SOLIX™ is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and the threedimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye. With the integrated reference database. SOLIX™ is also a quantitative tool for the comparison of the retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.

The SOLIX™ with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases.

The non-mydriatic color fundus camera of SOLIX™ is an integrated non-contact. high resolution digital imaging component which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The SOLIX™ fundus camera component is indicated for in-vivo viewing of the posterior and external area of the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

Device Description

SOLIX is a computer-controlled, ophthalmic imaging system with combined spectral-domain optical coherence tomography (SD-OCT) and non-mydriatic, digital fundus camera. The SD-OCT employs non-invasive, non-contact, low coherence interferometry to acquire crosssectional tomograms of the anterior and posterior segment of the eye and motion-contrast images of the retinal microvasculature (i.e., OCT "angiography" [OCTA]). The fundus camera produces color internal and external ocular images.

AI/ML Overview

The provided text details the 510(k) premarket notification for the Optovue SOLIX device, stating its substantial equivalence to predicate devices Avanti and iCam. It includes information on performance testing, but the document does not explicitly state defined acceptance criteria for many of the quantitative measurements (e.g., repeatability limits for OCT and OCTA parameters, quality metrics for fundus photography). Instead, it presents the results of these tests.

Therefore, the table below will present the reported device performance, and where an indirect acceptance can be inferred (e.g., for comparative image quality), that will be noted.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document primarily presents performance results without explicitly listing acceptance criteria with numerical targets for many parameters. Where an inference of acceptance can be made (e.g., general clinical utility, improvements over predicate), it is noted.

Category	Acceptance Criteria (Inferred/Reported)	Reported Device Performance
OCT Hardware	Achieves similar Signal to Noise Ratio (SNR) as Avanti. Light exposure safety is below all applicable exposure limits.	SOLIX with 1.45mW optical power achieves similar SNR as Avanti (0.75mW) due to higher scanner speed. Light exposure safety is below applicable exposure limits per Dr. David Sliney's report. Longer working distance (35mm vs 22mm for retina imaging, 20mm vs 13mm with CAM) improves usability.
OCT Software (Vessel Density)	Improved accuracy for vessel density measurements compared to the predicate device.	Improved accuracy was observed from SOLIX vessel density measurements using a local thresholding method (vs. global thresholding in Avanti). For superficial and deep vascular complexes, SOLIX vessel density values tended to be within a smaller range than Avanti XR. Differences are associated with increased scan density and updated algorithm.
OCT Software (PAR)	Further reduction of projection artifacts.	SOLIX's PAR is updated to further reduce projection artifacts, as evidenced by qualitative assessment of clinical study data.
OCT Software (Vessel Extraction)	Improved extraction of vessels in relatively low OCTA signal areas.	SOLIX's vessel extraction method is updated to extract vessels in low OCTA signal areas, evidenced by bench (phantom) and clinical studies.
Anterior Segment R&R	Repeatability and Reproducibility (R&R) generally comparable or improved to predicate. (No explicit numeric acceptance criteria specified in document, but stability across repeated measurements and between operators is the implicit measure of success). The results are presented in tables for "Normal" and "Cornea" subgroups across various parameters (Epithelia (Epi), Cornea (Pachy), Stroma).	For Normal subgroup, repeatability SD for Epithelia (Epi) ranges 0.6-1.2 µm, reproducibility SD 0.7-1.8 µm. For Cornea (Pachy), repeatability SD ranges 1.3-8.8 µm, reproducibility SD 1.9-13.8 µm. For Stroma, repeatability SD ranges 1.0-9.1 µm, reproducibility SD 1.8-14.1 µm. For Cornea subgroup, similar ranges observed. Scan attrition <3% for both devices. Manual edit rate 10.0% for SOLIX vs 14.8% for Avanti XR.
Posterior Segment R&R	Repeatability and Reproducibility for structural and vascular parameters generally comparable or improved to predicate. (No explicit numeric acceptance criteria specified in document).	For Normal, Glaucoma, and Retina subgroups, R&R results are tabulated for GCC, Retina Thickness, SVC, and DVC for AngioVue Retina, Retina Cube, and Wellness scans. For disc scans, R&R tabulated for RNFL and ONH parameters. Scan acceptability rates 93.7% to 100%. Manual editing rates for segmentation boundaries were low (e.g., 0.1% for ILM, 5.2% for IPL). Foveal center detection correction rates were low (0.5%-0.7%). FAZ boundary manual editing was 19.7%. Disc margin manual editing 1.5%.
Fundus Photography Image Quality & Utility	Proportions of similar or better quality images and clinically useful images comparable to predicate device.	Proportions of SOLIX images graded as similar or better quality compared to iCAM images ranged from 74-89% across subgroups and graders. The proportion of participants with clinically useful images was 97.3% for both SOLIX and iCam.
Reference Database (RDB)	Establish reference limits for structural quantitative parameters (1st, 5th, 95th, 99th percentiles).	RDB was generated from 416-426 eligible participants with no ocular pathology. Mean age ~48 years, diverse demographics. Rates of disqualified scans for RDB were low (<5% for macular, <15% for disc-based), mainly due to eye motion. No segmentation boundary editing for qualified RDB scans. Bruch's membrane opening (BMO) editing rate ~8%.
Non-Clinical Performance	Device functions as intended for spatial performance, sensitivity, auxiliary functions. Complies with relevant standards (safety, EMC, usability, biocompatibility, light hazard protection). Software is verified and validated to function as intended and meet safety. Level of concern unchanged.	Non-clinical bench tests covered spatial performance, sensitivity, OCT Angiography accuracy (improved for SOLIX), auxiliary functions. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 10993-1/5/10, ISO 15004-1/2, ANSI Z80.36-2016. Software V&V according to BS EN 62304:2006 and FDA guidance, demonstrating intended function, acceptance criteria met, overall product and patient safety. Software determined "moderate" level of concern, no change from predicates.

2. Sample Size Used for the Test Set and Data Provenance

Anterior Segment OCT Performance Study:
- Sample Size: 61 eligible participants (30 "Normal," 31 "Cornea" subgroup).
- Data Provenance: Prospective, observational study conducted at a single clinical U.S. site.
Posterior Segment OCT and OCTA Performance Study:
- Sample Size: 83 participants completed the study (30 "normal," 25 "Glaucoma," 28 "Retina" subgroup).
- Data Provenance: Prospective, observational study conducted at a single clinical U.S. site.
Fundus Photography Study:
- Sample Size: Data from 112 participants included (31 "normal," 26 glaucoma, 55 retinal disease). 126 were enrolled, 121 met enrollment criteria.
- Data Provenance: Prospective, observational study conducted at two clinical sites (country not explicitly specified but implies U.S. given other contexts).
Reference Database (RDB) Generation Study:
- Sample Size: 427 eligible participants (out of 482 enrolled). The number included for each scan pattern ranged from 416 to 426.
- Data Provenance: Prospective, observational study conducted at five U.S. clinical sites.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Anterior Segment OCT & Posterior Segment OCT/OCTA Studies:
- No external "experts" were formally used to establish ground truth in the sense of adjudication for these quantitative repeatability and reproducibility studies. The metrics (e.g., thickness, density) are generated by the device's algorithms based on the acquired OCT/OCTA data. The study design focused on evaluating the device's consistency and agreement with the predicate. Manual editing of segmentation boundaries and foveal center detection was performed by study personnel, implying expertise in OCT interpretation and anatomy, but specific qualifications are not detailed.
Fundus Photography Study:
- Number of Experts: Three independent graders.
- Qualifications: "at a third-party reading center." Specific qualifications (e.g., ophthalmologist, Ophthalmic Photographer, years of experience) are not explicitly stated in the provided text.
Reference Database (RDB) Generation Study:
- Ground truth for inclusion criteria was based on clinical examination, fundus photography, and visual field testing, reviewed by clinicians at 5 U.S. clinical sites. Segmentation boundaries and disc margins required manual correction in some cases (e.g., 8% for BMO), implying expert review but specific "number of experts" or their "qualifications" for this aspect are not specified beyond being "study personnel" or "clinicians." The ground truth for the RDB itself is derived from a cohort of normal subjects without significant ocular pathology.

4. Adjudication Method for the Test Set

Anterior Segment OCT & Posterior Segment OCT/OCTA Studies:
- No formal adjudication method (like 2+1 or 3+1) is described for these quantitative R&R studies. The primary analysis was statistical (ANOVA, Bland-Altman, Deming regression) comparing successive measurements from the device itself and against the predicate. Manual edits for segmentation errors were performed, but the process of who made these edits or if there was a consensus method is not detailed.
Fundus Photography Study:
- Adjudication Method: Images were graded by "three independent graders." It is not explicitly stated whether a consensus method (e.g., 2-out-of-3 majority) was used for conflicting grades, or if individual grader results were reported.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? Yes, for the fundus photography component. The study compared image quality and clinical utility of SOLIX images vs. iCam images, with three independent graders.
Effect size of human readers improvement with AI vs. without AI assistance? This study was not designed as an AI-assistance study (human-in-the-loop improving their performance with AI). It was a standalone comparison of the image quality of two devices (SOLIX vs. predicate iCam), where human readers were evaluating the device outputs. Thus, no effect size related to "human readers improving with AI vs. without AI assistance" is provided or applicable here. The study concluded that SOLIX image quality was similar or better, and clinical utility was equivalent to iCam (97.3%).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done? Yes, several aspects of the device's performance were evaluated in a standalone manner:
- OCT and OCTA Performance Studies (Anterior and Posterior Segments): These evaluated the device's quantitative measurements (repeatability, reproducibility, and agreement with predicate) entirely based on algorithmic outputs. While some manual editing of segmentations was noted, the core performance metrics derived were from the algorithm.
- OCT Angiography (Vessel Density): A dedicated bench test using 3D digital phantoms was performed to determine the accuracy of SOLIX device software for vessel density measurement. This is a clear standalone performance evaluation.

7. Type of Ground Truth Used

Anterior Segment OCT & Posterior Segment OCT/OCTA Studies (R&R/Agreement):
- The "ground truth" here is the consistency of the device's own measurements. For agreement, the predicate device (Avanti) served as a comparative reference. The accuracy of measurements like epithelial thickness, corneal pachymetry, GCC thickness, retina thickness, vessel density, RNFL thickness, and ONH parameters are directly calculated by the device's algorithms. Manual corrections of segmentation errors or foveal center detection by presumably expert human reviewers could be considered a form of "expert consensus" for refining the algorithmic output for analysis.
Fundus Photography Study (Image Quality/Utility):
- Expert Consensus: Three independent graders evaluated image quality and clinical utility based on pre-specified grading criteria.
Reference Database (RDB) Generation Study:
- Clinical Diagnosis/Expert Opinion: The ground truth for this set was based on a cohort of "normal subjects without significant ocular pathology" confirmed by clinical examination, fundus photography, and visual field testing, effectively an expert-determined healthy cohort.

8. Sample Size for the Training Set

The document does not explicitly provide information about the sample size used for the training set of the algorithms within SOLIX. The studies described are primarily for clinical performance validation and RDB generation, not for training data specifics.

9. How the Ground Truth for the Training Set Was Established

As the training set size is not provided, the method for establishing its ground truth is also not detailed in this document. Information regarding the development and training of the algorithms (including how features like PAR, vessel extraction, or segmentation were trained and validated) is typically part of a separate technical documentation.

Summary

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November 9 ,2022

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Optovue, Inc. Robert Lundberg VP Regulatory/Quality 2800 Bayview Drive Fremont, California 94538

Re: K222166

Trade/Device Name: Solix Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI Dated: September 30, 2022 Received: October 3, 2022

Dear Robert Lundberg:

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.

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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-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.

Elvin Y. I

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222166

Device Name SOLIXTM

Indications for Use (Describe)

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) Summarv

Submitter Information

Company	Optovue, Inc.2800 Bayview DriveFremont, CA 94538
Contact Person	Robert LundbergVP Regulatory/QualityTel: (951) 741-2776Email: b.lundberg@visionix.com
Date Prepared	07 November 2022

Device Information

Device Trade Name	SOLIXTM
Device Common Name	Optical Coherence Tomography
Classification Regulation	21 CFR 886.1570
Classification Name	Ophthalmoscope
Device Class	Class II
Device Regulation Panel	Ophthalmic
Product Code	OBO, HKI

Predicate/Reference Devices

Primary Predicate:	K180660: Avanti, cleared on June 8, 2018
Secondary Predicate:	K122572: iCam Fundus Camera, cleared on January 11, 2013

Indications for Use

SOLIX is an optical coherence tomography system intended for the in vivo imaging, crosssectional, and the three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye. With the integrated reference database, SOLIX is also a quantitative tool for the comparison of the retina, retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.

The SOLIX with the AngioVue® software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects, and in subjects with glaucoma and retinal diseases. The AngioAnalytics™ software feature of AngioVue® is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and

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nerve fiber laver, and measurement of optic disc parameters in normal subjects, and in subjects with glaucoma and retinal diseases.

The non-mydriatic color fundus camera of SOLIX, is an integrated non-contact, high resolution digital imaging component which is suitable for photographing, displaying and storing images of the retina and external areas of the eve to be evaluated under non-mvdriatic conditions. The SOLIX fundus camera component is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

