Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes image processing and algorithms for segmentation and analysis, but it does not explicitly mention the use of AI, ML, or deep learning. The algorithms described appear to be based on traditional image processing techniques like local and global thresholding.

Therapeutic

No.

The device is explicitly indicated for use as a "diagnostic device to aid in the detection and management of ocular diseases", for "in-vivo viewing of the posterior and external area of the images...intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health", and for "visualization of vascular structures". It focuses on imaging and measurement, not on treating or preventing disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases."

SaMD (Software as a Medical Device)

No

The device description explicitly states that SOLIX is a "computer-controlled, ophthalmic imaging system with combined spectral-domain optical coherence tomography (SD-OCT) and non-mydriatic, digital fundus camera." This indicates the presence of significant hardware components (OCT and fundus camera) in addition to the software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
SOLIX™ Function: The SOLIX™ system is an in vivo imaging device. It directly images structures within the living eye using optical coherence tomography and fundus photography. It does not analyze specimens derived from the body.
Intended Use: The intended use clearly states "in vivo imaging" and describes the device as a diagnostic device to aid in the detection and management of ocular diseases by imaging and measuring structures within the eye.
Device Description: The device description confirms it's an ophthalmic imaging system that acquires cross-sectional tomograms and images of the eye.

Therefore, because the SOLIX™ device operates by directly imaging structures within the living body rather than analyzing specimens outside the body, it falls outside the definition of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

OBO, HKI

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT), Color Fundus Photography

Anatomical Site

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.

Indicated Patient Age Range

Not Found. (Clinical studies included participants aged 18 or older)

Intended User / Care Setting

clinicians

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

Not Found

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

Solix OCT Performance – Anterior Segment:

Sample Size: 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]).
Data Source: Single clinical U.S. site.
Annotation Protocol: 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.
Additional Information: Repeata-bility 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.

Solix OCT and OCTA Performance - Posterior Segment:

Sample Size: 93 participants were enrolled and 83 participants completed the study (30 "normal," 25 "Glaucoma", 28 "Retina" subgroup).
Data Source: Single clinical U.S. site.
Annotation Protocol: 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.
Additional Information: 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.

Solix Fundus Photography:

Sample Size: 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).
Data Source: Two clinical sites.
Annotation Protocol: Every participant was imaged with one configuration (two repeated images per camera). 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.

Solix RDB (Reference Database) Generation:

Sample Size: 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.
Data Source: Five U.S. clinical sites.
Annotation Protocol: 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. 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%.
Additional Information: 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.

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

Study Type: Non-clinical bench tests and clinical performance testing including repeatability and reproducibility studies, and comparative image quality studies.

Non-clinical Performance Testing:

Study Type: Bench tests, verification and validation testing against standards.
Key Results:
- Spatial Performance: Performed.
- Sensitivity: Performed.
- OCT Angiography: Used 3D digital phantoms with known vessel density ground truth to determine accuracy of SOLIX software for vessel density measurement. Improved accuracy was observed from SOLIX vessel density measurements compared to Avanti.
- Auxiliary Functions: Performed.
- Testing to the standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 15004-1, ISO 15004-2, ANSI Z80.36-2016.
- Software Verification and Validation Testing: Performed as intended, met acceptance criteria, overall product safety, and patient safety. Software determined to be "moderate" level of concern.

Clinical Performance Testing:

Study Type: Prospective, observational studies conducted at single or multiple clinical U.S. sites.
- Solix OCT Performance – Anterior Segment: Repeatability and reproducibility (R&R) study, and agreement comparison with predicate device.
  - Sample Size: 61 eligible participants (30 "Normal," 31 "Cornea" subgroup).
  - Key Results: R&R results are shown in tables for Epithelia (Epi), Cornea (Pachy), and Stroma parameters. Manual edit rate for poor image quality was similar for both devices (

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

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

Summary

0

November 9 ,2022

Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

1

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)

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.

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 Drive
Fremont, CA 94538 |
|----------------|---------------------------------------------------------------------------------------------------|
| Contact Person | Robert Lundberg
VP Regulatory/Quality
Tel: (951) 741-2776
Email: 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

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.

