Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes image processing and quantitative analysis based on OCT and OCTA data, but there is no mention of AI or ML algorithms being used for these processes or for the integrated normative database comparison. The performance studies focus on repeatability, reproducibility, and agreement with manual measurements or phantom models, not on the performance of an AI/ML model.

Therapeutic

No
The device is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases, not for therapeutic purposes.

Diagnostic

Yes

Explanation: 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 the Avanti is a "computer-controlled ophthalmic imaging system" that "employs noninvasive, non-contact, low-coherence interferometry to obtain these high-resolution reflectance images". This indicates the device includes hardware components for image acquisition, not just software for processing.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Avanti's Function: The Avanti is an in vivo imaging system. It directly images structures within the living eye using optical coherence tomography (OCT) and OCT angiography (OCTA). It does not analyze samples taken 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 reinforces that it is a non-invasive, non-contact system that produces images of ocular structures without contacting the eye.

Therefore, the Avanti device falls under the category of medical imaging devices rather than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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, Avanti is also a quantitative 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.

Product codes

OBO, HLI

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT)

Anatomical Site

Anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye.

Indicated Patient Age Range

Adults (18 years or older) for the R&R study, specific age ranges are provided for subgroups in the clinical study (e.g., Normal (n=15) Mean 47, Glaucoma (n=16) Mean 72, Retina (n=36) Mean 68).

Intended User / Care Setting

Not Found

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

Not Found

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

Software Verification and Validation Testing:
- Sample Size: Not explicitly stated, but refers to "a series of 3D phantom models."
- Data Source: 3D phantom models constructed with the same raw data format as OCTA scans of the eye, containing an OCT volume and an OCTA volume with spatial colocalization.
- Annotation Protocol: "known ground truth for vessel density measurements." Phantoms contained "different wireframe densities and/or patterns to cover a range of physiologically relevant vascular densities and pathologies." Projection artifacts were simulated. Large vessels with varying diameters were included. "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."
Clinical Performance Testing for Repeatability & Reproducibility:
- Sample Size: 70 participants consented and enrolled (15 Normals, 16 Glaucoma, 39 Retina). 67 eligible participants completed the study. For FAZ Validation, 30 eyes of 26 subjects. For Corneal Epithelial Thickness Mapping, 62 participants enrolled, analysis on 60 (12 Normals, 12 Contact Lens, 11 Dry Eye, 12 Post-LRS, 13 Keratoconus).
- Data Source: Prospective, observational clinical studies conducted at single or three clinical U.S. sites.
- Annotation Protocol:
  - For Repeatability and Reproducibility: "The study eye is imaged three times using relevant OCTA scan patterns with each of three Avanti instrument-operator pairs."
  - For Retinal Thickness, RNFL Thickness, and Disc Measurements Agreement: "study eyes were also scanned once with each of four predicate ('legacy') posterior segment scan patterns."
  - For FAZ Parameter Validation: "One early phase FA image with sufficient quality to visualize the FAZ per case was included in the FA grading set, and one 3 mm AngioRetina scan per case with sufficient scan quality was included in the OCTA measurement set." Three readers experienced in FA image grading performed FAZ measurements, randomized grading order, masked to each other's results, masked to OCTA images. ImageJ software used for FAZ measurement.
  - For Corneal Epithelial Thickness Mapping: "Each study eye was imaged at least three times using the PachymetryWide scan pattern with each of three Avanti instrument/operator pairs." "Post-acquisition image review of signal strength, pupil alignment, eyelid artifact, scan range, and motion artifact was conducted on all scans." "Manual edits of the segmentation lines" were performed for some scans.
  - For Corneal Epithelial Thickness Mapping Agreement: "Manual measurements performed by three qualified graders at 15 locations along each of the eight meridians in the PachymetryWide scan pattern in a randomized order with a 2-section caliper tool that was available in the previously cleared RTVue XR with CAM device." Graders masked to each other's results.

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

Software Verification and Validation Testing:
- Study Type: Non-clinical performance testing using 3D phantom models.
- Sample Size: Not explicitly stated, "a series of 3D phantom models".
- Key Results: Acceptable accuracy for vessel density measurements across various parameters and phantom types (3-mm AngioRetina, 6-mm HD AngioRetina, 4.5-mm HD AngioDisc). Differences between software reported and expected values were small (ranging from -3.0% to 4.3% for superficial and deep vessel density in 3-mm AngioRetina, -4.7% to 5.8% for 6-mm HD AngioRetina, and -2.9% to 3.4% for 4.5-mm HD AngioDisc).
Clinical Performance Testing:
- Study Type: Prospective, observational studies evaluating repeatability, reproducibility, and agreement.
- Sample Size:
  - Repeatability and Reproducibility of AngioVue (vascular parameters, retinal thickness, optic disc parameters): 67 participants (15 Normal, 16 Glaucoma, 36 Retina).
  - FAZ Parameter Validation: 30 eyes of 26 subjects.
  - FAZ Parameters Agreement between AngioRetina scans: 62 subjects/eyes.
  - Retinal Thickness, RNFL Thickness, and Disc Measurements Agreement: 67 study eyes for Full Retina and Inner Retina thickness, 31 subjects for RNFL thickness and optic disc measurement.
  - Corneal Epithelial Thickness Mapping R&R: 60 participants (12 Normal, 12 CL, 11 Dry Eye, 12 Post-LRS, 13 KCN).
  - Corneal Epithelial Thickness Mapping Agreement: 85 subjects (17 Normal, 15 CL, 18 Dry Eye, 19 Post-LRS, 16 KCN).
- Key Results:
  - AngioVue Repeatability & Reproducibility: Detailed tables demonstrate good repeatability and reproducibility across normal, glaucoma, and retina groups for various vascular and thickness parameters, with low coefficients of variation (CV) and narrow 95% limits of reproducibility.
  - FAZ Parameter Validation (software vs. manual FA): Mean difference for Area was 0.070 mm² (17.7%), and for Perimeter was 0.205 mm (7.5%). Deming regression slopes were close to 1 (Area: 0.929, Perimeter: 1.163).
  - FAZ Parameters Agreement (3-mm vs. 6-mm scans): Mean difference for Area was -0.007 mm² (-0.3%), Perimeter -0.107 mm (-5.0%), FD-300 3.195% (6.9%). Deming regression slopes were close to 1 (Area: 1.002, Perimeter: 0.948, FD-300: 1.079).
  - Retinal Thickness, RNFL Thickness, and Disc Measurements Agreement (AngioRetina vs. Retina Map/GCC/ONH): LOA analyses showed small mean differences and reasonable spread, with Deming regression slopes generally close to 1 for various parameters.
  - Corneal Epithelial Thickness Mapping Repeatability & Reproducibility: Low SDs and CVs across various zonal parameters for pachymetry, epithelium, and stroma thickness measurements, indicating good R&R.
  - Corneal Epithelial Thickness Mapping Agreement (software vs. manual): LOA and Deming regression analyses showed general agreement between software and manual measurements for pachymetry, epithelial thickness, and stromal thickness in different patient groups.

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

Repeatability Standard Deviation (repeatability SD)
Reproducibility Standard Deviation (reproducibility SD)
Reproducibility Coefficient of Variation (Reproducibility CV)
95% Limits of Reproducibility
Mean of Differences (for agreement studies)
Standard Deviation of Differences (for agreement studies)
95% Limits of Agreement (LOA)
Deming Regression Intercept and Slope with 95% Confidence Intervals

Predicate Device(s)

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

Reference Device(s)

Optovue iVue (K163475)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

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

Summary

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)

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 1yr | 10 | 83.3% |
| > 3mo | 1 | 8.3% |
| > 1mo | 1 | 8.3% |

Table 24. Post-LRS Group Clinical Data Summary

The subjects in the KCN group all had a clinical diagnosis of keratoconus. None of the KCN subjects had any prior surgical treatment.