Device Description

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Substantial Equivalence

SOLIX vs Avanti

Device	SOLIX(Proposed Device)	Predicate DevicesPrimary Predicate Avanti	Substantial EquivalenceComparison
510(k) Number &Classification	K222166Class II	K180660Class II
Date of Clearance	TBD	June 8, 2018
Trade Name	SOLIX	Avanti
Manufacturer	Optovue, Inc.	Optovue, Inc.	Same
Indications For Use	SOLIX is an optical coherencetomography system intended for the invivo imaging, cross-sectional, and thethree-dimensional imaging andmeasurement of anterior and posteriorocular structures, including retina,retinal nerve fiber layer, ganglion cellcomplex (GCC), optic disc, cornea,corneal epithelium, corneal stroma,pachymetry, and anterior chamber ofthe eye. With the integrated referencedatabase, SOLIX is also a quantitativetool for the comparison of the retina,retinal nerve fiber layer, and optic discmeasurements in the human eye to adatabase of known normal subjects.It is indicated for use as a diagnosticdevice to aid in the detection andmanagement of ocular diseases.The SOLIX with the AngioVuesoftware feature is indicated as an aidin the visualization of vascularstructures of the retina and choroid innormal subjects, and in subjects withglaucoma and retinal diseases.The AngioAnalytics software featureof AngioVue is indicated for themeasurement of vascular density, thefoveal avascular zone, the thickness ofretinal layers, and nerve fiber layer,and measurement of optic discparameters in normal subjects, and insubjects with glaucoma and retinaldiseases.	The Avanti is an optical coherencetomography system intended for the invivo imaging, cross- sectional, and thethree- dimensional imaging andmeasurement of anterior and posteriorocular structures, including retina,retinal nerve fiber layer, ganglion cellcomplex (GCC), optic disc, cornea,corneal epithelia, corneal stroma,pachymetry, corneal power, andanterior chamber of the eye. With theintegrated normative database, Avantiis also a quantitative tool for thecomparison of retina, retinal nervefiber layer, and optic discmeasurements in the human eye to adatabase of a known normal subjects.It is indicated for use as a diagnosticdevice to aid in the detection andmanagement of ocular diseases.The Avanti with the AngioVuesoftware feature is indicated as an aidin the visualization of vascularstructures of the retina and choroid innormal subjects, and in subjects withglaucoma and retinal diseases.The AngioAnalytics software featureof AngioVue is indicated for themeasurement of vascular density, thefoveal avascular zone, the thickness ofretinal layers, and nerve fiber layer,and measurement of optic discparameters in normal subjects, and insubjects with glaucoma and retinaldiseases.	Same
TechnologicalCharacteristics	Spectral-Domain Optical CoherenceTomography (SD-OCT)	Spectral-Domain Optical CoherenceTomography (SD-OCT)	Same
System Components	• Scanner• Control Unit• Chin and Head rest• Joystick and base assembly• Computer with Windows operatingsystem• Monitor• Keyboard and Mouse• System Table• CAM Lens FullRange• CAM Lens	• Scanner• Control Unit• Chin and Head rest• Joystick and base assembly• Computer with Windows operatingsystem• Monitor• Keyboard and Mouse• System Table• CAM Lens	Same
Signal Type	Optical scattering from tissue forOCT	Optical scattering from tissue for OCT	Same
Device	SOLIX(Proposed Device)	Predicate DevicesPrimary Predicate Avanti	Substantial EquivalenceComparison
OCT Light Source	Superluminescent diode(SLD) 840nm	Superluminescent diode(SLD) 840nm	Same
OCT Optical Power	1.45mW (at cornea)	0.75mW (at cornea)	SLD power in SOLIX isincreased from 0.75mW to1.45mW to compensate theloss of photon energy due tohigher scanner speed. Withhigher power, it achievessimilar level of Signal toNoise Ratio (SNR) as Avanti.
OCT Optical Power	1.45mW (at cornea)	0.75mW (at cornea)	The light exposure safetyissue in SOLIX is analyzedin Dr. David Sliney's report.The near- infrared radiationfrom an SLD in SOLIX isbelow all of the applicableexposure limits -includingthe guidelines forophthalmic instrumentexposure.
Fixation Light Source	Blue LED	Blue LED	Same
IR Fundus ImagingLight Source	NIR LED	NIR LED	Same
Iris ViewerIllumination	IR LED	N/A	Iris imaging is added forexternal visualization tofacilitate patient alignment.No impact on the systems'essential functions - OCT.
Working Distance	Retina imaging: 35 mmWith CAM (Cornea AnteriorModule) attached: 20mm	Retina imaging: 22 mmWith CAM (Cornea Anterior Module)attached: 13mm	The longer workingdistance in SOLIXimproves the system'susability.
Ergonomic	• Chin and forehead rest• Joystick for alignment on the eye	• Chin and forehead rest• Joystick for alignment on the eye	Same
Electrical	Medical-grade power supply (IEC60601 compliant)	Medical-grade power supply (IEC60601 compliant)	Same
Cleaning andDisinfection	Chin and forehead rest can becleaned with a disinfecting agent,such as isopropyl alcohol wipes or agermicide with a lint-free cloth.	Chin and forehead rest can be cleanedwith a disinfecting agent, such asisopropyl alcohol wipes or a germicidewith a lint-free cloth.	Same
Axial Resolution (intissue)	5μm	5μm	Same
Scan Rate	120,000 A-Scan/second	70,000 A-Scan/second	The OCT scan speedincreased from 70Khz to120Khz with a faster linescan camera from samevendor.
Scan Depth	~up to 3 mm except full- range scansup to 6.25 mm such as FullRange™Retina and FullRange™ AC scans	~up to 3mm	Full-range technology isintroduced to increase scandepth for two specific scansonly.
Angio Vue(wider FOV)	AngioVue 12mm	N/A	With faster scan speed,SOLIX offers Angio Vuescan with wider field ofview: Scan area: 12mmx12mm and SamplingDensity: 600x600
Device	SOLIX(Proposed Device)	Predicate DevicesPrimary Predicate Avanti	Substantial EquivalenceComparison
AngioVue(wider FOV)	AngioVue 9mm	N/A	With faster scan speed, SOLIX offers Angio Vue scan with wider field of view: Scan area: 9mm x9mm and Sampling Density 600x600
AngioVue	AngioVue Retina	HD Angio Retina 6.0mm	SOLIX scan area: 6.4mmx6.4mm; Increase sampling density from 400 x400 (Avanti) to 512x512 (SOLIX)
AngioVue	AngioVue 3mm	Angio Retina 3.0mm	Same Scan Area: 3mmx3mm; Increase sampling density from 304x304 (Avanti) to 400x400 (SOLIX)
AngioVue	AngioVue Disc	HD Angio Disc 4.5mm	Same scan area: 6x6mm; Increase sampling density from 400x400 (Avanti) to 512x512 (SOLIX)
Retina	Line	Line	Similar. Adjustability: Length 6-12 mm (SOLIX) vs 2-12mm(Avanti)
Retina	FullRange Retina	N/A	Essentially it is an enhanced line scan. Scan Depth is 6.25mm
Retina	Retina Cube	3D Retina	Same scan Area: 6.4x6.4mm; Retina Cube: Sampling Density 512x200; 3D Retina: Sampling Density 385x141;
Retina	Raster	Raster	Similar. Adjustability: Height 2-10 mm(SOLIX) vs 1-8mm(Avanti)
Retina	Radial lines	Radial lines	SOLIX: 1024x12, Scan Length: 6-12mm; Avanti: 1024x18, Scan Length: 2-12mm;
Nerve Fiber	Disc Cube	3D Disc	Same scan area: 6x6mm; Disc Cube: Sampling Density 350x350; 3D Disc: Sampling Density 513x101
Retina	Wellness	N/A	Scan Area:12x9 mm; Sampling Density: 600x130
Cornea	Corneal Map	PachymetryPachymetry Wide	Same radial scan pattern. Scan length: Corneal Map 10mm vs Pachymetry 6mm and Pachymetry Wide 9mm
Cornea	Anterior Radial	Cornea Cross Line	Same type of meridian scans. Increased # of meridians from 2 (Avanti) to 16 (SOLIX)
Cornea	Cornea Line	Corneal Line	Similar. 1700 A-Scans/line (SOLIX) vs 1020 A-Scans/Line (Avanti)
Cornea	Cornea Angle	Angle	Same
Cornea	Cornea Cube	3D Cornea	Similar cube scan pattern. Increase sampling density from 513x101 (Avanti) to 513x256 (SOLIX)
Device	SOLIX(Proposed Device)	Predicate DevicesPrimary Predicate Avanti	Substantial EquivalenceComparison
Cornea	FullRange AC	N/A	Essentially it is an enhancedline scan. Scan Depth is6.25mm
Motion ArtifactsReduction	Tracking based on IR fundusimage + MCT	Tracking based on IR fundus image +MCT	Same
Post- Processing forOCT Scans	• Segmentation and analysis of OCTScans for Retina and Nerve Fiber• Segmentation and analysis of OCTScans for Cornea• Scan Quality• Manual editing of segmentationerror and propagation of manualcorrection to neighboring B-scans• Projection artifacts removal (PAR)• Visualization and qualitativeanalysis of retinal and vascularstructures based on en face images	• Segmentation and analysis of OCTScans for Retina and Nerve Fiber• Segmentation and analysis of OCTScans for Cornea• Scan Quality• Manual editing of segmentationerror and propagation of manualcorrection to neighboring B-scans• Projection artifacts removal (PAR)• Visualization and qualitativeanalysis of retinal and vascularstructures based on en face images	Substantial Equivalence:The results are substantialequivalent as verified byclinical study data.SOLIX's PAR is updated tofurther reduce the projectionartifacts, as evidenced by thequalitative assessment ofclinical study data.SOLIX's vessel extractionmethod is updated to extractvessels in the relatively lowOCTA signal areas, asevidenced by the bench(phantom) and clinicalstudies.
Post-Processing forOCT Scans	Feature under AngioAnalyticslicense:Quantitative analysis of vascularstructures based on en faceimagesQuantitative analysis of retinal,nerve fiber, and optic discstructure• Fovea detection• Optic disc margindetection	Feature under AngioAnalyticslicense:• Quantitative analysis of vascularstructures based on en face images• Quantitative analysis of retinal,nerve fiber, and optic disc structure• Fovea detection• Optic disc margindetection	studies.Same
Reference Database(RDB)	OCT structural RDB Collected forthe following scans: AngioVueRetina, Angio Vue Disc, Retina CubeDisc Cube and Wellness scans• No OCT Angiography RDBavailable	• Avanti RDB for OCT scans,including Retinal Map scan, GCCscan, and ONH scan• No OCT Angiography RDBavailable	Same as predicate device,SOLIX only offers OCTstructural RDB based ondifferent types of cubescans.SOLIX's RDB providesadditional colors when theconfidence intervals ofquantile limits areoverlapped.
Device Packaging andSterilization	The device is not sterile, does notrequire sterilization, and does notinclude shelf-life claims on productlabeling.	The device is not sterile, does notrequire sterilization, and does notinclude shelf-life claims on productlabeling.	Same
	The device is not sterile and doesnot require sterilization. Shippingpackaging has been designed tosafely transport the device to the enduser facility.	The device is not sterile and doesnot require sterilization. Shippingpackaging has been designed to safelytransport the device to the end userfacility.	Same
Device	SOLIX(Proposed Device)	Predicate DevicesSecondary Predicate iCam	Substantial EquivalenceComparison
510(k) Number &Classification	TBDClass II	K122572Class II
Date of Clearance	TBD	January 11, 2013
Trade Name	SOLIX	iCam
Manufacturer	Optovue, Inc.	Optovue, Inc.
Indications For Use	The non-mydriatic color funduscamera of SOLIX, is an integratednon-contact, high resolution digitalimaging component which is suitablefor photographing, displaying andstoring images of the retina andexternal areas of the eye to beevaluated under non-mydriaticconditions. The SOLIX fundus cameracomponent is indicated for in-vivoviewing of the posterior and externalarea of the eye and the images areintended for use as an aid to cliniciansin the evaluation, diagnosis anddocumentation of ocular health.	The iCam is a non- contact, highresolution digital imaging devicewhich is suitable for photographing,displaying and storing images of theretina and external areas of the eye tobe evaluated under non- mydriaticconditions.iCam is indicated for in- vivo viewingof the posterior and external area ofthe eye and the images are intendedfor use as an aid to clinicians in theevaluation, diagnosis anddocumentation ofocular health.iCam provides images only and doesnot provide any diagnostic,pathological analysis or classificationof ocular health or disease.	Same
TechnologicalCharacteristics	Color fundus imaging	Color fundus imaging	Same
System Components	• Retina illumination Optics path.• Retina image optics path• Retina Camera	• Retina illuminationOptics path.• Retina image optics path• Retina Camera	Same
Signal Type	Photography under white light flash	Photography under white light flash	Same
Flash light source forphotographing	White LED	White LED	Same
IR Fundus ImagingLight Source	NIR LED	NIR LED	Same
Splitbar Illumination	NIR LED	NIR LED	Same
Working DistanceIndicator (WDI)Illumination	NIR LED	NIR LED	Same
Iris ViewerIllumination	IR LED	N/A	Iris imaging is added forexternal visualization tofacilitate patient alignment.No impact on the systems'essential functions – ColorFundusPhotography.
Working Distance	Retina imaging: 35 mmWith CAM (Cornea AnteriorModule) attached: 20mm	Retina imaging: 25mm	The longer workingdistance in SOLIXimproves the system'susability.
Ergonomic	• Chin and forehead rest	• Chin and forehead rest	Same
Device	SOLIX(Proposed Device)	Predicate DevicesSecondary Predicate iCam	Substantial EquivalenceComparison
Pupil Diameter(Non-Mydriaticfundus imaging)	≥4.0mm≥3.3mm (small pupil mode)	≥4.0mm	Smaller light ring mode isadded to deliver more lightinto the eyes with smallpupils. The general designprinciple is similar fornormal and small pupilmodes.
Field of View(Color FundusImaging)	45°35° (small pupil mode)	45°	Smaller light ring mode isadded to deliver more lightinto the eyes with smallpupils. The general designprinciple is similar for normaland small pupil modes. Insmall pupil mode, the FOV isa tradeoff with small pupilmode.
Electrical	Medical-grade power supply (IEC60601 compliant)	Medical-grade power supply (IEC60601 compliant)	Same
Cleaning andDisinfection	Chin and forehead rest can becleaned with a disinfecting agent,such as isopropyl alcohol wipes or agermicide with a lint-free cloth.	Chin and forehead rest can be cleanedwith a disinfecting agent, such asisopropyl alcohol wipes or agermicide with a lint-free cloth.	Same
Photo	Fundus Photo	Color Fundus	Similar. Small pupil modeadded in SOLIX
Photo	Disc Photo	Color Fundus	Similar. Small pupil modeadded in SOLIX
Photo	Exterior Color	External Image	Same
Photo	External IR	N/A	940nm IR Illumination tovisualize external structure
Device Packaging andSterilization	The device is not sterile, does notrequire sterilization, and does notinclude shelf-life claims on productlabeling.	The device is not sterile, does notrequire sterilization, and does notinclude shelf-life claims on productlabeling.	Same
	The device is not sterile and doesnot require sterilization. Shippingpackaging has been designed tosafely transport the device to the enduser facility.	The device is not sterile and does notrequire sterilization. Shippingpackaging has been designed to safelytransport the device to the end userfacility.	Same

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Image /page/7/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized orange circle on the left side, with a small gap at the top. To the right of the circle is the word "OPTOVUE" in gray, sans-serif font. The logo is simple and modern.

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SOLIX vs iCam

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Image /page/10/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the word is a partial circle made of orange and yellow gradient colors. The circle is open on the right side, and the left side of the circle has a small, eye-shaped opening.

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Image /page/11/Picture/1 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the word is a circular graphic that is orange and yellow. The graphic is not a complete circle, but rather an arc that extends around the left side of the word.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE SUBJECT DEVICE AND PREDICATE DEVICE

The main comparison for the determination of substantial equivalence is between SOLIX and Avanti. The SOLIX and Avanti do not share identical technological characteristics. However, these differences do not raise different questions of safety and effectiveness.

SOLIX has the following OCT differences from the predicate, Avanti:

OCT hardware

The SOLIX OCT scan speed increased from 70kHz to 120kHz with a faster line scan ● camera.
The power of the SOLIX light source (superluminescent diode [SLD] with 840 nm . central wavelength and FWHM of 50 nm) is increased from 750 mW to 1.45 mW to compensate for the loss of photon energy due to the higher scanning speed. With higher power, it achieves similar level of Signal to Noise Ratio (SNR) as Avanti.
The line-scan camera-based SOLIX spectrometer was changed from an infrared ● charge-coupled device (CCD) camera sensor to a color complementary metal-oxide semiconductor (CMOS) sensor.
. The SOLIX reference arm modified with a new "phase galvo module" to allow for an increased scan depth to 6.25 mm in the FullRange Retina and FullRange AC scans.
The field of view (FOV) of the optical path for color fundus images and for OCT scan tracking/macula visualization was changed from 35° to 45°. The new color fundus image path is similar to that of the iCam.
An external eye image path (for iris images) was added to guide patient alignment ● and to allow for acquisition of infrared images of the external area of the eye.

OCT software

The SOLIX algorithm for OCTA-based vessel density (VD) parameters includes ● improved projection artifact removal (PAR), improved detection of vessels with low OCT signal, and improved accuracy of the binary vessel mask. The vessel extraction algorithm in SOLIX uses a local thresholding method applied to the OCTA image partitioned into sub-regions, while the Avanti vessel extraction algorithm uses a global thresholding method that is applied to the entire OCTA image without any partitioning.
The default Bruch's membrane opening (BMO) plane elevation for the calculation ● of the cup dimensions (AngioDisc and Disc Cube scans) is 150 um instead of zero.
SOLIX has two additional, wider-field AngioVue scans (9×9 mm and 12×12 mm). ●
The SOLIX 3×3-mm and 6.4×6.4-mm AngioVue Retina scan and 6.0×6.0-mm ● AngioVue Disc scan have higher scan density (400 A-scans × 400 B-scans vs. 304 A-scans × 304 B-scans; 512 A-scans × 512 B-scans vs. 400 A-scans × 400 B-scans, respectively); increased scan density for Retina Cube and Disc Cube scans.

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The SOLIX cornea map size increased from 9 mm to 10 mm in diameter. ●
New SOLIX scan pattern, the 12×9-mm Wellness scan. ●
New SOLIX reference database (RDB) for certain structural quantitative . parameters measured on five scan patterns (AngioVue Retina, AngioVue Disc, Retina Cube, Disc Cube, and Wellness scans).

Performance Testing

The following non-clinical and clinical performance testing were provided in support of the substantial equivalence determination.

Non-clinical Performance Testing

The following non-clinical bench tests were performed including,

Spatial Performance ●
Sensitivity
OCT Angiography: A set of 3D digital phantoms with known vessel density ground truth ● was designed to determine the accuracy of SOLIX device software for vessel density measurement from AngioVue Retina and AngioVue Disc scans. A similar set of phantoms was created to determine vessel density accuracy of the Avanti predicate device software for comparison to SOLIX accuracy. Improved accuracy was observed from SOLIX vessel density measurements.
Auxiliary Functions ●
Testing to the standards ●
- Safety and Essential Performance: AAMI/ANSI ES60601-1 O
- O Electromagnetic Compatibility: IEC 60601-1-2
- Usability: IEC 60601-1-6 o
- Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10 о
- Ophthalmic Instruments & Light Hazard Protection: ISO 15004-1, ISO 15004-2 O
Light Hazard Protection for Ophthalmic Instruments: ANSI Z80.36-2016 ●
Software Verification and Validation Testing: Device software was verified and validated ● to support the indications for use according to BS EN 62304:2006 Medical Device Software - Software life cycle processes and FDA 's General Principles of Software Validation; Final Guidance for Industry and FDA Staff. In accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005," documentation provided demonstrates that the software performed as intended, met acceptance criteria, overall product safety, and patient safety.