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Substantial Equivalence

SOLIX vs Avanti

| Device | SOLIX
(Proposed Device) | Predicate Devices
Primary Predicate Avanti | Substantial Equivalence
Comparison |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number &
Classification | K222166
Class II | K180660
Class 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 coherence
tomography system intended for the in
vivo imaging, cross-sectional, 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 nerve fiber layer,
and measurement of optic disc
parameters in normal subjects, and in
subjects with glaucoma and retinal
diseases. | The Avanti is an optical coherence
tomography system intended for the in
vivo imaging, cross- sectional, 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 epithelia, corneal stroma,
pachymetry, corneal power, and
anterior chamber of the eye. With the
integrated normative database, Avanti
is also a quantitative tool for the
comparison of retina, retinal nerve
fiber layer, and optic disc
measurements in the human eye to a
database of a known normal subjects.

It is indicated for use as a diagnostic
device to aid in the detection and
management of ocular diseases.

The Avanti 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 nerve fiber layer,
and measurement of optic disc
parameters in normal subjects, and in
subjects with glaucoma and retinal
diseases. | Same |
| Technological
Characteristics | Spectral-Domain Optical Coherence
Tomography (SD-OCT) | Spectral-Domain Optical Coherence
Tomography (SD-OCT) | Same |
| System Components | • Scanner
• Control Unit
• Chin and Head rest
• Joystick and base assembly
• Computer with Windows operating
system
• 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 operating
system
• Monitor
• Keyboard and Mouse
• System Table
• CAM Lens | Same |
| Signal Type | Optical scattering from tissue for
OCT | Optical scattering from tissue for OCT | Same |
| Device | SOLIX
(Proposed Device) | Predicate Devices
Primary Predicate Avanti | Substantial Equivalence
Comparison |
| 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 is
increased from 0.75mW to
1.45mW to compensate the
loss of photon energy due to
higher scanner speed. With
higher power, it achieves
similar level of Signal to
Noise Ratio (SNR) as Avanti. |
| OCT Optical Power | 1.45mW (at cornea) | 0.75mW (at cornea) | The light exposure safety
issue in SOLIX is analyzed
in Dr. David Sliney's report.
The near- infrared radiation
from an SLD in SOLIX is
below all of the applicable
exposure limits -including
the guidelines for
ophthalmic instrument
exposure. |
| Fixation Light Source | Blue LED | Blue LED | Same |
| IR Fundus Imaging
Light Source | NIR LED | NIR LED | Same |
| Iris Viewer
Illumination | IR LED | N/A | Iris imaging is added for
external visualization to
facilitate patient alignment.
No impact on the systems'
essential functions - OCT. |
| Working Distance | Retina imaging: 35 mm
With CAM (Cornea Anterior
Module) attached: 20mm | Retina imaging: 22 mm
With CAM (Cornea Anterior Module)
attached: 13mm | The longer working
distance in SOLIX
improves the system's
usability. |
| 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 (IEC
60601 compliant) | Medical-grade power supply (IEC
60601 compliant) | Same |
| Cleaning and
Disinfection | Chin and forehead rest can be
cleaned with a disinfecting agent,
such as isopropyl alcohol wipes or a
germicide with a lint-free cloth. | Chin and forehead rest can be cleaned
with a disinfecting agent, such as
isopropyl alcohol wipes or a germicide
with a lint-
free cloth. | Same |
| Axial Resolution (in
tissue) | 5μm | 5μm | Same |
| Scan Rate | 120,000 A-Scan/second | 70,000 A-Scan/second | The OCT scan speed
increased from 70Khz to
120Khz with a faster line
scan camera from same
vendor. |
| Scan Depth | ~up to 3 mm except full- range scans
up to 6.25 mm such as FullRange™
Retina and FullRange™ AC scans | ~up to 3mm | Full-range technology is
introduced to increase scan
depth for two specific scans
only. |
| Angio Vue
(wider FOV) | AngioVue 12mm | N/A | With faster scan speed,
SOLIX offers Angio Vue
scan with wider field of
view: Scan area: 12mm
x12mm and Sampling
Density: 600x600 |
| Device | SOLIX
(Proposed Device) | Predicate Devices
Primary Predicate Avanti | Substantial Equivalence
Comparison |
| 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 | Pachymetry
Pachymetry 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 Devices
Primary Predicate Avanti | Substantial Equivalence
Comparison |
| Cornea | FullRange AC | N/A | Essentially it is an enhanced
line scan. Scan Depth is
6.25mm |
| Motion Artifacts
Reduction | Tracking based on IR fundus
image + MCT | Tracking based on IR fundus image +
MCT | Same |
| Post- Processing for
OCT Scans | • Segmentation and analysis of OCT
Scans for Retina and Nerve Fiber
• Segmentation and analysis of OCT
Scans for Cornea
• Scan Quality
• Manual editing of segmentation
error and propagation of manual
correction to neighboring B-scans
• Projection artifacts removal (PAR)
• Visualization and qualitative
analysis of retinal and vascular
structures based on en face images | • Segmentation and analysis of OCT
Scans for Retina and Nerve Fiber
• Segmentation and analysis of OCT
Scans for Cornea
• Scan Quality
• Manual editing of segmentation
error and propagation of manual
correction to neighboring B-scans
• Projection artifacts removal (PAR)
• Visualization and qualitative
analysis of retinal and vascular
structures based on en face images | Substantial Equivalence:
The results are substantial
equivalent as verified by
clinical study data.
SOLIX's PAR is updated to
further reduce the projection
artifacts, as evidenced by the
qualitative assessment of
clinical study data.