Clinical Signs	Total	% Total
Slit lamp exam	8	57.1%
Topographic patterns	2	14.3%
Slit lamp exam & Topographic patterns	4	28.6%
Retinoscope reflex	0	0.0%
Severity (clinically established by PI)	Total	% Total
Mild	6	42.9%
Moderate	5	35.7%
Severe	3	21.4%

Table 25. KCN Group Distribution by Clinical Signs and Severity

Table 26. Distribution of Steep K and Delta K (difference between Steep K and Flat K) in KCN Group
----------------------------------------------------------------------------------------------------

Corneal Curvature	Min	Median	Mean	Max	SD
Steep K	45.73	52.36	52.27	62.72	5.098
Delta K	1.02	3.23	4.75	21.95*	5.154

The repeatability and reproducibility (R&R) results are show in Tables 27 through 31.

32

Image /page/32/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in a simple, sans-serif font. To the left of the word is a circular graphic that appears to be a gradient of orange and yellow, resembling a sunrise or a stylized eye. The text is in a light gray color, providing a subtle contrast against the white background.

												Normal Group (n = 105 scans)
	Pachymetry
Epithelium							Stroma
					Repeat
ability			Reproducibility				Repeat
ability			Reproducibility				Repeat
ability			Reproducibility
	Mean	SD	Min	Max	SD	SD COV	95%
Limits	Mean SD Min Max				SD	SD COV	95%
Limit	Mean	SD	Min	Max	SD	SD COV	95%
Limits
C_2	551.3 23.2		518.4 608.1		1.4	1.5 0.3%	4.3	54.5	5.9	45.3	69.1	0.7		0.8 1.4%	2.1	496.7	23.2	467.2	546.6	1.2	1.2 0.3%	3.5
T_2_5	564.7	23.9		527.5 615.0	2.3	2.3 0.4%	6.3	53.8	5.1	44.5	66.1	0.8		0.8 1.5%	2.2			510.9 23.4 476.9	555.3	2.1	2.1 0.4%	5.9
ST_2_5	580.9	22.4	547.8 625.7		3.4	3.5 0.6%	9.6	53.9	4.5	46.0	63.9	0.9		0.9 1.7%	2.6			527.0 22.0 494.1 569.4		3.3	3.4 0.7%	9.6
S 2 5			593.9 20.7 561.7 639.1		4.0	4.0 0.7%	11.0	54.2		4.3 46.1	63.9	1.2		1.2 2.2%	3.3			539.7 20.8 507.5	581.8	3.9	4.0 0.7%	11.0
SN 2 5	590.5 19.8		554.1 639.9		4.1	4.1 0.7%	11.5	54.5	4.5	46.3	65.7	1.2	1.2	2.2%	3.3			536.0 20.1 500.9	580.6	4.0	4.1 0.8%	11.3
N_2_5	579.2 20.3		545.6 631.2		3.3	3.3 0.6%	9.1	54.9		4.9 46.2	67.3	0.9		1.0 1.8%	2.7	524.3 20.5		493.0 570.9		3.1	3.1 0.6%	8.7
IN_2_5			571.2 21.8 542.0 625.9		2.7	2.7 0.5%	7.5	56.0		5.6 48.3	69.1	0.7		0.7 1.3%	2.1			515.2 21.5 488.6 564.1		2.5	2.5 0.5%	6.9
I_2_5	565.4 23.2			530.1 623.9	2.1	2.2 0.4%	6.1	56.2		6.6 46.9	71.7	0.8		0.8 1.5%	2.3			509.2 22.4 482.3 559.7		2.1	2.1 0.4%	5.8
IT_2_5	560.3	23.9	523.2 617.7		1.8	1.8 0.3%	4.9	54.8		6.0 45.7	70.1	0.9		0.9 1.7%	2.6	505.5 23.3		474.2 555.5		1.9	1.9 0.4%	5.1
T_5_7			592.9 23.6 544.7 634.7		3.8	3.8 0.6%	10.4	53.2			4.1 42.0 61.0	0.9		0.9 1.6%	2.4			539.7 22.8 500.3 578.8		3.8	3.8 0.7%	10.7
ST_5_7	621.0 20.9		584.5	661.5	4.8	5.0 0.8%	13.8	52.0		3.5 45.2	61.1	1.1		1.1 2.2%	3.1			569.0 20.7 533.7 609.8		5.0	5.2 0.9%	14.4
S_5_7			641.9 19.2 609.0 683.7		5.1	5.2 0.8%	14.4	52.3			3.4 45.8 65.0	1.4		1.5 2.9%	4.1			589.6 20.1 555.1 630.4		5.2	5.4 0.9%	14.9
SN 5 7	634.5	18.9	600.1	675.2	5.9	6.0 1.0%	16.7	54.2	3.1	47.9	62.1	1.2	1.3	2.3%	3.5			580.3 19.2 544.8 618.5		5.7	5.9 1.0%	16.4
N_5_7	615.2 18.2			584.0 654.9	4.9	4.9 0.8%	13.6	55.2		4.1 48.5	65.0	0.9		1.0 1.8%	2.7			560.1 18.2 529.9 596.5		4.6	4.6 0.8%	12.8
IN 5 7			604.3 20.3 569.9 652.9		4.7	4.7 0.8%	13.1	56.3	5.2	47.9	68.7	0.8		0.8 1.3%	2.1			548.0 19.9 521.9 598.3		4.5	4.5 0.8%	12.5
I_5_7	597.6 22.7			553.3 646.6	4.1	4.2 0.7%	11.6	56.7		6.7 45.1	71.1	0.8		0.8 1.4%	2.1			540.9 21.6 508.2 592.1		4.1	4.2 0.8%	11.6
IT_5_7	588.1	23.2	540.4 636.7		3.9	3.9 0.7%	10.7	55.1		5.6 45.1	66.8	1.0		1.0 1.8%	2.7	533.0 22.5		493.2 575.1		4.0	4.0 0.7%	11.1
T_7_9			628.0 24.6 569.6 674.7		6.8	7.0 1.1%	19.5	52.2		3.6 42.9	58.4	0.9		0.9 1.7%	2.5			575.8 23.9 525.6 623.0		6.8	7.1 1.2%	19.7
ST_7_9			666.2 22.1 616.6 703.4		7.9	8.3 1.2%	22.9	49.3		3.3 41.5	57.1	1.1		1.2 2.3%	3.2	616.9 22.3		571.6 655.8		8.1	8.5 1.4%	23.7
S_7_9			688.2 19.6 641.0 724.0		8.1	8.2 1.2%	22.7	49.7		3.4 41.3	56.5	1.5		1.5 3.0%	4.1			638.4 21.1 588.6 676.4		8.1	8.3 1.3%	23.0
SN_7_9			681.9 19.7 635.0 724.9		8.2	8.2 1.2%	22.7	53.4		3.0 48.0	61.0	1.5	1.5	2.9%	4.3	628.5		20.6 578.2 672.3		8.1	8.1 1.3%	22.5
N_7_9			658.0 20.3 619.7 697.4		6.8	6.8 1.0%	18.8	56.4		4.1 49.7	66.8	1.4		1.4 2.5%	4.0			601.6 20.4 567.5 643.3		6.4	6.4 1.1%	17.9
IN_7_9			646.2 23.0 598.0 713.3		7.3	7.3 1.1%	20.2	56.5		5.3 49.2	69.9	0.9		0.9 1.6%	2.6			589.7 23.4 548.0 658.2		7.1	7.1 1.2%	19.8
I_7_9	635.7		25.4 578.6 701.0		6.7	6.8 1.1%	18.9	56.4		6.6 46.9	71.0	0.7		0.7 1.2%	1.9			579.3 25.2 531.4 646.3		6.8	6.9 1.2%	19.2
IT_7_9			623.8 24.0 563.5 663.1		6.5	6.5 1.0%	18.1	55.2		5.8 44.2	68.0	0.8		0.9 1.5%	2.4			568.6 23.8 518.0 610.9		6.5	6.6 1.2%	18.2

Table 27. Normal Group R&R Results (Zonal Parameters)

	Table 28. Contact Lens Group R&R Results (Zonal Parameters)
--	-------------------------------------------------------------	--	--	--	--	--

