Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional OCT technology and image processing without mentioning AI/ML capabilities. The clinical study also focuses on comparing measurement agreement and precision with a predicate device, not on validating AI/ML performance.

Therapeutic

No
The device is described as an "imaging and measurement" tool to "aid in the diagnosis and management" of retinal diseases, not to directly treat or cure them.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the in-vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as a tool and an aid in the diagnosis and management of retinal diseases by a clinician." This phrase "aid in the diagnosis" clearly identifies it as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "Optical Coherence Tomography (OCT) system" and describes hardware components like a "low coherence interferometer" and a "traditional patient and instrument interface." This indicates it is a hardware device with associated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Canon OCT-A1 is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states "in-vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc". This indicates the device is used directly on a living patient, not on biological specimens in vitro (outside the body).
Device Description: The description reinforces the in-vivo nature by stating it's a "non-invasive imaging device for viewing and measuring ocular tissue structures". It describes scanning the patient's eye.
Anatomical Site: The specified anatomical sites (retina, retinal nerve fiber layer, optic disc) are all within the living body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or performing tests on these samples to provide diagnostic information.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Canon OCT-A1 is an imaging device used directly on the patient's eye.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Canon OCT-A1 is an optical coherence tomography system indicated for the in-vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and an aid in the diagnosis and management of retinal diseases by a clinician.

Product codes

OBO, HLI

Device Description

The Canon OCT-A1 *- is an Optical Coherence Tomography (OCT) system intended for use as a non-invasive imaging device for viewing and measuring ocular tissue structures with micrometer range resolution. The OCT-A1 is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices.

*: "Al" stands for the "Automatic-1" which means the first Canon OCT with the automatic alignment and adjustment feature.

The OCT-A1 uses Fourier Domain OCT, a method that involves spectral analysis of the returned light rather than mechanic moving parts in the depth scan. Fourier Domain OCT allows scan speeds about 65 times faster than the mechanical limited Time Domain scan speeds.

The OCT-A1 quantifies numerous ocular structures. The various retinal layers or structures, which are imaged or measured, include the following:

The internal limiting membrane (ILM)
The retinal nerve fiber layer (RNFL)
The NFL+GCL+IPL thickness
The retinal pigment epithelium (RPE)
Bruch's membrane (BM)
The full retina thickness

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT), Near IR observation (Confocal laser scanning)

Anatomical Site

Retina, retinal nerve fiber layer, optic disc, internal limiting membrane (ILM), NFL+GCL+IPL thickness, retinal pigment epithelium (RPE), Bruch's membrane (BM)

Indicated Patient Age Range

18 years of age or older

Intended User / Care Setting

Clinician

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

Clinical study: Prospective comparative, randomized, single center study conducted in the US.
Sample size: 125 subjects (37 normal, 37 glaucoma, 38 retinal disease).
Data source: Human eyes.
Annotation protocol: Device operators and investigators were masked to the automated results of segmentation.

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

Study type: Clinical study (prospective comparative, randomized, single center), Bench testing.
Sample size: 125 subjects in the clinical study.
AUC: Not Found.
MRMC: Not Found.
Standalone performance: Not Found.
Key results:
Bench Testing:

Scan Speed
Transverse and Depth Resolution
Field of View/Angle of View
Scan Depth
Testing to the Standards: Electrical Safety (AAMI/ANSI ES60601-1), Electromagnetic Compatibility (IEC 60601-1-2), Safety of Laser Products (IEC 60825-1), Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10), Ophthalmic Instruments (ISO 15004-1, ISO 15004-2), Optical Radiation Hazard Analysis (ANSI Z80.36-2016).
Software verification and validation: Considered "Moderate" level of concern. Conducted in two stages: bench testing based on layer recognition and quantitative measurement, and clinical evaluation involving human eyes.

Clinical Testing:
Objective: Assess agreement and precision of the Canon OCT-A1 (OCT-HS-100) in comparison with the Optovue RTVue Avanti for measurements of Full retinal thickness, Retinal nerve fiber layer (RNFL) thickness, Ganglion cell complex (GCC) thickness, and Optic nerve head (ONH).

Analysis of Agreement Summary:

Full Retinal Thickness (FRT): Canon Macula 3D scans tended to have higher FRTs (10-30 um depending on parameter and population). Differences attributed to Canon using 3rd hyper-reflective band (lower border of RPE) as outer border of retina and Optovue using 2nd hyper-reflective band (upper border of RPE). Canon includes RPE in FRT measurement while Optovue does not. Diameter of outer section of grid also differed (Canon 6mm, Optovue 5mm). Overall agreement was acceptable.
Retinal Nerve Fiber Layer Thickness (RNFL): Mean differences generally less than 10% of thickness. Some wide limits of agreement (LOA) for glaucoma and retinal disease patients in certain sectors due to subject variability and technological differences. Overall mean differences were small (-2.999 to 8.378 um).
Ganglion Cell Complex (GCC) Thickness: Mean differences generally less than 10% of GCC thickness. Some wide LOAs for glaucoma patients (total and superior sectors) and retinal disease patients (superior sector). Attributed to disease severity and differences in measurement grid placement.
Optic Nerve Head (ONH): Overall mean differences for ONH parameters were close to zero (-0.0754 to 0.2268).

Analyses of Precision:

Full Retinal Thickness (FRT): For normal group, Optovue RTVue Avanti generally had better repeatability and reproducibility for central FRT. For para and peri parameters, Canon OCT-A1 and Optovue Retinal Map had similar precision values.
Average TSNIT Retinal Nerve Fiber Layer Thickness: For normal group, Canon OCT-A1 had better repeatability and reproducibility for RNFL TSNIT average. For glaucoma group, mixed results with Optovue ONH slightly better repeatability and Canon OCT-A1 slightly better reproducibility. For retinal disease group, Canon OCT-A1 had better repeatability and reproducibility.
Ganglion Cell Complex (GCC) Thickness: Canon OCT-A1 showed better repeatability and reproducibility for total GCC thickness across all groups (normal, glaucoma, retinal disease).
Optic Nerve Head (ONH): For normal and retinal disease groups, Canon OCT-A1 had better repeatability and reproducibility for ONH disc area. For glaucoma group, Optovue ONH had better repeatability and reproducibility for ONH disc area.

Repeatability and Reproducibility for Canon-only Parameters:

Macula 3D: Showed varying repeatability and reproducibility limits across normal, glaucoma, and retinal disease groups for average, minimum, and volume measurements.
Disc 3D: Showed varying repeatability and reproducibility limits for RNFL TSNIT SD values across normal, glaucoma, and retinal disease groups.
Glaucoma 3D: Showed varying repeatability and reproducibility limits for Para and Peri measurements across normal, glaucoma, and retinal disease groups.
Disc 3D - ONH: Showed varying repeatability and reproducibility limits for ONH C/D Minimum and ONH DDLS across normal, glaucoma, and retinal disease groups.

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

Not Found

Predicate Device(s)

Optovue RTVue XR OCT Avanti with Normative Database (K153080)

Reference Device(s)

Not Found

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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 24, 2019

Canon Inc. % Ryan Bouchard VP, Medical Devices Ora. Inc. 300 Brickstone Square Andover, MA 01810

Re: K182942

Trade/Device Name: Canon OCT-A1 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HLI Dated: June 17, 2019 Received: June 18, 2019

Dear Ryan Bouchard:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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. 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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Bradley Cunningham Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182942

Device Name Canon OCT-A1

Indications for Use (Describe)

The Canon OCT-A1 is an optical coherence tomography system indicated for the in-vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and an aid in the diagnosis and management of retinal diseases by a clinician.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of the 510(k) premarket notification for the Canon OCT-A1 K182942 is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Owner Company name, address a.

Canon Inc. 9-1, Imaikami-cho Nakahara-ku. Kawasaki Kanagawa 211-8501 Japan

Contact person: Tatsuya Yamazaki

b. Contact/Application Correspondent

Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 Telephone: (978) 332-9574 Facsimile: (978) 689-0020 E-mail: rbouchard@oraclinical.com

Date Prepared C.

July 24, 2019

d. Name of Device

Trade Name:	Canon OCT-A1 *-
Common Names:	Optical Coherence Tomography
Classification Name:	Tomography, optical coherence
Classification Regulation:	21 CFR 886.1570
Product Code:	OBO
510(k) Number:	K182942

Predicate Device e.

Optovue RTVue XR OCT Avanti with Normative Database (K153080)

f. Device Description

The Canon OCT-A1 *- is an Optical Coherence Tomography (OCT) system intended for use as a non-invasive imaging device for viewing and measuring ocular tissue structures with micrometer range resolution. The OCT-A1 is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices.

4

*: "Al" stands for the "Automatic-1" which means the first Canon OCT with the automatic alignment and adjustment feature.

The OCT-A1 uses Fourier Domain OCT, a method that involves spectral analysis of the returned light rather than mechanic moving parts in the depth scan. Fourier Domain OCT allows scan speeds about 65 times faster than the mechanical limited Time Domain scan speeds.

The OCT-A1 quantifies numerous ocular structures. The various retinal layers or structures, which are imaged or measured, include the following:

The internal limiting membrane (ILM) 2) The retinal nerve fiber layer (RNFL) 3) The NFL+GCL+IPL thickness 4) The retinal pigment epithelium (RPE) 5) Bruch's membrane (BM) 6) The full retina thickness

Indications for Use g.

The Canon OCT-A1 is an optical coherence tomography system indicated for the invivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as a tool and an aid in the diagnosis and management of retinal diseases by a clinician.

h. Statement of Substantial Equivalence

Canon, Inc. believes that the Canon OCT-A1 described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device which is the Optovue RTVue XR OCT cleared in K153080.

5

Feature	Canon OCT-A1	RTVue XR OCT (K153080)
Manufacturer	Canon Inc.	Optovue, Inc.
Classification	886.1570	886.1570
Product Code	OBO	HLI, OBO
Indications for use	The Canon OCT-A1 is an optical
coherence tomography system indicated
for the in-vivo imaging and measurement
of the retina, retinal nerve fiber layer, and
optic disc as a tool and an aid in the
diagnosis and management of retinal
diseases by a clinician.	The RTVue XR OCT Avanti with
Normative Database is an optical
coherence tomography system indicated
for the in vivo imaging and measurement
of the retina, retinal nerve fiber layer, and
optic disc as a tool and aid in the
diagnosis and management of retinal
diseases by a clinician.

The RTVue XR OCT Avanti with
Normative Database is also a quantitative
tool for the comparison of retina, retinal
nerve fiber layer, and optic disc
measurements in the human eye to a
database of known normal subjects. It is
intended for use as a diagnostic device to
aid in the detection and management of
ocular diseases.

6

7

Feature	Canon OCT-A1	RTVue XR OCT (K153080)
Measurement and Analysis
Imaging of the
Fundus	SLO	SLO
Retinal Thickness Measurement
-Total	ILM to RPE	VRI to RPE
-Inner	No	VRI to IPL
-Outer	No	RPE to IPL
GCC Thickness
(NFL+GCL+IPL
Thickness)	Yes	Yes
- S - I difference	No	Yes
- Focal loss volume	No	Yes
- Global loss
volume	No	Yes
RNFL Thickness
Measurement	Along the circumference of a circle of
3.45 mm diameter which is targeted
around the ONH	Along the circumference of a circle of
3.45 mm diameter which is targeted
around the ONH
Optic Disc Analysis
-Disc area	Yes	Yes
-Rim area	Yes	Yes
-Cup area	No	Yes
-Cup volume	Yes	Yes
-Rim volume	Yes	Yes
-Nerve head
volume	No	Yes
-C/D area	Yes	Yes
-C/D vertical	Yes	Yes
-C/D horizontal	Yes	Yes
-R/D minimum	Yes	No

Both the Canon OCT-A1 and the Optovue XR OCT are OCT devices. The principle of operation is identical in that both devices employ a non-invasive, non-contact lowcoherence interferometry technique [specifically, spectral domain optical coherence tomography (SD-OCT)] to generate high-resolution cross-sectional images of internal ocular tissue microstructures by measuring optical reflections from tissue. Both provide cross sectional images of the posterior structures of the eye (i.e., retina, including the ganglion and retinal nerve fiber layers.