The software for this device is determined to be a "moderate" level of concern, since a malfunction of, or a latent design flaw in the software device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury. There was no change in the level of concern from the proposed SOLIX and its predicates Avanti and iCam devices.

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Image /page/13/Picture/1 description: The image shows the logo for Optovue. The logo consists of a stylized orange and yellow crescent shape on the left, resembling a partial ring. To the right of the crescent is the company name, "OPTOVUE," in a simple, sans-serif gray font. The crescent shape appears to be a stylized eye, with the company name next to it.

Clinical Performance Testing

Clinical studies were conducted according to BS EN ISO 14155:2011, Clinical investigation of medical devices for human subjects - Good clinical practice, and 21 CFR 50 and 21 CFR 56 to demonstrate substantial equivalence of the subject SOLIX device to the predicate Avanti and iCam devices.

Two clinical studies were conducted to evaluate the following:

1. Estimation of repeatability and reproducibility of the SOLIX in measuring posterior and anterior segment quantitative parameters;
1. Comparison of image quality in fundus photographs from SOLIX and from the predicate, iCAM.

An additional clinical study was conducted to generate a reference database (RDB) for structural quantitative parameters derived from five SOLIX scan patterns and a cohort of individuals without significant ocular pathology.

Solix OCT Performance – Anterior Segment

This was a prospective, observational study conducted at a single clinical U.S. site. Eligible participants aged 18 or older were enrolled and assigned to one of two study groups: 1) individuals with no corneal pathology, eyelid margin disease, or conditions qualifying for the other sub-group - "Normal" subgroup; 2) those with four specified corneal conditions (soft and hard contact lens wearers, post-refractive surgery, dry eye, keratoconus) - "Cornea" subgroup. Three acceptable quality scans were acquired from each study eye using each scan pattern - Solix Corneal Map scan and Avanti Pachymetry Wide, with each of three Solix/Avanti instrument/operator pairs. Post-acquisition image review of signal strength, pupil alignment, eyelid artifact, scan range, and motion artifact were conducted on all scans. Repeatability analysis was based on the variability of repeated scans of the same eye with the same device/operator pair, while the reproducibility analysis was based on repeatability and the combined device/operator effect for multiple devices. The repeatability and reproducibility (R&R) were estimated for each study subgroup using a random-effects analysis of variance (ANOVA) model. Reproducibility is the sum of Residual, DevOp, and Subject:DevOp variance components. Repeatability and reproducibility limits are 2.8×SD (standard deviation). Agreement between SOLIX and Avanti was evaluated with the estimation of the 95% limits of agreement (LOAs), Bland-Altman plots, and Deming regression analyses stratified by sub-group.

Results

63 participants were enrolled and 61 were eligible (30 "Normal," 31 in "Cornea" subgroup [7 with dry eye, 7 with contact lens wear, 8 post-refractive surgery and 9 with keratoconus]). The mean age in the "Normal" sub-group was 43±16.9 (range 22-67) and 43±15.3 (range 22-74) in the "cornea" sub-group. 52% of the cohort are women and 48% are men. 69% of the cohort was Caucasian and 31% were Native American.

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556 Solix scans and 555 Avanti XR scans were acquired across 6 devices. Scan attrition for poor image quality was similar for both devices (<3%). The manual edit rate was 10.0% and 14.8% for SOLIX and XR, respectively, with majority of edits performed for KCN eyes (63.6% for SOLIX, 50.6% for Avanti XR).

Normal (N=269 scans)
				Epithelia (Epi)				Cornea (Pachy)			Stroma
Parameter(φ9 mm)	Unit	Mean	Repeatability	Reproducibility		Mean	Repeatability	Reproducibility			Mean	Repeatability	Reproducibility
			SD	SD	CV	Limit*		SD	SD	CV	Limit*		SD	SD	CV	Limit*
C(2)	μm	53.6	0.7	0.9	1.6%	2.4	527.1	1.3	1.9	0.4%	5.3	473.4	1.0	1.8	0.4%	5.0
T(2-5)	μm	52.8	0.8	0.9	1.6%	2.4	537.1	2.4	3.1	0.6%	8.6	484.2	2.4	3.0	0.6%	8.3
ST(2-5)	μm	52.7	0.8	1.0	2.0%	2.9	552.9	4.3	5.8	1.0%	16.2	500.2	4.2	5.6	1.1%	15.6
S(2-5)	μm	53.0	0.9	1.2	2.2%	3.2	565.7	5.4	7.5	1.3%	21.0	512.7	5.4	7.4	1.4%	20.6
SN(2-5)	μm	53.9	0.9	1.1	2.0%	3.1	563.5	4.9	6.6	1.2%	18.6	509.5	4.7	6.4	1.3%	17.9
N(2-5)	μm	54.1	0.7	0.9	1.7%	2.5	553.5	3.8	4.9	0.9%	13.8	499.4	3.7	4.8	1.0%	13.3
IN(2-5)	μm	54.7	0.7	0.8	1.5%	2.3	546.6	3.7	4.5	0.8%	12.7	491.9	3.6	4.4	0.9%	12.3
I(2-5)	μm	54.9	0.8	0.9	1.6%	2.5	541.0	3.6	4.6	0.9%	12.9	486.0	3.5	4.5	0.9%	12.5
IT(2-5)	μm	54.0	0.8	0.9	1.7%	2.5	534.6	2.8	3.4	0.6%	9.5	480.6	2.7	3.3	0.7%	9.3
T(5-7)	μm	53.3	0.6	0.8	1.5%	2.2	569.0	3.8	5.1	0.9%	14.3	515.7	3.8	4.9	0.9%	13.7
ST(5-7)	μm	52.0	0.7	1.0	1.9%	2.8	597.3	6.0	8.1	1.4%	22.8	545.3	6.2	8.1	1.5%	22.7
S(5-7)	μm	51.7	1.0	1.3	2.5%	3.6	618.0	6.7	10.2	1.7%	28.7	566.3	6.9	10.5	1.8%	29.3
SN(5-7)	μm	54.8	1.0	1.2	2.2%	3.4	614.7	6.4	8.5	1.4%	23.8	559.8	6.4	8.4	1.5%	23.5
N(5-7)	μm	54.8	0.8	1.0	1.8%	2.7	596.4	5.5	7.2	1.2%	20.0	541.6	5.2	6.8	1.3%	19.1
IN(5-7)	μm	54.9	0.7	0.8	1.4%	2.2	587.7	5.6	7.0	1.2%	19.7	532.8	5.5	7.0	1.3%	19.6
I(5-7)	μm	55.1	0.6	0.8	1.4%	2.1	580.5	5.7	7.1	1.2%	19.9	525.4	5.7	7.2	1.4%	20.1
IT(5-7)	μm	54.8	0.6	0.7	1.3%	2.0	567.7	4.8	5.9	1.0%	16.4	512.9	4.7	5.8	1.1%	16.1
T(7-9)	μm	53.3	0.9	1.2	2.2%	3.3	610.0	7.0	8.9	1.5%	24.8	556.7	7.2	8.8	1.6%	24.6
ST(7-9)	μm	49.6	1.1	1.2	2.5%	3.5	648.9	8.7	11.4	1.8%	32.0	599.2	9.1	11.9	2.0%	33.2
S(7-9)	μm	48.2	1.2	1.5	3.1%	4.2	668.8	8.8	13.8	2.1%	38.7	620.6	9.1	14.1	2.3%	39.6
SN(7-9)	μm	53.1	1.2	1.8	3.3%	5.0	663.4	7.1	9.7	1.5%	27.3	610.2	7.4	10.0	1.6%	28.0
N(7-9)	μm	56.8	0.8	0.9	1.6%	2.6	644.9	6.9	9.1	1.4%	25.4	588.1	6.6	8.6	1.5%	24.1
IN(7-9)	μm	54.9	0.8	1.0	1.7%	2.6	637.1	7.9	9.9	1.6%	27.7	582.2	7.9	9.9	1.7%	27.7
I(7-9)	μm	54.0	0.8	1.2	2.1%	3.2	628.3	8.1	10.2	1.6%	28.6	574.2	8.3	10.6	1.8%	29.7
IT(7-9)	μm	55.1	0.9	1.1	1.9%	3.0	609.9	7.5	8.7	1.4%	24.4	554.8	7.6	8.7	1.6%	24.5

The repeatability and reproducibility (R&R) results are show in the tables below.

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		Epithelia (Epi)					Cornea (Pachy)					Stroma
Cornea (N=279scans)
Parameter(φ9 mm)	Unit	Mean	Repeatability	Reproducibility			Mean	Repeatability	Reproducibility			Mean	Repeatability	Reproducibility
			SD	SD	CV	Limit*		SD	SD	CV	Limit*		SD	SD	CV	Limit*
C(2)	μm	54.3	0.8	1.0	1.8%	2.8	508.5	2.3	3.1	0.6%	8.6	454.1	2.1	3.0	0.7%	8.5
T(2-5)	μm	53.6	1.1	1.4	2.5%	3.8	524.5	4.5	6.5	1.2%	18.2	470.9	4.7	6.7	1.4%	18.9
ST(2-5)	μm	53.4	1.3	1.6	3.0%	4.5	543.1	5.0	7.1	1.3%	19.9	489.7	4.9	6.9	1.4%	19.3
S(2-5)	μm	53.9	1.1	1.3	2.4%	3.6	556.5	5.5	7.3	1.3%	20.4	502.6	5.6	7.5	1.5%	20.9
SN(2-5)	μm	55.0	0.9	1.1	2.1%	3.2	553.8	5.4	6.4	1.2%	18.0	498.7	5.4	6.6	1.3%	18.4
N(2-5)	μm	56.0	0.9	1.1	1.9%	3.0	542.2	4.7	5.6	1.0%	15.7	486.2	4.6	5.5	1.1%	15.5
IN(2-5)	μm	55.9	1.0	1.3	2.3%	3.6	531.1	4.5	6.2	1.2%	17.4	475.1	4.5	5.9	1.2%	16.6
I(2-5)	μm	55.0	1.2	1.5	2.8%	4.3	518.9	4.5	6.6	1.3%	18.6	463.8	4.7	7.0	1.5%	19.7
IT(2-5)	μm	54.6	1.2	1.5	2.7%	4.2	513.8	3.6	4.2	0.8%	11.8	459.2	3.9	4.3	0.9%	12.1
T(5-7)	μm	52.5	1.0	1.6	3.1%	4.6	563.0	5.5	7.4	1.3%	20.8	510.5	5.6	7.0	1.4%	19.7
ST(5-7)	μm	51.5	1.2	1.5	2.8%	4.1	592.3	6.5	8.9	1.5%	24.9	540.8	6.8	9.2	1.7%	25.9
S(5-7)	μm	51.2	1.4	1.8	3.5%	5.0	614.2	6.9	9.2	1.5%	25.8	563.0	7.0	9.5	1.7%	26.6
SN(5-7)	μm	53.2	1.0	1.4	2.6%	3.9	608.6	6.4	8.2	1.3%	23.0	555.4	6.5	8.4	1.5%	23.6
N(5-7)	μm	54.7	0.9	1.2	2.1%	3.2	588.2	6.0	7.4	1.3%	20.7	533.4	6.0	7.4	1.4%	20.7
IN(5-7)	μm	54.6	1.0	1.2	2.1%	3.2	575.2	6.0	8.0	1.4%	22.4	520.5	6.1	8.1	1.6%	22.6
I(5-7)	μm	53.7	1.1	1.2	2.3%	3.4	563.1	6.0	8.1	1.4%	22.6	509.3	6.3	8.1	1.6%	22.6
IT(5-7)	μm	53.4	1.0	1.2	2.2%	3.3	554.7	5.5	6.3	1.1%	17.5	501.3	5.6	6.2	1.2%	17.3
T(7-9)	μm	52.3	1.2	1.4	2.7%	4.0	607.9	7.3	9.3	1.5%	25.9	555.6	7.3	9.3	1.7%	25.9
ST(7-9)	μm	49.5	1.3	1.7	3.3%	4.6	644.7	8.9	12.2	1.9%	34.2	595.2	8.9	12.3	2.1%	34.4
S(7-9)	μm	49.5	1.6	2.2	4.4%	6.2	669.9	9.4	13.2	2.0%	37.0	620.4	9.6	13.3	2.1%	37.1
SN(7-9)	μm	52.1	1.3	1.6	3.0%	4.4	658.3	6.5	8.9	1.4%	25.0	606.2	6.8	9.2	1.5%	25.9
N(7-9)	μm	55.6	1.0	1.2	2.1%	3.3	635.2	6.7	8.2	1.3%	23.0	579.6	6.5	7.8	1.3%	21.8
IN(7-9)	μm	54.2	0.9	1.0	1.9%	2.9	624.5	7.4	9.9	1.6%	27.7	570.3	7.4	9.6	1.7%	26.9
I(7-9)	μm	52.9	0.8	1.0	2.0%	2.9	612.4	8.2	10.6	1.7%	29.6	559.5	8.4	10.8	1.9%	30.3
IT(7-9)	μm	54.0	0.9	1.1	2.1%	3.2	600.3	7.4	9.2	1.5%	25.7	546.3	7.1	9.0	1.6%	25.1

Solix OCT and OCTA Performance - Posterior Segment

This was a prospective, observational study conducted at a single clinical U.S. site. Eligible participants aged 18 or older were enrolled and assigned to one of three study groups: 1) individuals with no ocular disease ("normal"); 2) individuals with glaucoma of varying severity (with confirmed glaucomatous visual field defect and/or glaucomatous optic nerve changes), and 3) individuals with pathological retinal conditions. One eligible eye per participant was designated the study eye. Three SOLIX and three Avanti devices were paired with designated device operators to form six different device-operator pairs ("configurations"). Three acceptable quality scans were acquired from each study eye using each scan pattern with each of the three Solix/Avanti configurations. All scans underwent post-acquisition image quality review. Repeatability analysis was based on the variability of repeated scans of the same eye with the same device/operator pair, while the reproducibility analysis was based on repeatability and the combined device/operator effect for multiple devices. The repeatability and reproducibility (R&R) were estimated for each study subgroup using a random-effects analysis of variance (ANOVA) model. Agreement between SOLIX and Avanti was evaluated with the estimation of the 95% limits of agreement (LOAs), Bland-Altman plots, and Deming regression analyses stratified by sub-group.

Results

93 participants were enrolled and 83 participants completed the study (30 "normal," 25 "Glaucoma", 28 "Retina" subgroup). 44 (53%) participants are women and 39 (47%) are men. The mean age was 65.5±15.3 (range 21 to 91). 86 (94.5%) participants were Caucasian. The glaucoma sub-group consisted of 10, 7, and 8 participants with early, moderate, and advanced

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glaucoma, respectively. Mean visual field mean deviation (MD) was -2.00. -4.40, and -9.89 dB in early, moderate, and severe glaucoma participants, respectively, and ranged from -13.84 dB to -0.72 dB. Mean pattern standard deviation (PSD) was -2.27, -3.83, and -9.30 dB in early, moderate, and severe glaucoma participants, respectively, and ranged from -1.76 dB to -13.65 dB. Glaucomatous optic nerve findings were observed in all glaucoma sub-group participants. The retinal conditions represented in the "Retina" sub-group were exudative and non-exudative age-related macular degeneration ("wet" and "dry" AMD; n=10 and 6, respectively), proliferative and non-proliferative diabetic retinopathy (PDR and NPDR, n=6 and 2, respectively), and other retinal vascular conditions (adult vitelliform dystrophy [n=1] and retinitis pigmentosa [n=2]).

Scan acceptability rates ranged from 93.7% to 100%. The main reasons for scan disqualification were motion artifacts for Disc Cube scan and local weak signal for AngioVue Retina. Across the five study scan types and sub-groups, the manual editing rates for segmentation boundaries were 0.1% for ILM (Retina Cube scan), 5.2% for IPL (Retina Cube Scan), 0.1% for RPE (Retina Cube scan), and 3.9% for NFL (AngioVue Disc scan); the foveal center detection correction rates were 0.5% for Wellness scan, 0.7% for AngioVue Retina scan and 0.7% for Retina Cube scan; the FAZ boundary manual editing rate was 19.7% for AngioVue Retina scans; the disc margin manual editing was performed for the baseline scan in 1.5% of study eyes per instrument.

