Who is the manufacturer of Avanti?

Optovue, Inc. filed the 510(k) submission for Avanti (K180660).

What is the FDA product code for Avanti?

OBO. It is classified under 21 CFR 886.1570 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for Avanti?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Avanti?

Optovue RTVue XR OCT Avanti with AngioVue Software (K153080); Optovue RTVue CAM with Corneal Power Upgrade (K111505).

Who can help prepare an FDA 510(k) submission like Avanti?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Avanti

K180660 · Optovue, Inc. · OBO · Jun 8, 2018 · Ophthalmic

Device Facts

Record ID	K180660
Device Name	Avanti
Applicant	Optovue, Inc.
Product Code	OBO · Ophthalmic
Decision Date	Jun 8, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.1570
Device Class	Class 2

Intended Use

The Avanti is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and threedimensional imaging and measurement of anterior ocular structures, including retina, retinal netve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avantitative tool for the comparison of 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 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.

Device Story

Avanti is a computer-controlled ophthalmic imaging system using non-invasive, non-contact, low-coherence interferometry to acquire high-resolution cross-sectional and 3D tomograms of anterior and posterior ocular structures. It produces motion-contrast images of retinal microvasculature (OCT angiography). Operated by clinicians in a clinic setting, the device includes a scanner head, chinrest, joystick, and computer with application software. The system processes, stores, and displays exam data. New software features include quantitative analysis of vascular structures (vessel density, FAZ), corneal layer thickness (epithelia, stroma), and updated 3D segmentation/artifact removal. Healthcare providers use these outputs to visualize vascular structures and measure retinal/corneal parameters, aiding in the detection and management of ocular diseases like glaucoma and retinal vascular conditions.

Clinical Evidence

Prospective, observational study (n=67) evaluated repeatability/reproducibility of new OCTA and thickness parameters in normal, glaucoma, and retinal disease subjects. Two additional anterior segment studies evaluated pachymetry/corneal thickness agreement with manual measurements. Results showed acceptable repeatability/reproducibility and agreement with manual grading.

Technological Characteristics

Non-contact, low-coherence interferometry; medical-grade power supply; USB connectivity; motorized chinrest/table. Software includes 3D segmentation, automated fovea/disc detection, and OCTA projection artifact removal. Complies with BS EN 62304 and ISO 14971.

Indications for Use

Indicated for in vivo imaging and measurement of anterior and posterior ocular structures (retina, RNFL, GCC, optic disc, cornea, anterior chamber) in patients to aid in detection and management of ocular diseases. AngioVue/AngioAnalytics features indicated for visualization and measurement of retinal/choroidal vascular structures, FAZ, and retinal/RNFL thickness in normal subjects and those with glaucoma or retinal diseases.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Optovue RTVue XR OCT Avanti with AngioVue Software (K153080)
Optovue RTVue CAM with Corneal Power Upgrade (K111505)

Reference Devices

Optovue iVue (K163475)