SOLIX's vessel extraction
method is updated to extract
vessels in the relatively low
OCTA signal areas, as
evidenced by the bench
(phantom) and clinical
studies. |
| Post-Processing for
OCT Scans | Feature under AngioAnalytics
license:
Quantitative analysis of vascular
structures based on en face
images
Quantitative analysis of retinal,
nerve fiber, and optic disc
structure
• Fovea detection
• Optic disc margin
detection | Feature under AngioAnalytics
license:
• Quantitative analysis of vascular
structures based on en face images
• Quantitative analysis of retinal,
nerve fiber, and optic disc structure
• Fovea detection
• Optic disc margin
detection | studies.
Same |
| Reference Database
(RDB) | OCT structural RDB Collected for
the following scans: AngioVue
Retina, Angio Vue Disc, Retina Cube
Disc Cube and Wellness scans
• No OCT Angiography RDB
available | • Avanti RDB for OCT scans,
including Retinal Map scan, GCC
scan, and ONH scan
• No OCT Angiography RDB
available | Same as predicate device,
SOLIX only offers OCT
structural RDB based on
different types of cube
scans.
SOLIX's RDB provides
additional colors when the
confidence intervals of
quantile limits are
overlapped. |
| Device Packaging and
Sterilization | The device is not sterile, does not
require sterilization, and does not
include shelf-life claims on product
labeling. | The device is not sterile, does not
require sterilization, and does not
include shelf-life claims on product
labeling. | Same |
| | The device is not sterile and does
not require sterilization. Shipping
packaging has been designed to
safely transport the device to the end
user facility. | The device is not sterile and does
not require sterilization. Shipping
packaging has been designed to safely
transport the device to the end user
facility. | Same |
| Device | SOLIX
(Proposed Device) | Predicate Devices
Secondary Predicate iCam | Substantial Equivalence
Comparison |
| 510(k) Number &
Classification | TBD
Class II | K122572
Class II | |
| Date of Clearance | TBD | January 11, 2013 | |
| Trade Name | SOLIX | iCam | |
| Manufacturer | Optovue, Inc. | Optovue, Inc. | |
| Indications For Use | 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 eye and the images are
intended for use as an aid to clinicians
in the evaluation, diagnosis and
documentation of ocular health. | The iCam is a non- contact, high
resolution digital imaging device
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.
iCam 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.
iCam provides images only and does
not provide any diagnostic,
pathological analysis or classification
of ocular health or disease. | Same |
| Technological
Characteristics | Color fundus imaging | Color fundus imaging | Same |
| System Components | • Retina illumination Optics path.
• Retina image optics path
• Retina Camera | • Retina illumination
Optics path.
• Retina image optics path
• Retina Camera | Same |
| Signal Type | Photography under white light flash | Photography under white light flash | Same |
| Flash light source for
photographing | White LED | White LED | Same |
| IR Fundus Imaging
Light Source | NIR LED | NIR LED | Same |
| Splitbar Illumination | NIR LED | NIR LED | Same |
| Working Distance
Indicator (WDI)
Illumination | NIR LED | NIR LED | Same |
| Iris Viewer
Illumination | IR LED | N/A | Iris imaging is added for
external visualization to
facilitate patient alignment.
No impact on the systems'
essential functions – Color
Fundus
Photography. |
| Working Distance | Retina imaging: 35 mm
With CAM (Cornea Anterior
Module) attached: 20mm | Retina imaging: 25mm | The longer working
distance in SOLIX
improves the system's
usability. |
| Ergonomic | • Chin and forehead rest | • Chin and forehead rest | Same |
| Device | SOLIX
(Proposed Device) | Predicate Devices
Secondary Predicate iCam | Substantial Equivalence
Comparison |
| Pupil Diameter
(Non-Mydriatic
fundus imaging) | ≥4.0mm
≥3.3mm (small pupil mode) | ≥4.0mm | Smaller light ring mode is
added to deliver more light
into the eyes with small
pupils. The general design
principle is similar for
normal and small pupil
modes. |
| Field of View
(Color Fundus
Imaging) | 45°
35° (small pupil mode) | 45° | Smaller light ring mode is
added to deliver more light
into the eyes with small
pupils. The general design
principle is similar for normal
and small pupil modes. In
small pupil mode, the FOV is
a tradeoff with small pupil
mode. |
| Electrical | Medical-grade power supply (IEC
60601 compliant) | Medical-grade power supply (IEC
60601 compliant) | Same |
| Cleaning and
Disinfection | Chin and forehead rest can be
cleaned with a disinfecting agent,
such as isopropyl alcohol wipes or a
germicide with a lint-free cloth. | Chin and forehead rest can be cleaned
with a disinfecting agent, such as
isopropyl alcohol wipes or a
germicide with a lint-
free cloth. | Same |
| Photo | Fundus Photo | Color Fundus | Similar. Small pupil mode
added in SOLIX |
| Photo | Disc Photo | Color Fundus | Similar. Small pupil mode
added in SOLIX |
| Photo | Exterior Color | External Image | Same |
| Photo | External IR | N/A | 940nm IR Illumination to
visualize external structure |
| Device Packaging and
Sterilization | The device is not sterile, does not
require sterilization, and does not
include shelf-life claims on product
labeling. | The device is not sterile, does not
require sterilization, and does not
include shelf-life claims on product
labeling. | Same |
| | The device is not sterile and does
not require sterilization. Shipping
packaging has been designed to
safely transport the device to the end
user facility. | The device is not sterile and does not
require sterilization. Shipping
packaging has been designed to safely
transport the device to the end user
facility. | Same |