There are minor differences in technological characteristics between the Canon OCT-A1 and the predicate device for the OCT including wavelength, size of field of view, optical

8

resolution, and exposure power at pupil. There are also minor differences in technological characteristics between the Canon OCT-A1 and the predicate device for the SLO including wavelength and field of view. There are also differences related to minimum pupil diameter required for measurement and focus range. Regarding measurement and analysis, the retinal thickness measurement methodology differs between the Canon OCT-A1 and the predicate device. There are also differences in the optic disc analysis.

Performance testing including both bench testing and clinical testing demonstrated substantial equivalence. Therefore, based on the same intended use and similar technological characteristics with substantial equivalence to the predicate device confirmed with performance testing, the Canon OCT-A1 is technologically and functionally equivalent to the predicate device, RTVue XR OCT (K153080). The differences between the proposed device, OCT-A1, and the predicate device are insignificant and do not raise new issues of safety or effectiveness of the device. The Canon OCT-A1 is as safe and effective as its predicate devices, and thus, may be considered substantially equivalent.

i. Performance Testing

Canon, Inc. performed bench tests to ensure safety and effectiveness and to demonstrate substantial equivalence of the OCT-A1 to the predicate device. A list of testing conducted included:

· Scan Speed
· Transverse and Depth Resolution
Field of View/Angle of View
· Scan Depth
· Testing to the Standards

Electrical Safety: AAMI/ANSI ES60601-1 Electromagnetic Compatibility: IEC 60601-1-2 Safety of Laser Products: IEC 60825-1 Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10 Ophthalmic Instruments: ISO 15004-1, ISO 15004-2 Optical Radiation Hazard Analysis: ANSI Z80.36-2016.

Software verification and validation testing were conducted and documentation was 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 a "Moderate" level of concern-. The software verification and validation was conducted in two stages, one which included bench testing based on proper recognition of layer and quantitative measurement of thickness or area. The second stage of the software validation was performed by involving human eyes in a clinical evaluation.

Clinical Testing: A clinical study was conducted to demonstrate substantial equivalence of the Canon OCT-A1 (OCT-HS-100) in comparison with Optovue RTVue Avanti. The repeatability and reproducibility were evaluated for the measurements of: Full retinal

9

thickness: Retinal nerve fiber layer (RNFL) thickness: Ganglion cell complex (GCC) thickness; and Optic nerve head (ONH) The main objective of the clinical study was to assess agreement and precision of the Canon OCT-A1 (OCT-HS-100) in comparison with the Optovue RTVue Avanti. The study was a prospective comparative, randomized, single center study conducted in the US to gather agreement and precision data in at least 99 evaluable eyes, approximately 33 eligible subjects in each of the study subject groups: normal subjects; subjects with glaucoma; and subjects with retinal disease.

The primary inclusion criteria for all groups included: Male or female subjects from 18 vears of age or older who have full legal capacity to volunteer on the date the informed consent is signed; Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date; Subjects who agree to participate in the study

In addition each of the groups had inclusion criteria associated with the specific group.

Normal Group:

. Subjects with normal eye examinations (without pathology) in one or both eyes on the date of the study visit as observed with a +90 Diopter Fundus Lens;
Subjects with current best-spectacle-corrected visual acuity (BSCVA) of 20/40 or . better in the normal eye(s)

Glaucoma Group:

. Subjects who have been diagnosed with glaucoma in the glaucoma study eye(s)
with a current BSCVA of 20/40 or better in the glaucoma study eve(s) ●
. History of visual field defects within the previous two (2) months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage

Retinal Disease Group:

Subjects with a current BSCVA of 20/400 or better in the retinal disease study eve(s) . at the study visit
Subjects diagnosed with retinal pathology including but not limited to: Non . Exudative Macular Degeneration (dry AMD), Diabetic Macular Edema, Macular Hole, Epiretinal Membrane, Cystoid Macular Edema, or other retinal disease in the study eye(s) as confirmed within the past six (6) months, who exhibit structural lesions in the study eye
Subjects diagnosed with retinal pathology including but not limited to: Neovascular . Macular Degeneration (wet AMD), Diabetic Retinopathy, Retinal Artery Occlusion, Retinal Vein Occlusion or other retinal disease in the study eye(s) as confirmed within the past six (6) months, who exhibit vascular and/or ischemic lesions in the study eye.

The exclusion criteria was similar for all groups and included:

Subjects unable to tolerate ophthalmic imaging;
Subjects with ocular media not sufficiently clear to obtain acceptable OCT images; .
. Subjects with a history of leukemia, dementia or multiple sclerosis.

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. Subject has a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Group specific exclusion criteria included:
. Normal Group: Subjects with any current ocular pathology other than cataract in the normal eye(s), as determined by self-report and/or investigator assessment at the studv visit:
. Retinal Disease Group: Subjects with glaucoma in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit

Three Canon OCT-A1 devices and 3 Optovue RTVue Avanti devices were used. Each Canon OCT-A1 device was paired with 1 of the Optovue RTVue Avanti devices. One device operator was assigned to each device pair to create 3 distinct operator/device configurations. Device operators and investigators were masked to the automated results of segmentation.

This study included 125 subjects with 37 in the normal group, 37 in the glaucoma group, and 38 in the retinal disease group. The study included two main analyses: 1) analysis of agreement and 2) analysis of precision.

In the effectiveness population, the mean (SD) age was 39.1 (15.28) years for the normal eve subjects. 71.6 (8.78) years for the glaucoma eve subjects. 62.1 (15.11) years for the retinal disease eye subjects, 53.5 (17.38) years for the FFA normal eye subjects, and 59.3 (14.73) years FFA retinal disease eve subjects. The overall mean age of all subjects was 57.5 (18.67) years. Sixty-one females and 64 males participated (48.8% and 51.2%, respectively), and the majority of subjects were white 92 (73.6%) and not Hispanic or Latino 101 (80.8%).

Analysis of Agreement Summary

Full Retinal Thickness (FRT)

The normal population showed Canon Macula 3D scans tended to have higher FRTs by about 10 to 30 um depending on the parameter with mean differences ranging from 12.56 to 29.95 um.

The glaucoma population showed Canon Macula 3D scans tended to have higher FRTs by about 15 to 30 um depending on the parameter with mean differences ranging from 15.42 to 29.39 um.

The retinal disease population showed Canon Macula 3D scans tended to have higher FRTs by about 15 to 25 um depending on the parameter with mean differences ranging from 12.52 to 24.46 um.

See Table 1 for the mean differences and 95% Limits of Agreement (LOA). Some of the 95% LOAs were fairly wide, as seen in Table 1.

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The differences shown between the Canon and the Optovue devices are largely because the two devices use different bands in the RPE as the outer of the retina. Optovue uses the 2nd hyper reflective band (upper border of RPE) as an outer border of the retina and the Canon uses the 3th hyper reflective band (lower border of RPE) as an outer border of the retina. In addition, the diameter of the outer section of the grid for the Canon OCT-A1 is 6mm whereas the Optovue uses a 5mm diameter.

FRT is summarized in Table 1.

| Subject Population
Comparable
Parameter | Canon OCT-A1
Mean (SD) | Optovue
Avanti
RTVue
Mean (SD) | Mean
Difference
(SD) | 95% CI for Mean
Difference | 95% LOA
for
Differences |
|-------------------- | All Configurations | Normal – N | Central (µm) | Para Inferior (µm) | Para Nasal (µm) | Para Superior (µm) | Para Temporal (µm) | Peri Inferior (µm) | Peri Nasal (µm) | Peri Superior (µm) | Peri Temporal (µm) | Glaucoma – N | Central (µm) | Para Inferior (µm) | Para Nasal (µm) | Para Superior (µm) | Para Temporal (µm) | Peri Inferior (µm) | Peri Nasal (µm) | Peri Superior (µm) | Peri Temporal (µm) | Retinal Disease - N | Central (µm) | Para Inferior (µm) | Para Nasal (µm) | Para Superior (µm) | Para Temporal (µm) | Peri Inferior (µm) | Peri Nasal (µm) | Peri Superior (µm) | Peri Temporal (µm) ---------------------------|---------------------------|-----------------------------------------|----------------------------|-------------------------------|-------------------------------|
| | | | | |
| 37 | 37 | | | |
| 267.20 (19.396) | 248.89 (18.222) | 18.32 (5.056) | (16.69, 19.95) | (8.20, 28.43) |
| 339.95 (15.682) | 310.00 (16.159) | 29.95 (6.066) | (28.00, 31.91) | (17.82, 42.09) |
| 344.05 (17.430) | 315.30 (18.034) | 28.75 (7.179) | (26.44, 31.06) | (14.39, 43.11) |
| 343.27 (18.369) | 314.62 (18.160) | 28.65 (7.468) | (26.25, 31.06) | (13.72, 43.59) |
| 329.85 (16.339) | 301.92 (16.948) | 27.93 (6.769) | (25.75, 30.11) | (14.39, 41.47) |
| 285.94 (13.608) | 273.38 (13.303) | 12.56 (7.029) | (10.30, 14.83) | (-1.49, 26.62) |
| 314.45 (18.170) | 296.76 (16.744) | 17.69 (6.606) | (15.56, 19.82) | (4.48, 30.90) |
| 300.56 (14.849) | 283.70 (14.024) | 16.86 (5.773) | (15.00, 18.72) | (5.31, 28.41) |
| 284.87 (12.895) | 271.54 (12.747) | 13.33 (6.084) | (11.37, 15.29) | (1.16, 25.50) |
| 37 | 37 | | | |
| 281.48 (35.758) | 261.59 (34.850) | 19.90 (24.654) | (11.95, 27.84) | (-29.41, 69.21) |
| 325.21 (28.364) | 301.11 (28.801) | 24.10 (7.184) | (21.78, 26.41) | (9.73, 38.47) |
| 336.74 (33.194) | 308.35 (26.378) | 28.39 (27.059) | (19.67, 37.11) | (-25.73, 82.51) |
| 327.52 (31.249) | 300.97 (25.159) | 26.55 (19.224) | (20.35, 32.74) | (-11.90, 64.99) |
| 319.34 (39.493) | 298.03 (40.564) | 21.31 (6.153) | (19.33, 23.29) | (9.00, 33.62) |
| 278.66 (47.999) | 262.14 (34.713) | 16.53 (21.158) | (9.71, 23.35) | (-25.79, 58.85) |
| 299.82 (40.902) | 284.22 (29.109) | 15.60 (17.921) | (9.83, 21.37) | (-20.24, 51.44) |
| 286.41 (49.447) | 268.70 (27.373) | 17.71 (34.760) | (6.51, 28.91) | (-51.81, 87.23) |
| 278.93 (38.129) | 263.51 (36.210) | 15.42 (13.724) | (10.99, 19.84) | (-12.03, 42.86) |
| 38 | 38 | | | |
| 301.31 (76.663) | 283.08 (87.687) | 18.23 (26.086) | (9.93, 26.52) | (-33.94, 70.40) |
| 339.82 (62.561) | 318.58 (58.490) | 21.24 (26.018) | (12.97, 29.52) | (-30.79, 73.28) |
| 341.23 (48.955) | 320.34 (56.855) | 20.89 (12.453) | (16.93, 24.85) | (-4.02, 45.79) |
| 340.67 (60.800) | 316.21 (60.384) | 24.46 (26.722) | (15.97, 32.96) | (-28.98, 77.91) |
| 332.88 (73.242) | 313.21 (72.336) | 19.67 (19.849) | (13.36, 25.98) | (-20.03, 59.37) |
| 292.15 (47.420) | 275.61 (40.020) | 16.54 (19.180) | (10.44, 22.64) | (-21.82, 54.90) |
| 313.46 (35.589) | 297.42 (39.443) | 16.04 (10.678) | (12.65, 19.44) | (-5.31, 37.40) |
| 297.10 (33.689) | 284.58 (40.834) | 12.52 (14.643) | (7.86, 17.17) | (-16.77, 41.80) |
| 293.17 (65.016) | 279.74 (62.990) | 13.44 (15.711) | (8.44, 18.43) | (-17.99, 44.86) |

Table 1 FRT between Macula 3D and Retinal Map (Effectiveness Population)

Abbreviations: CI = confidence interval; FRT = full retinal thickness; LOA = limit of agreement; N = number of eves; SD = standard deviation

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. N was the number of eyes with measurements from each device. Difference was calculated as the test device minus the predicate device. The 95% CIs for the mean difference was based on t-distribution. 95% LOA = mean difference +/- 2 x difference SD.