Related Devices

K153080 — RTVue XR OCT Avanti with AngioVue Software · Optovue, Inc. · Feb 11, 2016
K222166 — SOLIX · Optovue, Inc. · Nov 9, 2022
K092470 — OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 · Topcon Corp. · Sep 2, 2009
K150977 — CIRRUS HD-OCT · Carl Zeiss Meditec, Inc. · Sep 1, 2015
K181534 — CIRRUS HD-OCT · Carl Zeiss Meditec, Inc. · Feb 15, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". June 8, 2018 Optovue, Inc. Indu Lakshman Senior Director, Regulatory Affairs and Quality Assurance 2800 Bayview Drive Fremont, CA 94538 Re: K180660 Trade/Device Name: Avanti Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HLI Dated: March 12, 2018 Received: March 14, 2018 Dear Indu Lakshman: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing {1}------------------------------------------------ (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Denise L. Hampton -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K180660 Device Name Avanti #### Indications for Use (Describe) The Avanti is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and threedimensional imaging and measurement of anterior ocular structures, including retina, retinal netve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avantitative tool for the comparison of 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 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. 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/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 left side. To the right of the circle is the word "OPTOVUE" in a sans-serif font. The word is gray. #### 510(k) Summary #### Submitter Information | Company | Optovue, Inc 2800 Bayview Drive Fremont, CA 94538 (510) 897-1734 | |----------------|---------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Indu Lakshman Senior Director, Regulatory Affairs and Quality Assurance Tel: (510) 897-1575 Email: indu_lakshman@optovue.com | | Date Prepared | 04 June 2018 | #### Device Information | Device Trade Name | Avanti | |---------------------------|------------------------------------------------------------------------------------------------------------------------------| | 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, HLI | | Predicate Devices | | | Company | Optovue, Inc. | | Devices | 1) Optovue RTVue XR OCT Avanti with AngioVue Software (K153080) 2) Optovue RTVue CAM with Corneal Power Upgrade (K111505) | | Reference Device | | Optovue, Inc. Company Device Optovue iVue (K163475) ## Indications for Use The Avanti is an optical coherence tomography system intended for the in vivo imaging, crosssectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, {4}------------------------------------------------ Image /page/4/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 on the left side and fades to yellow on the right side. The graphic is open on the right side, creating a crescent shape. 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 retinal nerve fiber layer, and optic disc measurements in the human eve 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 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 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. ## Device Description The Avanti is a computer-controlled ophthalmic imaging system that acquires cross-sectional tomograms of the anterior and posterior ocular structures (including cornea, anterior chamber angle, retina, ganglion cell complex, retinal nerve fiber layer, and optic disc). It employs noninvasive, non-contact, low-coherence interferometry to obtain these high-resolution reflectance images and, by rapidly repeating the cross-sectional image at same location, to produce high resolution motion-contrast images of the retina microvasculature. Using this non-invasive optical technique, the Avanti produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye) and non-invasive angiographic imaging of the retinal microvasculature based on OCT angiography (OCTA). Qualitative analyses are provided for the cornea and layers of the cornea, the retina and layers of the retina, the optic disc and the nerve fiber layer, and the retinal microvasculature. #### Description of Key Functional Components The Avanti device consists of the following components. #### Avanti Scanner Head The Avanti scanner head is the main component of the Avanti device. It is used to view and scan the patient's eye, collect the OCT signal, and send it to the computer for processing and storage. Communication between the camera and computer is achieved via a USB connection. The Avanti device uses a medical-grade power supply. #### Computer with Application Software The Avanti computer supports scanner operation, and processes, stores, and displays exam data through the Avanti application software. The searchable database stores and organizes patient and exam data. The computer is used to control the camera's image acquisition and image processing during the patient examination. The application software also is a data processing, presentation, and storage center. The computer is powered by a medical-grade power supply. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized orange circle that is not fully closed, with the word "OPTOVUE" in gray, sans-serif font to the right of the circle. The circle appears to be made up of multiple shades of orange, creating a gradient effect. ## Chinrest/Forehead Rest Assembly The chinrest/forehead rest assembly is for ensuring patient alignment and stability for imaging. This is the only point of direct patient contact with the device. The chinrest/forehead rest assembly is part of the Avanti scanner head assembly. #### Joystick The joystick assembly allows the Avanti scanner head to be moved in the X, Y, and Z directions using the joystick. The joystick includes a button that captures an image when depressed. The joystick assembly is part of the Avanti scanner head assembly. #### System Table The system table holds all system components and powers them through a medical-grade isolation transformer, which prevents current leakage from main AC power. It rests on lockable wheels, making the system portable, and its height is adjustable through a medical-grade motorized telescopic lift. #### Corneal Adapter Module (CAM) Lens The Avanti device may be used with the Avanti CAM lens, which is used for imaging the cornea and anterior chamber of the eye. The Avanti CAM lens is supplied with the Avanti device. #### Comparison of Technological Characteristics with the Predicate Device The Avanti device with software modification is substantially equivalent to its RTVue XR Avanti and RTVue CAM predicate devices, cleared in K153080 on February 11, 2016 and K111505 on September 8, 2011, respectively. The intended use, system performance, subassemblies, and key components remain the same. The design and performance characteristics of the subject and predicate devices remain the same. The indications for use for the Avanti device are similar to the indications for use of its RTVue XR Avanti and RTVue CAM predicate devices with the addition of measurement of vascular density and the foveal avascular zone which can be assessed qualitatively with the predicate device and the addition of measurement of the corneal epithelia thickness and the corneal stroma thickness which can be measured with a manual caliper in the predicate device. The differences are not critical to the intended diagnostic use of the device, and do not affect the safety and effectiveness of the device when used as labeled. The following are the proposed software modifications to the Avanti device: #### New Quantitative analysis of vascular structures based on OCTA scan en face images: - Measurement of the vessel density of the Superficial (ILM to IPL-10 O um) and the Deep (IPL-10 um to OPL+10 um) en face slabs of the retinal microvasculature in the macula - Measurement of the vessel density of the RPC en face slab (ILM to O NFL) surrounding the optic disc {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in a simple, sans-serif font. The letters are gray. A partial circle surrounds the left side of the word. The circle is colored with a gradient that transitions from yellow to orange. - Measurement of the foveal avascular zone (FAZ) area. FAZ perimeter, O and vessel density of the region 300 µm beyond the FAZ perimeter. New - Measurement of corneal layers based on PachymetryWide cornea scan: - o Added PachymetryWide cornea scan pattern with scan area of 9 mm in diameter - Measurement of the full corneal thickness (pachymetry) of the 9 mm O diameter area - o Measurement of the corneal epithelial thickness of the 9 mm diameter area - Measurement of the corneal stromal thickness of the 9 mm diameter O area #### Updated 3D segmentation and quantitative analysis of posterior ocular structures based on OCTA scans: - o AngioRetina scan segmentation (8 layers) - o Automatic fovea center detection for the 3-mm AngioRetina and 6-mm HD AngioRetina scan patterns - o Measurement of the thickness of the retina and layers of retina in the macula - AngioDisc scan segmentation (7 layers) O - Automatic optic disc margin detection o - Measurement of the thickness of the retinal nerve fiber layer (RNFL) O and layers of retina in the peripapillary region - o Measurement of the optic disc parameters at the plane of Bruch's membrane opening (BMO) - Manual editing of segmentation error and propagation O - Updated OCTA Scan Projection Artifacts Removal (PAR): Expansion of PAR implementation to the Outer Retina, Deep Plexus, and Choroid en face slabs. - Updated Scan Quality (SQ) index for OCTA scans: An image quality indicator for OCTA scans based on signal-to-noise ratio, image sharpness (i.e., focus), and motion artifacts. ## Risk Analysis The risk management process at Optovue complies with BS EN ISO 14971:2012, Medical devices - Application of risk analysis to medical devices. All software modifications were assessed to make sure all risks were sufficiently mitigated and that no new hazards were introduced in to the Avanti device as a result of the new software features according to the intended use. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the text 'K180660'. The text is in a sans-serif font and is black. The background is white. Image /page/7/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 colored with a gradient from yellow to orange. The circle is incomplete, with a gap at the top left. ## Performance Data The following performance data are provided to support substantial equivalence determination. ## 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 was provided that demonstrates the software changes performed as intended, met acceptance criteria, and did not have a negative impact on product performance, overall product safety, or patient safety. The software for this device was 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 Avanti and its RTVue XR Avanti and RTVue CAM predicate devices. ## Non-clinical Performance Testing A series of 3D phantom models with known ground truth for vessel density measurements was designed to validate the accuracy of the proposed device software for measurement of vessel density from 3-mm AngioRetina, 6-mm HD AngioRetina, and 4.5-mm HD AngioDisc scans. The vessel diameters covered in these phantoms range from 7um to 25um for small vessels and 50um to 180um for large vessels. The phantoms were designed to assess the impact of projection artifacts removal (PAR) on vessel density measurements (especially Deep vessel density) and large vessel masking for RPC vessel density. The 3D phantoms were constructed with the same raw data format as that of an OCTA scan of the eye, containing an OCT volume and an OCTA volume with spatial colocalization. A series of phantoms containing different wireframe densities and/or patterns to cover a range of physiologically relevant vascular densities and pathologies, such as branch occlusions, were designed. Projection artifacts were simulated in the OCTA volume for each phantom throughout the depth. Larger vessels with varying diameters (50um ~ 180μm) were included in the AngioDisc scan 3D phantom design. Vessel density measurements by the software are based on the RPC en face images for all vessels and for small vessels (applying large vessel mask to mask the regions occupied by large vessels). Phantoms were processed directly with the device software with all the steps that lead to the generation of vessel density map and associated measurement parameters, including en face slab generation, projection artifacts removal, image processing to generate vessel density map/measurements, and detection of large vessel mask for RPC vessel density analysis. The agreement between software reported measurements and the expected "vascular" density values computed directly from the model were used to validate the accuracy of the software. {8}------------------------------------------------ Image /page/8/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 design that is colored with a gradient from yellow to orange. The circular design appears to be incomplete, with the top portion missing. ## 3-mm AngioRetina Scan To evaluate accuracy of measurements of 3-mm AngioRetina scan, 4 phantoms with various vessel density were used, including one phantom with occlusion (vessel dropout) pattern. The measurement parameters tested included all software density measurement parameters for Superficial plexus and Deep plexus, as well as the foveal vessel density (FD-300) based on the Retina slab. The difference between the software reported vessel density value and the expected vessel density value of the phantom were evaluated for each parameter and for each of the 4 phantoms. The range and accuracy for the 3-mm AngioRetina scan parameters are summarized below, for Superficial and Deep plexuses. | Superficial Vessel Density (%) | Expected | SW Reported | Difference | Deep Vessel Density (%) | Expected | SW Reported | Difference | |-----------------------------------|----------|----------------|------------|----------------------------|----------|----------------|------------| | Average | 46.5 | 48.7 | 2.3 | Average | 39.8 | 39.8 | 0.0 | | Std Dev | 13.0 | 13.0 | 1.0 | Std Dev | 14.3 | 13.9 | 1.2 | | Min | 17.2 | 20.2 | -1.0 | Min | 0.2 | 0.2 | -3.0 | | Max | 73.5 | 75.7 | 4.3 | Max | 50.5 | 50.9 | 2.4 | #### Accuracy for 3-mm AngioRetina scan (pooled results of 4 individual phantoms and all zonal parameters) | FD-300 Vessel Density (%) | Expected | SW Reported | Difference | |---------------------------------|----------|----------------|------------| | Average | 57.5 | 55.3 | -2.2 | | Std Dev | 2.2 | 1.5 | -0.7 | | Min | 54.7 | 53.5 | -1.2 | | Max | 60.0 | 57.0 | -3.0 | Pooling results of the 4 phantoms and both plexuses, the measured vessel density values cover a broad range (from ~ 20% to ~ 75% as measured by the software). ## 6-mm HD AngioRetina Scan To evaluate accuracy of measurements of 6-mm HD AngioRetina scan, 3 phantoms with various vessel density were used, including one phantom with occlusion (vessel dropout) pattern. The measurement parameters tested included all software density measurement parameters for Superficial plexus and Deep plexus, as well as the foveal vessel density (FD-300) based on the Retina slab. The difference between the software reported vessel density value and the expected vessel density value (i.e., the "known" vessel density value of the phantom) were evaluated for each parameter respectively and for each of the 3 phantoms. The tables below summarize the measurement range for the 6mm HD Angio Retina scan parameters, for Superficial and Deep plexuses. {9}------------------------------------------------ Image /page/9/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 partial orange circle that surrounds the first letter of the word. The circle is open on the right side. | Superficial Vessel Density (%) | Expected | SW