													Contact Lens Group (n = 101 scans)
					Pachymetry				Epithelium								Stroma
	Mean	SD	Min	Max	Repeat
ability			Reproducibility	Mean SD Min Max				Repeat
ability			Reproducibility	Mean	SD	Min Max		Repeat
ability			Reproducibility
					SD	SD	COV	95%
Limits					SD		SD COV	95%
Limits					SD	SD	COV	95%
Limits
C_2	555.4	46.1		454.7 662.6	2.3		2.6 0.5%	7.1	51.1	4.2	40.3	63.0	2.0		2.1 4.0%	5.7	504.3 46.5	400.5 610.5	1.2	1.5	0.3%	4.2
T_2_5	569.2 47.2		465.1	679.2	3.3	3.4	0.6%	9.4	50.4	3.8	41.1	60.3	2.0		2.0 3.9%	5.5	518.9 47.9	412.3 630.4	2.6	2.6	0.5%	7.3
ST_2_5			587.6 45.8 474.0 699.0		4.6	4.7	0.8%	12.9	51.0	3.9		42.7 61.0	1.9		1.9 3.8%	5.3		536.5 47.0 420.6 651.6	4.3	4.4	0.8%	12.3
S_2_5			602.6 45.8 482.3 712.2		4.6	4.9	0.8%	13.5	51.4	3.7	41.8 60.7		1.7	1.7	3.4%	4.8		551.2 46.9 427.7 663.8	4.4	4.8	0.9%	13.4
SN_2_5	598.1	45.1	482.6 704.9		4.2	4.5	0.8%	12.4	51.8		3.9 40.3	61.2	1.7		1.8 3.4%	4.9	546.3 46.2	426.5 655.3	4.0	4.4	0.8%	12.1
N_2_5	584.1 46.1		477.3 690.4		3.3	3.6	0.6%	9.9	51.5	3.7	42.4	58.9	1.7		1.7 3.3%	4.7	532.6 46.7	420.2 637.9	3.3	3.5	0.7%	9.6
IN_2_5	574.3	48.2		476.9 686.0	3.0	3.1	0.5%	8.5	51.6	3.5	43.9	58.9	1.0		1.0 2.0%	2.8		522.7 47.9 418.9 631.1	2.9	2.9	0.6%	8.1
I_2_5			568.3 49.7 472.9 685.4		2.6	2.6	0.5%	7.1	51.8 3.6 44.9 59.4				1.3		1.3 2.5%	3.5		516.5 49.0 416.7 629.1	2.2	2.2	0.4%	6.0
IT_2_5	564.0 49.4			466.8 678.6	2.7	2.7	0.5%	7.5	50.8			3.7 42.8 61.0	1.8		1.8 3.6%	5.1		513.2 49.0 412.3 624.6	1.8	1.8	0.3%	4.9
T_5_7	598.2 49.7			487.5 712.9	4.8	4.8	0.8%	13.4	50.3			2.8 43.1 57.2	ાં ડ		1.5 3.0%	4.2		547.9 49.8 434.7 665.2	4.5	4.5	0.8%	12.4
ST_5_7	630.5 47.7		508.4 745.1		6.4	6.4	1.0%	17.9	49.9	3.7	39.5	59.0	1.9		2.1 4.1%	5.7		580.7 48.2 453.6 698.9	6.5	6.6	1.1%	18.3
S_5_7	655.5	46.1		526.8 756.6	5.9	6.1	0.9%	16.8	50.1	3.3	43.8	59.2	1.9		2.0 4.0%	5.6		605.4 47.0 471.0 709.8	5.8	6.1	1.0%	16.9
SN 5 7			645.1 45.4 518.2 747.3		6.0	6.4	1.0%	17.7	51.8		3.3 41.4 61.4		1.8		1.8 3.5%	5.0		593.3 46.2 463.7 698.1	5.9	6.3	1.1%	17.4
N_5_7	620.0 45.4			504.8 721.4	5.0	5.2	0.8%	14.4	52.0		3.4 42.3	59.6	1.4		1.4 2.7%	3.9		568.0 45.8 450.6 669.4	5.0	5.1	0.9%	14.2
IN_5_7			608.1 47.9 502.9 714.1		5.1	5.1	0.8%	14.2	52.3			2.7 46.8 58.8	1.0		1.0 1.9%	2.8		555.9 47.8 447.8 661.5	4.9	4.9	0.9%	13.5
I_5_7	601.8 50.4			500.9 716.8	4.3	4.3	0.7%	11.8	52.6		3.0 47.0 60.6		1.3		1.3 2.5%	3.7		549.2 50.0 443.9 662.0	4.2	4.2	0.8%	11.7
IT_5_7			592.9 51.5 490.3 710.2		4.4	4.4	0.7%	12.1	51.6 2.6 45.5 60.0				1.4		1.4 2.7%	3.8		541.3 51.1 435.6 657.0	3.9	3.9	0.7%	10.9
T 7 9			633.6 51.4 521.0 755.4		9.4	9.4	1.5%	26.0	50.2		3.3 44.2	59.9	1.7		1.8 3.5%	4.9		583.4 51.0 469.8 709.2	8.8	8.8	1.5%	24.5
ST_7_9	677.7	48.4	549.7 790.1		12.0		12.1 1.8%	33.6	48.9	5.2	34.5	64.6	2.1	2.2	4.5%	6.1	628.8 48.9	499.5 747.7	12.1	12.2	2.0%	33.9
S 7 9			706.0 45.6 571.7 797.4		9.6	9.6	1.4%	26.6	47.7	5.1		38.2 64.9	2.6		2.6 5.5%	7.3	658.3 46.1	523.7 759.2	10.2		10.2 1.6%	28.3
SN_7_9	695.2	44.5		566.3 780.6	7.3	7.8	1.1%	21.7	50.8	4.7		39.7 62.6	1.9		1.9 3.7%	5.2	644.4 45.3	516.7 736.7	7.7	8.2	1.3%	22.7
N_7_9				662.3 43.9 550.3 759.2	6.0	6.2	0.9%	17.1	53.8	3.7		41.8 62.6	1.4		1.4 2.6%	3.8		608.5 44.7 497.4 708.2	5.5	5.6	0.9%	15.5
IN_7_9	649.5		47.0 544.1 750.7		7.7	7.7	1.2%	21.4	53.2		3.7 44.9 62.7		1.1		1.1 2.1%	3.1		596.3 47.5 489.4 702.1	7.3	7.3	1.2%	20.2
I_7_9	640.2		49.8 537.5 753.6		6.6	6.6	1.0%	18.3	53.0 3.2 45.7 60.9				1.2		1.3 2.4%	3.5		587.3 50.7 480.6 703.0	6.7	6.8	1.2%	18.8
IT_7_9			628.0 52.5 524.0 747.3		7.7	7.7	1.2%	21.2	52.7 2.7 45.2 62.1				1.3		1.3 2.5%	3.7		575.4 52.5 470.6 695.9	7.3	7.3	1.3%	20.3

33

Image /page/33/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized circle on the left, with the word "OPTOVUE" to the right of the circle. The circle is colored with a gradient that transitions from orange to yellow. The text "OPTOVUE" is in a simple, sans-serif font and is colored in gray.