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Structural Parameters of the Macula Scans – R&R Results

Normal Subjects
			AngioVue Retina (N = 269)					Retina Cube (N=269)			Wellness (N=270)
			Repeata					Repeata					Repeata
Measurement	Unit		bility		Reproducibility			bility		Reproducibility			bility		Reproducibility
		Mean (SD)	SD	SD	CV	Limit*	Mean (SD)	SD	SD	CV	Limit*	Mean (SD)	SD	SD	CV	Limit*
GCC								ETDRS Grid (Ø 6mm)
C(1) GCC	um	60.7 (9.6)	0.7	1.0	1.6%	2.7	61.3 (9.4)	1.1	1.4	2.2%	3.8	67.9 (9.1)	1.3	1.4	2.0%	3.8
T(1-3) GCC	um	102.2 (6.6)	0.7	0.9	0.9%	2.6	103.1 (6.5)	0.7	1.0	0.9%	2.7	102.0 (6.4)	0.7	1.0	1.0%	2.7
S(1-3) GCC	um	114.5 (7.4)	0.7	1.1	0.9%	3.0	114.2 (7.3)	0.9	1.2	1.1%	3.4	111.6 (7.9)	1.0	1.2	1.1%	3.5
N(1-3) GCC	um	112.6 (6.9)	0.8	1.0	0.9%	2.8	112.9 (6.8)	1.0	1.2	1.1%	3.3	112.3 (6.6)	0.9	1.2	1.1%	3.4
I(1-3) GCC	um	114.9 (7.0)	0.7	1.1	1.0%	3.1	114.3 (7.0)	0.9	1.2	1.0%	3.3	111.1 (7.3)	0.9	1.3	1.1%	3.5
S-Hemi (1-3)_GCC	um	110.7 (6.9)	0.6	0.9	0.8%	2.6	110.9 (6.8)	0.7	1.0	0.9%	2.9	109.6 (7.1)	0.8	1.0	0.9%	2.9
I-Hemi (1-3)_GCC	um	111.4 (6.7)	0.6	0.9	0.8%	2.6	111.4 (6.6)	0.7	1.0	0.9%	2.8	109.6 (6.6)	0.8	1.1	1.0%	3.0
All(1-3) GCC	um	111.1 (6.7)	0.5	0.9	0.8%	2.4	111.1 (6.6)	0.6	0.9	0.8%	2.6	109.6 (6.8)	0.7	1.0	0.9%	2.7
T(3-6) GCC	um	84.2 (7.2)	0.8	1.1	1.3%	3.0	84.7 (7.1)	0.8	1.0	1.2%	2.7	80.1 (6.6)	0.8	1.0	1.3%	2.8
S(3-6) GCC	um	100.7 (8.2)	0.8	1.0	1.0%	2.8	99.3 (8.2)	0.9	1.1	1.1%	3.0	91.2 (7.8)	1.0	1.3	1.5%	3.8
N(3-6) GCC	um	119.3 (8.8)	0.6	0.9	0.8%	2.6	118.6 (8.6)	0.8	1.1	0.9%	3.1	115.4 (9.5)	1.1	1.5	1.3%	4.3
I(3-6) GCC	um	100.2 (8.4)	0.7	1.1	1.1%	3.0	99.0 (8.3)	0.9	1.2	1.2%	3.4	95.4 (8.3)	1.3	2.0	2.1%	5.7
S-Hemi (3-6) GCC	um	100.7 (7.6)	0.6	0.9	0.9%	2.4	100.0 (7.5)	0.7	0.9	0.9%	2.5	93.4 (7.4)	0.9	1.2	1.2%	3.2
I-Hemi (3-6) GCC	um	101.5 (8.1)	0.6	0.9	0.9%	2.6	100.8 (8.0)	0.8	1.0	1.0%	2.9	96.8 (7.9)	1.0	1.6	1.7%	4.5
All (3-6)_GCC	um	101.1 (7.6)	0.5	0.8	0.8%	2.3	100.4 (7.5)	0.6	0.9	0.9%	2.4	95.1 (7.3)	0.8	1.2	1.3%	3.5
S-Hemi (0-6)_GCC	um	101.8 (7.0)	0.6	0.8	0.8%	2.3	101.3 (6.9)	0.6	0.8	0.8%	2.3	96.3 (6.8)	0.8	1.0	1.1%	2.8
I-Hemi (0-6)_GCC	um	102.6 (7.2)	0.6	0.9	0.9%	2.5	102.0 (7.2)	0.7	0.9	0.9%	2.6	98.9 (7.2)	0.9	1.4	1.4%	3.8
All (0-6)_GCC	um	102.2 (6.9)	0.5	0.8	0.8%	2.2	101.7 (6.8)	0.6	0.8	0.8%	2.2	97.6 (6.8)	0.7	1.1	1.1%	3.0
GCC							ETDRS Grid (Ø 6mm)						7mm x 8mm
WI GCC	um	103.3 (7.0)	0.5	0.8	0.7%	2.2	102.7 (6.9)	0.6	0.8	0.8%	2.3	92.1 (6.2)	0.7	1.1	1.2%	3.2
WI-S-Hemi GCC	um	102.2 (7.1)	0.6	0.8	0.8%	2.3	101.6 (7.0)	0.7	0.9	0.8%	2.4	91.1 (6.4)	0.8	1.0	1.1%	2.9
WI-I-Hemi GCC	um	104.4 (7.4)	0.6	0.9	0.8%	2.5	103.7 (7.4)	0.7	1.0	1.0%	2.8	93.0 (6.7)	0.9	1.5	1.6%	4.2
FLV GCC	0/0	0.57 (0.92)	0.1	0.2	29.5%	0.5	0.54 (0.91)	0.2	0.2	32.2%	0.5
GLV GCC	0/0	3.6 (3.7)	0.3	0.5	12.3%	1.3	3.6 (3.7)	0.3	0.5	13.8%	1.4		NA
Retina Thickness								ETDRS Grid (Ø 6mm)
C(1) R	um	269.6 (21.0)	1.0	1.6	0.6%	4.4	270.4 (21.0)	1.6	2.3	0.9%	6.5	269.1 (21.0)	1.4	2.1	0.8%	5.9
T(1-3) R	um	312.3 (13.9)	1.0	1.5	0.5%	4.2	313.5 (14.1)	1.3	1.9	0.6%	5.3	311.7 (14.1)	1.0	1.6	0.5%	4.5
S(1-3) R	um	327.2 (14.6)	1.0	1.8	0.5%	5.0	328.0 (14.6)	1.4	2.3	0.7%	6.3	325.6 (14.5)	1.2	1.9	0.6%	5.3
N(1-3) R	um	329.9 (13.9)	1.0	1.6	0.5%	4.5	330.9 (14.1)	1.4	2.1	0.6%	5.8	328.0 (14.3)	1.2	1.8	0.5%	4.9
I(1-3) R	um	322.2 (13.6)	1.0	1.6	0.5%	4.5	323.2 (14.0)	1.6	2.0	0.6%	5.5	322.3 (13.9)	1.1	1.6	0.5%	4.4
S-Hemi(1-3) R	um	324.3 (14.2)	0.9	1.6	0.5%	4.5	325.2 (14.2)	1.2	2.0	0.6%	5.7	322.6 (14.2)	1.1	1.7	0.5%	4.9
I-Hemi-(1-3) R	um	321.4 (13.3)	0.9	1.5	0.5%	4.1	322.6 (13.7)	1.4	1.8	0.6%	5.1	321.1 (13.7)	1.0	1.5	0.5%	4.1
All(1-3) R	um	322.9 (13.7)	0.8	1.5	0.4%	4.1	323.9 (13.8)	1.1	1.8	0.6%	5.1	321.9 (13.8)	0.9	1.5	0.5%	4.3
T(3-6) R	um	262.7 (14.5)	1.1	1.4	0.5%	4.0	264.8 (14.5)	1.4	1.8	0.7%	5.1	274.0 (15.4)	1.0	1.6	0.6%	4.4
S(3-6) R	um	282.5 (14.6)	1.0	1.7	0.6%	4.7	283.5 (14.5)	1.5	2.0	0.7%	5.6	290.4 (15.1)	1.2	1.7	0.6%	4.8
N(3-6) R	um	300.9 (15.5)	0.9	1.4	0.5%	3.9	302.3 (15.6)	1.1	1.7	0.6%	4.8	302.7 (16.2)	1.1	1.6	0.5%	4.6
I(3-6) R	um	269.7 (13.5)	1.0	1.4	0.5%	4.0	270.7 (13.8)	1.4	1.7	0.6%	4.8	278.9 (15.1)	1.3	1.8	0.6%	5.0
S-Hemi(3-6) R	um	282.7 (14.6)	0.8	1.4	0.5%	4.0	284.0 (14.5)	1.2	1.7	0.6%	4.8	289.6 (15.1)	1.0	1.5	0.5%	4.2
I-Hemi(3-6) R	um	275.2 (13.8)	0.9	1.3	0.5%	3.7	276.7 (14.0)	1.2	1.6	0.6%	4.5	283.3 (15.0)	1.0	1.5	0.5%	4.3
All(3-6) R	um	279.0 (14.0)	0.8	1.3	0.5%	3.5	280.3 (14.0)	1.0	1.5	0.5%	4.3	286.5 (14.9)	0.9	1.4	0.5%	3.9
S-Hemi(0-6) R	um	291.6 (13.9)	0.8	1.4	0.5%	3.9	292.8 (13.9)	1.1	1.7	0.6%	4.8	296.4 (14.4)	1.0	1.5	0.5%	4.2
I-Hemi(0-6) R	um	285.3 (13.2)	0.9	1.3	0.4%	3.6	286.7 (13.4)	1.2	1.6	0.6%	4.5	291.4 (14.1)	0.9	1.5	0.5%	4.1
All(0-6) R	um	288.5 (13.4)	0.7	1.3	0.4%	3.5	289.8 (13.5)	1.0	1.6	0.5%	4.4	293.9 (14.1)	0.8	1.4	0.5%	3.9
All (0-6) R Vol	mm	8.2 (0.38)	0.02	0.04	0.5%	0.10	8.2 (0.38)	0.03	0.05	0.6%	0.13			NA

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Glaucoma Subjects
			AngioVue Retina (N = 224)				Retina Cube (N=225)		Wellness (N=225)
Measurement	Unit		Repeatabi					Repeata			Repeata
			lity		Reproducibility			bility		Reproducibility			bility		Reproducibility
		Mean (SD)	SD	SD	CV	Limit*	Mean (SD)	SD	SD	CV	Limit*	Mean (SD)	SD	SD	CV	Limit*
GCC							ETDRS Grid (Ø 6mm)
C(1) GCC	um	51.9 (10.7)	0.8	1.0	2.0%	2.9	52.1 (11.0)	1.3	1.6	3.0%	4.4	58.1 (11.0)	1.3	1.6	2.7%	4.4
T(1-3) GCC	um	82.6 (11.6)	0.7	0.8	1.0%	2.4	83.2 (11.6)	0.9	1.0	1.2%	2.8	82.2 (11.0)	1.0	1.1	1.3%	3.1
S(1-3) GCC	um	95.6 (13.0)	0.9	1.0	1.0%	2.7	94.6 (12.6)	0.9	1.0	1.1%	2.9	91.6 (12.0)	1.0	1.3	1.4%	3.5
N(1-3) GCC	um	96.1 (12.1)	0.8	1.0	1.0%	2.7	96.3 (11.8)	1.0	1.0	1.0%	2.8	95.4 (11.7)	0.9	1.0	1.1%	2.9
I(1-3) GCC	um	92.1 (13.2)	0.7	0.9	0.9%	2.4	91.1 (12.7)	0.9	1.0	1.1%	2.9	87.1 (11.8)	0.9	1.1	1.2%	3.0
S-Hemi (1-3) GCC	um	92.7 (12.2)	0.7	0.8	0.9%	2.3	92.5 (11.9)	0.8	0.9	1.0%	2.5	90.8 (11.4)	0.8	1.0	1.1%	2.8
I-Hemi (1-3) GCC	um	90.4 (12.4)	0.6	0.8	0.9%	2.3	90.1 (12.1)	0.7	0.9	1.0%	2.4	87.5 (11.3)	0.8	0.9	1.1%	2.6
All(1-3) GCC	um	91.6 (11.5)	0.5	0.7	0.7%	1.9	91.3 (11.3)	0.6	0.7	0.8%	2.0	89.1 (10.5)	0.6	0.8	0.9%	2.3
T(3-6) GCC	um	69.4 (8.4)	0.7	0.9	1.3%	2.5	69.5 (8.3)	0.8	1.0	1.4%	2.8	66.1 (7.8)	0.8	0.9	1.4%	2.5
S(3-6)_GCC	um	81.5 (12.7)	0.7	0.8	1.0%	2.2	80.0 (12.3)	0.9	1.1	1.4%	3.1	72.2 (12.3)	1.1	1.4	1.9%	3.8
N(3-6)_GCC	um	97.4 (11.8)	0.6	0.8	0.8%	2.1	96.2 (11.5)	1.0	1.3	1.4%	3.7	90.9 (12.0)	1.0	1.4	1.6%	4.0
I(3-6)_GCC	um	76.5 (12.1)	0.7	0.8	1.0%	2.2	75.2 (11.5)	0.8	1.1	1.5%	3.2	70.6 (12.1)	1.1	1.5	2.1%	4.1
S-Hemi (3-6) GCC	um	83.2 (11.1)	0.6	0.7	0.8%	1.8	82.2 (10.8)	0.7	0.9	1.1%	2.6	75.4 (10.9)	0.8	1.1	1.5%	3.1
I-Hemi (3-6) GCC	um	79.2 (11.0)	0.6	0.7	0.9%	1.9	78.3 (10.6)	0.7	1.0	1.2%	2.7	73.2 (11.0)	0.9	1.1	1.5%	3.2
All (3-6)_GCC	um	81.2 (9.7)	0.5	0.6	0.7%	1.5	80.2 (9.4)	0.6	0.8	1.0%	2.2	74.3 (9.7)	0.7	0.9	1.2%	2.6
S-Hemi (0-6) GCC	um	84.5 (10.9)	0.5	0.6	0.7%	1.7	83.6 (10.6)	0.6	0.8	0.9%	2.2	78.3 (10.6)	0.7	1.0	1.3%	2.8
I-Hemi (0-6) GCC	um	81.0 (10.7)	0.5	0.6	0.8%	1.8	80.2 (10.3)	0.6	0.8	1.0%	2.3	76.0 (10.4)	0.8	1.0	1.3%	2.7
All (0-6) GCC	um	82.7 (9.7)	0.40.7%1.50.5				81.9 (9.4)	0.6	0.7	0.9%	2.0	77.1 (9.4)	0.6	0.8	1.0%	2.3
GCC							ETDRS Grid (Ø 6mm)						7mm x 8mm
WI GCC	um	82.5 (10.3)	0.4	0.5	0.6%	1.4	81.7 (9.9)	0.6	0.7	0.9%	2.1	73.4 (8.9)	0.7	0.8	1.1%	2.3
WI-S-Hemi GCC	um	84.1 (11.6)	0.5	0.6	0.8%	1.8	83.2 (11.3)	0.7	0.9	1.0%	2.4	74.6 (10.2)	0.8	1.0	1.3%	2.8
WI-I-Hemi GCC	um	80.9 (11.5)	0.5	0.7	0.8%	1.8	80.1 (11.1)	0.7	0.9	1.1%	2.5	72.1 (9.7)	0.9	1.0	1.4%	2.9
FLV GCC	%	5.7 (3.5)	0.4	0.4	6.9%	1.1	5.5 (3.3)	0.4	0.5	8.6%	1.3		NA
GLV GCC	0%	19.8 (9.4)	0.4	0.5	2.5%	1.4	20.1 (9.1)	0.5	0.7	3.4%	1.9
Retina Thickness								ETDRS Grid (Ø 6mm)
C(1) R	um	252.2 (18.9)	1.0	1.7	0.7%	4.8	253.4 (19.3)	1.7	2.4	0.9%	6.7	252.1 (18.7)	1.6	2.1	0.8%	6.0
T(1-3) R	um	287.3 (17.4)	1.1	1.5	0.5%	4.3	288.9 (17.8)	1.4	2.0	0.7%	5.7	286.6 (17.6)	1.3	1.8	0.6%	5.0
S(1-3) R	um	300.7 (18.1)	1.1	1.6	0.5%	4.4	302.2 (18.3)	1.7	2.2	0.7%	6.1	299.5 (18.1)	1.4	1.9	0.6%	5.4
N(1-3) R	um	307.6 (16.9)	1.1	1.7	0.5%	4.7	309.6 (17.3)	1.4	1.9	0.6%	5.3	306.4 (17.2)	1.2	1.8	0.6%	4.9
I(1-3) R	um	293.6 (16.7)	1.3	1.8	0.6%	5.2	295.2 (17.1)	1.5	2.0	0.7%	5.6	293.9 (17.1)	1.2	1.7	0.6%	4.7
S-Hemi(1-3) R	um	299.6 (17.4)	1.0	1.5	0.5%	4.2	301.2 (17.8)	1.5	1.9	0.6%	5.4	298.4 (17.4)	1.2	1.8	0.6%	5.0
I-Hemi-(1-3) R	um	294.9 (16.6)	1.0	1.6	0.5%	4.5	296.7 (17.0)	1.2	1.9	0.6%	5.2	294.8 (17.0)	1.0	1.6	0.5%	4.4
All(1-3) R	um	297.3 (16.5)	0.9	1.4	0.5%	4.0	299.0 (16.9)	1.1	1.7	0.6%	4.8	296.6 (16.8)	1.0	1.6	0.5%	4.4
T(3-6) R	um	241.9 (17.1)	1.1	1.5	0.6%	4.2	244.2 (17.7)	1.4	1.9	0.8%	5.2	250.9 (18.3)	1.3	1.7	0.7%	4.9
S(3-6) R	um	255.5 (20.0)	1.0	1.5	0.6%	4.3	257.3 (20.6)	1.7	2.2	0.8%	6.1	262.9 (20.5)	1.5	1.9	0.7%	5.4
N(3-6) R	um	273.3 (16.6)	1.0	1.4	0.5%	4.0	275.4 (16.9)	1.2	1.7	0.6%	4.9	276.6 (17.5)	1.2	1.6	0.6%	4.3
I(3-6) R	um	239.8 (16.5)	1.1	1.5	0.6%	4.3	241.3 (17.1)	1.5	1.8	0.7%	5.0	248.5 (17.9)	1.2	1.6	0.6%	4.5
S-Hemi(3-6) R	um	258.2 (18.1)	0.8	1.3	0.5%	3.7	260.2 (18.7)	1.3	1.8	0.7%	5.1	264.5 (18.8)	1.2	1.7	0.7%	4.8
I-Hemi(3-6) R	um	247.1 (16.2)	1.0	1.4	0.6%	3.9	248.9 (16.9)	1.3	1.7	0.7%	4.8	255.0 (17.5)	1.0	1.4	0.6%	4.0
All(3-6) R	um	252.7 (16.5)	0.7	1.2	0.5%	3.4	254.5 (17.0)	1.0	1.5	0.6%	4.3	259.7 (17.5)	0.9	1.4	0.5%	3.9
S-Hemi(0-6) R	um	267.3 (17.3)	0.8	1.3	0.5%	3.7	269.1 (17.7)	1.3	1.8	0.7%	4.9	271.7 (17.8)	1.2	1.7	0.6%	4.7
I-Hemi(0-6)_R	um	257.8 (15.6)	0.9	1.4	0.5%	3.8	259.7 (16.2)	1.2	1.7	0.6%	4.7	263.8 (16.7)	1.0	1.4	0.5%	3.9
All(0-6) R	um	262.6 (15.9)	0.7	1.2	0.5%	3.4	264.4 (16.4)	1.0	1.5	0.6%	4.3	267.7 (16.6)	0.9	1.4	0.5%	3.9
All (0-6) R Vol	mm³	7.4 (0.45)	0.02	0.04	0.5%	0.10	7.5 (0.46)	0.03	0.05	0.6%	0.13		NA