Retinal Nerve Fiber Layer Thickness

Refer to Table 2 for the mean differences and 95% Limits of Agreement (LOA) for measurements of the Retinal Nerve Fiber Laver (RNFL) thickness. Mean differences are

12

generally less than 10% of the thickness. Some of the RFNL sectors for glaucoma patients and for retinal disease patients show wide limits of agreement. For this population in these sectors subject variability in the scans between the Canon and the Optovue devices resulted in larger mean differences and greater standard deviations (SD) resulting in wide LOA. A review of the patients included in this particular study subgroup shows significant disease and disruption in the layers of the retina. Differences in technology between the test and predicate devices can cause these wider LOAs.

Overall the mean differences were small, ranging from -2.999 to 8.378 um for all comparable parameters and eve populations. As noted above the LOA for temporal and nasal sectors for the glaucoma population was wide, indicating substantial variation in the measurements between the two devices. (Table 2).

| Subject Population
Comparable
Parameter | Canon OCT-A1
Mean (SD) | Optovue Avanti
Mean (SD) | Mean Difference
(SD) | 95% CI for
Mean
Difference | 95% LOA for
Differences |
|-----------------------------------------------|---------------------------|-----------------------------|-------------------------|----------------------------------|----------------------------|
| All Configurations | | | | | |
| Normal - N | 37 | 37 | | | |
| Inferior-4 (µm) | 132.792 (17.9680) | 124.414 (15.0461) | 8.378 (9.3310) | (5.372, 11.385) | (-10.284, 27.040) |
| Nasal-4 (µm) | 85.962 (12.2673) | 79.339 (7.2549) | 6.623 (9.3357) | (3.615, 9.631) | (-12.048, 25.294) |
| Superior-4 (µm) | 126.668 (14.0183) | 124.050 (12.3126) | 2.619 (12.3586) | (-1.364, 6.601) | (-22.099, 27.336) |
| Temporal-4 (µm) | 70.409 (14.6871) | 73.408 (11.7727) | -2.999 (6.6947) | (-5.156, -0.842) | (-16.389, 10.390) |
| RNFL
TSNIT
Average (µm) | 103.673 (9.5828) | 100.302 (7.9933) | 3.371 (4.9991) | (1.760, 4.981) | (-6.628, 13.369) |
| Glaucoma - N | 36 | 36 | | | |
| Inferior-4 (µm) | 99.744 (25.3340) | 92.455 (22.1833) | 7.289 (10.3872) | (3.896, 10.683) | (-13.485, 28.064) |
| Nasal-4 (µm) | 70.437 (13.9450) | 64.364 (19.0955) | 6.073 (17.3258) | (0.413, 11.733) | (-28.579, 40.724) |
| Superior-4 (µm) | 93.855 (19.4669) | 92.792 (19.1738) | 1.064 (11.2139) | (-2.600, 4.727) | (-21.364, 23.491) |
| Temporal-4 (µm) | 64.696 (23.1708) | 62.124 (10.3552) | 2.572 (18.0637) | (-3.329, 8.472) | (-33.556, 38.699) |
| RNFL
TSNIT
Average (µm) | 82.026 (16.5404) | 77.934 (15.3871) | 4.092 (7.4361) | (1.663, 6.521) | (-10.781, 18.964) |
| Retinal Disease - N | 38 | 38 | | | |
| Inferior-4 (µm) | 120.532 (19.0732) | 116.174 (17.3649) | 4.357 (7.5823) | (1.947, 6.768) | (-10.807, 19.522) |
| Nasal-4 (µm) | 79.972 (18.1247) | 76.303 (16.4436) | 3.669 (11.5128) | (0.008, 7.329) | (-19.357, 26.695) |
| Superior-4 (µm) | 117.430 (22.8718) | 113.553 (22.0223) | 3.877 (8.7714) | (1.088, 6.665) | (-13.666, 21.419) |
| Temporal-4 (µm) | 73.968 (17.9025) | 74.470 (13.7876) | -0.502 (13.8825) | (-4.916, 3.912) | (-28.267, 27.263) |
| RNFL
TSNIT
Average (µm) | 97.742 (14.7850) | 95.124 (13.4346) | 2.618 (4.6673) | (1.134, 4.102) | (-6.717, 11.952) |

Table 2 RNFL Thickness between Disc 3D and ONH (Effectiveness Population)

Abbreviations: CI = confidence interval; LOA = limit of agreement; N = number of eyes; RNFL = retinal nerve fiber layer; SD = standard deviation

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. N was the number of eyes with measurements from each device. Difference was calculated as the test device minus the predicate device. The 95% Cls for the mean difference was based on t-distribution. 95% LOA = mean difference +/- 2 x difference SD.

Ganglion Cell Complex Thickness

Refer to Table 3 for a summary of the mean differences and 95% LOAs between the two devices in the measurements of the Ganglion Cell Complex (GCC). Mean differences are generally less than 10% of the GCC thickness. However, some of the GCC sectors for glaucoma patients (e.g., the total and superior sectors) and retinal disease patients (superior sector) have wide LOAs. The

13

mean difference of -9.689 with a SD of 29.0092 resulted in wide LOA for this parameter. In the glaucoma population of this study, disease severity creates a difference in the devices based on technology.

The thickness measures for GCC were thinner for Canon Glaucoma 3D than Optovue GCC scans with mean differences ranging from -9.689 to -0.334 um. The LOA for the superior sector for the glaucoma population was wide. Wide LOAs may be attributed to differences in placement of the measurement grid pattern.

| Subject
Population
Comparable
Parameter | Canon OCT-A1
Mean (SD) | Optovue
Avanti
Mean (SD) | RTVue
Mean Difference
(SD) | 95% CI for Mean
Difference | 95% LOA for
Differences |
|--------------------------------------------------|---------------------------|--------------------------------|----------------------------------|-------------------------------|----------------------------|
| All
Configurations | | | | | |
| Normal – N | 37 | 37 | | | |
| Inferior (µm) | 94.675 (7.5952) | 95.009 (7.5194) | -0.334 (3.7451) | (-1.541, 0.872) | (-7.825, 7.156) |
| Superior (µm) | 87.218 (6.9420) | 94.097 (6.6213) | -6.880 (3.7008) | (-8.072, -5.687) | (-14.281, 0.522) |
| Total (µm) | 90.934 (6.7238) | 94.548 (6.9738) | -3.614 (2.7775) | (-4.509, -2.719) | (-9.169, 1.941) |
| Glaucoma – N | 37 | 37 | | | |
| Inferior (µm) | 84.135 (14.3771) | 85.325 (19.5880) | -1.189 (8.8027) | (-4.026, 1.647) | (-18.795, 16.416) |
| Superior (µm) | 80.215 (14.9530) | 89.904 (40.0218) | -9.689 (29.0092) | (-19.037, -0.342) | (-67.708, 48.329) |
| Total (µm) | 82.126 (14.1996) | 87.612 (28.7960) | -5.486 (17.0916) | (-10.994, 0.021) | (-39.669, 28.697) |
| Retinal Disease – N | 38 | 38 | | | |
| Inferior (µm) | 95.534 (14.7452) | 98.821 (18.9006) | -3.287 (7.4246) | (-5.648, -0.926) | (-18.136, 11.562) |
| Superior (µm) | 90.975 (18.3027) | 99.073 (25.3985) | -8.098 (9.5359) | (-11.130, -5.066) | (-27.170, 10.974) |
| Total (µm) | 93.273 (16.1076) | 98.944 (21.5411) | -5.671 (7.5186) | (-8.062, -3.281) | (-20.709, 9.366) |

Table 3GCC Thickness between Glaucoma 3D and GCC (Effectiveness Population)
-----------------------------------------------------------------------------	--	--

Abbreviations: 3-D = 3-dimensional; CI = confidence interval; GCC= ganglion cell complex; LOA = limit of agreement; N = number of eyes; SD = standard deviation

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. N was the number of eyes with measurements from each device. Difference was calculated as the test device minus the predicate device. The 95% CIs for the mean difference was based on t-distribution. 95% LOA = mean difference +/- 2 x difference SD.

Optic Nerve Head

ONH parameters from Canon Disc 3D scans were converted to millimeters (mm), mm² for area and mm3 for volume comparison. Refer to Table 4 for a summary of the mean differences and 95% LOAs between the two devices in the measurements of the ONH. Overall the mean differences for ONH parameters were close to zero with mean differences ranging from -0.0754 (C/D Horizontal) to 0.2268 (Disc Area).

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	Table 4 ONH between Disc 3D and ONH (Effectiveness Population)
--	----------------------------------------------------------------	--	--	--	--

| Subject Population
Comparable
Parameter | Canon OCT-A1
Mean (SD) | Optovue
Avanti
Mean (SD) | RTVue
Mean
(SD) | Mean
Difference
(SD) | 95% CI for Mean
Difference | 95% LOA for
Differences |
|-----------------------------------------------|---------------------------|--------------------------------|-----------------------|----------------------------|-------------------------------|----------------------------|
| All Configurations | | | | | | |
| Normal - N | 37 | 37 | | | | |
| ONH
Cup
Volume (mm³) | 0.1331 (0.13060) | 0.1310 (0.12665) | 0.0021 (0.04309) | (-0.0124, 0.0166) | (-0.0841, 0.0883) | |
| ONH Disc Area
(mm²) | 2.0482 (0.42161) | 2.0230 (0.38576) | 0.0252 (0.22361) | (-0.0468, 0.0973) | (-0.4220, 0.4725) | |
| ONH C/D Area | 0.2483 (0.13460) | 0.2926 (0.13372) | -0.0444 (0.03701) | (-0.0568, -0.0319) | (-0.1184, 0.0297) | |
| ONH
C/D
Horizontal | 0.4993 (0.16443) | 0.5709 (0.15776) | -0.0716 (0.06384) | (-0.0930, -0.0501) | (-0.1993, 0.0561) | |
| ONH
C/D
Vertical | 0.4750 (0.14179) | 0.4944 (0.15118) | -0.0194 (0.05032) | (-0.0364, -0.0025) | (-0.1201, 0.0812) | |
| ONH Rim Area
(mm²) | 1.5234 (0.25977) | 1.4215 (0.29611) | 0.1020 (0.20068) | (0.0345, 0.1694) | (-0.2994, 0.5033) | |
| ONH
Rim
Volume (mm³) | 0.2864 (0.09048) | 0.1686 (0.06336) | 0.1177 (0.04805) | (0.1016, 0.1339) | (0.0216, 0.2138) | |
| Glaucoma - N | 36 | 36 | | | | |
| ONH
Cup
Volume (mm³) | 0.2934 (0.24571) | 0.2825 (0.23555) | 0.0109 (0.14690) | (-0.0445, 0.0663) | (-0.2829, 0.3047) | |
| ONH Disc Area
(mm²) | 2.2282 (0.83476) | 2.0014 (0.38825) | 0.2268 (0.85919) | (-0.0539, 0.5074) | (-1.4916, 1.9452) | |
| ONH C/D Area | 0.5192 (0.19413) | 0.5442 (0.16971) | -0.0249 (0.06896) | (-0.0475, -0.0024) | (-0.1629, 0.1130) | |
| ONH
C/D
Horizontal | 0.7111 (0.14728) | 0.7794 (0.13771) | -0.0683 (0.07980) | (-0.0944, -0.0422) | (-0.2279, 0.0913) | |
| ONH
C/D
Vertical | 0.7171 (0.16020) | 0.7264 (0.15878) | -0.0093 (0.05470) | (-0.0272, 0.0085) | (-0.1187, 0.1001) | |
| ONH Rim Area
(mm²) | 1.0198 (0.39995) | 0.8894 (0.32102) | 0.1304 (0.31822) | (0.0264, 0.2343) | (-0.5061, 0.7668) | |
| ONH
Rim
Volume (mm³) | 0.1269 (0.08103) | 0.0651 (0.05119) | 0.0618 (0.03702) | (0.0497, 0.0739) | (-0.0123, 0.1358) | |
| Retinal Disease - N | 38 | 38 | | | | |
| ONH
Cup
Volume (mm³) | 0.0840 (0.07588) | 0.1025 (0.09039) | -0.0185 (0.03338) | (-0.0294, -0.0076) | (-0.0852, 0.0483) | |
| ONH Disc Area
(mm²) | 2.0591 (0.43518) | 1.9779 (0.37971) | 0.0812 (0.24191) | (0.0043, 0.1581) | (-0.4026, 0.5650) | |
| ONH C/D Area | 0.2432 (0.14268) | 0.3043 (0.12794) | -0.0611 (0.05301) | (-0.0782, -0.0440) | (-0.1671, 0.0449) | |
| ONH
C/D
Horizontal | 0.4895 (0.17092) | 0.5649 (0.16441) | -0.0754 (0.08214) | (-0.1018, -0.0489) | (-0.2396, 0.0889) | |
| ONH
C/D
Vertical | 0.4692 (0.18058) | 0.5132 (0.17872) | -0.0440 (0.08124) | (-0.0702, -0.0178) | (-0.2065, 0.1185) | |
| ONH Rim Area
(mm²) | 1.5533 (0.39718) | 1.3627 (0.27079) | 0.1906 (0.25459) | (0.1085, 0.2726) | (-0.3186, 0.6998) | |
| ONH
Rim
Volume (mm³) | 0.2682 (0.10845) | 0.1426 (0.06041) | 0.1256 (0.05703) | (0.1072, 0.1440) | (0.0115, 0.2397) | |