													Dry Eye Group (n = 89 scans)
					Pachymetry				Epithelium							Stroma
	Mean	SD	Min	Max	Repeat
ability		Reproducibility		Mean SD Min Max				Repeat
ability			Reproducibility	Mean	SD	Min	Max	Repeat
ability			Reproducibility
					SD	SD	COV	95%
Limits					SD		SD COV	95%
Limits					SD		SD COV	95%
Limits
C_2			536.1 29.0 485.0 588.5		1.6		2.0 0.4%	5.5	54.0		2.8 48.8	59.8	1.1		1.3 2.3%	3.5				482.1 28.9 428.6 529.2	1.4	1.5 0.3%	4.2
T_2_5			549.7 29.1 493.0 598.5		2.9	2.9	0.5%	8.1	53.4		2.6 47.9	59.4	0.9		1.0 1.9%	2.8	496.3 29.3			436.5 541.3	2.7	2.7 0.5%	7.5
ST 2 5	565.9 27.7		507.4 609.7		4.0	4.0	0.7%	11.1	52.1			2.6 45.6 59.5	1.3		1.3 2.5%	3.6			513.8 28.0 453.6 553.1		3.9	3.9 0.8%	10.8
S_2_5	578.7 26.8		527.1	619.4	4.3	4.4	0.8%	12.2	52.0	2.7	45.3	59.2	1.4		1.4 2.8%	4.0	526.7 27.2			473.7 566.3	4.5	4.5 0.9%	12.6
SN 2 5	574.8 26.4		525.1	621.4	4.1	4.3	0.7%	11.9	52.8	2.8	46.6	59.9	1.5		1.5 2.9%	4.2	522.0 26.8			470.8 561.8	4.2	4.4 0.8%	12.1
N_2_5	562.3 27.4		510.1	614.7	3.3	3.7	0.7%	10.2	53.8		2.8 48.6	62.3	1.3		1.4 2.6%	3.8	508.6 27.5		454.3	555.4	3.3	3.6 0.7%	10.0
IN_2_5	554.7 28.5		506.3 606.2		2.5		2.8 0.5%	7.7	54.6			2.8 48.6 63.5	1.2		1.2 2.3%	3.4			500.1 28.8 449.5 546.6		2.4	2.5 0.5%	7.0
I_2_5	550.4 29.2		502.6 598.1		2.3		2.6 0.5%	7.2	55.1		2.8 49.7	60.9	1.1		1.2 2.1%	3.2			495.3 29.4 444.2 543.1		2.0	2.2 0.4%	6.0
IT_2_5			545.2 30.1 491.2 596.1		2.0	2.3	0.4%	6.3	54.3		2.8 48.1	60.7	0.9		1.0 1.8%	2.7				490.9 30.0 433.6 537.0	1.7	1.9 0.4%	5.2
T_5_7	576.6 28.7		513.3 621.6		4.6	4.6	0.8%	12.9	52.3		2.6 46.1	59.2	1.0		1.1 2.0%	2.9	524.3 29.1		458.4	563.7	4.7	4.7 0.9%	12.9
ST_5_7	605.3 28.1			542.2 657.2	5.6	5.6	0.9%	15.6	49.2	3.1	41.4	57.2	1.3		1.3 2.7%	3.7	556.2 28.8			492.3 608.6	5.8	5.8 1.0%	16.1
S_5_7	627.1 27.4		581.3 682.8		5.9	6.0	1.0%	16.7	48.5		4.0 35.2	57.1	1.7		1.7 3.6%	4.8				578.6 28.2 528.1 634.0	6.3	6.3 1.1%	17.6
SN_5_7	616.9 26.1		566.3	654.1	5.6		6.0 1.0%	16.6	51.5	3.5		43.0 59.8	1.5		1.5 3.0%	4.2	565.4 27.2		511.7	603.0	5.9	6.2 1.1%	17.3
N_5_7	594.6 26.9		538.5 641.3		5.1		5.4 0.9%	14.9	53.3			2.6 49.4 63.8	1.3		1.4 2.6%	3.8	541.3 27.4 484.0 582.3				4.9	5.2 1.0%	14.4
IN_5_7	584.6 27.8		536.6 630.4		3.9	4.0	0.7%	11.2	54.1			3.1 49.0 63.7	1.3		1.4 2.6%	4.0			530.5 28.6 480.5	578.5	3.8	3.9 0.7%	10.7
I_5_7	580.1 28.7		533.6 634.5		3.8	4.1	0.7%	11.3	54.4	3.3	48.7	60.8	1.2		1.4 2.5%	3.8	525.7 29.9		476.1	584.4	3.5	3.7 0.7%	10.1
IT_5_7	571.6 29.9		516.6 622.1		4.0	4.1	0.7%	11.4	54.3	2.7	49.9	60.7	1.2	1.2	2.3%	3.4	517.3	29.9	459.6 568.1		3.7	3.8 0.7%	10.6
T_7_9	607.4 30.3		538.3	656.0	7.6	7.6	1.3%	21.1	50.0		3.2 41.1	56.1	1.2		1.2 2.4%	3.4			557.4 31.4 485.3 607.6		7.9	7.9 1.4%	21.8
ST 7 9	645.1 31.7		586.2 730.9		8.2		8.2 1.3%	22.8	46.2			4.0 37.6 53.7	1.2		1.3 2.9%	3.7			598.9 32.9 534.8 679.9		8.2	8.3 1.4%	23.0
S_7_9	675.3 34.3		614.5 790.9		13.5		14.2 2.1%	39.4	46.4	4.9	27.3	55.9	2.0		2.0 4.3%	5.5	628.9	34.6		566.9 742.3	14.0	14.7 2.3%	40.7
SN_7_9			658.8 33.0 604.2 733.1		8.6		9.1 1.4%	25.1	49.5			4.4 37.8 56.6	1.6		1.7 3.4%	4.6			609.3 34.2 548.7 680.6		9.0	9.4 1.5%	26.1
N_7_9	626.4 30.8		562.0 670.3		7.0		7.3 1.2%	20.3	53.2	3.2	46.3	64.8	1.7		1.8 3.4%	5.0			573.2 31.4 506.0 619.9		6.5	7.0 1.2%	19.5
IN_7_9	615.4 29.2		563.4 663.8		6.9	6.9	1.1%	19.2	53.3	5.3	44.2	63.6	1.8		1.9 3.6%	5.4			562.1 31.6 506.7	618.6	6.8	6.8 1.2%	18.8
I_7_9	611.1 31.7		557.5 667.8		5.7	5.7	0.9%	15.8	53.2		5.2 40.3	62.0	1.2		1.3 2.5%	3.7	557.9 34.1			502.7 627.6	6.1	6.1 1.1%	16.9
IT_7_9			603.7 31.7 540.9 659.5		6.0		6.2 1.0%	17.2	53.5		3.1 48.2	59.6	1.0		1.0 1.9%	2.8			550.2 32.6 483.6 608.6		6.1	6.2 1.1%	17.2

Table 29. Dry Eye Group R&R Results (Zonal Parameters)

Table 30. Post-LRS Group R&R Results (Zonal Parameters)

