570 | 21CFR§886.1120 |
| Indications for Use | The Topcon DRI OCT Triton is a non-contact, high
resolution tomographic and biomicroscopic imaging
device that incorporates a digital camera for
photographing, displaying and storing the data of the
retina and surrounding parts of the eye to be
examined under Mydriatic and non-Mydriatic
conditions.
The DRI OCT Triton is indicated for in vivo viewing,
axial cross sectional, and three-dimensional imaging
and measurement of posterior ocular structures,
including retina, retinal nerve fiber layer, macula and
optic disc as well as imaging of anterior ocular
structures.
It also includes a Reference Database for posterior
ocular measurements which provide for the
quantitative comparison of retinal nerve fiber layer,
optic nerve head, and the macula in the human retina
to a database of known normal subjects. The DRI
OCT Triton is indicated for use as a diagnostic device
to aid in the diagnosis, documentation and
management of ocular health and diseases in the
adult population. | The TRC-50DX Retinal Camera is intended for use in
capturing images of the retina and anterior segment
of the eye and presenting the data to the eye care
professional, with the use of a mydriatic. |
| Applicant | TOPCON | TOPCON |
| Device Name | DRI OCT Triton (plus) | TRC-50DX |
| 510k Number | K173119 | K123101 |
| Technological
Characteristics | OCT:
Optical coherence tomography is employed to obtain
cross-sectional images of the fundus and the anterior
segment of the eye.

Fundus Camera:
A Xenon flash and a CMOS camera are employed to
obtain fundus/anterior Color/digital red-free/FA/FAF
images. | OCT:
NA

Fundus Camera:
A Xenon flash and a CCD camera are employed to
obtain fundus/anterior Color/red-free/FA/FAF/ICG
images. |
| Fundus Camera
Observation | Light source

IR LED

Camera

CMOS camera (0.3M pixels) | Light source
Halogen lamp

Camera (Color/red-free/FA/FAF)

NA (optical finder)

Camera (ICG)

CCD camera (0.4M pixels) |

61

62