Reported | Difference | Deep Vessel Density (%) | Expected | SW Reported | Difference | |--------------------------------------|----------|----------------|------------|-------------------------------|----------|----------------|------------| | Average | 49.0 | 48.7 | -0.2 | Average | 63.0 | 63.3 | 0.3 | | Std Dev | 9.8 | 10.0 | 1.3 | Std Dev | 12.5 | 12.0 | 2.5 | | Min | 28.6 | 30.7 | -3.7 | Min | 0.8 | 1.4 | -4.7 | | Max | 62.5 | 62.8 | 2.3 | Max | 68.2 | 69.2 | 5.8 | | FD-300 Vessel Density (%) | Expected | SW Reported | Difference | | | | | | Average | 63.0 | 62.1 | -0.9 | | | | | | Std Dev | 3.9 | 6.1 | 2.2 | | | | | | Min | 60.7 | 58.5 | -1.6 | | | | | | Max | 67.5 | 69.3 | 1.8 | | | | | Accuracy for 6mm HD AngioRetina scan (pooled results of 3 individual phantoms and all zonal parameters) Pooling results of the 3 phantoms and both plexuses, the measured vessel density values cover a broad range (from ~ 31 % to ~ 69% as measured by the software). #### 4.5-mm HD AngioDisc Scan, with and without Large Vessel Masking To evaluate accuracy of measurements of 4.5mm HD AngioDisc scan, 3 phantoms with various vessel density were used, including one phantom with occlusion (vessel dropout) pattern. The measurement parameters tested included all software density measurement parameters for RPC slab, small vessels only vessel density (with applying large vessel mask) and all vessels density (without large vessel mask), respectively. The small vessels only vessel density is measured with the application of large vessel mask which has threshold of 3 pixels (approximately 33um for the 4.5-mm HD AngioDisc scans), therefore representing small vessels in the RPC slab. The difference between the software reported vessel density value and the expected vessel density value of the phantom were evaluated for each parameter and for each of the 3 phantoms. The tables below summarize the measurements range for the 4.5-mm AngioDisc scan parameters, RPC plexus; small vessels only vessel density (with applying large vessel mask) and RPC all vessels density, respectively. {10}------------------------------------------------ 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 circular design that is colored with a gradient from orange to yellow. The circle is not fully closed, with a small gap at the top left. | Small Vessel Density (%) | Expected | SW Reported | Difference | All Vessels Density (%) | Expected | SW Reported | Difference | |-----------------------------|----------|----------------|------------|----------------------------|----------|----------------|------------| | Average | 46.9 | 47.9 | 1.0 | Average | 56.1 | 55.6 | -0.5 | | Std Dev | 10.2 | 10.3 | 1.1 | Std Dev | 9.4 | 8.6 | 1.7 | | Min | 7.0 | 6.3 | -1.1 | Min | 22.4 | 23.6 | -2.9 | | Max | 56.9 | 57.1 | 3.4 | Max | 68.3 | 65.5 | 2.9 | #### Accuracy for 4.5-mm HD AngioDisc scan (pooled results of 3 individual phantoms and all zonal parameters) Pooling results of the 3 phantoms, the measured vessel density values cover a broad range (from ~ 6.0% to ~ 57% for small vessels only and from ~ 24% to ~ 66% for all vessels as measured by the software). Overall, phantom model testing produced acceptable accuracy results, while covering a sufficiently wide range of vessel density and vessel pattern distribution. #### Clinical Performance Testing A clinical study was conducted according to BS EN ISO 14155:2011, Clinical investigation of medical devices for human subjects - Good clinical practice, to demonstrate substantial equivalence of the subject Avanti device to the predicate Avanti device software. The repeatability and reproducibility were evaluated for the measurements of vessel density, retinal thickness, retinal sub-layer thicknesses, and optic disc measurements based on the AngioRetina scans and AngioDisc scans. Measurement for structural parameters measured by both devices was also evaluated. In addition, two anterior segment clinical studies were conducted to demonstrate substantial equivalence of the subject device to the predicate RTVue XR with CAM for pachymetry, corneal epithelial thickness, and corneal stromal thickness measurements with PachymetryWide scan. One study evaluated the repeatability and reproducibility of the cornea measurements, and the second study evaluated agreement with manual measurements based on the PachymetryWide scan software results. ## 1. Evaluation of the Repeatability and Reproducibility ("R&R") of AngioVue in Normal Subjects, Retinal Patients, and Glaucoma Patients This was a prospective, observational study conducted at a single clinical U.S. site. Eligible participants age 18 or older were enrolled and assigned to one of three study groups: 1) individuals with no ocular disease; 2) individuals with glaucoma of varying severity (with confirmed glaucomatous visual field defect and/or glaucomatous optic nerve changes), and 3) individuals with exudative age-related macular degeneration (AMD), proliferative and nonproliferative diabetic retinopathy (DR), and other retinal vascular conditions. Individuals with media opacity or significant refractive error precluding adequate image quality were excluded. For repeatability/reproducibility and agreement, the study eve is imaged three times using relevant OCTA scan patterns with each of three Avanti instrument-operator