													Post-LRS Group (n = 112 scans)
					Pachymetry				Epithelium							Stroma
	Mean	SD	Min	Max	Repeat
ability			Reproducibility	Mean SD Min Max				Repeat
ability			Reproducibility	Mean	SD	Min	Max	Repeat
ability		Reproducibility
					SD	SD	COV	95%
Limits					SD		SD COV	95%
Limits					SD		SD COV	95%
Limits
C_2			504.6 44.6 418.3 573.5		1.3		1.6 0.3%	4.4	57.4		4.3 46.9 64.1		0.7		0.8 1.4%	2.3	447.2 46.4			359.2 519.2	1.2	1.4	0.3%	3.8
T_2_5			531.2 35.5 459.4 594.2		4.2		4.2 0.8%	11.7	58.2		3.4 50.7 66.5		1.0		1.1 1.8%	3.0	473.1 37.5		396.3 539.3		4.3	4.3	0.9%	12.0
ST_2_5			548.2 39.1 461.7 611.9		5.9		6.0 1.1%	16.5	57.4	4.3		48.5 65.4	1.0		1.1 1.8%	2.9	490.7	41.1		399.5 555.9	6.0	6.0	1.2%	16.6
S_2_5			562.3 40.4 474.6 630.0		7.0	7.1	1.3%	19.7	56.9		4.7 44.3 65.7		1.1	1.2	2.1%	3.3	505.4	42.7	412.2 575.7		7.0	7.1	1.4%	19.8
SN_2_5			556.6 40.4 466.2 633.8		6.8		7.0 1.3%	19.4	58.0		4.0 49.1 66.4		1.1		1.2 2.1%	3.3			498.6 42.4 403.1 577.1		7.0	7.2	1.4%	20.0
N_2_5	544.1	38.1	460.5 617.8		5.1		5.4 1.0%	14.9	58.5	3.1		52.1 64.6	0.9		1.0 1.8%	2.9	485.7	39.7	398.4 560.9		5.3	5.7	1.2%	15.7
IN_2_5			539.1 35.3 465.5 599.8		4.5		4.5 0.8%	12.6	58.0			3.2 50.9 63.3	0.8		0.9 1.6%	2.6			481.1 37.0 405.1 546.1		4.9		4.9 1.0%	13.5
I_2_5			535.7 34.7 463.2	595.8	4.7	4.7	0.9%	13.1	58.3		3.5 50.7 63.7		0.8		0.8 1.3%	2.1	477.3	36.9	400.4 542.9		4.9		4.9 1.0%	13.5
IT_2_5			528.9 34.1 454.6 586.9		4.7	4.7	0.9%	13.0	58.3		3.0 50.4 63.7		0.9		0.9 1.5%	2.4			470.6 36.0 390.8 530.4		4.9	4.9	1.0%	13.6
T_5_7			575.3 27.9 515.1	634.2	5.1		5.2 0.9%	14.4	54.7		3.5 47.6 65.1		1.2	1.2	2.3%	3.4			520.5 29.6 457.3 582.1		5.6	5.6	1.1%	15.5
ST_5_7			606.6 30.1 541.1	669.7	7.7	7.7	1.3%	21.4	53.6		4.2 40.3 61.7		1.6	1.7	3.2%	4.7			553.1 31.2 481.8 616.9		8.5	8.5	1.5%	23.6
S_5_7			631.8 30.0 562.8 700.7		8.1		8.1 1.3%	22.5	52.0			4.0 39.5 58.6	1.8		1.9 3.6%	5.2			579.8 30.4 506.4 647.1		8.7	8.8	1.5%	24.4
SN_5_7			620.1 31.5 547.4 699.1		8.3		8.4 1.4%	23.3	54.3		3.8 41.3 60.7		1.4		1.6 3.0%	4.5			565.8 31.7 492.0 645.7		8.8	9.0	1.6%	25.0
N_5_7			598.0 31.0 537.3 680.8		6.2		6.4 1.1%	17.7	55.5 4.0 46.1 65.1				1.1		1.2 2.2%	3.4			542.6 31.6 484.5 625.4		6.6		6.8 1.3%	18.9
IN 5 7			591.5 28.9 534.6 662.4		5.4		5.4 0.9%	14.9	54.8			3.3 47.7 61.4	0.8		0.8 1.4%	2.2	536.7		29.6 474.4 606.7		5.7	5.7	1.1%	15.8
I_5_7			588.3 27.2 538.0 658.3		6.1		6.2 1.0%	17.1	55.4		2.6 49.4	59.9	0.9		0.9 1.7%	2.6			532.9 27.8 479.7 604.1		6.3	6.4	1.2%	17.7
IT_5_7			574.1 26.0 520.3 639.6		6.4		6.4 1.1%	17.8	55.8		3.4 49.5 64.5		1.1	1.2	2.1%	3.3			518.3 27.1 463.4 585.6		6.8	6.8	1.3%	18.9
T_7_9			616.6 23.3 564.0 679.7		6.2		6.4 1.0%	17.7	51.4		2.6 44.4	55.7	1.1	1.2	2.3%	3.3	565.2		23.7 510.5 627.8		6.5	6.7	1.2%	18.7
ST_7_9			653.7 23.8 608.0 712.3		8.5		8.5 1.3%	23.6	50.3			3.8 41.0 59.6	1.5		1.5 3.1%	4.2			603.4 22.6 558.2 659.7		8.9		8.9 1.5%	24.6
S_7_9			682.2 26.6 622.0 739.1		12.6		13.6 2.0%	37.8	48.7		4.2 36.5 57.5		2.5		2.5 5.2%	7.0	633.5		25.2 576.2 690.0		12.8	13.9	2.2%	38.4
SN_7_9			673.9 24.9 613.8 730.7		7.9		7.9 1.2%	21.9	52.1		5.3 41.5 66.6		1.4		1.4 2.7%	3.9			621.7 22.5 566.5 676.7		7.8	7.8	1.2%	21.5
N 7 9			647.5 25.4 604.7 717.3		5.9		6.2 1.0%	17.2	54.6		3.6 47.8 65.1		1.3	1.3	2.3%	3.5	592.9	24.7	552.8 661.4		5.7	6.1	1.0%	16.9
IN_7_9	638.1		26.6 575.3 704.7		7.6		7.6 1.2%	21.1	53.8			2.6 47.0 60.3	0.9		0.9 1.6%	2.5	584.3		25.8 524.6 648.7		7.6	7.6	1.3%	21.2
I_7_9			633.1 24.8 595.2 699.4		6.1		6.1 1.0%	16.9	53.8		2.6 47.3 58.0		1.0	1.1	2.0%	2.9			579.4 25.1 541.7 646.1		6.3	6.3	1.1%	17.5
IT_7_9			618.1 23.7 575.7 683.9		7.5		7.5 1.2%	20.9	53.7		2.5 47.4	59.2	1.2	1.3	2.3%	3.5			564.4 24.3 524.3 631.0		7.6	7.6	1.3%	21.0

34

Image /page/34/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized circle on the left, with the word "OPTOVUE" in gray, sans-serif font to the right of the circle. The circle is colored with a gradient that transitions from orange at the bottom to yellow at the top.