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Image /page/19/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized letter 'O' on the left, formed by an orange gradient arc. To the right of the 'O' is the company name, 'OPTOVUE', in gray, sans-serif font. The overall design is clean and modern.

Retina Subjects
			AngioVue Retina (N = 252)Retina Cube (N=251)										Wellness (N=250)
Measurement	Unit		Repeatab					Repeata					Repeata
			ility		Reproducibility			bility		Reproducibility			bility		Reproducibility
		Mean (SD)	SD	SD	CV	Limit*	Mean (SD)	SD	SD	CV	Limit*	Mean (SD)	SD	SD	CV	Limit*
GCC								ETDRS Grid (Ø 6mm)
C(1) GCC	um	55.4 (11.5)	0.9	1.0	1.8%	2.8	55.3 (11.6)	1.3	1.6	2.9%	4.4	59.8 (12.7)	2.4	3.2	5.3%	8.8
T(1-3) GCC	um	95.2 (11.2)	1.0	1.1	1.2%	3.1	95.3 (11.5)	0.9	1.0	1.1%	2.8	92.9 (12.5)	1.4	2.3	2.5%	6.5
S(1-3) GCC	um	107.7 (13.1)	0.9	1.0	0.9%	2.7	106.6 (12.7)	1.1	1.2	1.1%	3.3	102.9 (15.4)	1.5	5.0	4.9%	14.0
N(1-3) GCC	um	106.8 (13.7)	0.9	1.0	1.0%	2.9	106.8 (13.8)	1.1	1.2	1.1%	3.2	104.8 (15.1)	2.6	4.3	4.1%	12.2
I(1-3) GCC	um	107.7 (12.3)	0.8	1.0	0.9%	2.8	106.5 (12.6)	1.1	1.2	1.1%	3.4	103.2 (13.3)	1.7	1.8	1.7%	5.0
S-Hemi (1-3) GCC	um	103.7 (12.4)	0.9	0.9	0.9%	2.5	103.3 (12.2)	0.9	0.9	0.9%	2.5	100.8 (14.4)	1.3	4.5	4.5%	12.6
I-Hemi (1-3) GCC	um	104.9 (12.0)	0.7	0.9	0.8%	2.4	104.3 (12.2)	0.9	1.0	0.9%	2.7	101.9 (12.9)	1.6	1.8	1.7%	5.0
All(1-3) GCC	um	104.3 (12.1)	0.7	0.7	0.7%	2.1	103.8 (12.1)	0.7	0.7	0.7%	2.0	101.3 (13.3)	1.3	2.8	2.8%	8.0
T(3-6) GCC	um	84.6 (11.4)	0.6	0.8	0.9%	2.2	84.5 (11.4)	0.7	0.9	1.0%	2.4	78.9 (10.6)	1.0	1.3	1.7%	3.7
S(3-6) GCC	um	99.2 (12.1)	0.7	1.1	1.1%	3.1	97.6 (12.1)	1.1	1.2	1.2%	3.3	88.0 (13.7)	1.3	2.6	2.9%	7.2
N(3-6) GCC	um	114.9 (12.9)	0.5	0.7	0.6%	1.9	113.7 (13.1)	0.9	1.1	0.9%	3.0	108.3 (13.1)	1.5	2.9	2.7%	8.1
I(3-6) GCC	um	98.7 (12.3)	0.7	1.0	1.0%	2.8	96.9 (12.4)	1.2	1.6	1.7%	4.5	91.3 (11.9)	1.7	2.3	2.5%	6.5
S-Hemi (3-6) GCC	um	98.9 (11.0)	0.5	0.8	0.8%	2.2	97.8 (11.1)	0.8	0.9	0.9%	2.6	89.7 (12.2)	1.0	2.3	2.6%	6.5
I-Hemi (3-6) GCC	um	99.9 (11.7)	0.5	0.8	0.8%	2.2	98.5 (11.7)	1.0	1.2	1.2%	3.4	92.8 (11.5)	1.3	1.8	2.0%	5.1
All (3-6) GCC	um	99.4 (11.1)	0.4	0.6	0.6%	1.6	98.2 (11.1)	0.7	0.9	0.9%	2.5	91.3 (11.4)	0.9	1.7	1.9%	4.9
S-Hemi (0-6) GCC	um	98.8 (10.4)	0.5	0.7	0.7%	2.0	97.8 (10.4)	0.7	0.8	0.8%	2.2	91.3 (11.7)	0.8	2.6	2.9%	7.4
I-Hemi (0-6) GCC	um	99.7 (11.1)	0.5	0.7	0.7%	2.0	98.6 (11.1)	0.8	1.0	1.0%	2.8	93.9 (11.1)	1.2	1.6	1.7%	4.5
All (0-6)_GCC	um	99.3 (10.5)	0.4	0.6	0.6%	1.5	98.2 (10.6)	0.6	0.8	0.8%	2.1	92.6 (11.1)	0.8	1.8	2.0%	5.2
GCC							ETDRS Grid (Ø 6mm)						7mm x 8mm
wi GCC	um	100.8 (10.7)	0.4	0.7	0.6%	1.8	99.6 (10.7)	0.7	0.9	0.9%	2.5	88.7 (10.0)	0.7	1.6	1.8%	4.4
WI-S-Hemi GCC	um	99.7 (10.9)	0.5	0.8	0.8%	2.2	98.6 (10.9)	0.8	0.9	0.9%	2.6	87.6 (10.8)	0.9	2.1	2.4%	6.0
WI-I-Hemi_GCC	um	101.9 (11.1)	0.6	0.9	0.9%	2.6	100.5 (11.1)	1.0	1.3	1.3%	3.5	89.7 (10.1)	1.1	1.7	1.9%	4.7
FLV GCC	0%	1.7 (2.2)	0.3	0.3	15.8%	0.8	1.8 (2.3)	0.3	0.3	18.3%	0.9		NA
GLV GCC	0/0	6.4 (6.3)	0.3	0.5	7.9%	1.4	6.7 (6.6)	0.4	0.6	8.7%	1.6
Retina Thickness								ETDRS Grid (Ø 6mm)
C(1) R	um	232.1 (40.0)	1.2	1.7	0.7%	4.7	233.1 (40.0)	2.0	2.3	1.0%	6.6	231.4 (39.8)	1.9	2.9	1.3%	8.1
T(1-3) R	um	283.1 (35.8)	1.2	1.6	0.6%	4.5	284.2 (36.2)	1.4	1.8	0.6%	5.1	282.5 (34.9)	1.6	2.1	0.8%	5.9
S(1-3) R	um	292.3 (36.4)	1.3	1.6	0.6%	4.6	293.8 (36.8)	1.8	2.2	0.8%	6.2	291.4 (35.9)	1.6	2.3	0.8%	6.3
N(1-3) R	um	300.0 (36.6)	1.3	1.5	0.5%	4.3	301.6 (37.0)	1.5	1.9	0.6%	5.2	298.3 (36.0)	1.3	2.0	0.7%	5.5
I(1-3) R	um	292.7 (35.3)	1.1	1.3	0.5%	3.7	293.5 (35.7)	1.4	1.6	0.5%	4.4	291.8 (34.9)	1.6	2.6	0.9%	7.2
S-Hemi(1-3) R	um	291.0 (35.6)	0.9	1.3	0.4%	3.5	292.4 (36.0)	1.3	1.7	0.6%	4.9	289.9 (35.0)	1.4	2.0	0.7%	5.5
I-Hemi-(1-3) R	um	293.1 (35.3)	1.0	1.2	0.4%	3.4	294.1 (35.7)	1.2	1.5	0.5%	4.1	292.1 (34.7)	1.3	2.1	0.7%	5.8
All(1-3) R	um	292.0 (35.2)	0.8	1.1	0.4%	3.0	293.3 (35.6)	1.0	1.4	0.5%	3.9	291.0 (34.6)	1.1	1.8	0.6%	5.2
T(3-6) R	um	250.2 (30.4)	1.0	1.3	0.5%	3.7	251.5 (30.8)	1.2	1.7	0.7%	4.6	258.7 (31.9)	1.2	1.8	0.7%	5.1
S(3-6) R	um	261.8 (30.8)	0.9	1.2	0.5%	3.3	263.1 (31.2)	1.5	1.8	0.7%	5.0	267.3 (31.9)	1.5	2.1	0.8%	5.9
N(3-6) R	um	277.7 (30.2)	0.9	1.2	0.4%	3.5	278.8 (30.2)	1.2	1.5	0.5%	4.1	279.6 (30.5)	1.3	1.7	0.6%	4.8
I(3-6) R	um	254.2 (25.2)	0.9	1.4	0.6%	3.9	255.5 (25.6)	1.4	1.8	0.7%	5.0	261.0 (28.4)	1.5	1.9	0.7%	5.4
S-Hemi(3-6) R	um	262.8 (29.2)	0.7	1.0	0.4%	2.8	264.0 (29.6)	1.1	1.4	0.5%	4.1	268.1 (29.8)	1.3	1.8	0.7%	5.2
I-Hemi(3-6) R	um	259.2 (26.8)	0.8	1.2	0.5%	3.3	260.4 (27.1)	1.1	1.4	0.6%	4.0	265.3 (29.3)	1.2	1.6	0.6%	4.6
All(3-6) R	um	261.0 (27.7)	0.6	0.9	0.4%	2.6	262.2 (28.1)	0.9	1.2	0.5%	3.5	266.7 (29.2)	1.0	1.5	0.6%	4.3
S-Hemi(0-6) R	um	268.2 (29.4)	0.6	0.9	0.3%	2.6	269.5 (29.8)	1.0	1.4	0.5%	3.9	271.9 (29.9)	1.2	1.8	0.7%	5.0
I-Hemi(0-6) R	um	266.0 (27.7)	0.7	1.1	0.4%	3.1	267.2 (28.1)	1.0	1.3	0.5%	3.7	270.3 (29.6)	1.1	1.6	0.6%	4.6
All(0-6) R	um	267.1 (28.3)	0.6	0.9	0.3%	2.5	268.3 (28.7)	0.9	1.2	0.4%	3.4	271.1 (29.5)	1.0	1.6	0.6%	4.4
All (0-6) R Vol	mm³	7.5 (0.81)	0.02	0.04	0.5%	0.11	7.6 (0.83)	0.04	0.06	0.8%	0.16		NA

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Image /page/20/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized orange and yellow circle that is open on the right side. The word "OPTOVUE" is written in gray, sans-serif letters to the right of the circle. The letters are evenly spaced and aligned horizontally.