Abbreviations: 3-D = 3-dimensional; CI = confidence interval; LOA = limit of agreement; N = number of eyes; ONH = optic nerve head; SD = standard deviation

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. N was the number of eyes with measurements from each device. Difference was calculated as the test device minus the predicate device. The 95% CIs for the mean difference was based on t-distribution. 95% LOA = mean difference +/- 2 x difference SD. Subjects missing any Disc Area, Rim Area, C/D Vertical, or C/D Horizontal parameters in the Canon Disc 3D or Optovue ONH scans were excluded from all agreement analyses for ONH comparable parameters

15

Analyses of Precision

Precision analysis results are summarized by measurement in Table 5, Table 7 and Table 8.

Both repeatability and reproducibility were calculated for the precision analyses. Repeatability represents the variation among images within a subject within a given configuration of a machine. Reproducibility represents the overall variation among and within the configurations. To assist with the comparison of the Canon OCT-A1 and the Optovue RTVue Avanti, the ratios of the variation components were determined by dividing the component of the Canon OCT-A1 by the corresponding component of the Optovue RTVue Avanti. Ratios less than 1 indicate that OCT-A1 was less variable, while ratios greater than 1 indicate that the Optovue RTVue Avanti was less variable.

Full Retinal Thickness

Repeatability and reproducibility of FRT scans by Canon Macula 3D and Optovue Retinal Map (Effectiveness Population) were compared (Table 5).

For the normal group, central FRT as measured with the Canon OCT-A1 had a repeatability limit of 17.37 as compared with 5.28 for the Optovue RTVue Avanti. The limit ratio was 3.2893 in favor of Optovue RTVue Avanti. Central FRT as measured with the Canon OCT-A1 had a reproducibility limit of 18.10 as compared with 6.20 for the Optovue RTVue Avanti. The limit ratio was 2.9178 in favor of Optovue RTVue Avanti.

For the glaucoma group, central FRT as measured with the Canon OCT-A1 had a repeatability limit of 18.17 as compared with 10.29 for the Optovue RTVue Avanti. The limit ratio was 1.7658 in favor of Optovue RTVue Avanti. Central FRT as measured with the Canon OCT-A1 had a reproducibility limit of 18.24 as compared with 11.31 for the Optovue RTVue Avanti. The limit ratio was 1.6122 in favor of Optovue RTVue Avanti.

For the retinal disease group, central FRT as measured with the Canon OCT-A1 had a repeatability limit of 27.65 as compared with 32.29 for the Optovue RTVue Avanti. The limit ratio was 0.8565 in favor of Canon OCT-A1. Central FRT as measured with the Canon OCT-A1 had a reproducibility limit of 75.42 as compared with 46.36 for the Optovue RTVue Avanti. The limit ratio was 1.6268 in favor of Optovue RTVue Avanti.

Table 5 Repeatability and Reproducibility on FRT between Canon Macula 3D and Optovue Retinal Map (Effectiveness Population)

| Device - Scan Type
Comparable Parameter | Overall
Mean | Repeatability | | | Reproducibility | | |
|--------------------------------------------|-----------------|---------------|-----------------|--------|-----------------|-----------------|--------|
| | | SD | Limit (Ratio) | CV% | SD | Limit (Ratio) | CV% |
| Normal - N = 37 | | | | | | | |
| Canon - Macula 3D | | | | | | | |
| Central (µm) | 264.97 | 6.20 | 17.37 (3.2893) | 2.34% | 6.46 | 18.10 (2.9178) | 2.44% |
| Para Inferior (μm) | 338.59 | 5.70 | 15.97 (1.8495) | 1.68% | 5.97 | 16.71 (1.6483) | 1.76% |
| Para Nasal (µm) | 342.85 | 3.59 | 10.04 (1.2467) | 1.05% | 3.92 | 10.97 (1.1650) | 1.14% |
| Para Superior (μm) | 341.83 | 6.19 | 17.34 (1.8588) | 1.81% | 6.56 | 18.36 (1.8008) | 1.92% |
| Para Temporal (µm) | 328.82 | 5.75 | 16.10 (1.9315) | 1.75% | 5.94 | 16.63 (1.7292) | 1.81% |
| Peri Inferior (µm) | 285.18 | 3.21 | 8.99 (1.4461) | 1.13% | 3.44 | 9.63 (1.3572) | 1.21% |
| Peri Nasal (μm) | 313.43 | 1.28 | 3.57 (0.5718) | 0.41% | 1.88 | 5.28 (0.6739) | 0.60% |
| Device - Scan Type
Comparable Parameter | Overall
Mean | Repeatability | | | Reproducibility | | |
| | | SD | Limit (Ratio) | CV% | SD | Limit (Ratio) | CV% |
| Peri Superior (μm) | 298.85 | 4.25 | 11.90 (1.3352) | 1.42% | 4.57 | 12.81 (1.2173) | 1.53% |
| Peri Temporal (µm) | 284.37 | 3.62 | 10.12 (1.4822) | 1.27% | 3.90 | 10.91 (1.4063) | 1.37% |
| Optovue - Retinal Map | | | | | | | |
| Central (um) | 246.73 | 1.89 | 5.28 | 0.76% | 2.22 | 6.20 | 0.90% |
| Para Inferior (μm) | 309.29 | 3.08 | 8.63 | 1.00% | 3.62 | 10.14 | 1.17% |
| Para Nasal (um) | 313.95 | 2.88 | 8.06 | 0.92% | 3.36 | 9.42 | 1.07% |
| Para Superior (μm) | 313.00 | 3.33 | 9.33 | 1.06% | 3.64 | 10.19 | 1.16% |
| Para Temporal (um) | 300.88 | 2.98 | 8.33 | 0.99% | 3.43 | 9.62 | 1.14% |
| Peri Inferior (µm) | 272.23 | 2.22 | 6.22 | 0.82% | 2.53 | 7.10 | 0.93% |
| Peri Nasal (µm) | 295.48 | 2.23 | 6.25 | 0.76% | 2.80 | 7.83 | 0.95% |
| Peri Superior (μm) | 282.58 | 3.18 | 8.91 | 1.13% | 3.76 | 10.52 | 1.33% |
| Peri Temporal (µm) | 270.74 | 2.44 | 6.83 | 0.90% | 2.77 | 7.76 | 1.02% |
| Glaucoma - N = 37 | | | | | | | |
| Canon - Macula 3D | | | | | | | |
| Central (µm) | 282.98 | 6.49 | 18.17 (1.7658) | 2.29% | 6.51 | 18.24 (1.6122) | 2.30% |
| Para Inferior (μm) | 324.54 | 4.43 | 12.39 (1.3017) | 1.36% | 4.89 | 13.69 (1.2105) | 1.51% |
| Para Nasal (µm) | 337.21 | 3.53 | 9.89 (0.3651) | 1.05% | 4.03 | 11.28 (0.4154) | 1.20% |
| Para Superior (µm) | 326.69 | 6.75 | 18.89 (2.0787) | 2.07% | 7.11 | 19.90 (1.9196) | 2.18% |
| Para Temporal (µm) | 317.03 | 5.61 | 15.72 (1.6606) | 1.77% | 5.68 | 15.89 (1.5209) | 1.79% |
| Peri Inferior (µm) | 277.99 | 7.00 | 19.60 (1.3309) | 2.52% | 8.28 | 23.17 (1.5649) | 2.98% |
| Peri Nasal (µm) | 299.83 | 7.14 | 19.99 (2.6399) | 2.38% | 7.31 | 20.47 (2.4075) | 2.44% |
| Peri Superior (μm) | 286.37 | 7.87 | 22.03 (1.7060) | 2.75% | 8.10 | 22.69 (1.7533) | 2.83% |
| Peri Temporal (µm) | 278.06 | 4.49 | 12.59 (1.2493) | 1.62% | 4.57 | 12.80 (1.1665) | 1.64% |
| Optovue - Retinal Map | | | | | | | |
| Central (µm) | 260.13 | 3.67 | 10.29 | 1.41% | 4.04 | 11.31 | 1.55% |
| Para Inferior (μm) | 299.90 | 3.40 | 9.52 | 1.13% | 4.04 | 11.31 | 1.35% |
| Para Nasal (µm) | 309.49 | 9.68 | 27.09 | 3.13% | 9.70 | 27.16 | 3.13% |
| Para Superior (µm) | 301.63 | 3.25 | 9.09 | 1.08% | 3.70 | 10.37 | 1.23% |
| Para Temporal (µm) | 295.08 | 3.38 | 9.47 | 1.15% | 3.73 | 10.45 | 1.26% |
| Peri Inferior (μm) | 261.54 | 5.26 | 14.73 | 2.01% | 5.29 | 14.81 | 2.02% |
| Peri Nasal (µm) | 284.96 | 2.70 | 7.57 | 0.95% | 3.04 | 8.50 | 1.07% |
| Peri Superior (µm) | 269.86 | 4.61 | 12.91 | 1.71% | 4.62 | 12.94 | 1.71% |
| Peri Temporal (µm) | 263.70 | 3.60 | 10.07 | 1.36% | 3.92 | 10.98 | 1.49% |
| Retinal Disease - N = 38 | | | | | | | |
| Canon - Macula 3D | | | | | | | |
| Central (µm) | 299.21 | 9.88 | 27.65 (0.8565) | 3.30% | 26.94 | 75.42 (1.6268) | 9.00% |
| Para Inferior (μm) | 340.54 | 10.22 | 28.60 (1.7561) | 3.00% | 13.08 | 36.61 (1.5940) | 3.84% |
| Para Nasal (µm) | 339.14 | 11.53 | 32.28 (1.3368) | 3.40% | 19.06 | 53.36 (0.5247) | 5.62% |
| Para Superior (μm) | 333.01 | 15.89 | 44.49 (1.4614) | 4.77% | 25.64 | 71.78 (0.7910) | 7.70% |
| Para Temporal (µm) | 327.97 | 8.63 | 24.17 (1.2939) | 2.63% | 18.58 | 52.02 (2.5658) | 5.67% |
| Peri Inferior (µm) | 292.90 | 8.62 | 24.14 (1.5210) | 2.94% | 12.52 | 35.05 (1.9836) | 4.27% |
| Peri Nasal (µm) | 312.57 | 7.77 | 21.75 (1.0839) | 2.48% | 15.79 | 44.20 (0.3722) | 5.05% |
| Peri Superior (μm) | 296.44 | 6.56 | 18.36 (0.4615) | 2.21% | 23.17 | 64.88 (0.8008) | 7.82% |
| Peri Temporal (µm) | 287.19 | 8.30 | 23.23 (1.2057) | 2.89% | 10.11 | 28.30 (1.2377) | 3.52% |
| Optovue - Retinal Map | | | | | | | |
| Central (µm) | 277.60 | 11.53 | 32.29 | 4.15% | 16.56 | 46.36 | 5.96% |
| Para Inferior (μm) | 315.70 | 5.82 | 16.29 | 1.84% | 8.20 | 22.97 | 2.60% |
| Para Nasal (µm) | 321.55 | 8.62 | 24.15 | 2.68% | 36.33 | 101.71 | 11.30% |
| Para Superior (µm) | 314.62 | 10.87 | 30.44 | 3.46% | 32.41 | 90.75 | 10.30% |
| Para Temporal (µm) | 306.08 | 6.67 | 18.68 | 2.18% | 7.24 | 20.28 | 2.37% |
| Peri Inferior (µm) | 275.51 | 5.67 | 15.87 | 2.06% | 6.31 | 17.67 | 2.29% |
| Peri Nasal (µm) | 300.76 | 7.17 | 20.06 | 2.38% | 42.41 | 118.76 | 14.10% |
| Peri Superior (µm) | 284.87 | 14.20 | 39.77 | 4.99% | 28.93 | 81.02 | 10.16% |
| Peri Temporal (µm) | 274.07 | 6.88 | 19.27 | 2.51% | 8.17 | 22.87 | 2.98% |
| Device - Scan Type
Comparable Parameter | Overall
Mean | Repeatability | | | Reproducibility | | |
| | | SD | Limit (Ratio) | CV% | SD | Limit (Ratio) | CV% |
| Normal - N = 37 | | | | | | | |
| Canon - Disc 3D | | | | | | | |
| Inferior-4 ( $\mu$ m) | 134.198 | 2.857 | 8.000 (0.7439) | 2.129% | 3.144 | 8.804 (0.7979) | 2.343% |
| Nasal-4 ( $\mu$ m) | 87.810 | 2.438 | 6.827 (0.9373) | 2.777% | 2.736 | 7.662 (1.0503) | 3.116% |
| Superior-4 ( $\mu$ m) | 126.694 | 3.308 | 9.263 (0.6268) | 2.611% | 3.845 | 10.766 (0.7230) | 3.035% |
| Temporal-4 ( $\mu$ m) | 69.131 | 2.803 | 7.847 (0.8852) | 4.054% | 2.805 | 7.854 (0.8716) | 4.057% |
| RNFL TSNIT Average
( $\mu$ m) | 104.171 | 1.299 | 3.638 (0.6460) | 1.247% | 1.622 | 4.540 (0.7823) | 1.557% |
| Optovue - | | | | | | | |
| ONH with 3D Disc | | | | | | | |
| Inferior-4 ( $\mu$ m) | 124.523 | 3.841 | 10.754 | 3.084% | 3.941 | 11.034 | 3.165% |
| Nasal-4 ( $\mu$ m) | 79.729 | 2.601 | 7.283 | 3.263% | 2.605 | 7.295 | 3.268% |
| Superior-4 ( $\mu$ m) | 124.560 | 5.278 | 14.779 | 4.237% | 5.318 | 14.890 | 4.269% |
| Temporal-4 ( $\mu$ m) | 73.102 | 3.166 | 8.865 | 4.331% | 3.218 | 9.011 | 4.402% |
| RNFL TSNIT Average
( $\mu$ m) | 100.478 | 2.011 | 5.631 | 2.001% | 2.073 | 5.804 | 2.063% |
| Glaucoma - N = 37 | | | | | | | |
| Canon - Disc 3D | | | | | | | |
| Inferior-4 ( $\mu$ m) | 97.605 | 3.955 | 11.075 (1.1489) | 4.052% | 4.011 | 11.230 (1.1026) | 4.109% |
| Nasal-4 ( $\mu$ m) | 68.881 | 3.941 | 11.036 (1.2720) | 5.722% | 4.141 | 11.594 (0.8202) | 6.012% |
| Superior-4 ( $\mu$ m) | 94.472 | 4.309 | 12.067 (1.3962) | 4.562% | 4.475 | 12.529 (1.3303) | 4.737% |