													Keratoconus Group (n = 110 scans)
					Pachymetry								Epithelium				Stroma
	Mean	SD	Min	Max	Repeat
ability		Reproducibility		Mean	SD	Min	Max	Repeat
ability		Reproducibility		Mean	SD	Min	Max	Repeat
ability		Reproducibility
					SD	SD	COV	95%
Limits					SD	SD	COV	95%
Limits					an	SD	COV	95%
Limits
C_2	487.0	28.1	403.4	523.7	7.0	7.0	1.4%	19.4	50.9	4.8	40.6	65.5	1.9	19	3.7%	5.2	436.0	26.9	358.3	473.1	6.4	6.4	1.5%	17.8
T_2_5	503.5	29.4	411.4	553.5	8.0	8.0	1.6%	22.2	47.3	5.3	36.6	59.0	2.1	2.1	4.4%	5.7	456.1	28.4	366.3	502.7	6.9	7.0	1.5%	19.3
ST_2_5	540.3	29.4	458.6	595.9	7.3	7.5	1.4%	20.8	52.4	4.7	39.8	66.0	2.1	2.1	3.9%	5.7	488.0	29.7	406.5	537.4	6.2	6.5	1.3%	18.0
S_2_5	559.4	32.6	473.2	617.9	7.9	8.1	1.4%	22.4	54.4	3.4	45.4	62.6	2.1	2.2	3.9%	6.0	505.0	32.5	413.9	561.0	6.9	7.2	1.4%	19.9
SN_2_5	555.8	32.1	466.2	615.7	7.5	7.5	1.4%	20.9	54.8	4.6	41.9	63.9	1.8	19	3.4%	5.2	501.0	32.2	405.4	556.7	6.9	7.0	1.4%	19.5
N 2 5	537.5	31.9	454.7	596.2	8.7	8.7	1.6%	24.0	54.6	5.1	43.2	67.5	1.6	1.6	3.0%	4.5	482.9	31.0	395.9	536.1	7.9	7.9	1.6%	22.0
IN_2_5	509.9	34.0	431.0	557.9	9.5	9.5	1.9%	26.2	53.9	4.7	44.5	71.6	2.1	2.1	3.9%	5.8	456.1	32.4	380.2	502.7	9.3	9.3	2.0%	25.8
I_2_5	480.0	36.3	397.4	533.1	7.2	7.3	1.5%	20.2	50.9	4.8	40.9	63.9	2.3	2.3	4.6%	6.4	429.1	36.2	341.1	478.5	7.6	7.7	1.8%	21.3
IT_2_5	477.7	29.2	392.0	529.9	8.0	8.1	1.7%	22.4	47.0	4.7	37.4	56.9	19	19	4.0%	5.3	430.8	27.6	346.1	476.4	7.6	7.7	1.8%	21.3
T_5_7	539.0	42.4	402.1	600.5	9.2	9.2	1.7%	25.5	50.5	5.4	37.0	60.4	1.6	1.6	3.2%	4.5	488.5	42.2	347.7	546.7	8.7	8.8	1.8%	24.5
ST_5_7	586.4	45.8	460.1	675.8	7.5	7.8	1.3%	21.6	52.4	4.3	43.0	63.0	1.8	19	3.6%	5.2	534.0	43.9	413.9	619.4	7.4	7.8	1.5%	21.5
S_5_7	610.1	49.3	474.5	689.3	6.9	7.1	1.2%	19.5	51.7	3.7	45.0	60.6	1.8	1.8	3.5%	5.0	558.4	46.9	426.7	633.8	7.0	7.2	1.3%	20.1
SN 5 7	604.0	42.7	486.2	684.7	8.5	8.6	1.4%	24.0	52.7	3.7	43.0	63.0	1.9	2.0	3.8%	5.6	551.3	41.3	431.4	628.2	8.7	9.0	1.6%	25.0
N_5_7	580.5	39.3	479.2	667.1	8.4	8.4	1.4%	23.3	53.6	4.3	44.4	63.1	1.4	1.4	2.6%	3.8	527.0	37.3	424.2	605.9	8.5	8.5	1.6%	23.6
IN_5_7	553.8	34.9	463.6	608.2	9.1	9.1	1.6%	25.3	54.1	5.5	44.4	68.5	1.6	1.6	3.0%	4.4	499.7	31.0	414.6	550.5	9.0	9.0	1.8%	25.0
I_5_7	520.5	40.3	413.6	571.2	8.0	8.3	1.6%	23.0	52.0	8.3	36.8	69.5	2.0	2.0	3.8%	5.5	468.5	36.7	374.1	516.6	7.8	8.0	1.7%	22.3
IT_5_7	514.4	39.4	380.4	583.0	9.9	9.9	1.9%	27.5	50.3	5.6	36.8	59.6	2.3	2.3	4.6%	6.4	464.1	38.5	331.9	526.0	9.0	9.0	1.9%	24.8
T_7_9	587.0	42.0	463.1	663.5	12.4	12.6	2.1%	35.0	51.0	3.7	42.8	58.2	1.1	1.1	2.2%	3.1	536.0	40.8	414.5	615.5	12.1	12.4	2.3%	34.5
ST 7 9	613.2	51.0	474.3	730.7	15.4	15.4	2.5%	42.8	49.6	3.0	43.1	58.3	1.6	1.7	3.4%	4.6	563.6	50.7	427.2	683.5	15.6	15.6	2.8%	43.2
S_7_9	638.6	53.8	479.1	745.7	18.3	18.3	2.9%	50.6	47.5	4.1	35.8	56.1	2.2	2.2	4.5%	6.0	591.1	52.9	437.3	693.9	18.3	18.3	3.1%	50.7
SN_7_9	635.8	42.6	505.4	704.1	13.6	13.7	2.1%	37.8	50.8	4.3	39.0	61.4	1.7	1.7	3.4%	4.8	585.0	40.3	459.4	655.7	13.6	13.6	2.3%	37.8
N_7_9	617.0	36.9	522.4	688.1	9.9	9.9	1.6%	27.5	52.8	4.6	43.4	66.7	1.2	1.2	2.3%	3.4	564.2	33.5	474.5	629.6	9.7	9.7	1.7%	26.8
IN_7_9	602.9	41.3	491.8	698.0	13.6	13.6	2.2%	37.7	53.2	5.5	41.3	63.0	1.3	1.3	2.5%	3.6	549.7	36.8	447.8	638.0	13.6	13.6	2.5%	37.7
I_7_9	579.7	50.9	438.8	692.4	16.3	17.0	2.9%	47.2	52.6	7.9	31.1	67.0	2.1	2.1	4.0%	5.9	527.0	45.3	400.0	628.1	15.9	16.7	3.2%	46.2
IT_7_9	572.5	47.8	413.0	663.5	14.8	14.9	2.6%	41.2	52.2	5.3	37.8	61.2	1.7	1.7	3.3%	4.8	520.3	44.3	367.5	604.6	14.4	14.5	2.8%	40.1

Table 31. KCN Group R&R Results (Zonal Parameters)

6. Evaluation of the Agreement of the Corneal Epithelial Thickness Mapping with SD-OCT

This was a prospective, observational study conducted at three study sites to evaluate the agreement of the Avanti 9mm ETM software with manual measurements performed by three qualified graders. Eligible participants age 18 or older were enrolled and assigned to one of two groups as described under #5 above. The manual measurements were performed at 15 locations along each of the eight meridians in the PachymetryWide scan pattern in a randomized order with a 2-section caliper tool that was available in the previously cleared RTVue XR with CAM device. One eye per study subject was included in the study. One scan of sufficient image quality was required per study eye. Agreement was evaluated with calculation of 95% limits of agreement (LOAs) and Deming regression analyses.

A total of 89 subjects were enrolled. Scans from a total of 85 (17 "normal," 15 contact lens wearers, 18 with dry eye, 19 post-laser refractive surgery, and 16 with keratoconus) were included in analyses. The age distribution and clinical characteristics of the study cohort are shown in Tables 32 through 38.

35

Image /page/35/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 orange on the left side and fades to yellow on the right side. The circular design is incomplete, with a gap at the top.

Age Distribution	Min	Median	Mean	Max	SD
Entire Group	23	34	38.6	73	12.6
Normal	25	32	33.5	66	10.4
Contact Lens	25	30	35.2	58	11.1
Dry Eye	24	51	46.5	73	15.3
Post Laser Refractive Surgery	23	38	38.8	56	8.9
Keratoconus	25	34	38.0	62	11.7

Table 32. Age Distribution by Entire Study Group and by Sub-Groups

Of the 16 subjects enrolled in the Contact Lens group, 15 wore soft contact lens and one wore hard contact lens. Subjects wore contact lenses for eight or more hours each day for at least one year prior to testing.

Table 33. Contact Lens Wear Data for the Contact Lens Sub-Group

Contact Lens Wear	Min	Median	Mean	Max	SD
Duration (yr)	1	10	11	20	6.07
Hours/Day	8	12	12.6	16	2.06

For the subjects in the Dry Eye group, the severity of the dry eye condition for each study subject was documented using Ocular Surface Disease Index (OSDI) score with a scale from 0 to 100 (mild to severe) and Tear Break Up Time (TBUT).

Dry Eye	Min	Median	Mean	Max	SD
OSDI score	6.3	20.8	22.2	40.9	5.28
TBUT	1	4.8	4.6	7	1.83

Table 34. OSDI Score and Tear Break Up Time (TBUT) Distribution of the Dry Eve Sub-Group

For the subjects in the Post-LRS group, the majority (75%) had had a LASIK procedure versus the PRK procedure (25%), mainly for myopic vision correction (83.3%) and most had the procedure done at least one year or more prior to testing (83.3%).

Procedure	Total	% Total (n=20)
LASIK	15	75.0%
PRK	5	25.0%
Correction
Myopic	13	65.0%
Hyperopic	4	20.0%
Astigmatism	0	0.0%
Mixed*	3	15.0%
Duration since procedure
> 1yr	16	80.0%
> 3mo	4	20.0%
> 1mo	0	0.0%

Table 35. Summary of the Post LRS Sub-Group

Mixed represented procedures either combining myopic correction with astigmatism correction or hyperopic correction with astigmatism correction.

36

Image /page/36/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized orange circle that is not fully complete, with a gap in the upper left quadrant. To the right of the circle is the word "OPTOVUE" in gray, sans-serif font. The text is aligned horizontally with the circle.