Vascular Parameters of the Macula Scan – R&R Results

						Normal Subjects
	Unit		N = 269						N = 269
Superficial VascularComplex (SVC)			RepeatabReproducibilityility				Deep VascularComplex (DVC)	Unit		Repeatability		Reproducibility
		Mean (SD)	SD	SD	CV	Limit*			Mean (SD)	SD	SD	CV	Limit*
SVC		ETDRS Grid (Ø 6mm)				DVC		ETDRS Grid (Ø 6mm)
C(1)_SVC	%	29.7 (5.4)	2.1	2.6	8.7%	7.3	C(1)_DVC	%	33.0 (6.0)	2.2	2.8	8.6%	7.9
T(1-3)_SVC	%	47.5 (2.7)	1.9	2.5	5.3%	7.0	T(1-3)_DVC	%	53.6 (1.9)	1.7	2.0	3.7%	5.5
S(1-3)_SVC	%	48.3 (2.8)	2.1	2.6	5.4%	7.3	S(1-3)_DVC	%	53.3 (2.0)	1.8	2.0	3.7%	5.5
N(1-3)_SVC	%	47.2 (3.3)	2.3	2.8	6.0%	8.0	N(1-3)_DVC	%	53.3 (2.2)	1.9	2.2	4.0%	6.0
I(1-3)_SVC	%	48.3 (2.9)	2.0	2.7	5.5%	7.5	I(1-3)_DVC	%	53.4 (1.9)	1.7	1.8	3.5%	5.2
S-Hemi(1-3)_SVC	%	47.8 (2.6)	1.9	2.4	5.1%	6.8	S-Hemi(1-3)_DVC	%	53.5 (1.5)	1.2	1.6	2.9%	4.4
I-Hemi(1-3)_SVC	%	47.8 (2.7)	1.9	2.6	5.4%	7.2	I-Hemi(1-3)_DVC	%	53.4 (1.7)	1.4	1.7	3.2%	4.7
All(1-3)_SVC	%	47.8 (2.6)	1.8	2.4	5.1%	6.8	All(1-3)_DVC	%	53.4 (1.4)	1.1	1.4	2.6%	3.9
T(3-6)_SVC	%	44.0 (2.4)	1.5	2.2	4.9%	6.1	T(3-6)_DVC	%	53.2 (1.9)	1.7	1.9	3.7%	5.4
S(3-6)_SVC	%	47.5 (2.2)	1.4	1.7	3.7%	4.9	S(3-6)_DVC	%	52.5 (2.3)	1.9	2.3	4.4%	6.4
N(3-6)_SVC	%	50.9 (1.8)	1.3	1.5	3.0%	4.3	N(3-6)_DVC	%	52.4 (2.3)	1.9	2.3	4.3%	6.3
I(3-6)_SVC	%	47.4 (2.2)	1.3	1.7	3.7%	4.9	I(3-6)_DVC	%	52.3 (2.4)	1.9	2.4	4.6%	6.8
S-Hemi(3-6)_SVC	%	47.4 (2.0)	1.3	1.7	3.5%	4.7	S-Hemi(3-6)_DVC	%	52.7 (1.8)	1.4	1.8	3.4%	5.1
I-Hemi(3-6)_SVC	%	47.5 (1.9)	1.2	1.7	3.5%	4.7	I-Hemi(3-6)_DVC	%	52.5 (1.9)	1.3	1.9	3.6%	5.3
All(3-6)_SVC	%	47.5 (1.8)	1.2	1.6	3.4%	4.5	All(3-6)_DVC	%	52.6 (1.6)	1.1	1.6	3.1%	4.5
All(0-6)_SVC	%	47.1 (1.9)	1.3	1.7	3.7%	4.9	All(0-6)_DVC	%	52.3 (1.4)	1.0	1.4	2.7%	3.9
SVC			6 mm x 6 mm				DVC		6 mm x 6 mm
WI_SVC	%	47.5 (1.8)	1.2	1.6	3.4%	4.5	WI_DVC	%	51.8 (1.7)	1.0	1.7	3.2%	4.7
WI-S-Hemi_SVC	%	47.5 (1.8)	1.3	1.6	3.4%	4.5	WI-S-Hemi_DVC	%	51.9 (1.8)	1.2	1.8	3.4%	4.9
WI-I-Hemi_SVC	%	47.5 (1.8)	1.2	1.7	3.5%	4.6	WI-I-Hemi_DVC	%	51.7 (2.0)	1.2	1.9	3.7%	5.4
FAZ Parameters (N=233)			Retina Slab
FAZ Area	mm²	0.23 (0.089)	0.01	0.01	4.6%	0.03
FAZ Perimeter	mm	1.8 (0.38)	0.1	0.1	3.4%	0.2
FD-300 Vessel Density	%	48.4 (4.6)	2.9	3.9	8.0%	10.9

Glaucoma Subjects							Glaucoma Subjects
Superficial VascularComplex (SVC)	Unit	Mean (SD)	Repeatability SD	Reproducibility SD	CV	Limit*	Deep VascularComplex (DVC)	Unit	Mean (SD)	Repeatability SD	Reproducibility SD	CV	Limit*
SVC		ETDRS Grid (Ø 6mm)					DVC		ETDRS Grid (Ø 6mm)
C(1)_SVC	%	27.3 (6.0)	2.4	2.7	10.0%	7.7	C(1)_DVC	%	31.6 (7.0)	3.2	3.6	11.2%	9.9
T(1-3)_SVC	%	46.3 (3.2)	2.3	2.9	6.2%	8.1	T(1-3)_DVC	%	53.0 (1.9)	1.8	1.9	3.5%	5.2
S(1-3)_SVC	%	47.4 (3.3)	2.2	2.6	5.5%	7.3	S(1-3)_DVC	%	52.7 (2.4)	2.3	2.4	4.5%	6.6
N(1-3)_SVC	%	46.5 (3.3)	2.3	2.8	5.9%	7.7	N(1-3)_DVC	%	52.7 (2.6)	2.4	2.5	4.7%	6.9
I(1-3)_SVC	%	47.4 (3.4)	2.1	2.6	5.5%	7.3	I(1-3)_DVC	%	52.7 (2.1)	1.9	2.0	3.8%	5.6
S-Hemi(1-3)_SVC	%	46.9 (2.9)	1.9	2.4	5.1%	6.7	S-Hemi(1-3)_DVC	%	52.9 (2.0)	1.9	1.9	3.7%	5.5
I-Hemi(1-3)_SVC	%	47.0 (2.8)	1.8	2.3	4.8%	6.3	I-Hemi(1-3)_DVC	%	52.7 (1.7)	1.6	1.7	3.1%	4.6
All(1-3)_SVC	%	46.9 (2.7)	1.6	2.2	4.6%	6.0	All(1-3)_DVC	%	52.8 (1.4)	1.2	1.3	2.5%	3.8
T(3-6)_SVC	%	42.7 (2.7)	1.6	2.1	4.9%	5.9	T(3-6)_DVC	%	52.2 (2.2)	2.0	2.1	4.1%	6.0
S(3-6)_SVC	%	45.9 (2.7)	1.4	1.7	3.7%	4.7	S(3-6)_DVC	%	51.2 (2.6)	2.2	2.4	4.7%	6.7
N(3-6)_SVC	%	49.4 (2.5)	1.3	1.7	3.4%	4.8	N(3-6)_DVC	%	51.0 (3.0)	2.4	2.6	5.2%	7.4
I(3-6)_SVC	%	43.6 (3.8)	1.4	1.7	4.0%	4.9	I(3-6)_DVC	%	51.1 (3.2)	2.5	2.9	5.7%	8.2
S-Hemi(3-6)_SVC	%	46.2 (2.3)	1.3	1.7	3.6%	4.7	S-Hemi(3-6)_DVC	%	51.5 (2.2)	1.7	1.9	3.7%	5.4
I-Hemi(3-6)_SVC	%	44.6 (2.9)	1.2	1.6	3.5%	4.4	I-Hemi(3-6)_DVC	%	51.3 (2.5)	1.9	2.3	4.4%	6.4
All(3-6)_SVC	%	45.4 (2.1)	1.2	1.5	3.4%	4.3	All(3-6)_DVC	%	51.4 (2.0)	1.3	1.7	3.4%	4.8
All(0-6)_SVC	%	45.2 (2.0)	1.2	1.6	3.5%	4.4	All(0-6)_DVC	%	51.2 (1.6)	1.1	1.4	2.8%	3.9
SVC		6 mm x 6 mm					DVC		6 mm x 6 mm
WI SVC	%	45.3 (2.1)	1.1	1.5	3.4%	4.3	WI DVC	%	50.6 (1.9)	1.1	1.5	3.0%	4.3
WI-S-Hemi SVC	%	46.0 (2.1)	1.2	1.6	3.6%	4.6	WI-S-Hemi DVC	%	50.8 (2.0)	1.3	1.7	3.3%	4.7
WI-I-Hemi SVC	%	44.6 (2.8)	1.1	1.6	3.5%	4.4	WI-I-Hemi DVC	%	50.5 (2.2)	1.5	1.9	3.8%	5.3
FAZ Parameters (N=215)			Retina Slab
FAZ Area	mm²	0.26 (0.12)	0.01	0.01	4.5%	0.03
FAZ Perimeter	mm	2.0 (0.51)	0.1	0.1	5.4%	0.3
FD-300 Vessel Density	%	44.8 (5.4)	3.2	3.7	8.2%	10.3

{21}------------------------------------------------

Image /page/21/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the word is a stylized graphic of a partial circle, colored with a gradient from yellow to orange. The circle is open on the left side, with the open end pointing towards the first letter of the company name.

			Retina Subjects
				N = 252					N = 252
Superficial VascularComplex (SVC)	Unit		Repeatability				Reproducibility	Deep VascularComplex (DVC)	Unit		Repeatability		Reproducibility
		Mean (SD)	SD	SD	CV	Limit*			Mean (SD)	SD	SD	CV	Limit*
SVC			ETDRS Grid (Ø 6mm)					DVC		ETDRS Grid (Ø 6mm)
C(1)_SVC	%	26.8 (5.2)	2.3	3.0	11.1%	8.4	C(1) DVC	%	29.7 (6.1)	3.2	3.8	12.8%	10.6
T(1-3)_SVC	%	45.6 (3.0)	1.7	2.2	4.8%	6.2	T(1-3) DVC	%	52.7 (2.2)	1.7	2.0	3.8%	5.6
S(1-3)_SVC	%	46.3 (3.2)	1.9	2.5	5.4%	6.9	S(1-3) DVC	%	52.8 (2.7)	2.3	2.5	4.7%	6.9
N(1-3)_SVC	%	45.2 (3.4)	2.0	2.6	5.7%	7.1	N(1-3) DVC	%	52.4 (3.0)	2.2	2.6	5.0%	7.4
I(1-3)_SVC	%	46.5 (3.1)	1.8	2.4	5.1%	6.6	I(1-3) DVC	%	52.9 (2.0)	1.8	1.9	3.5%	5.2
S-Hemi(1-3) SVC	%	45.8 (2.8)	1.6	2.2	4.8%	6.1	S-Hemi(1-3) DVC	%	52.6 (2.3)	1.6	1.9	3.5%	5.2
I-Hemi(1-3)_SVC	%	46.0 (2.9)	1.5	2.0	4.4%	5.7	I-Hemi(1-3)_DVC	%	52.8 (1.8)	1.4	1.6	3.1%	4.6
All(1-3)_SVC	%	45.9 (2.7)	1.4	2.0	4.3%	5.5	All(1-3) DVC	%	52.7 (1.7)	1.2	1.4	2.7%	4.0
T(3-6)_SVC	%	43.1 (2.4)	1.4	2.0	4.7%	5.7	T(3-6)_DVC	%	52.5 (2.3)	1.8	2.1	3.9%	5.8
S(3-6)_SVC	%	46.4 (2.3)	1.4	1.6	3.4%	4.4	S(3-6)_DVC	%	51.9 (2.5)	1.9	2.1	4.0%	5.9
N(3-6)_SVC	%	49.6 (2.1)	1.5	1.6	3.3%	4.6	N(3-6) DVC	%	51.4 (2.5)	2.0	2.2	4.2%	6.1
I(3-6)_SVC	%	45.9 (2.7)	1.3	1.6	3.4%	4.4	I(3-6)_DVC	%	51.0 (3.3)	2.2	2.4	4.7%	6.8
S-Hemi(3-6)_SVC	%	46.3 (1.9)	1.3	1.6	3.4%	4.3	S-Hemi(3-6)_DVC	%	52.1 (2.0)	1.4	1.7	3.2%	4.6
I-Hemi(3-6)_SVC	%	46.3 (2.3)	1.2	1.5	3.2%	4.2	I-Hemi(3-6)_DVC	%	51.2 (2.7)	1.7	1.9	3.7%	5.4
All(3-6)_SVC	%	46.3 (1.9)	1.2	1.5	3.1%	4.1	All(3-6) DVC	%	51.7 (1.9)	1.2	1.4	2.8%	4.0
All(0-6)_SVC	%	45.6 (1.8)	1.2	1.5	3.2%	4.1	All(0-6) DVC	%	51.3 (1.6)	1.0	1.2	2.3%	3.4
SVC			6 mm x 6 mm					DVC		6 mm x 6 mm
WI SVC	%	46.3 (1.9)	1.1	1.4	3.0%	3.9	WI DVC	%	50.7 (1.9)	1.0	1.5	2.9%	4.1
WI-S-Hemi SVC	%	46.3 (1.9)	1.2	1.5	3.1%	4.1	WI-S-Hemi DVC	%	51.1 (1.9)	1.2	1.6	3.2%	4.6
WI-I-Hemi SVC	%	46.2 (2.0)	1.1	1.4	3.0%	3.9	WI-I-Hemi DVC	%	50.3 (2.5)	1.4	1.8	3.5%	4.9
FAZ Parameters (N=252)				Retina Slab
FAZ Area	mm²	0.35 (0.22)	0.01	0.02	5.2%	0.05
FAZ Perimeter	mm	2.4 (1.1)	0.1	0.1	5.3%	0.4
FD-300 Vessel Density	%	45.3 (5.3)	2.7	4.0	8.7%	11.1

Structural Parameters of the Disc Scans – R&R Results

		AngioVue Disc (N=270)					Disc Cube (N=270)
				Repeatability	Reproducibility			Repeatability	Reproducibility
Measurement	Unit	Mean (SD)	SD	SD	CV	Limit*	Mean (SD)	SD	SD	CV	Limit*
RNFL									Ø2.5 ~ Ø4.5 mm Ring
TS RNFL	μm	62.5 (8.1)	1.0	1.9	3.1%	5.4	62.8 (8.0)	1.2	1.9	3.0%	5.3
ST RNFL	μm	114.5 (17.2)	1.3	2.7	2.4%	7.6	111.8 (16.3)	1.5	2.7	2.4%	7.5
SN RNFL	μm	109.8 (25.5)	1.1	1.9	1.8%	5.4	109.8 (25.0)	1.7	2.3	2.1%	6.6
NS RNFL	μm	90.4 (15.8)	0.7	1.7	1.9%	4.8	90.3 (15.7)	1.4	2.1	2.3%	5.9
NI RNFL	μm	70.9 (12.0)	0.9	2.0	2.9%	5.7	71.3 (12.3)	1.3	2.2	3.1%	6.2
IN RNFL	μm	111.4 (19.5)	1.0	2.1	1.9%	5.9	111.0 (19.4)	1.6	2.6	2.3%	7.2
IT RNFL	μm	132.7 (16.2)	1.1	2.6	2.0%	7.3	129.5 (15.5)	1.7	3.0	2.3%	8.4
TI RNFL	μm	56.0 (7.5)	0.8	1.8	3.1%	4.9	56.6 (8.0)	1.3	2.3	4.0%	6.4
T RNFL	μm	59.5 (7.1)	0.8	1.5	2.5%	4.2	59.9 (7.3)	1.0	1.6	2.6%	4.4
S RNFL	μm	111.9 (16.2)	0.9	1.6	1.4%	4.3	110.7 (16.4)	1.2	1.8	1.6%	5.1
N RNFL	μm	81.7 (12.9)	0.6	1.6	2.0%	4.5	81.8 (13.1)	1.0	1.7	2.0%	4.6
I RNFL	μm	120.8 (14.0)	0.8	1.3	1.1%	3.7	119.1 (14.2)	1.2	1.7	1.5%	4.8
S-Hemi RNFL	μm	93.0 (11.3)	0.5	1.0	1.1%	2.9	92.5 (11.4)	0.8	1.1	1.2%	3.0
I-Hemi RNFL	μm	92.0 (10.2)	0.5	0.9	1.0%	2.6	91.4 (10.4)	0.8	1.1	1.3%	3.2
PP RNFL	μm	92.5 (9.9)	0.4	0.9	0.9%	2.4	92.0 (10.1)	0.6	0.9	1.0%	2.5
ONH Parameters							Within Disc Margin
Cup Area	mm2	0.36 (0.28)	0.010	0.015	4.2%	0.042	0.33 (0.28)	0.018	0.024	7.1%	0.067
Rim Area	mm2	1.4 (0.27)	0.012	0.064	4.7%	0.180	1.4 (0.28)	0.019	0.065	4.7%	0.180
C-D Area Ratio		0.20 (0.14)	0.006	0.011	5.8%	0.032	0.19 (0.14)	0.010	0.014	7.8%	0.040
C-D H Ratio		0.41 (0.22)	0.015	0.024	5.9%	0.068	0.39 (0.23)	0.020	0.024	6.3%	0.068
C-D V Ratio		0.39 (0.21)	0.011	0.021	5.3%	0.058	0.37 (0.22)	0.018	0.023	6.1%	0.063
Cup Volume	mm3	0.073 (0.085)	0.004	0.005	6.8%	0.014	0.065 (0.084)	0.007	0.012	18.5%	0.034
Disc Area	mm2	1.7 (0.32)	0.003	0.064	3.8%	0.180	1.7 (0.32)	0.002	0.064	3.8%	0.180

{22}------------------------------------------------

Image /page/22/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized letter 'O' that is formed by a gradient orange circle on the left side. The right side of the logo contains the word "OPTOVUE" in gray, sans-serif font. The word is aligned horizontally with the circle.