16

Abbreviations: 3-D = 3-dimensional; CV% = coefficient of variance; FRT = full retinal thickness; N = number of eyes; SD = standard deviation

Limit (Ratio) is defined as the ratio between the repeatability limit for the Canon device and the predicate device and calculated by dividing the Canon device limit by the predicate device limit (C/P).

17

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. CV% was calculated as the repeatability or reproducibility SD/overall mean.

Average TSNIT Retinal Nerve Fiber Layer Thickness

Repeatability and reproducibility of RNFL thickness scans by Canon Disc 3D and Optovue ONH were compared (Table 6).

For the normal gA1roup, the RNFL TSNIT average across all areas had a repeatability limit of 3.638 for Canon OCT-A1 and 5.631 for Optovue ONH. The limit ratio was 0.6460, in favor of Canon OCT-A1. The RNFL TSNIT average across all areas had a reproducibility limit of 4.540 for Canon OCT-A1 and 5.804 for Optovue ONH. The limit ratio was 0.7823, in favor of Canon Disc 3D.

For the glaucoma group, the RNFL TSNIT average across all areas had a repeatability limit of 5.129 for Canon OCT-A1and 4.197 for Optovue ONH. The limit ratio was 1.2223, in favor of Optovue ONH. The RNFL TSNIT average across all areas had a reproducibility limit of 5.430 for Canon OCT-A1and 5.623 for Optovue ONH. The limit ratio was 0.9656. in favor of Canon OCT-A1.

For the retinal disease group, the RNFL TSNIT average across all areas had a repeatability limit of 5.932 for Canon OCT-A1and 6.398 for Optoyue ONH. The limit ratio was 0.9272, in favor of Canon OCT-A1. The RNFL TSNIT average across all areas had a reproducibility limit of 7.244 for Canon OCT-A1 and 12.402 for Optovue ONH. The limit ratio was 0.5841, in favor of Canon OCT-A1.

Table 6 Repeatability and Reproducibility on RNFL Thickness between Canon Disc 3D and Optovue ONH
(Effectiveness Population)

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Device - Scan Type	Overall	Repeatability			Reproducibility
Comparable Parameter	Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Temporal-4 (µm)	61.692	2.891	8.095 (0.9397)	4.686%	2.909	8.145 (0.8950)	4.716%
RNFL TSNIT Average	80.512	1.832	5.129 (1.2223)	2.275%	1.939	5.430 (0.9656)	2.409%
(µm)
Optovue -
ONH with 3D Disc
Inferior-4 (µm)	92.026	3.443	9.639	3.741%	3.637	10.185	3.953%
Nasal-4 (µm)	61.658	3.099	8.676	5.025%	5.048	14.135	8.188%
Superior-4 (µm)	90.725	3.086	8.642	3.402%	3.364	9.418	3.708%
Temporal-4 (µm)	60.443	3.077	8.614	5.090%	3.250	9.101	5.378%
RNFL TSNIT Average	76.213	1.499	4.197	1.967%	2.008	5.623	2.635%
(µm)
Retinal Disease - N = 38
Canon - Disc 3D
Inferior-4 (µm)	120.867	4.319	12.094 (1.1550)	3.573%	4.508	12.622 (1.1977)	3.730%
Nasal-4 (µm)	80.339	4.219	11.813 (0.9203)	5.251%	4.647	13.011 (1.0137)	5.784%
Superior-4 (µm)	119.823	5.573	15.604 (1.3015)	4.651%	5.689	15.928 (1.0044)	4.747%
Temporal-4 (µm)	75.233	2.070	5.795 (0.5239)	2.751%	7.276	20.374 (0.6229)	9.672%
RNFL TSNIT Average	98.778	2.119	5.932 (0.9272)	2.145%	2.587	7.244 (0.5841)	2.619%
(µm)
Optovue -
ONH with 3D Disc
Inferior-4 (µm)	115.347	3.739	10.470	3.242%	3.764	10.539	3.263%
Nasal-4 (µm)	74.826	4.584	12.836	6.126%	4.584	12.836	6.126%
Superior-4 (µm)	114.919	4.282	11.989	3.726%	5.664	15.858	4.928%
Temporal-4 (µm)	76.014	3.950	11.060	5.197%	11.682	32.710	15.368%
RNFL TSNIT Average	95.276	2.285	6.398	2.398%	4.429	12.402	4.649%
(um)

Abbreviations: 3-D = 3-dimensional; CV% = coefficient of variance; N = number of eyes; ONH = optic nerve head; RNFL = retinal nerve fiber layer; SD = standard deviation

Limit (Ratio) is defined as the ratio between the repeatability limit for the Canon device and the predicate device and calculated by dividing the Canon device limit by the predicate device limit (C/P).

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. CV% was calculated as the repeatability or reproducibility SD/overall mean.

Ganglion Cell Complex Thickness

Repeatability and reproducibility of GCC thickness scans by Canon Glaucoma 3D and Optovue GCC were compared. Total GCC thickness values are summarized below, with superior and inferior values individually listed in Table 7.

For the normal group, total GCC thickness had a repeatability limit of 1.740 for Canon OCT-A1 and 2.773 for Optovue GCC. The limit ratio was 0.6275, in favor of Canon OCT-A1. Total GCC thickness had a reproducibility limit of 2.405 for Canon OCT-A1 and 2.786 for Optovue GCC. The limit ratio was 0.8633, in favor of Canon OCT-A1.

For the glaucoma group, total GCC thickness had a repeatability limit of 6.901 for Canon OCT-A13D and 18.896 for Optovue GCC. The limit ratio was 0.3652, in favor of Canon OCT-A1. Total GCC thickness had a repeatability limit of 7.002 for Canon OCT-A1 and 18.896 for Optovue GCC. The limit ratio was 0.3705, in favor of Canon OCT-A1.

For the retinal disease group, total GCC thickness had a repeatability limit of 4.917 for Canon OCT-A1 and 8.220 for Optovue GCC. The limit ratio was 0.5982, in favor of Canon OCT-A1.