The 16 subjects in the KCN sub-group all had a clinical diagnosis of keratoconus. None of the subjects in the KCN sub-group underwent any surgical treatment for KCN. The clinical signs of KCN diagnosis for the study subjects, severity of keratoconus for the KCN subjects, and details on corneal curvature are summarized in the table below.

| Subject ID | Severity | slit lamp
thinning | slit lamp
protrusion | slit lamp
munson | slit lamp
vogt | slit lamp
fleisher | slit lamp
rizutti | topo bow-
tie | topo
steep | topo
claw |
|------------|----------|-----------------------|-------------------------|---------------------|-------------------|-----------------------|----------------------|------------------|---------------|--------------|
| DS-10 | moderate | 1 | | | | | | | | 1 |
| DS-12 | mild | 1 | | | | | | | | 1 |
| DS-21 | moderate | 1 | | | 1 | | | | 1 | |
| DS-29 | moderate | 1 | 1 | | | | | | 1 | 1 |
| DS-31 | severe | 1 | | | | | | | 1 | 1 |
| DS-32 | moderate | 1 | | | | | | | 1 | 1 |
| DS-34 | severe | 1 | 1 | | | | | | 1 | |
| DS-36 | moderate | 1 | | | | | | 1 | 1 | |
| DS-37 | mild | 1 | | | | | | | 1 | |
| MP-08 | severe | | | | | | | | 1 | |
| MP-14 | moderate | | | | | | | 1 | 1 | |
| MP-19 | moderate | 1 | 1 | | | | | | | |
| MP-25 | mild | | | | | | | | 1 | |
| MP-28 | severe | | | | | | | | | 1 |
| MP-31 | moderate | | | | | | | 1 | | |
| K1, SH | moderate | | | | | | | | | 1 |

Table 36. KCN Subiects Diagnosis by Clinical Signs

Table 37. KCN Group Distribution by Severity

Severity	Total	% Total (n=16)
Mild	3	18.8%
Moderate	9	56.3%
Severe	4	25.0%

	Table 38. Distribution of Steep K and Delta K (difference between Steep K and Flat K) of the KCN Sub-
Group

| Corneal

Curvature	Min	Median	Mean	Max	SD
Steep K	41.80	47.76	49.65	70.80	6.47
Delta K	0.36	2.67	3.30	8.33	2.17

12 of the 85 total study scans required manual segmentation editing (five from the keratoconus sub-group, three from the post-laser refractive surgery group, three from the contact lens groups, and one from the normal group).

Manual image grading was performed by three qualified grader was assigned one randomized grading order to follow. The graders were masked to each other's results.

37

Image /page/37/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 orange on the left side and fades to yellow on the right side. The circle is not fully closed, with a gap at the top.

Results

Normal Group Agreement

			Epithelial Thickness							Stromal Thickness
Parameter	mean	SD	LOA
lower
bound*	LOA
upper
bound**	mean	SD	LOA
lower
bound*	LOA
upper
bound**	mean	SD	LOA
lower
bound*	LOA
upper
bound**
C_2	-0.4	1.3	-3.1	2.2	-2.5	1.6	-5.6	0.6	-2.9	0.8	-4.4	-1.4
T_2_5	-0.2	2.0	-4.1	3.7	1.0	1.9	-2.8	4.8	0.8	0.9	-1.0	2.6
ST_2_5	-0.3	2.0	-4.1	3.6	2.1	2.0	-1.8	6.1	1.9	1.0	-0.1	3.8
S_2_5	0.4	1.8	-3.2	4.0	2.9	1.8	-0.5	6.4	3.3	0.9	1.6	5.0
SN_2_5	0.3	1.7	-3.0	3.6	2.6	1.6	-0.6	5.8	2.9	1.1	0.7	5.0
N_2_5	0.5	1.4	-2.3	3.3	1.6	1.7	-1.7	4.8	2.1	0.9	0.3	3.9
IN_2_5	0.7	1.7	-2.7	4.1	1.1	2.0	-2.8	4.9	1.8	1.0	-0.1	3.7
I_2_5	0.3	1.8	-3.3	3.9	1.1	2.1	-3.1	5.2	1.4	1.0	-0.5	3.3
IT_2_5	-0.1	1.8	-3.6	3.4	1.0	2.0	-2.9	5.0	1.0	1.0	-1.1	3.0
T_5_7	0.5	2.3	-4.1	5.0	-1.1	2.2	-5.4	3.2	-0.7	0.9	-2.5	1.2
ST_5_7	-0.2	2.4	-4.8	4.4	1.0	2.7	-4.3	6.3	0.8	1.9	-2.9	4.5
S_5_7	0.0	1.9	-3.8	3.7	2.1	3.2	-4.1	8.3	2.0	2.5	-2.9	6.9
SN_5_7	1.2	1.9	-2.6	5.0	-0.2	2.1	-4.3	3.9	1.0	1.2	-1.3	3.3
N_5_7	1.6	2.0	-2.3	5.6	-1.7	2.2	-6.0	2.7	0.0	1.2	-2.4	2.4
IN_5_7	1.5	2.1	-2.6	5.6	-1.2	2.3	-5.7	3.3	0.3	0.9	-1.5	2.2
I_5_7	0.9	2.1	-3.1	4.9	0.1	2.8	-5.5	5.7	1.0	1.8	-2.5	4.5
IT_5_7	0.6	2.3	-3.9	5.1	0.3	4.3	-8.1	8.7	0.9	3.9	-6.7	8.5
T_7_9	-0.5	2.9	-6.3	5.3	0.6	4.7	-8.5	9.8	0.1	3.1	-5.9	6.1
ST_7_9	-1.8	3.5	-8.7	5.0	6.6	8.5	-10.1	23.3	4.8	7.7	-10.2	19.8
S_7_9	-1.9	2.9	-7.5	3.7	11.3	11.4	-11.2	33.7	9.4	10.6	-11.4	30.2
SN_7_9	-0.8	2.9	-6.5	4.9	7.1	8.3	-9.2	23.4	6.3	6.9	-7.2	19.9
N_7_9	1.3	3.0	-4.6	7.1	-0.4	5.4	-11.0	10.2	0.9	4.4	-7.8	9.5
IN_7_9	0.8	2.6	-4.3	6.0	0.7	4.8	-8.7	10.0	1.5	3.9	-6.2	9.2
I_7_9	-0.3	3.1	-6.4	5.9	2.4	5.7	-8.9	13.7	2.1	4.5	-6.6	10.9
IT_7_9	0.1	3.1	-5.9	6.2	2.5	7.4	-12.0	16.9	2.6	7.0	-11.1	16.3

Table 39a. Limits of Agreement Analysis between Software and Manual Measurements Difference (Software vs. Manual). Normal Group (n= 17)

LOA lower bound = mean-1.96xSD

38

Image /page/38/Picture/0 description: The image shows the alphanumeric string "K180660" in a simple, sans-serif font. The string is presented in a straightforward, unadorned manner, with each character clearly legible. The characters are uniformly sized and spaced, contributing to the overall clarity of the image. The black text on a white background provides a high contrast, making the string easily readable.

Image /page/38/Picture/1 description: The image shows the logo for Optovue. The logo consists of a stylized orange circle that is not fully complete. To the right of the circle is the word "OPTOVUE" in gray, sans-serif font. The logo is simple and modern.