Glaucoma Subjects
			AngioVue Disc (N=225)					Disc Cube (N=225)
Measurement	Unit		Repeatability		Reproducibility			Repeatability		Reproducibility
		Mean (SD)	SD	SD	CV	Limit*	Mean (SD)	SD	SD	CV	Limit*
RNFL							Ø2.5 ~ Ø4.5 mm Ring
TS RNFL	µm	54.3 (13.2)	1.0	1.5	2.7%	4.1	54.0 (13.1)	1.2	1.5	2.8%	4.3
ST RNFL	µm	76.1 (31.0)	1.2	2.1	2.8%	6.0	73.4 (29.5)	1.3	2.4	3.2%	6.6
SN RNFL	µm	71.1 (22.1)	1.0	1.7	2.3%	4.7	70.4 (22.1)	1.7	2.5	3.6%	7.1
NS RNFL	µm	58.4 (17.5)	1.2	1.7	2.9%	4.8	58.5 (17.0)	1.8	2.1	3.7%	6.0
NI RNFL	µm	49.7 (12.6)	1.1	1.4	2.8%	3.9	49.9 (12.6)	1.7	1.9	3.7%	5.2
IN RNFL	µm	73.4 (23.4)	1.1	1.9	2.6%	5.4	72.4 (24.0)	1.8	2.2	3.1%	6.2
IT RNFL	µm	76.7 (31.7)	0.9	2.0	2.6%	5.7	74.3 (30.5)	1.5	2.1	2.8%	5.8
TI RNFL	µm	46.7 (9.6)	0.8	1.3	2.8%	3.7	46.5 (9.9)	1.7	2.0	4.3%	5.5
T RNFL	µm	50.8 (10.6)	0.8	1.2	2.3%	3.3	50.5 (10.7)	1.2	1.4	2.9%	4.0
S RNFL	µm	73.3 (23.1)	0.9	1.2	1.6%	3.3	71.8 (23.0)	1.1	1.9	2.6%	5.2
N RNFL	µm	54.5 (14.5)	1.0	1.3	2.3%	3.5	54.7 (14.3)	1.5	1.7	3.0%	4.6
I RNFL	µm	74.8 (25.7)	0.9	1.7	2.2%	4.7	73.2 (25.7)	1.4	1.7	2.3%	4.8
S-Hemi RNFL	µm	63.9 (16.3)	0.7	0.8	1.3%	2.3	63.1 (16.4)	0.9	1.2	1.9%	3.4
I-Hemi RNFL	µm	61.3 (16.4)	0.7	0.9	1.5%	2.6	60.5 (16.5)	0.9	1.1	1.8%	3.0
PP RNFL	µm	62.6 (14.5)	0.6	0.7	1.2%	2.0	61.9 (14.7)	0.8	1.0	1.6%	2.7
ONH Parameters							Within Disc Margin
Cup Area	mm²	1.1 (0.53)	0.043	0.043	3.8%	0.120	1.1 (0.54)	0.035	0.048	4.2%	0.130
Rim Area	mm²	0.69 (0.32)	0.047	0.071	10.3%	0.200	0.67 (0.32)	0.037	0.079	11.7%	0.220
C-D Area Ratio		0.60 (0.21)	0.021	0.026	4.4%	0.074	0.61 (0.21)	0.019	0.031	5.1%	0.087
C-D H Ratio		0.77 (0.21)	0.016	0.024	3.2%	0.068	0.78 (0.21)	0.029	0.037	4.7%	0.100
C-D V Ratio		0.77 (0.20)	0.019	0.024	3.2%	0.068	0.76 (0.21)	0.026	0.036	4.7%	0.100
CupVolume	mm³	0.29 (0.17)	0.013	0.016	5.4%	0.043	0.28 (0.17)	0.020	0.025	8.7%	0.069
DiscArea	mm²	1.8 (0.40)	0.004	0.069	3.8%	0.190	1.8 (0.40)	0.003	0.069	3.8%	0.190
Retina Subjects
		AngioVue Disc (N=252)			Disc Cube (N=252)
Measurement	Unit	Repeatability		Reproducibility		Limit*
		Mean (SD)	SD	SD	CV
RNFL		Ø2.5 ~ Ø4.5 mm Ring
TS RNFL	μm	64.1 (14.4)	1.4	2.2	3.5%	6.3	64.1 (14.1)	1.4	2.0	3.1%	5.5
ST RNFL	μm	106.8 (27.8)	1.5	2.8	2.6%	7.9	104.2 (27.1)	2.1	3.3	3.1%	9.1
SN RNFL	μm	101.5 (27.3)	1.3	2.7	2.6%	7.5	100.0 (26.7)	2.3	3.0	3.0%	8.5
NS RNFL	μm	84.9 (19.9)	1.4	2.2	2.6%	6.2	85.1 (19.7)	2.1	2.4	2.8%	6.7
NI RNFL	μm	69.0 (15.8)	1.2	2.1	3.1%	5.9	69.0 (15.9)	1.9	2.3	3.3%	6.4
IN RNFL	μm	107.7 (24.7)	1.6	2.7	2.5%	7.5	106.7 (25.1)	2.2	2.9	2.7%	8.1
IT RNFL	μm	123.6 (22.1)	2.0	3.2	2.6%	8.9	119.6 (22.3)	2.3	3.7	3.1%	10.5
TI RNFL	μm	58.4 (11.9)	1.0	1.9	3.3%	5.3	58.4 (11.5)	1.2	2.1	3.6%	5.8
T RNFL	μm	61.5 (12.7)	1.1	1.6	2.6%	4.4	61.5 (12.3)	1.1	1.4	2.3%	3.9
S RNFL	μm	103.9 (23.0)	1.0	2.2	2.1%	6.2	101.9 (22.8)	1.8	2.7	2.6%	7.5
N RNFL	μm	77.8 (17.2)	1.1	1.7	2.2%	4.8	77.9 (17.1)	1.5	1.8	2.3%	5.0
I RNFL	μm	114.7 (20.2)	1.2	1.7	1.5%	4.8	112.4 (20.9)	1.7	2.1	1.8%	5.8
S-Hemi RNFL	μm	88.2 (15.8)	0.8	1.5	1.7%	4.3	87.3 (15.7)	1.3	1.6	1.9%	4.6
I-Hemi RNFL	μm	89.0 (14.2)	0.7	1.1	1.3%	3.2	87.9 (14.4)	1.0	1.3	1.5%	3.6
PP RNFL	μm	88.6 (14.3)	0.7	1.2	1.4%	3.4	87.6 (14.4)	0.9	1.3	1.4%	3.5
ONH Parameters		Within Disc Margin
Cup Area	mm²	0.38 (0.30)	0.013	0.018	4.7%	0.051	0.37 (0.30)	0.016	0.020	5.5%	0.057
Rim Area	mm²	1.4 (0.41)	0.014	0.072	5.2%	0.200	1.4 (0.41)	0.018	0.074	5.3%	0.210
C-D Area Ratio		0.22 (0.17)	0.008	0.014	6.4%	0.039	0.21 (0.17)	0.009	0.015	7.1%	0.042
C-D H Ratio		0.41 (0.24)	0.014	0.022	5.4%	0.062	0.39 (0.25)	0.022	0.027	7.0%	0.077
C-D V Ratio		0.41 (0.27)	0.011	0.017	4.2%	0.049	0.41 (0.27)	0.023	0.027	6.5%	0.074
CupVolume	mm³	0.065 (0.075)	0.003	0.004	6.3%	0.011	0.060 (0.068)	0.012	0.012	19.7%	0.033
DiscArea	mm²	1.8 (0.30)	0.003	0.069	3.9%	0.190	1.8 (0.30)	0.002	0.069	3.9%	0.190

{23}------------------------------------------------

Image /page/23/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the word is a circular design made of orange brush strokes. The brush strokes vary in intensity, creating a gradient effect.

	Normal Subjects (N=270)					Glaucoma Subjects (N=225)					Retina Subjects (N=252)
	Unit	Mean (SD)	Repeatability SD	Reproducibility SD	CV	Limit*	Mean (SD)	Repeatability SD	Reproducibility SD	CV	Limit*	Mean (SD)	Repeatability SD	Reproducibility SD	CV	Limit*
AngioVue Disc
RPC Vessel Density		Ø2.5 ~ Ø4.5 mm Ring
TS RPC Sml	%	56.2 (3.9)	1.6	2.0	3.6%	5.6	53.8 (6.4)	1.9	2.5	4.7%	7.1	56.0 (4.3)	2.1	2.3	4.2%	6.5
ST RPC Sml	%	52.5 (4.4)	1.9	2.1	4.1%	6.0	42.1 (10.4)	2.2	2.8	6.6%	7.8	49.0 (6.3)	2.3	2.5	5.2%	7.1
SN RPC Sml	%	46.1 (4.2)	1.8	2.3	5.0%	6.4	38.6 (7.8)	2.2	2.6	6.6%	7.2	43.4 (5.7)	2.2	2.5	5.7%	6.9
NS RPC Sml	%	46.5 (4.0)	1.5	1.9	4.1%	5.3	37.2 (5.6)	2.0	2.8	7.6%	7.9	44.7 (4.8)	1.9	2.4	5.3%	6.6
NI RPC Sml	%	46.2 (3.8)	1.7	2.0	4.3%	5.5	39.8 (6.1)	2.9	3.2	8.0%	8.9	44.8 (5.4)	2.1	2.2	4.8%	6.1
IN RPC Sml	%	46.0 (4.5)	1.6	2.0	4.3%	5.5	37.7 (8.5)	2.4	3.2	8.5%	9.0	44.7 (5.5)	2.6	3.2	7.2%	9.0
IT RPC Sml	%	55.0 (3.2)	1.7	2.2	3.9%	6.0	44.1 (9.9)	2.2	2.7	6.0%	7.4	52.5 (4.8)	2.5	2.8	5.4%	7.9
TI RPC Sml	%	53.3 (4.1)	1.7	1.9	3.6%	5.4	49.7 (5.4)	2.0	2.5	5.1%	7.0	53.4 (3.9)	2.2	2.4	4.5%	6.7
S-Hemi RPC Sml	%	50.1 (3.1)	1.3	1.5	2.9%	4.1	42.7 (5.9)	1.4	2.0	4.8%	5.7	48.1 (3.9)	1.6	1.8	3.8%	5.1
I-Hemi RPC Sml	%	49.7 (3.1)	1.1	1.3	2.7%	3.8	42.5 (5.8)	1.8	2.1	5.0%	5.9	48.5 (3.6)	1.6	1.8	3.7%	5.0
PP RPC Sml	%	49.9 (2.9)	1.1	1.3	2.6%	3.6	42.6 (5.2)	1.5	1.9	4.5%	5.4	48.3 (3.5)	1.5	1.7	3.4%	4.7
S-Hemi RPC All	%	56.5 (3.0)	1.1	1.2	2.1%	3.3	49.7 (5.5)	1.2	1.7	3.3%	4.6	54.5 (3.7)	1.3	1.5	2.7%	4.1
I-Hemi RPC All	%	55.9 (3.0)	1.0	1.1	1.9%	3.0	49.0 (5.2)	1.6	1.8	3.7%	5.1	54.3 (3.6)	1.4	1.5	2.8%	4.2
PP RPC All	%	56.2 (2.8)	1.0	1.0	1.9%	2.9	49.3 (4.8)	1.3	1.6	3.2%	4.5	54.4 (3.5)	1.3	1.4	2.5%	3.8
RPC Vessel Density		6 mm x 6 mm
WI RPC Sml	%	47.5 (2.7)	0.9	1.2	2.5%	3.3	41.6 (4.1)	1.3	1.8	4.3%	5.0	46.6 (2.9)	1.1	1.4	3.0%	4.0
WI RPC All	%	53.7 (2.6)	0.9	1.2	2.2%	3.4	48.2 (3.7)	1.2	1.6	3.3%	4.4	52.7 (2.8)	1.0	1.3	2.5%	3.6

Vascular Parameters of the Disc Scan - R&R Results

OCTA vessel density measurements - agreement with the Avanti XR predicate device

For both the superficial and deep vascular complexes imaged with the macular AngioVue scans. the vessel density values from SOLIX tended to be within a smaller range than the vessel density values from Avanti XR (e.g., absolute values of SOLIX vs. Avanti XR Deming regression slopes are less than 1). For the radial peripapillary capillaries imaged with disc scans, vessel density measurement agreement between SOLIX and Avanti XR was closer than what was observed with macular AngioVue scans. Differences between SOLIX and Avanti XR vessel density measurements are associated with the increased scan density (due to smaller OCTA image pixel size) with SOLIX and updates to the vessel density software algorithm in SOLIX.

Solix Fundus Photography

This was a prospective, observational study conducted at two clinical sites. Eligible participants were assigned to either the "normal," glaucoma, or retinal disease sub-group. Three SOLIX and three iCam devices were paired with three designated operators to form three SOLLX-iCAMoperator configurations. Every participant was imaged with one configuration (two repeated images per camera). The eligibility criteria were very similar to those used in the study conducted to evaluate repeatability and reproducibility. Of 126 participants were enrolled, 121 met enrollment criteria, and data from 112 was included in the dataset (31 "normal," 26 glaucoma, 55 retinal disease). Images were graded by three independent graders at a third-party reading center for image quality and clinical utility based on pre-specified grading criteria . The proportions of SOLIX images graded as similar or better quality compared to iCAM images ranged from 74-89% across sub-groups and graders. The proportion of participants with clinically useful images was the same for both SOLIX and iCam at 97.3%.

Solix RDB

This was a prospective, observational study conducted at five U.S. clinical sites. The key eligibility criteria included participants age ≥18 with no history of ocular pathology or treatment, and no signs of ocular pathology based on clinical examination, fundus photography, and visual field testing. Retinal pathologies (except hard drusen or non-significant incidental findings),

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Image /page/24/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized letter 'C' that is colored in shades of orange and yellow, with the word "OPTOVUE" in gray, sans-serif font to the right of the 'C'. The 'C' is open on the right side, creating a crescent shape.

glaucomatous optic nerve damage or visual field (VF) abnormalities, best-corrected visual acuity (BCVA) worse than 20/40, intraocular pressure (IOP) >21 mm Hg, and unreliable VF testing results were exclusion criteria. Individuals with history of systemic conditions potentially affecting the eye, such as hydroxychloroquine or chloroquine use, leukemia, dementia or multiple sclerosis were excluded. Only one eye per eligible participant was included in the RDB dataset. If both eyes qualified, then one eye was randomly selected as the study eye for RDB inclusion. Reference limits at the 1st, 5th, 95th and 99th percentiles were estimated with quantile regression analysis. Age and/or disc size were used as regression covariates.

Results

482 participants were enrolled and 427 were determined to be eligible. The number of participants included into the RDB for each scan pattern ranged from 416 to 426. The mean age was 48.2 to 48.3 years (range 18 to 89 years). 56.7% (242/427) of the cohort are women and 43.3% (185/427) are men. 63.7% are Caucasian. 13.1% are African-American, 11.5% are Asian, 7.3% are American Indian/Alaskan, 1.2% are multiracial, 1.2% are designated as "other" race, and race was not reported in 2.1%. 15.2% was reported as being of Hispanic, Latino, and/or Spanish origin. The median best-corrected Snellen visual acuity (BCVA) was 20/20 (range 20/13 to 20/40). The mean refractive error (manifest refraction-based spherical error [MRSE]) was -0.87±1.91 D (range -7.75 to +3.00 D). The mean axial length (AL) was 23.97±1.20 mm (range 20.11 to 28.30 mm).

Scans from all included participants underwent post-acquisition image quality review. OCT and OCTA scans with a SQ score of less than 6, local weak signal affecting regional structure and/or vasculature visibility, motion artifacts, blink, and cropped B-scan images etc. were excluded from analysis. Five scan patterns were evaluated, three macular scans (AngioVue Retina, Retina Cube and Wellness), and two disc-based scans (AngioVue Disc Cube). For the macular scan patterns, the rate of disqualified scans was less than 5% for all scan patterns, and for the disc-based scans, the rate of disqualified scans was less than 4% for AngioVue Disc scan and less than 15% for Disc Cube scan, mainly due to eye motion during image acquisition. There was no segmentation boundary editing for any of the qualified scans included in the RDB data set for any of the 5 scan patterns. There was no manual adjustment of fovea center for ETDRS grid placement. Disc margin manual correction was performed for the baseline scan. The Bruch's membrane opening (BMO) editing rate was about 8%.

Race	Subject #	%
African American	56	13.1 %
Asian	49	11.5 %
Caucasian	272	63.7 %
Pacific Islander	0	0.0%
American Indian	31	7.3%
Multiracial	5	1.2 %
Other	5	1.2 %
Not Disclosed	9	2.1 %
Total	427
Ethnicity	Subject #	%
Hispanic	65	15.2
Non-Hispanic	359	84.1 %
Not Disclosed	3	0.7 %
Total	427

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Image /page/25/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized letter 'C' on the left side, formed by a gradient of orange and yellow. To the right of the 'C' is the company name, 'OPTOVUE', written in a simple, sans-serif font and colored in gray.