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Total GCC thickness had a reproducibility limit of 10.006 for Canon OCT-A1 and 11.035 for Optovue GCC. The limit ratio was 0.9067, in favor of Canon OCT-A1.

| Device - Scan Type
Comparable
Parameter | Overall
Mean | Repeatability | | | Reproducibility | | | |
|-----------------------------------------------|-----------------|---------------|-----------------|----------|-----------------|-----------------|----------|--|
| | | SD | Limit (Ratio) | CV% | SD | Limit (Ratio) | CV% | |
| Normal - N = 37 | | | | | | | | |
| Canon - Glaucoma 3D | | | | | | | | |
| Inferior (µm) | 94.329 | 1.931 | 5.407 (1.7919) | 2.047% | 2.163 | 6.058 (1.9943) | 2.294% | |
| Superior (µm) | 87.004 | 1.125 | 3.150 (1.1102) | 1.293% | 1.312 | 3.673 (1.2229) | 1.508% | |
| Total (µm) | 90.650 | 0.621 | 1.740 (0.6275) | 0.686% | 0.859 | 2.405 (0.8633) | 0.948% | |
| Optovue – GCC | | | | | | | | |
| Inferior (µm) | 94.628 | 1.078 | 3.017 | 1.139% | 1.085 | 3.037 | 1.146% | |
| Superior (µm) | 93.721 | 1.013 | 2.838 | 1.081% | 1.073 | 3.004 | 1.145% | |
| Total (µm) | 94.169 | 0.990 | 2.773 | 1.052% | 0.995 | 2.786 | 1.057% | |
| Glaucoma - N = 37 | | | | | | | | |
| Canon - Glaucoma 3D | | | | | | | | |
| Inferior (µm) | 83.941 | 2.886 | 8.080 (0.5765) | 3.438% | 3.189 | 8.93 (0.5948) | 3.799% | |
| Superior (µm) | 80.348 | 2.221 | 6.218 (0.2053) | 2.764% | 2.263 | 6.336 (0.2092) | 2.816% | |
| Total (µm) | 82.138 | 2.465 | 6.901 (0.3652) | 3.001% | 2.501 | 7.002 (0.3705) | 3.044% | |
| Optovue – GCC | | | | | | | | |
| Inferior (µm) | 84.553 | 5.005 | 14.014 | 5.920% | 5.361 | 15.012 | 6.341% | |
| Superior (µm) | 86.284 | 10.817 | 30.287 | 12.536% | 10.817 | 30.287 | 12.536% | |
| Total (µm) | 85.419 | 6.749 | 18.896 | 7.901% | 6.749 | 18.896 | 7.901% | |
| Retinal Disease - N = 38 | | | | | | | | |
| Canon - Glaucoma 3D | | | | | | | | |
| Inferior (µm) | 95.728 | 3.540 | 9.911 (0.9337) | 3.698% | 4.023 | 11.266 (0.7006) | 4.203% | |
| Superior (µm) | 90.160 | 1.555 | 4.354 (0.5650) | 1.725% | 4.975 | 13.931 (1.6795) | 5.518% | |
| Total (µm) | 92.972 | 1.756 | 4.917 (0.5982) | 1.889% | 3.574 | 10.006 (0.9067) | 3.844% | |
| Optovue – GCC | | | | | | | | |
| Inferior (µm) | 98.768 | 3.791 | 10.615 | 3.838% | 5.743 | 16.080 | 5.815% | |
| Superior (µm) | 97.256 | 2.752 | 7.705 | 2.829% | 2.962 | 8.295 | 3.046% | |
| Total (µm) | 98.009 | 2.936 | 8.220 | 2.995% | 3.941 | 11.035 | 4.021% | |
| Device - Scan Type
Comparable Parameter | Overall
Mean | Repeatability | | | Reproducibility | | | |
| | | SD | Limit (Ratio) | CV% | SD | Limit (Ratio) | CV% | |
| Normal N= 37
Canon - Disc 3D | | | | | | | | |
| ONH Cup Volume (mm³) | 0.1221 | 0.0069 | 0.0193 (0.2955) | 5.6514% | 0.0069 | 0.0193 (0.2583) | 5.6514% | |
| ONH Disc Area (mm²) | 2.0505 | 0.0714 | 0.1998 (0.6792) | 3.4800% | 0.0714 | 0.1998 (0.5968) | 3.4800% | |
| ONH C/D Area | 0.2488 | 0.0106 | 0.0296 (0.5278) | 4.2453% | 0.0107 | 0.0299 (0.4860) | 4.2919% | |
| ONH C/D Horizontal | 0.4993 | 0.0166 | 0.0466 (0.5042) | 3.3297% | 0.0166 | 0.0466 (0.4693) | 3.3297% | |
| ONH C/D Vertical | 0.4786 | 0.0268 | 0.0752 (0.5813) | 5.6085% | 0.0297 | 0.0831 (0.6023) | 6.2053% | |
| ONH Rim Area (mm²) | 1.5427 | 0.0629 | 0.1761 (0.6689) | 4.0760% | 0.0629 | 0.1761 (0.6185) | 4.0760% | |
| ONH Rim Volume (mm³) | 0.2892 | 0.0147 | 0.0411 (1.0155) | 5.0756% | 0.0147 | 0.0412 (0.9004) | 5.0839% | |
| Optovue - ONH with 3D
Disc | | | | | | | | |
| ONH Cup Volume (mm³) | 0.1244 | 0.0233 | 0.0654 | 18.7617% | 0.0267 | 0.0748 | 21.4684% | |
| ONH Disc Area (mm²) | 2.0036 | 0.1051 | 0.2942 | 5.2436% | 0.1196 | 0.3348 | 5.9674% | |
| ONH C/D Area | 0.2928 | 0.0200 | 0.0560 | 6.8342% | 0.0220 | 0.0615 | 7.5027% | |
| ONH C/D Horizontal | 0.5597 | 0.0330 | 0.0923 | 5.8911% | 0.0354 | 0.0992 | 6.3297% | |
| ONH C/D Vertical | 0.4983 | 0.0462 | 0.1293 | 9.2662% | 0.0493 | 0.1381 | 9.8947% | |
| ONH Rim Area (mm²) | 1.4122 | 0.0940 | 0.2632 | 6.6569% | 0.1017 | 0.2847 | 7.1992% | |
| ONH Rim Volume (mm³) | 0.1696 | 0.0145 | 0.0405 | 8.5205% | 0.0163 | 0.0457 | 9.6253% | |
| Glaucoma N= 37
Canon - Disc 3D | | | | | | | | |
| ONH Cup Volume (mm³) | 0.2019 | 0.0070 | 0.0197 (0.1629) | 3.4915% | 0.0070 | 0.0197 (0.1483) | 3.4915% | |
| ONH Disc Area (mm²) | 2.1704 | 0.3404 | 0.9532 (2.2489) | 15.6849% | 0.3571 | 1.0000 (2.3321) | 16.4553% | |
| ONH C/D Area | 0.5206 | 0.0253 | 0.0709 (0.8589) | 4.8637% | 0.0262 | 0.0735 (0.7757) | 5.0424% | |
| ONH C/D Horizontal | 0.7129 | 0.0262 | 0.0735 (0.9153) | 3.6805% | 0.0270 | 0.0757 (0.8176) | 3.7915% | |
| ONH C/D Vertical | 0.7209 | 0.0378 | 0.1058 (0.9385) | 5.2398% | 0.0399 | 0.1119 (0.8971) | 5.5412% | |
| ONH Rim Area (mm²) | 1.0091 | 0.1553 | 0.4348 (1.4948) | 15.3868% | 0.1553 | 0.4348 (1.3831) | 15.3868% | |
| ONH Rim Volume (mm³) | 0.1260 | 0.0159 | 0.0445 (1.5257) | 12.6084% | 0.0162 | 0.0453 (1.3531) | 12.8380% | |
| Optovue - ONH with 3D
Disc | | | | | | | | |
| ONH Cup Volume (mm³) | 0.2074 | 0.0433 | 0.1212 | 20.8668% | 0.0475 | 0.1330 | 22.9132% | |
| ONH Disc Area (mm²) | 2.0282 | 0.1514 | 0.4238 | 7.4635% | 0.1531 | 0.4288 | 7.5508% | |
| ONH C/D Area | 0.5477 | 0.0295 | 0.0825 | 5.3824% | 0.0338 | 0.0947 | 6.1789% | |
| ONH C/D Horizontal | 0.7786 | 0.0287 | 0.0803 | 3.6819% | 0.0331 | 0.0926 | 4.2462% | |
| ONH C/D Vertical | 0.7321 | 0.0403 | 0.1127 | 5.4981% | 0.0445 | 0.1247 | 6.0823% | |
| ONH Rim Area (mm²) | 0.8927 | 0.1039 | 0.2908 | 11.6352% | 0.1123 | 0.3143 | 12.5749% | |
| ONH Rim Volume (mm³) | 0.0646 | 0.0104 | 0.0292 | 16.1236% | 0.0120 | 0.0335 | 18.5109% | |
| Retinal Diseases N = 38
Canon - Disc 3D | | | | | | | | |
| ONH Cup Volume (mm³) | 0.0763 | 0.0048 | 0.0135 (0.2076) | 6.3388% | 0.0063 | 0.0176 (0.2284) | 8.2219% | |
| ONH Disc Area (mm²) | 2.0727 | 0.0764 | 0.2139 (0.4917) | 3.6856% | 0.0992 | 0.2776 (0.5999) | 4.7840% | |
| ONH C/D Area | 0.2576 | 0.0130 | 0.0365 (0.4240) | 5.0606% | 0.0200 | 0.0561 (0.6521) | 7.7835% | |
| Device - Scan Type | Overall
Mean | Repeatability | | | | Reproducibility | | |
| Comparable Parameter | | SD | Limit (Ratio) | CV% | SD | Limit (Ratio) | CV% | |
| ONH C/D Vertical | 0.4997 | 0.0241 | 0.0674 (0.4202) | 4.8203% | 0.0277 | 0.0776 (0.4753) | 5.5478% | |
| ONH Rim Area ( $mm^2$ ) | 1.5431 | 0.0621 | 0.1738 (0.4367) | 4.0225% | 0.0808 | 0.2263 (0.5625) | 5.2371% | |
| ONH Rim Volume ( $mm^3$ ) | 0.2602 | 0.0119 | 0.0334 (0.6895) | 4.5789% | 0.0161 | 0.0451 (0.8410) | 6.1856% | |
| Optovue - ONH with 3D Disc | | | | | | | | |
| ONH Cup Volume ( $mm^3$ ) | 0.0906 | 0.0233 | 0.0652 | 25.7085% | 0.0275 | 0.0769 | 30.3072% | |
| ONH Disc Area ( $mm^2$ ) | 1.9706 | 0.1554 | 0.4350 | 7.8835% | 0.1653 | 0.4628 | 8.3875% | |
| ONH C/D Area | 0.3198 | 0.0307 | 0.0861 | 9.6141% | 0.0307 | 0.0861 | 9.6141% | |
| ONH C/D Horizontal | 0.5908 | 0.0322 | 0.0902 | 5.4509% | 0.0332 | 0.0931 | 5.6270% | |
| ONH C/D Vertical | 0.5372 | 0.0573 | 0.1605 | 10.6702% | 0.0583 | 0.1633 | 10.8569% | |
| ONH Rim Area ( $mm^2$ ) | 1.3448 | 0.1421 | 0.3980 | 10.5695% | 0.1437 | 0.4023 | 10.6843% | |
| ONH Rim Volume ( $mm^3$ ) | 0.1388 | 0.0173 | 0.0484 | 12.4494% | 0.0191 | 0.0536 | 13.7880% | |

Table 7 Repeatability and Reproducibility on GCC Thickness between Canon Glaucoma 3D and Optovue GCC (Effectiveness Population)

Abbreviations: 3-D = 3-dimensional; CV% = coefficient of variance; GCC = ganglion cell complex; N = number of eyes; SD = standard deviation

Limit (Ratio) is defined as the ratio between the repeatability limit for the Canon device and the predicate device and calculated by dividing the Canon device limit by the predicate device limit (C/P).

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. CV% was calculated as the repeatability or reproducibility SD/overall mean.

Optic Nerve Head

Repeatability and reproducibility of ONH scans by Canon Disc 3D and Optovue ONH were compared. ONH disc area measurements are summarized below with cup volume, C/D area, C/D horizontal, C/D vertical, rim area, and rim volume detailed in Table 8.

For the normal group, ONH disc area (mm²) had a repeatability limit of 0.1998 for Canon OCT-A 1 and 0.2942 for Optovue ONH. The limit ratio was 0.6792, in favor of Canon OCT-A1. Total GCC thickness had a reproducibility limit of 0.1998 for Canon OCT-A1 and 0.3348 for Optovue GCC. The limit ratio was 0.5968, in favor of Canon OCT-A1.

20

For the glaucoma group, ONH disc area (mm²) had a repeatability limit of 0.9532 for Canon OCT-A1 and 0.4238 for Optovue ONH. The limit ratio was 2.2489, in favor of Optovue ONH. Total GCC thickness had a reproducibility limit of 1.0000 for Canon OCT-A1 and 0.4288 for Optovue GCC. The limit ratio was 2.3321, in favor of Optovue ONH.

For the retinal disease group, ONH disc area (mm²) had a repeatability limit of 0.2139 for Canon OCT-A1 and 0.4350 for Optovue ONH. The limit ratio was 0.4917, in favor of Canon OCT-A1. ONH disc area (mm²) had a reproducibility limit of 0.2776 for Canon OCT-A1 and 0.4628 for Optovue ONH. The limit ratio was 0.5999, in favor of Canon OCT-A1.