pairs. For agreement assessment of retinal thickness and optic nerve head (ONH) parameters, study eyes were also scanned once with each of four predicate ("legacy") posterior segment scan patterns. All eligible study eyes with at least two acceptable scans were included into {11}------------------------------------------------ Image /page/11/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 text is a circular graphic that is colored with a gradient from yellow to orange. The graphic is not a complete circle, but rather an arc that wraps around the left side of the text. final statistical analyses. All scans underwent post-acquisition image quality review. OCTA scans with a SQ score of less than 6 were excluded from analysis; "legacy" scan SSIs of <39 (Retina Map), <32 (GCC), or <28 (ONH scan pattern) were also excluded. Repeatability and reproducibility of the measured parameters (new OCTA parameters and non-OCTA thickness parameters) were calculated using a random-effects analysis of variance (ANOVA) model. Agreement was evaluated with calculation of 95% limits of agreement (LOAs) and Deming regression analyses. A total of 70 participants were consented and enrolled, 15 "normals," 16 with glaucoma ("Glaucoma" sub-group), and 39 with retinal conditions ("Retina" sub-group). Three participants from the Retina sub-group could not complete the required imaging. Therefore, a total of 67 eligible participants completed the study. Of the 36 "Retina" sub-group participants, 12 were assigned to the exudative AMD, DR, and "other" groups each. The age distribution and clinical characteristics of the study cohort are shown in Tables 1 through 5. | | Mean | SD | Median | Min | Max | |---------------------|------|------|--------|-----|-----| | Normal (n=15) | 47 | 21.8 | 41 | 19 | 84 | | Glaucoma (n=16) | 72 | 7.4 | 73 | 62 | 87 | | Retina (n=36) | 68 | 16.1 | 71 | 21 | 95 | | Wet AMD (n=12) | 77 | 9.6 | 74 | 66 | 95 | | DR (n=12) | 56 | 12.7 | 57 | 31 | 77 | | Retina other (n=12) | 70 | 18.0 | 75 | 21 | 90 | | | Table 1. Age Distribution for All Subjects by Enrollment Category | | |--|-------------------------------------------------------------------|--| | | | | | Table 2. Visual Field and Optic Nerve Head Characteristics Distribution in Glaucoma Group | |--------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------| | Glaucoma Stage (Total N=16) | VF PSD mean (range) dB | VF MD mean (range) dB | VF GHT outside normal limits (N of eyes) | ONH rim thinning (N of eyes) | RNFL defect (N of eyes) | ONH cupping (N of eyes) | |--------------------------------|---------------------------|---------------------------------|------------------------------------------------|------------------------------------|-------------------------------|-------------------------------| | Early N=7 | 2.69 (1.76 to 3.52) | -1.71 (-2.71 to -0.32) | 5 | 5 | 0 | 7 | | Moderate N=4 | 4.74 (3.33 to 6.08) | -3.62 (-4.42 to -3.04) | 4 | 4 | 1 | 3 | | Advanced N=5 | 11.66 (10.72 to 12.23) | -14.06 (-25.79 to - 7.84) | 5 | 5 | 2 | 5 | #### Table 3. Imaging Findings and Treatment in Retina Wet AMD Sub-group | Subject | Eye | Sub- Group | Type 1 CNV | Type 2 CNV | IRF | SRF | PED | CNV seen on OCTA | Treatment | |---------|-----|---------------|---------------|---------------|-----|-----|-----|---------------------|-----------| | SD7529 | OS | wetAMD | 1 | | 1 | | | 1 | | | SD7533 | OD | wetAMD | | 1 | 1 | | | 1 | 1 | | SD7549 | OS | wetAMD | 1 | | 1 | | | 1 | 1 | | SD7551 | OD | wetAMD | | 1 | | 1 | 1 | | | | SD7553 | OS | wetAMD | 1 | | | 1 | | | | | SD7555 | OS | wetAMD | | 1 | | | | | 1 | | SD7557 | OD | wetAMD | | 1 | 1 | | | | 1 | | SD7558 | OD | wetAMD | 1 | | | | | 1 | 1 | | SD7561 | OD | wetAMD | | 1 | | | | 1 | 1 | | SD7563 | OS | wetAMD | 1 | | | 1 | | | | | SD7564 | OD | wetAMD | 1 | | | 1 | | 1 | 1 | | SD7568 | OS | wetAMD | 1 | | | | | 1 | 1 | | Sum | | | 7 | 5 | 4 | 4 | 1 | 7 | 8 | {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in a simple, sans-serif font, with the letters in a light gray color. To the left of the word is a circular graphic that is open on the right side. The graphic transitions in color from a bright orange at the bottom to a lighter yellow at the top, creating a gradient effect. | Subject | Eye | Sub- Group | DR Severity | w/ DME | w/o DME | IRF | Reduced Retinal Vascular Density | Other Vascular Change | Treatment | |---------|-----|---------------|---------------|--------|---------|-----|-------------------------------------|-----------------------------|-----------| | SD7537 | OD | DR | Moderate NPDR | 1 | | 1 | 1 | | | | SD7538 | OD | DR | PDR | 1 | | 1 | 1 | | | | SD7539 | OS | DR | Moderate NPDR | 1 | | 1 | 1 | IRMA | | | SD7540 | OS | DR | PDR | 1 | | 1 | | dilation, tortuosity | | | SD7543 | OS | DR | Moderate NPDR | 1 | | 1 | 1 | dilation, tortuosity, MA | | | SD7547 | OS | DR | PDR | 1 | | 1 | 1 | FAZ Outpouching | 1 | | SD7554 | OD | DR | Moderate NPDR | 1 | | 1 | 1 | dilation, tortuosity | | | SD 7556 | OD | DR | Moderate NPDR | 1 | | 1 | 1 | | | | SD7560 | OS | DR | PDR | 1 | | 1 | 1 | FAZ outpouching | 1 | | SD7565 | OS | DR | PDR | | 1 | | 1 | FAZ outpouching | 1 | | SD7566 | OS | DR | PDR | | 1 | | | FAZ outpouching | 1 | | SD7567 | OD | DR | Mild NPDR | | 1 | | 1 | | | | | Sum | | | 8 | 3 | 8 | 10 | | 4 | Table 