Variables Summary by Scan Type

For each scan type, the table below summarizes the variables distribution

FactorLevel	Solix AngioVue Retina	Solix Retina Cube	Solix Wellness
N (subjects)	426	424	423
C(1)_GCC
Mean(SD)	56.3 (10.2)	56.5 (10.4)	62.6 (10.3)
Median	55.4	55.7	61.9
Min, Max	[30.8, 85.7]	[31.5, 86.9]	[36.8, 89.7]
T(1-3)_GCC
Mean(SD)	102.6 (7.7)	103.5 (7.7)	102.5 (7.5)
Median	102.4	103.2	102.0
Min, Max	[78.3, 126.5]	[78.0, 127.9]	[77.8, 126.3]
S(1-3)_GCC
Mean(SD)	114.2 (8.4)	113.7 (8.5)	111.8 (8.5)
Median	113.6	113.3	111.4
Min, Max	[85.9, 138.7]	[85.9, 137.5]	[85.0, 135.1]
N(1-3)_GCC
Mean(SD)	111.4 (8.8)	111.8 (8.9)	111.0 (8.7)
Median	111.2	111.6	110.7
Min, Max	[81.5, 138.0]	[81.1, 140.1]	[81.1, 137.8]
I(1-3)_GCC
Mean(SD)	115.2 (8.3)	114.5 (8.5)	111.8 (8.4)
Median	115.1	114.7	111.3
Min, Max	[86.5, 138.5]	[84.1, 138.3]	[81.7, 136.8]
S-Hemi(1-3)_GCC
Mean(SD)	110.1 (8.2)	110.2 (8.2)	109.5 (8.0)
Median	109.7	109.9	108.8
Min, Max	[82.4, 134.5]	[82.7, 134.3]	[82.6, 130.8]
I-Hemi(1-3)_GCC
Mean(SD)	111.5 (8.1)	111.5 (8.2)	110.0 (7.9)
Median	111.4	111.2	109.8
Min, Max	[83.7, 133.1]	[81.8, 133.4]	[81.0, 132.1]
All(1-3)_GCC
Mean(SD)	110.8 (8.0)	110.9 (8.1)	109.7 (7.8)
Median	110.5	110.5	109.1
Min, Max	[83.0, 132.9]	[82.3, 133.3]	[81.8, 130.4]
T(3-6)_GCC
Mean(SD)	85.6 (6.6)	86.1 (6.6)	81.6 (6.4)
FactorLevel	Solix AngioVue Retina	Solix Retina Cube	Solix Wellness
Median	85.5	85.8	81.2
Min, Max	[63.4, 105.4]	[63.8, 106.1]	[59.3, 100.9]
S(3-6)_GCC
Mean(SD)	100.8 (8.3)	99.6 (8.3)	91.9 (8.6)
Median	100.3	99.3	91.5
Min, Max	[73.7, 125.3]	[71.8, 123.2]	[64.7, 120.2]
N(3-6)_GCC
Mean(SD)	117.3 (9.7)	116.6 (9.8)	113.1 (10.2)
Median	117.5	116.8	113.3
Min, Max	[83.2, 147.4]	[83.6, 148.3]	[78.8, 146.7]
I(3-6)_GCC
Mean(SD)	100.3 (8.4)	99.1 (8.4)	95.0 (9.4)
Median	100.0	98.6	95.0
Min, Max	[70.7, 126.9]	[69.4, 125.6]	[65.2, 123.2]
S-Hemi(3-6)_GCC
Mean(SD)	100.5 (7.7)	99.9 (7.8)	93.6 (7.8)
Median	100.1	99.5	93.2
Min, Max	[74.0, 123.0]	[73.1, 121.5]	[67.2, 119.5]
I-Hemi(3-6)_GCC
Mean(SD)	101.5 (8.0)	100.8 (8.0)	96.6 (8.5)
Median	101.5	100.8	96.5
Min, Max	[72.6, 126.5]	[72.1, 126.1]	[67.4, 122.9]
All(3-6)_GCC
Mean(SD)	101.0 (7.6)	100.4 (7.6)	95.1 (7.8)
Median	100.7	100.2	94.9
Min, Max	[75.8, 122.4]	[75.1, 122.1]	[69.4, 116.2]
S-Hemi(0-6)_GCC
Mean(SD)	101.4 (7.3)	101.0 (7.4)	96.2 (7.4)
Median	100.9	100.3	95.9
Min, Max	[75.9, 124.3]	[75.2, 123.1]	[70.5, 121.1]
I-Hemi(0-6)_GCC
Mean(SD)	102.5 (7.5)	102.0 (7.5)	98.6 (7.9)
Median	102.5	102.1	98.8
Min, Max	[75.7, 124.2]	[74.8, 123.9]	[70.1, 122.3]
All(0-6)_GCC
Mean(SD)	101.9 (7.2)	101.5 (7.2)	97.4 (7.4)
Median	101.5	101.0	96.9
Min, Max	[77.5, 122.3]	[76.6, 122.1]	[71.3, 118.0]
FactorLevel	Solix AngioVue Retina	Solix Retina Cube	Solix Wellness
C(1)_R
Mean(SD)	259.2 (21.7)	259.1 (21.9)	257.8 (21.9)
Median	258.9	258.9	257.8
Min, Max	[201.0, 325.5]	[202.6, 325.6]	[194.5, 327.5]
T(1-3)_R
Mean(SD)	315.3 (14.4)	316.0 (14.3)	314.3 (14.5)
Median	315.2	316.1	313.5
Min, Max	[278.5, 372.1]	[281.8, 370.8]	[276.3, 371.8]
S(1-3)_R
Mean(SD)	328.6 (14.6)	329.1 (14.4)	326.7 (14.9)
Median	327.9	328.3	326.3
Min, Max	[287.7, 377.5]	[287.4, 378.2]	[281.7, 377.3]
N(1-3)_R
Mean(SD)	329.5 (14.8)	329.9 (14.9)	326.9 (15.0)
Median	329.5	329.9	327.2
Min, Max	[289.6, 376.1]	[290.3, 374.8]	[283.7, 375.9]
I(1-3)_R
Mean(SD)	324.2 (14.1)	324.6 (14.1)	323.7 (14.4)
Median	324.1	324.4	324.1
Min, Max	[286.5, 368.9]	[289.5, 368.1]	[281.3, 369.1]
S-Hemi(1-3)_R
Mean(SD)	325.4 (14.4)	325.9 (14.3)	323.4 (14.6)
Median	325.2	326.0	323.1
Min, Max	[285.2, 375.6]	[286.7, 375.6]	[280.3, 375.0]
I-Hemi(1-3)_R
Mean(SD)	323.4 (14.0)	323.8 (14.1)	322.4 (14.2)
Median	323.2	323.6	322.1
Min, Max	[285.9, 370.3]	[289.0, 370.2]	[281.3, 370.1]
All(1-3)_R
Mean(SD)	324.4 (14.1)	324.9 (14.0)	322.9 (14.3)
Median	324.4	324.8	322.9
Min, Max	[285.6, 372.9]	[287.9, 372.9]	[280.8, 372.6]
T(3-6)_R
Mean(SD)	266.9 (13.1)	268.4 (13.3)	279.0 (14.1)
Median	267.0	268.4	279.3
Min, Max	[227.1, 310.2]	[229.4, 310.6]	[240.9, 325.1]
S(3-6)_R
Mean(SD)	284.4 (13.5)	285.2 (13.4)	292.5 (14.3)
FactorLevel	Solix AngioVue Retina	Solix Retina Cube	Solix Wellness
Median	283.7	284.9	291.8
Min, Max	[244.5, 322.8]	[245.7, 320.5]	[249.7, 336.3]
N(3-6)_R
Mean(SD)	299.8 (14.9)	300.7 (14.9)	302.1 (15.6)
Median	299.8	300.7	302.9
Min, Max	[257.5, 336.8]	[259.2, 338.7]	[257.5, 341.7]
I(3-6)_R
Mean(SD)	270.9 (13.1)	271.4 (13.3)	281.0 (14.5)
Median	270.9	271.6	281.7
Min, Max	[234.4, 311.0]	[232.9, 312.9]	[239.5, 325.9]
S-Hemi(3-6)_R
Mean(SD)	284.3 (13.3)	285.3 (13.3)	291.7 (14.1)
Median	284.1	285.1	291.2
Min, Max	[243.8, 321.8]	[245.1, 321.6]	[250.3, 331.5]
I-Hemi(3-6)_R
Mean(SD)	276.7 (13.1)	277.5 (13.2)	285.6 (14.2)
Median	276.7	277.9	286.2
Min, Max	[238.0, 314.8]	[238.5, 316.7]	[243.5, 328.7]
All(3-6)_R
Mean(SD)	280.5 (13.0)	281.4 (13.0)	288.6 (13.9)
Median	280.6	281.2	288.7
Min, Max	[240.9, 318.2]	[241.8, 317.7]	[246.9, 329.1]
S-Hemi(0-6)_R
Mean(SD)	292.8 (12.9)	293.6 (12.9)	297.8 (13.6)
Median	292.5	293.1	297.2
Min, Max	[251.8, 332.7]	[253.2, 333.1]	[255.4, 339.1]
I-Hemi(0-6)_R
Mean(SD)	286.6 (12.6)	287.3 (12.7)	293.0 (13.5)
Median	286.5	286.9	293.1
Min, Max	[247.6, 322.3]	[248.7, 322.5]	[250.6, 331.7]
All(0-6)_R
Mean(SD)	289.7 (12.6)	290.5 (12.6)	295.4 (13.4)
Median	289.1	290.4	295.1
Min, Max	[249.7, 327.5]	[251.0, 327.7]	[253.0, 335.4]
All(0-6)_R_Vol
Mean(SD)	8.2 (0.4)	8.2 (0.4)	NA
Median	8.2	8.2	NA
Min, Max	[7.1, 9.3]	[7.1, 9.3]

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Image /page/26/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the word is a circular design made of orange and yellow brush strokes. The brush strokes start thick and fade to thin as they move around the circle.

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Image /page/27/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized orange and yellow circle on the left, with the word "OPTOVUE" in gray, sans-serif font to the right of the circle. The circle is not fully closed, with a gap at the top left, and the colors transition from orange at the top to yellow at the bottom.

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Image /page/28/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized letter 'C' on the left, formed by a gradient of orange and yellow. To the right of the 'C' is the company name, "OPTOVUE", in gray, sans-serif font. The logo is clean and modern, with a focus on visual appeal and brand recognition.

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Image /page/29/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the word is a circular graphic that is colored with a gradient from yellow to orange. The graphic appears to be a partial circle, with the open end facing towards the right.

FactorLevel	Solix AngioVue Retina	Solix Retina Cube	Solix Wellness
WI_GCC
Mean(SD)	103.1 (7.4)	102.5 (7.5)	92.3 (6.8)
Median	102.8	102.2	92.0
Min, Max	[78.4, 124.7]	[77.4, 123.9]	[68.7, 109.7]
WI-S-Hemi_GCC
Mean(SD)	102.0 (7.6)	101.5 (7.7)	91.4 (7.0)
Median	101.1	100.8	91.0
Min, Max	[76.6, 128.3]	[75.6, 126.9]	[67.5, 112.6]
WI-I-Hemi_GCC
Mean(SD)	104.1 (7.8)	103.6 (7.9)	93.3 (7.2)
Median	104.3	103.7	93.3
Min, Max	[75.6, 126.5]	[75.4, 125.9]	[68.2, 116.3]

FactorLevel	Solix AngioVue Disc	Solix Disc Cube
N (subjects)	423	416
TS_RNFL
Mean(SD)	64.59 (10.22)	64.75 (10.04)
Median	63.90	64.50
Min, Max	[40.30, 112.70]	[39.40, 105.90]
ST_RNFL
Mean(SD)	120.23 (20.41)	117.43 (19.50)
Median	119.80	116.75
Min, Max	[58.90, 169.20]	[59.30, 174.20]
SN_RNFL
Mean(SD)	110.39 (21.10)	110.42 (20.55)
Median	109.10	108.80
Min, Max	[58.40, 174.30]	[59.80, 167.50]
NS_RNFL
Mean(SD)	90.91 (14.88)	91.27 (14.57)
Median	91.40	92.15
Min, Max	[43.40, 136.40]	[49.80, 137.20]
NI_RNFL
Mean(SD)	69.54 (13.76)	69.77 (13.73)
Median	69.90	69.50
Min, Max	[33.40, 127.20]	[35.80, 129.20]
IN_RNFL
Mean(SD)	115.90 (23.12)	115.39 (22.76)
FactorLevel	Solix AngioVue Disc	Solix Disc Cube
Median	114.30	114.00
Min, Max	[61.40, 193.80]	[61.30, 189.80]
IT_RNFL
Mean(SD)	134.63 (19.99)	131.79 (19.67)
Median	134.70	132.60
Min, Max	[63.70, 194.00]	[64.60, 201.60]
TI_RNFL
Mean(SD)	58.98 (11.98)	59.26 (11.82)
Median	57.70	57.90
Min, Max	[35.90, 140.50]	[35.70, 134.40]
T_RNFL
Mean(SD)	62.01 (9.98)	62.21 (9.72)
Median	61.70	61.70
Min, Max	[39.20, 125.50]	[39.10, 114.80]
S_RNFL
Mean(SD)	114.86 (13.88)	113.59 (13.94)
Median	115.70	113.95
Min, Max	[79.50, 155.60]	[77.90, 156.40]
N_RNFL
Mean(SD)	81.40 (13.33)	81.71 (13.15)
Median	81.80	81.85
Min, Max	[38.90, 130.20]	[45.00, 130.90]
I_RNFL
Mean(SD)	124.18 (16.03)	122.61 (16.10)
Median	123.60	121.65
Min, Max	[84.60, 176.20]	[82.30, 173.80]
S-Hemi_RNFL
Mean(SD)	94.97 (9.86)	94.58 (9.87)
Median	95.30	95.25
Min, Max	[66.20, 118.30]	[67.30, 117.70]
I-Hemi_RNFL
Mean(SD)	93.94 (10.67)	93.26 (10.77)
Median	94.10	93.40
Min, Max	[63.40, 122.80]	[62.70, 122.00]
PP_RNFL
Mean(SD)	94.48 (9.73)	93.95 (9.78)
Median	94.60	94.10
Min, Max	[64.90, 118.40]	[65.20, 117.90]
FactorLevel	Solix AngioVue Disc	Solix Disc Cube
DiscArea(mm2)
Mean(SD)	1.85 (0.35)	1.84 (0.35)
Median	1.82	1.81
Min, Max	[1.06, 3.41]	[1.05, 3.40]
CupArea(mm2)
Mean(SD)	0.51 (0.35)	0.49 (0.35)
Median	0.46	0.43
Min, Max	[0.00, 2.24]	[0.00, 2.38]
RimArea(mm2)
Mean(SD)	1.34 (0.30)	1.35 (0.31)
Median	1.32	1.32
Min, Max	[0.57, 2.33]	[0.46, 2.49]
CupVolume(mm3)
Mean(SD)	0.11 (0.11)	0.10 (0.11)
Median	0.07	0.07
Min, Max	[0.00, 0.88]	[0.00, 0.81]
C/DAreaRatio
Mean(SD)	0.26 (0.15)	0.26 (0.16)
Median	0.26	0.25
Min, Max	[0.00, 0.71]	[0.00, 0.76]
C/DHRatio
Mean(SD)	0.52 (0.21)	0.51 (0.22)
Median	0.54	0.53
Min, Max	[0.00, 0.97]	[0.00, 0.97]
C/DVRatio
Mean(SD)	0.46 (0.17)	0.45 (0.18)
Median	0.49	0.48
Min, Max	[0.00, 0.83]	[0.00, 0.82]

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Image /page/30/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the word is a circular graphic that is colored with a gradient from yellow to orange. The graphic is incomplete, with a gap at the top, giving the impression of a crescent or partial ring.

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Image /page/31/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized, incomplete circle on the left, rendered in shades of orange and yellow, resembling a sunrise or a lens flare. To the right of the circle is the company name, "OPTOVUE," in a simple, sans-serif gray font. The overall design is clean and modern.

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Conclusions

The SOLIX has the same intended use as the legally marketed predicate devices identified in this 510(k) notification. The IFU statement differs from those for the predicate devices, but these differences do not change the intended use of the device. The technological characteristics of the SOLIX differ from those of the predicate devices, however, the differences do not raise new or different questions of safety or effectiveness. Results of the non-clinical performance testing demonstrate that the SOLIX functions as intended. Results of clinical performance testing demonstrate a favorable clinical performance profile that supports a determination of substantial equivalence. The non-clinical and clinical performance testing demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicates.

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.