Table 8 Repeatability and Reproducibility on ONH between Canon Disc 3D and Optovue ONH (Effectiveness Population)

21

Abbreviations: 3-D = 3-dimensional; CV% = coefficient of variance; N = number of eyes; ONH = optic nerve head: SD = standard deviation

Limit (Ratio) is defined as the ratio between the repeatability limit for the Canon device and the predicate device and calculated by dividing the Canon device limit by the predicate device limit (C/P).

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. CV% was calculated as the repeatability or reproducibility SD/overall mean. Ratios, noted with C/D, are unitless.

Analyses of Other Measurements

Repeatability and Reproducibility for Canon-only Parameters

Repeatability and reproducibility analysis was performed for parameters measured by the Canon OCT-A1 for which there was no comparator in the Optovue device. These included:

Canon Macula 3D ●
Canon Disc 3D ●
Canon Glaucoma 3D

Macula 3D

For the normal group, Macula 3D had an average (um) repeatability limit of 7.95 and a reproducibility limit of 8.87. For the glaucoma group, Macula 3D had an average (um) repeatability limit of 11.43 and a reproducibility limit of 11.88. For the retinal disease group. Macula 3D had an average (um) repeatability limit of 15.18 and a reproducibility limit of 27.74.

22

| Device - Scan Type
Comparable Parameter | Overall
Mean | Repeatability | | | Reproducibility | | |
|--------------------------------------------|-----------------|---------------|---------------|---------|-----------------|---------------|---------|
| | | SD | Limit (Ratio) | CV% | SD | Limit (Ratio) | CV% |
| Normal N= 37 | | | | | | | |
| Canon - Macula 3D | | | | | | | |
| Average (µm) | 304.09 | 2.84 | 7.95 (N/A) | 0.93% | 3.17 | 8.87 (N/A) | 1.04% |
| Minimum (µm) | 216.14 | 10.26 | 28.73 (N/A) | 4.75% | 10.49 | 29.38 (N/A) | 4.86% |
| Volume (µm) | 8.59 | 0.16 | 0.45 (N/A) | 1.87% | 0.17 | 0.47 (N/A) | 1.95% |
| Glaucoma N= 37 | | | | | | | |
| Canon - Macula 3D | | | | | | | |
| Average (µm) | 294.57 | 4.08 | 11.43 (N/A) | 1.39% | 4.24 | 11.88 (N/A) | 1.44% |
| Minimum (µm) | 224.22 | 18.62 | 52.13 (N/A) | 8.30% | 18.76 | 52.53 (N/A) | 8.37% |
| Volume (µm) | 8.33 | 0.13 | 0.36 (N/A) | 1.52% | 0.13 | 0.37 (N/A) | 1.57% |
| Retinal Diseases N = 38 | | | | | | | |
| Canon - Macula 3D | | | | | | | |
| Average (µm) | 305.73 | 5.42 | 15.18 (N/A) | 1.77% | 9.91 | 27.74 (N/A) | 3.24% |
| Minimum (µm) | 239.29 | 28.71 | 80.38 (N/A) | 12.00% | 40.44 | 113.24 (N/A) | 16.90% |
| Volume (µm) | 8.64 | 0.18 | 0.50 (N/A) | 2.05% | 0.29 | 0.82 (N/A) | 3.41% |
| Device - Scan Type | Overall | Repeatability | | | Reproducibility | | |
| Comparable Parameter | Mean | SD | Limit (Ratio) | CV% | SD | Limit (Ratio) | CV% |
| Normal N= 37 | | | | | | | |
| Canon - Disc 3D | | | | | | | |
| Inferior-12 (µm) | 139.003 | 5.129 | 14.362 (N/A) | 3.690% | 5.541 | 15.516 (N/A) | 3.987% |
| Inferior-Inf-Nasal (µm) | 110.670 | 5.606 | 15.696 (N/A) | 5.065% | 5.921 | 16.580 (N/A) | 5.350% |
| Inferior-Inf-Temporal (µm) | 149.577 | 5.963 | 16.697 (N/A) | 3.987% | 6.132 | 17.169 (N/A) | 4.099% |
| Nasal-12 (µm) | 73.383 | 2.929 | 8.200 (N/A) | 3.991% | 3.188 | 8.926 (N/A) | 4.344% |
| Nasal-Inf-Nasal (µm) | 74.305 | 3.486 | 9.762 (N/A) | 4.692% | 3.792 | 10.617 (N/A) | 5.103% |
| Nasal-Sup-Nasal (µm) | 113.552 | 5.222 | 14.621 (N/A) | 4.599% | 5.980 | 16.745 (N/A) | 5.267% |
| Superior-12 (µm) | 139.540 | 6.283 | 17.591 (N/A) | 4.502% | 6.965 | 19.501 (N/A) | 4.991% |
| Superior-Sup-Nasal (µm) | 121.330 | 4.832 | 13.529 (N/A) | 3.982% | 5.051 | 14.144 (N/A) | 4.163% |
| Superior-Sup-Temporal (µm) | 118.369 | 4.849 | 13.577 (N/A) | 4.096% | 5.275 | 14.769 (N/A) | 4.456% |
| Temporal-12 (µm) | 53.673 | 3.880 | 10.865 (N/A) | 7.230% | 3.885 | 10.879 (N/A) | 7.239% |
| Temporal-Inf-Temporal (µm) | 79.230 | 4.964 | 13.900 (N/A) | 6.266% | 5.063 | 14.176 (N/A) | 6.390% |
| Temporal-Sup-Temporal (µm) | 72.832 | 2.561 | 7.170 (N/A) | 3.516% | 2.731 | 7.646 (N/A) | 3.750% |
| RNFL TSNIT SD (µm) | 38.166 | 1.294 | 3.624 (N/A) | 3.391% | 1.462 | 4.094 (N/A) | 3.831% |
| Glaucoma N= 37 | | | | | | | |
| Canon - Disc 3D | | | | | | | |
| Inferior-12 (µm) | 106.298 | 7.187 | 20.123 (N/A) | 6.761% | 7.313 | 20.477 (N/A) | 6.880% |
| Inferior-Inf-Nasal (µm) | 89.843 | 6.491 | 18.174 (N/A) | 7.225% | 6.491 | 18.174 (N/A) | 7.225% |
| Inferior-Inf-Temporal (µm) | 103.312 | 6.205 | 17.373 (N/A) | 6.006% | 6.402 | 17.924 (N/A) | 6.196% |
| Nasal-12 (µm) | 61.748 | 4.795 | 13.426 (N/A) | 7.765% | 5.144 | 14.403 (N/A) | 8.331% |
| Nasal-Inf-Nasal (µm) | 64.706 | 5.404 | 15.132 (N/A) | 8.352% | 5.649 | 15.817 (N/A) | 8.730% |
| Nasal-Sup-Nasal (µm) | 83.759 | 8.531 | 23.887 (N/A) | 10.185% | 8.531 | 23.887 (N/A) | 10.185% |
| Superior-12 (µm) | 105.426 | 8.967 | 25.108 (N/A) | 8.506% | 9.052 | 25.345 (N/A) | 8.586% |
| Superior-Sup-Nasal (µm) | 93.052 | 6.991 | 19.574 (N/A) | 7.513% | 7.441 | 20.834 (N/A) | 7.996% |
| Superior-Sup-Temporal (µm) | 87.523 | 4.960 | 13.888 (N/A) | 5.667% | 5.182 | 14.508 (N/A) | 5.920% |
| Temporal-12 (µm) | 55.136 | 5.743 | 16.081 (N/A) | 10.416% | 5.902 | 16.526 (N/A) | 10.705% |
| Temporal-Inf-Temporal (µm) | 69.688 | 6.568 | 18.389 (N/A) | 9.424% | 7.030 | 19.685 (N/A) | 10.088% |
| Temporal-Sup-Temporal (µm) | 68.302 | 7.648 | 21.415 (N/A) | 11.197% | 7.648 | 21.415 (N/A) | 11.197% |
| RNFL TSNIT SD (µm) | 27.654 | 2.107 | 5.900 (N/A) | 7.620% | 2.107 | 5.900 (N/A) | 7.620% |
| Retinal Diseases N = 38 | | | | | | | |
| Canon - Disc 3D | | | | | | | |
| Inferior-12 (µm) | 123.174 | 6.614 | 18.519 (N/A) | 5.369% | 6.669 | 18.673 (N/A) | 5.414% |
| Inferior-Inf-Nasal (µm) | 100.675 | 6.019 | 16.852 (N/A) | 5.978% | 6.552 | 18.345 (N/A) | 6.508% |
| Inferior-Inf-Temporal (µm) | 135.859 | 5.649 | 15.816 (N/A) | 4.158% | 5.765 | 16.143 (N/A) | 4.244% |
| Nasal-12 (µm) | 68.882 | 7.639 | 21.390 (N/A) | 11.090% | 8.022 | 22.463 (N/A) | 11.647% |
| Nasal-Inf-Nasal (µm) | 69.318 | 3.834 | 10.735 (N/A) | 5.531% | 4.175 | 11.689 (N/A) | 6.023% |
| Nasal-Sup-Nasal (µm) | 100.821 | 7.410 | 20.747 (N/A) | 7.349% | 7.504 | 21.012 (N/A) | 7.443% |
| Superior-12 (µm) | 127.399 | 11.726 | 32.832 (N/A) | 9.204% | 11.902 | 33.325 (N/A) | 9.342% |
| Superior-Sup-Nasal (µm) | 113.969 | 7.019 | 19.654 (N/A) | 6.159% | 7.089 | 19.848 (N/A) | 6.220% |
| Superior-Sup-Temporal (µm) | 116.116 | 6.068 | 16.992 (N/A) | 5.226% | 6.145 | 17.206 (N/A) | 5.292% |
| Temporal-12 (µm) | 60.615 | 2.205 | 6.174 (N/A) | 3.637% | 8.143 | 22.801 (N/A) | 13.434% |
| Temporal-Inf-Temporal (µm) | 83.244 | 4.114 | 11.518 (N/A) | 4.942% | 11.377 | 31.857 (N/A) | 13.667% |
| Temporal-Sup-Temporal (µm) | 80.498 | 4.814 | 13.480 (N/A) | 5.981% | 5.091 | 14.254 (N/A) | 6.324% |
| RNFL TSNIT SD (µm) | 34.132 | 2.531 | 7.086 (N/A) | 7.414% | 2.609 | 7.304 (N/A) | 7.643% |

Table 13.9 Canon Repeatability and Reproducibility on Macula 3D (Effectiveness Population)

Abbreviations: 3-D = 3-dimensional; CV% = coefficient of variability percentage; N = number of eyes; ONH = optic nerve head; SD = standard deviation; N/A = Not Applicable

Limit (Ratio) is defined as the ratio between the repeatability limit for the Canon device and the predicate device and calculated by dividing the Canon device limit by the predicate device limit (C/P).

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. CV% was calculated as the repeatability or reproducibility SD/overall mean. Ratios, noted with C/D, are unitless.

Disc 3D

For the normal group, Disc 3D had an RNFL TSNIT SD (um) overall mean of 38.166, a repeatability limit of 3.624 and a reproducibility limit of 4.094. For the glaucoma group. Disc 3D had an RNFL TSNIT SD (um) overall mean of 27.654, a repeatability limit of 5.900 and a reproducibility limit of 5.900. For the retinal disease group. Disc 3D had an RNFL TSNIT SD (um) overall mean of 34.132, a repeatability limit of 7.086 and a reproducibility limit of 7.304.

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Table 13.10 Canon Repeatability and Reproducibility on Disc 3D (Effectiveness Population)

Abbreviations: 3-D = 3-dimensional; CV% = coefficient of variability percentage; N = number of eyes; ONH = optic nerve head; SD = standard deviation; N/A = Not Applicable

Limit (Ratio) is defined as the ratio between the repeatability limit for the Canon device and the predicate device and calculated by dividing the Canon device limit by the predicate device limit (C/P).

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. CV% was calculated as the repeatability or reproducibility SD/overall mean. Ratios, noted with C/D, are unitless.

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Glaucoma 3D

For the normal group, Glaucoma 3D had a Para (um) repeatability limit (inferior nasal/ temporal, superior nasal/ temporal) that ranged from 2.570 (Para Temporal) to 9.073 (Para Superior) with a reproducibility limit that ranged from 3.463 (Para Temporal) to 9.293 (Para Superior).