6

Image /page/6/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 made of orange and yellow gradient colors. The graphic is incomplete, forming an arc that partially surrounds the word "OPTOVUE".

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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.

8

Image /page/8/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.

9

Image /page/9/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 that is orange and yellow. The circle is open on the right side.

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.

11

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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Image /page/12/Picture/1 description: The image contains 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, forming an arc that partially surrounds the word "OPTOVUE".

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.

13

Image /page/13/Picture/0 description: The image shows the text 'K222166' in a simple, sans-serif font. The text is presented in a horizontal arrangement, with the letter 'K' followed by a series of digits. The numbers are '222166'. The text is black against a white background.

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.

14

Image /page/14/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 that is colored with a gradient from yellow to orange.

556 Solix scans and 555 Avanti XR scans were acquired across 6 devices. Scan attrition for poor image quality was similar for both devices (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

25

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

| Factor

Level	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)
Factor
Level	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]
Factor
Level	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)
Factor
Level	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]

26

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.

27

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.

28

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.

29

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.

| Factor

Level	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]

| Factor

Level	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)
Factor
Level	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]
Factor
Level	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]

30

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.

31

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.

32

Image /page/32/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized orange circle that is open on the left side. To the right of the circle is the company name, "OPTOVUE", in gray sans-serif font. The logo is simple and modern.

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.