4. Clinical and Imaging Findings, and Treatment in Retina DR Sub-group #### Table 5. Clinical and Imaging Findings, and Treatment in Retina Other Sub-group | Subject | Eye | Sub- Group | Details | IRF | SRF | CNV on OCTA | Reduced Retinal Vascular Density | Other Vascular Change | Treatment | |---------|-----|---------------|-------------------------|-----|-----|----------------|-------------------------------------|--------------------------|-----------| | SD7528 | OS | Other | ERM | | | | | | | | SD7534 | OD | Other | BRVO w/CME | | | | 1 | | 1 | | SD7535 | OD | Other | dryAMD | | | | | | | | SD7541 | OD | Other | dryAMD | | | | | | | | SD7542 | OD | Other | dryAMD | | | | | | | | SD7544 | OS | Other | Traumatic CNV | | | 1 | | | | | SD7545 | OD | Other | PCV | | 1 | 1 | | | 1 | | SD7546 | OS | Other | BRVO | 1 | | | 1 | | 1 | | SD7548 | OS | Other | | | | | | | | | SD7550 | OD | Other | ERM w/ lamellar hole | | | | | | | | SD7559 | OD | Other | BRVO | 1 | | | 1 | | 1 | | SD7569 | OD | Other | BRVO | 1 | | | 1 | dilation, tortuosity | 1 | | | Sum | | | 3 | 1 | 2 | 4 | | 5 | #### Results The frequency of scan exclusion due to insufficient image quality are shown as follows: - 3-mm AngioRetina scan 12.9% (77 out of 595 scans) ● - 6-mm HD AngioRetina scan - 14.4% (86 out of 598 scans) - . 4.5-mm HD AngioDisc – 3.7% (10 out of 268 scans) (only Normal and Glaucoma groups) For the 3-mm AngioRetina scan, the edit rates were: IPL 13.3%, BRM 11.6%, OPL 6%, RPE 3.5%, and ILM 0% for segmentation, FAZ boundary 10.8%, and ETDRS grid re-centering 1.5%. For the 6-mm HD AngioRetina scan, the edit rates were: IPL 13.9%, BRM 10.4%, {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in a sans-serif font, with the letters in gray. To the left of the word is a circular design that is colored in shades of orange and yellow, creating a gradient effect. The circular design appears to be incomplete, with an opening at the top. OPL 5.5%, RPE 2.3%, and ILM 0.6% for segmentation, FAZ boundary17.7%, and ETDRS grid re-centering 1.8%. The results are provided below, organized by scan patterns and measurements. Vascular Parameters of the 3-mm Angio Retina and 6-mm HD AngioRetina Scans Tables 6 through 11 summarize the results of the R&R analysis of vascular parameters of 3-mm Angio Retina and 6-mm HD AngioRetina scans. {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized orange circle on the left, with the word "OPTOVUE" in gray, sans-serif font to the right of the circle. The circle is not a complete circle, but rather an arc that fades from a darker orange at the bottom to a lighter orange at the top. ## Table 6 Vascular Parameters of AngioRetina Scans, Normal Group | | | | | | | | | | Normal | | | | | | | | | | | |---------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------|----------------|----------------|----------------|-------------------------|---------------------------|---------------------------|--------------------------------------|--------------|----------------|----------------|----------------|----------------|-------------------------|----------------------------------|---------------------------|--------------------------------------| | | | | | | | | | 6-mm HD AngioRetina Scan | | | | | | | | 3-mm AngioRetina Scan | | | | | | Parameter | Scan # | Mean | SD | min | max | repeat ability SD | reprodu cibility SD | Reprodu cibility CV | 95% limits of reprodu cibility | Scan # | Mean | SD | min | max | ability SD | repeat reprodu cibility SD | Reprodu cibility CV | 95% limits of reprodu cibility | | | WI | 128 | 50.5 | 3.2 | 41.0 | 56.0 | 2.3 | 2.4 | 4.8% | 6.7 | 129 | 48.0 | 3.5 | 38.3 | 53.2 | 1.7 | 1.9 | 3.9% | 5.2 | | | WI_S_Hemi | 128 | 50.8 | 3.3 | 40.8 | 56.5 | 2.3 | 2.5 | 4.9% | 6.9 | 129 | 48.7 | 3.8 | 38.0 | 54.4 | 1.8 | 2.1 | 4.2% | 5.7 | | | WI_I_Hemi | 128 | 50.3 | 3.3 | 41.1 | 55.9 | 2.4 | 2.4 | 4.9% | 6.8 | 129 | 47.3 | 3.5 | 38.5 | 54.3 | 2.0 | 2.1 | 4.4% | 5.8 | | | All (0-6) C (1) | 128 128 | 50.6 27.4 | 3.3 7.1 | 40.6 8.6 | 56.1 44.3 | 2.3 1.9 | 2.4 2.2 | 4.8% 8.2% | 6.7 6.1 | 129 129 | 47.6 24.0 | 3.4 6.5 | 37.9 7.9 | 53.1 39.6 | 1.6 1.4 | 1.8 1.5 | 3.7% 6.4% | 4.9 4.2 | | | All (1-3) | 128 | 53.0 | 3.5 | 42.7 | 59.2 | 2.7 | 2.8 | 5.4% | 7.9 | 129 | 50.7 | 3.3 | 41.6 | 55.7 | 1.8 | 1.9 | 3.7% | 5.2 | | | S_Hemi (1-3) | 128 | 53.3 | 3.4 | 45.0 | 60.0 | 2.4 | 2.6 | 4.9% | 7.3 | 129 | 50.8 | 3.5 | 41.3 | 56.6 | 1.7 | 1.9 | 3.7% | 5.2 | | | I_Hemi (1-3) | 128 | 52.7 | 4.0 | 36.2 | 58.5 | 3.2 | 3.3 | 6.4% | 9.2 | 129 | 50.5 | 3.4 | 41.1 | 55.9 | 2.1 | 2.1 | 4.3% | 6.0 | | | T (1-3) | 128 | 53.8 | 3.4 | 35.8 | 60.2 | 2.7 | 2.8 | 5.3% | 7.9 | 129 | 50.2 | 2.9 | 42.3 | 56.0 | 1.7 | 1.9 | 3.8% | 5.3 | | | ર (1-3) | 128 128 | 53.5 52.2 | 3.8 4.0 | 43.6 40.5 | 61.2 58.7 | 2.7 3.3 | 2.9 3.3 | 5.5% 6.4% | 8.1 9.3 | 129 129 | 51.5 49.9 | 3.8 3.6 | 40.6 38.9 | 58.2 56.7 | 2.0 1.9 | 2.2 2.1 | 4.2% 4.2% | 6.0 5.8 | | Superficial | N (1-3) I (1-3) | 128 | 52.5 | 4.7 | 30.6 | 59.0 | 3.9 | 4.0 | 7.6% | 11.0 | 128 | 51.1 | 4.0 | 40.4 | 57.4 | 2.5 | 2.5 | 4.9% | 7.0 | | (ILM to | All (3-6) | 128 | 50.7 | 3.4 | 40.7 | 56.7 | 2.3 | 2.4 | 4.8% | 6.8 | - | | | - | - | - | | - | - | | IPL-10μm) | S_Hemi (3-6) | 128 | 50.9 | 3.5 | 40.2 | 56.3 | 2.4 | 2.6 | 5.1% | 7.1 | | | - | | | - | - | | - | | Vessel | I_Hemi (3-6) | 128 | 50.5 | 3.5 | 41.2 | 57.2 | 2.4 | 2.5 | 4.9% | 6.8 | - | | - | - | - | | - | | - | | Density | T (3-6) | 128 | 47.6 | 3.4 | 36.7 | 53.3 | 2.5 | 2.7 | 5.7% | 7.5 | - | | - | | | - | - | | - | | (%) | ર (3-6) N (3-6) | 128 128 | 51.0 54.1 | 3.8 3.7 | 40.4 44.5 | 57.8 60.3 | 2.6 2.4 | 2.7 2.5 | 5.4% 4.6% | 7.6 6.9 | - | - - | - - | | - - | - | - - | | - - | | | ા (3-6) | 128 | 50.2 | 3.8 | 38.3 | 57.0 | 2.6 | 2.6 | 5.2% | 7.3 | - | | - | | - | - | - | | - | | | G11 | 128 | 52.1 | 6.3 | 36.8 | 61.9 | 2.5 | 2.5 | 4.8% | 6.9 | 129 | 50.7 | 4.2 | 37.6 | 58.9 | 2.4 | 2.5 | 4.9% | 6.9 | | | G12 | 128 | 51.6 | 3.7 | 41.7 | 58.6 | 2.6 | 2.8 | 5.4% | 7.7 | 129 | 52.2 | 3.6 | 39.7 | 58.1 | 2.0 | 2.1 | 4.1% | 5.9 | | | C13 | 128 | 48.9 | 6.4 | 33.9 | 61.4 | 2.9 | 3.3 | 6.7% | 9.1 | 129 | 49.7 | 4.9 | 35.3 | 59.3 | 2.4 | 2.9 | 5.8% | 7.9 | | | G21 | 128 | 51.6 | 4.3 | 40.1 | 59.3 | 2.6 | 2.6 | 5.1% | 7.3 | 129 | 49.7 | 3.4 | 38.9 | 55.8 | 2.0 | 2.2 | 4.4% | 6.0 | | | G22 G23 | 128 128 | 48.3 50.8 | 3.5 4.3 | 37.6 38.0 | 54.9 59.9 | 2.4 2.4 | 2.6 2.7 | 5.4% 5.3% | 7.2 7.4 | 129 129 | 29.5 49.3 | 5.7 3.1 | 14.2 41.2 | 42.1 55.3 | 1.8 1.6 | 1.9 1.8 | 6.5% 3.6% | 5.3 4.9 | | | G31 | 128 | 51.0 | 6.0 | 36.1 | 61.3 | 2.7 | 2.7 | 5.3% | 7.4 | 129 | 50.5 | 4.8 | 30.6 | 57.4 | 3.2 | 3.2 | 6.4% | 8.9 | | | G32 | 128 | 50.7 | 4.0 | 35.7 | 58.2 | 2.9 | 2.9 | 5.7% | 8.0 | 129 | 50.3 | 4.1 | 38.6 | 57.2 | 2.6 | 2.7 | 5.3% | 7.4 | | | ૯૩૩ | 128 | 49.6 | 5.6 | 35.6 | 61.3 | 2.8 | 2.9 | 5.9% | 8.2 | 129 | 50.3 | 4.2 | 39.1 | 57.6 | 2.3 | 2.5 | 4.9% | 6.9 | | | WI | 128 | 50.7 | 4.8 | 40.4 | 64.5 | 3.9 | 3.9 | 7.8% | 10.9 | 129 | 49.5 | 3.5 | 42.0 | 59.2 | 2.3 | 2.5 | 5.0% | 6.8 | | | WI_S_Hemi | 128 | 50.9 | 5.0 | 40.8 | 64.9 | 4.1 | 4.2 | 8.3% 7.6% | 11.7 | 129 | 50.0 | 3.7 | 42.2 | 60.4 | 2.4 | 2.7 | 5.3% 4.9% | 7.4 | | | WI_I_Hemi All (0-6) | 128 128 | 50.4 52.0 | 4.9 4.7 | 38.0 42.3 | 64.5 64.7 | 3.8 3.7 | 3.8 3.8 | 7.3% | 10.6 10.5 | 129 129 | 49.1 49.4 | 3.5 3.4 | 41.6 43.0 | 58.6 59.9 | 2.4 2.0 | 2.4 2.1 | 4.3% | 6.7 5.9 | | | C (1) | 128 | 38.2 | 7.8 | 16.8 | 50.9 | 1.9 | 2.0 | 5.2% | 5.4 | 129 | 33.0 | 7.4 | 13.9 | 46.2 | 1.3 | 1.3 | 4.1% | 3.7 | | | All (1-3) | 128 | 54.0 | 3.6 | 46.1 | 63.5 | 2.8 | 2.8 | 5.2% | 7.8 | 129 | 51.5 | 3.5 | 43.1 | 62.2 | 2.2 | 2.4 | 4.6% | 6.6 | | | S_Hemi (1-3) | 128 | 54.2 | 3.6 | 45.6 | 62.7 | 2.9 | 2.9 | 5.3% | 8.0 | 129 | 51.6 | 3.5 | 43.3 | 63.2 | 2.3 | 2.4 | 4.7% | 6.7 | | | l_Hemi (1-3) | 128 | 53.8 | 3.9 | 42.6 | 64.7 | 3.0 | 3.2 | 5.9% | 8.8 | 129 | 51.5 | 3.6 | 43.0 | 61.3 | 2.3 | 2.5 | 4.8% | 6.8 | | | T (1-3) | 128 128 | 54.9 53.3 | 3.8 4.1 | 38.9 43.1 | 64.2 63.4 | 2.9 3.4 | 3.0 3.5 | 5.4% 6.5% | 8.2 9.6 | 129 129 | 52.1 51.2 | 3.3 3.9 | 45.4 39.9 | 62.2 64.0 | 2.1 2.6 | 2.2 2.8 | 4.3% 5.5% | 6.2 7.8 | | | ટ (1-3) N (1-3) | 128 | 55.0 | 3.8 | 46.3 | 64.9 | 3.1 | 3.1 | 5.6% | 8.6 | 129 | 51.9 | 3.5 | 42.8 | 62.5 | 2.1 | 2.3 | 4.5% | 6.4 | | Deep | I (1-3) | 128 | 52.8 | 4.6 | 30.0 | 65.4 | 3.7 | 3.9 | 7.5% | 10.9 | 128 | 50.8 | 4.0 | 41.2 | 60.2 | 2.8 | 2.9 | 5.6% | 7.9 | | (IPL-10μ to | All (3-6) | 128 | 51.9 | 5.2 | 39.9 | 65.9 | 4.2 | 4.2 | 8.2% | 11.7 | | | | - | | - | - | - | | | OPL+10μ) | S_Hemi (3-6) | 128 | 52.2 | 5.3 | 41.4 | 66.0 | 4.3 | 4.4 | 8.5% | 12.2 | | - | - | | - | - | | | - | | Vessel Density | I_Hemi (3-6) | 128 | 51.6 | 5.4 | 36.0 | 66.5 | 4.2 | 4.3 | 8.3% | 11.8 | - | - | - | | - | | י | | י | | (%) | 1 (3-6) ર (3-6) | 128 128 | 54.8 51.7 | 4.4 5.8 | 43.6 40.8 | 65.0 67.7 | 3.6 4.7 | 3.7 4.8 | 6.7% 9.3% | 10.1 13.3 | - | | - | - - | - | | - - | | - - | | | n (3-6) | 128 | 50.4 | 6.0 | 36.5 | 66.6 | 4.9 | 5.0 | 9.9% | 13.8 | - | - | - | - | - | - | - | | - | | | ા (3-6) | 128 | 50.7 | 5.9 | 32.9 | 66.4 | 4.7 | 4.7 | 9.3% | 13.0 | - | | | | | | - | - | | | | G11 | 128 | 49.0 | 6.4 | 37.7 | 66.6 | 5.6 | 5.7 | 11.6% | 15.8 | 129 | 50.2 | 4.3 | 39.8 | 60.7 | 3.6 | 3.7 | 7.4% | 10.2 | | | G12 | 128 | 51.2 | 5.7 | 40.4 | 67.2 | 4.7 | 4.8 | 9.3% | 13.2 | 129 | 51.1 | 3.9 | 40.5 | 62.1 | 2.7 | 2.8 | 5.5% | 7.8 | | | G13 G21 | 128 128 | 49.5 52.8 | 6.7 4.9 | 33.5 42.3 | 65.0 66.4 | 4.9 4.1 | 5.1 4.1 | 10.4% 7.8% | 14.2 11.4 | 129 129 | 50.8 52.2 | 4.3 3.3 | 39.2 44.5 | 62.5 60.8 | 3.0 2.1 | 3.4 2.1 | 6.7% 4.1% | ਰੇ.5 5.9 | | | G22 | 128 | 51.8 | 3.2 | 45.2 | 60.4 | 2.3 | 2.3 | 4.4% | 6.3 | 129 | 37.5 | 5.8 | 20.2 | 48.9 | 1.8 | 2.0 | 5.4% | 5.6 | | | G23 | 128 | 53.7 | 4.8 | 41.5 | 64.0 | 3.8 | 3.9 | 7.2% | 10.7 | 129 | 52.0 | 3.3 | 45.0 | 62.2 | 2.0 | 2.1 | 4.0% | 5.8 | | | G31 | 128 | 48.1 | 6.3 | 31.6 | 65.8 | 4.9 | 4.9 | 10.2% | 13.6 | 129 | 50.3 | 4.4 | 39.5 | 60.3 | 3.5 | 3.6 | 7.1% | ਰੇ. 9. 9 | | | G32 | 128 | 50.9 | 5.5 | 34.9 | 65.8 | 4.5 | 4.6 | 9.0% | 12.7 | 129 | 51.3 | 4.2 | 41.0 | 61.6 | 3.0 | 3.1 | 6.0% | 8:5 | | | G33 | 128 | 49.1 | 7.3 | 30.1 | 64.3 | 4.6 | 4.6 | 9.5% | 12.9 | 129 | 50.3 | 4.5 | 38.7 | 60.8 | 3.4 | 3.6 | 7.2% | 10.0 | | FAZ | FAZ (mm") PERIM (mm) | 128 128 | 0.270 1.975 | 0.120 0.456 | 0.069 0.964 | 0.585 3.080 | 0.012 0.085 | 0.012 0.086 | 4.2% 4.3% | 0.032 0.238 | 129 129 | 0.284 2.092 | 0.127 0.494 | 0.080 1.127 | 0.582 3.189 | 0.008 0.063 | 0.009 0.066 | 3.0% 3.1% | 0.024 0.182 | | | FD-300 (%) | 128 | 54.0 | 4.1 | 39.6 | 61.6 | 2.5 | 2.6 | 4.9% | 7.3 | 129 | 50.7 | 3.7 | 41.2 | 57.7 | 2.0 | 2.0 | 3.8% | 5.4 | | | | | | | | | | | Glaucoma…

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