For the normal group, Glaucoma 3D had a Peri (um) repeatability limit (inferior nasal/ temporal, superior nasal/ temporal) that ranged from 2.983 (Peri Temporal) to 13.279 (Peri Inferior) with a reproducibility limit that ranged from 3.432 (Peri Temporal) to 16.624 (Peri Inferior).

For the glaucoma group, Glaucoma 3D had a Para (um) repeatability limit (inferior nasal/ temporal, superior nasal/ temporal) that ranged from 5.153 (Para Nasal) to 10.017 (Para Inferior) with a reproducibility limit that ranged from 5.566 (Para Nasal) to 14.220 (Para Inferior).

For the glaucoma group, Glaucoma 3D had a Peri (um) repeatability limit (inferior nasal/ temporal, superior nasal/ temporal) that ranged from 6.442 (Peri Temporal) to 16.392 (Peri Superior) with a reproducibility limit that ranged from 6.483 (Peri Temporal) to 16.451 (Peri Superior).

For the retinal disease group, Glaucoma 3D had a Para (um) repeatability limit (inferior nasal/ temporal, superior nasal/ temporal) that ranged from 6.306 (Para Inferior) to 13.572 (Para Nasal) with a reproducibility limit that ranged from 10.908 (Para Temporal) to 54.284 (Para Superior).

For the retinal disease group. Glaucoma 3D had a Peri (um) repeatability limit (inferior nasal/ temporal, superior nasal/ temporal) that ranged from 4.617 (Peri Temporal) to 13.366 (Peri Nasal) with a reproducibility limit that ranged from 5.088 (Peri Temporal) to 18.035 (Peri Superior).

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| Device - Scan Type
Comparable Parameter | Overall
Mean | Repeatability | | Reproducibility | | |
|--------------------------------------------|-----------------|---------------|------------------------|-----------------|---------------|---------|
| | | SD | Limit (Ratio)
CV% | SD | Limit (Ratio) | CV% |
| Normal N= 37 | | | | | | |
| Canon - Glaucoma 3D | | | | | | |
| Para Inferior (µm) | 112.358 | 1.497 | 4.191 (N/A)
1.332% | 1.836 | 5.140 (N/A) | 1.634% |
| Para Nasal (µm) | 100.794 | 1.070 | 2.996 (N/A)
1.062% | 1.387 | 3.883 (N/A) | 1.376% |
| Para Superior (µm) | 112.070 | 3.240 | 9.073 (N/A)
2.891% | 3.319 | 9.293 (N/A) | 2.961% |
| Para Temporal (µm) | 95.860 | 0.918 | 2.570 (N/A)
0.958% | 1.237 | 3.463 (N/A) | 1.290% |
| Peri Inferior (µm) | 114.769 | 4.743 | 13.279 (N/A)
4.132% | 5.937 | 16.624 (N/A) | 5.173% |
| Peri Nasal (µm) | 76.667 | 1.943 | 5.441 (N/A)
2.534% | 2.242 | 6.279 (N/A) | 2.925% |
| Peri Superior (µm) | 102.714 | 2.561 | 7.171 (N/A)
2.493% | 2.939 | 8.230 (N/A) | 2.861% |
| Peri Temporal (µm) | 68.860 | 1.066 | 2.983 (N/A)
1.547% | 1.226 | 3.432 (N/A) | 1.780% |
| Glaucoma N= 37 | | | | | | |
| Canon - Glaucoma 3D | | | | | | |
| Para Inferior (µm) | 102.437 | 3.578 | 10.017 (N/A)
3.493% | 5.078 | 14.220 (N/A) | 4.958% |
| Para Nasal (µm) | 90.533 | 1.841 | 5.153 (N/A)
2.033% | 1.988 | 5.566 (N/A) | 2.196% |
| Para Superior (µm) | 102.851 | 2.672 | 7.480 (N/A)
2.598% | 2.742 | 7.679 (N/A) | 2.666% |
| Para Temporal (µm) | 87.778 | 2.082 | 5.829 (N/A)
2.371% | 2.331 | 6.526 (N/A) | 2.655% |
| Peri Inferior (µm) | 93.487 | 3.350 | 9.379 (N/A)
3.583% | 4.046 | 11.330 (N/A) | 4.328% |
| Peri Nasal (µm) | 71.259 | 2.941 | 8.235 (N/A)
4.127% | 2.949 | 8.256 (N/A) | 4.138% |
| Peri Superior (µm) | 88.205 | 5.854 | 16.392 (N/A)
6.637% | 5.875 | 16.451 (N/A) | 6.661% |
| Peri Temporal (µm) | 67.250 | 2.301 | 6.442 (N/A)
3.421% | 2.315 | 6.483 (N/A) | 3.443% |
| Retinal Diseases N = 38 | | | | | | |
| Canon - Glaucoma 3D | | | | | | |
| Para Inferior (µm) | 114.880 | 2.252 | 6.306 (N/A)
1.961% | 7.208 | 20.184 (N/A) | 6.275% |
| Para Nasal (µm) | 102.530 | 4.847 | 13.572 (N/A)
4.728% | 5.430 | 15.203 (N/A) | 5.296% |
| Para Superior (µm) | 116.272 | 3.031 | 8.486 (N/A)
2.606% | 19.387 | 54.284 (N/A) | 16.674% |
| Para Temporal (µm) | 97.288 | 3.018 | 8.449 (N/A)
3.102% | 3.896 | 10.908 (N/A) | 4.004% |
| Peri Inferior (µm) | 111.539 | 3.141 | 8.796 (N/A)
2.816% | 3.522 | 9.863 (N/A) | 3.158% |
| Peri Nasal (µm) | 79.734 | 4.774 | 13.366 (N/A)
5.987% | 4.904 | 13.732 (N/A) | 6.151% |
| Peri Superior (µm) | 103.720 | 3.030 | 8.485 (N/A)
2.922% | 6.441 | 18.035 (N/A) | 6.210% |
| Peri Temporal (µm) | 73.115 | 1.649 | 4.617 (N/A)
2.255% | 1.817 | 5.088 (N/A) | 2.485% |

Canon Repeatability and Reproducibility on Glaucoma 3D (Effectiveness Population) Table 13.11

Abbreviations: 3-D = 3-dimensional; CV% = coefficient of variability percentage; N = number of eyes; ONH = optic nerve head: SD = standard deviation: N/A = Not Applicable

Limit (Ratio) is defined as the ratio between the repeatability limit for the Canon device and the predicate device and calculated by dividing the Canon device limit by the predicate device limit (C/P).

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. CV% was calculated as the repeatability or reproducibility SD/overall mean. Ratios, noted with C/D, are unitless.

Disc 3D - ONH

For the normal group, Disc 3D-ONH had an ONH C/D Minimum repeatability limit of 0.0294 and a reproducibility limit of 0.0294. Disc 3D-ONH had an ONH DDLS repeatability limit of 0.8491 and a reproducibility limit of 0.9171. For the glaucoma group. Disc 3D-ONH had an ONH C/D Minimum repeatability limit of 0.0392 and a reproducibility limit of 0.0393. Disc 3D-ONH had an ONH DDLS repeatability limit of 1.4086 and a reproducibility limit of 1.4537. For the retinal disease group, Disc 3D-ONH had an ONH C/D Minimum repeatability limit of 0.0548 and a reproducibility limit of 0.0638. Disc 3D-ONH had an ONH DDLS repeatability limit of 1.0373 and a reproducibility limit of 1.

26

		Repeatability				Reproducibility
Device - Scan Type	Comparable Parameter	Overall Mean	SD	Limit (Ratio)	CV%	SD	Limit (Ratio)	CV%
Normal N= 37
Canon - Disc 3D
	ONH C/D Minimum	0.1399	0.0105	0.0294 (N/A)	7.5100%	0.0105	0.0294 (N/A)	7.5100%
	ONH DDLS	4.2414	0.3032	0.8491 (N/A)	7.1495%	0.3275	0.9171 (N/A)	7.7224%
Glaucoma N= 37
Canon - Disc 3D
	ONH C/D Minimum	0.0502	0.0140	0.0392 (N/A)	27.8771%	0.0140	0.0392 (N/A)	27.8854%
	ONH DDLS	5.2901	0.5031	1.4086 (N/A)	9.5097%	0.5192	1.4537 (N/A)	9.8141%
Retinal Diseases N = 38
Canon - Disc 3D
	ONH C/D Minimum	0.1282	0.0196	0.0548 (N/A)	15.2739%	0.0228	0.0638 (N/A)	17.7852%
	ONH DDLS	4.4379	0.3705	1.0373 (N/A)	8.3481%	0.4265	1.1942 (N/A)	9.6108%

Canon Repeatability and Reproducibility on Disc 3D ONH (Effectiveness Population) Table 13.12

Abbreviations: 3-D = 3-dimensional; CV% = coefficient of variability percentage; N = number of eyes; ONH = optic nerve head; SD = standard deviation; N/A = Not Applicable

Limit (Ratio) is defined as the ratio between the repeatability limit for the Canon device and the predicate device and calculated by dividing the Canon device limit by the predicate device limit (C/P).

Note: The effectiveness population was defined as any subject with at least 1 acceptable scan on each device from any 1 configuration, excluding any subjects with major protocol deviations. CV% was calculated as the repeatability or reproducibility SD/overall mean. Ratios, noted with C/D, are unitless.

Discussion and Overall Conclusions

This study evaluated the agreement and precision of the Canon OCT-A1 ultra-high resolution ophthalmic imaging system for fundus imaging and axial, cross-sectional, and 3-dimensional (3D) imaging of retinal structures with Optovue RTVue Avanti XR OCT as the predicate device. Optovue RTVue Avanti XR OCT is an FDA-cleared and commercially available device that is similar in characteristics and features to the Canon device. It also has similar technologies and intended uses as the Canon OCT-A1.

However, the measurement methodologies for the full retinal thickness and the area measurement specifications are slightly different between the Canon OCT-A1 and the Optovue RTVue Avanti XR OCT resulting in a constant thickness difference between them and a different behavior of measurement at the central area. These differences result in a difference of thickness parameters as seen in the study results. The difference in methodology is that each OCT instrument produced by each manufacturer uses a different hyper reflective band as an outer border of the retina. The Optovue (RTVue) uses the 2nd hyper reflective band (upper border of RPE) as an outer border of the retina whereas the Canon OCT-A1 uses the 3th hyper reflective band (lower border of RPE) as the outer of the retina. Therefore, about 25 um difference is observed in the FRT measurement between Canon and Optovue. This difference is just equal to the thickness of RPE. Canon includes RPE in the FRT measurement while the Optovue does not include the RPE. Overall, agreement of the measurements with the Canon OCT-A1 and the Optovue RTVue Avanti was found to be acceptable. Measurements from both cameras were compared across three groups: normal eve, glaucoma eye, and retinal disease eye populations. Measurements of full retinal thickness, retinal nerve fiber layer thickness, ganglion cell complex thickness, and the optic nerve head were all assessed.

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Agreement between Canon OCT-A1 and Optovue RTVue Avanti was determined by comparing the mean differences in measurements. Mean differences, LOAs, and LOAs that included 0 are reviewed for the agreement analyses.

Both repeatability and reproducibility were calculated for the precision analyses. Repeatability represents the variation among images within a subject within a given configuration of a machine. The ratios of the variation components were determined by dividing the component of the Canon OCT-A1 by the corresponding component of the Optovue RTVue Avanti. Ratios less than 1 indicate that OCT-A1 was less variable, while ratios greater than 1 indicate that the Optovue RTVue Avanti XR was less variable. For FRT central, Optovue RTVue Avanti generally had less variable values than Canon OCT-A1 due to the difference in measurement methodology. For FRT para and peri parameters and for RNFL, the two cameras had similar precision values, respectively. GCC and ONH parameters had mixed results, with the Canon OCT-A1 camera having better precision in 2 out of the 3 eye populations for each parameter.

In summary, based upon the overall assessment of non-clinical performance testing, a determination of substantial equivalence was made.