Table 39b. Deming Regression Analysis between Software and Manual Measurements

Normal Group (n= 17)
	Epithelial Thickness						Stromal Thickness						Corneal Thickness
Parameter	intercept	intercept
CI lower	intercept
Cl upper	slope	slope
CI lower	slope
CI upper	intercept	intercept
Cl lower	intercept
Cl upper	slope	slope
CI lower	slope
CI upper	intercept	intercept
Cl lower	intercept
Cl upper	slope	slope
Cl lower	slope
Cl upper
C_2	-10.1	-22.4	2.3	1.18	0.95	1.41	3.0	-5.5	11.6	0.99	0.97	1.01	-1.8	-5.1	1.4	1.00	0.99	1.00
T_2_5	-20.6	-42.1	0.9	1.38	0.97	1.78	3.1	-11.7	18.0	1.00	0.97	1.03	-1.2	-8.3	5.9	1.00	0.99	1.02
ST_2_5	-8.7	-19.6	2.1	1.16	0.95	1.36	3.8	-5.2	12.8	1.00	0.98	1.01	-0.2	-7.6	7.2	1.00	0.99	1.02
S_2_5	-8.2	-19.9	3.5	1.16	0.94	1.38	4.6	-4.8	14.0	1.00	0.98	1.01	-1.8	-4.0	0.3	1.01	1.01	1.01
SN_2_5	-11.0	-22.7	0.8	1.21	1.00	1.42	3.6	-6.5	13.6	1.00	0.98	1.02	-3.1	-11.8	5.5	1.01	1.00	1.03
N_2_5	-7.4	-19.7	5.0	1.15	0.92	1.38	1.6	-3.8	7.1	1.00	0.99	1.01	1.7	-3.1	6.5	1.00	0.99	1.01
IN_2_5	-10.3	-21.8	1.2	1.20	0.99	1.42	5.3	-2.8	13.4	0.99	0.98	1.01	2.4	-5.0	9.9	1.00	0.99	1.01
I_2_5	-11.4	-23.4	0.7	1.21	0.99	1.43	5.7	-6.1	17.5	0.99	0.97	1.01	1.6	-3.9	7.1	1.00	0.99	1.01
IT_2_5	-18.8	-32.9	-4.7	1.34	1.08	1.60	0.9	-10.5	12.2	1.00	0.98	1.02	-2.6	-8.1	3.0	1.01	1.00	1.02
T_5_7	-14.9	-45.6	15.8	1.29	0.71	1.87	4.9	-8.7	18.6	0.99	0.96	1.01	0.9	-11.3	13.1	1.00	0.98	1.02
ST_5_7	-10.9	-20.1	-1.7	1.20	1.03	1.37	9.5	-0.8	19.8	0.98	0.97	1.00	8.4	0.6	16.2	0.99	0.98	1.00
S_5_7	-8.3	-15.9	-0.6	1.16	1.02	1.29	18.0	9.5	26.5	0.97	0.96	0.99	15.8	5.8	25.9	0.98	0.96	0.99
SN_5_7	-8.4	-21.5	4.6	1.18	0.93	1.42	4.9	-6.3	16.1	0.99	0.97	1.01	-0.6	-7.4	6.1	1.00	0.99	1.01
N_5_7	-2.3	-17.8	13.3	1.07	0.79	1.36	7.0	-11.5	25.5	0.98	0.95	1.02	3.4	-11.3	18.1	0.99	0.97	1.02
IN_5_7	-4.3	-13.6	5.0	1.11	0.94	1.28	-3.1	-10.5	4.3	1.00	0.99	1.02	-3.8	-9.8	2.3	1.01	1.00	1.02
I_5_7	-8.2	-16.7	0.3	1.17	1.01	1.32	3.1	-12.1	18.3	0.99	0.96	1.02	-0.8	-11.7	10.0	1.00	0.98	1.02
IT_5_7	-12.0	-29.4	5.5	1.23	0.90	1.56	-5.4	-26.8	16.1	1.01	0.97	1.05	-13.1	-35.2	9.0	1.02	0.98	1.07
T_7_9	-8.0	-54.7	38.7	1.14	0.26	2.02	20.3	-5.7	46.4	0.96	0.92	1.01	13.7	-13.9	41.4	0.98	0.93	1.02
ST_7_9	-8.1	-49.6	33.4	1.12	0.33	1.92	16.8	-28.3	62.0	0.98	0.91	1.06	12.0	-50.1	74.2	0.99	0.89	1.08
S_7_9	-1.8	-18.0	14.4	1.00	0.68	1.31	5.6	-109.4	120.6	1.01	0.83	1.19	11.0	-98.8	120.9	1.00	0.84	1.16
SN_7_9	-0.6	-11.3	10.1	1.00	0.80	1.19	-16.8	-89.0	55.4	1.04	0.92	1.16	-21.4	-91.7	48.9	1.04	0.93	1.15
N_7_9	7.4	-6.2	21.0	0.89	0.64	1.13	10.9	-33.3	55.1	0.98	0.90	1.06	3.5	-41.0	47.9	1.00	0.93	1.07
IN_7_9	-0.6	-9.7	8.5	1.03	0.85	1.20	7.5	-12.7	27.8	0.99	0.95	1.02	5.6	-13.4	24.7	0.99	0.96	1.02
I_7_9	-14.3	-27.4	-1.2	1.26	1.02	1.50	8.4	-39.7	56.4	0.99	0.90	1.08	1.4	-45.3	48.2	1.00	0.92	1.08
IT_7_9	-8.8	-26.6	9.0	1.16	0.83	1.49	-13.9	-60.8	33.0	1.03	0.94	1.12	-23.8	-78.7	31.0	1.04	0.95	1.14

Contact Lens Group Agreement

Table 40a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Contact Lens Group (n= 15)
		Epithelial Thickness					Stromal Thickness				Corneal Thickness
Parameter	mean	SD	LOA
lower
bound*	LOA
upper
bound**	mean	SD	LOA
lower
bound*	LOA
upper
bound**	mean	SD	LOA
lower
bound*	LOA
upper
bound**
C_2	-0.4	1.3	-2.9	2.1	-1.7	2.0	-5.6	2.3	-2.1	1.6	-5.2	1.0
T_2_5	-0.2	1.7	-3.6	3.1	1.5	1.5	-1.4	4.5	1.3	1.0	-0.6	3.2
ST_2_5	-0.1	1.8	-3.6	3.4	2.4	1.4	-0.4	5.3	2.3	1.1	0.3	4.4
S_2_5	0.3	1.3	-2.2	2.8	3.0	1.5	0.1	5.8	3.3	1.4	0.6	5.9
SN_2_5	0.2	1.4	-2.6	2.9	2.8	1.4	0.1	5.6	3.0	0.9	1.1	4.8
N_2_5	0.4	1.5	-2.7	3.4	1.7	1.3	-0.9	4.3	2.1	0.8	0.6	3.6
IN_2_5	0.4	1.6	-2.7	3.5	1.2	1.6	-2.0	4.3	1.6	0.9	-0.1	3.3
I_2_5	0.0	1.3	-2.4	2.5	1.2	1.2	-1.2	3.6	1.2	0.7	-0.2	2.6
IT_2_5	0.0	1.8	-3.6	3.6	1.1	1.6	-2.1	4.2	1.1	1.0	-0.9	3.1
T_5_7	0.1	2.2	-4.1	4.4	-0.1	2.5	-5.1	4.9	0.0	1.4	-2.7	2.8
ST_5_7	-0.1	2.3	-4.6	4.4	0.6	2.3	-3.9	5.1	0.5	1.0	-1.4	2.4
S_5_7	0.1	1.9	-3.6	3.7	1.4	2.0	-2.4	5.3	1.5	1.0	-0.5	3.4
SN_5_7	0.2	1.8	-3.4	3.8	0.8	2.0	-3.2	4.8	1.0	0.9	-0.9	2.8
N_5_7	1.0	1.7	-2.3	4.3	-0.8	1.9	-4.5	2.9	0.1	1.0	-1.8	2.1
IN_5_7	1.2	1.8	-2.2	4.7	-0.8	1.9	-4.5	2.9	0.5	0.9	-1.4	2.3
I_5_7	0.3	1.7	-2.9	3.6	-0.3	1.7	-3.6	3.1	0.1	0.9	-1.8	1.9
IT_5_7	0.7	2.6	-4.3	5.8	-0.5	4.4	-9.2	8.2	0.2	3.3	-6.4	6.8
T_7_9	0.1	3.0	-5.7	5.8	1.5	4.3	-6.9	10.0	1.6	3.5	-5.3	8.5
ST_7_9	-1.7	3.4	-8.4	5.0	4.1	7.2	-10.0	18.2	2.4	5.8	-9.0	13.8
S_7_9	-1.7	3.1	-7.8	4.3	6.8	7.8	-8.5	22.2	5.1	6.3	-7.2	17.4
SN_7_9	-1.3	2.7	-6.5	4.0	3.3	7.5	-11.5	18.0	2.0	6.0	-9.8	13.9
N_7_9	0.4	2.2	-4.0	4.7	0.0	4.2	-8.3	8.3	0.4	3.0	-5.5	6.3
IN_7_9	1.2	2.3	-3.2	5.6	-0.6	3.6	-7.7	6.6	0.6	2.7	-4.6	5.9
I_7_9	0.0	2.7	-5.3	5.3	0.9	4.4	-7.7	9.4	0.9	2.7	-4.4	6.2
IT_7_9	0.5	3.4	-6.0	7.1	-1.0	11.9	-24.3	22.4	-0.4	11.2	-22.3	21.5

LOA lower bound = mean-1.96xSD

39

Image /page/39/Picture/0 description: The image shows the alphanumeric string "K180660" in a simple, sans-serif font. The characters are uniformly sized and spaced, with the "K" being the only letter present. The numbers "180660" follow the "K", creating a unique identifier or code. The text is presented in black against a white background, ensuring high contrast and readability.

Image /page/39/Picture/1 description: The image shows the logo for Optovue. The logo consists of a stylized orange circle on the left side, with the word "OPTOVUE" in gray letters to the right of the circle. The circle is not a complete circle, but rather an arc that is thicker on the left side and tapers off to a point on the right side.

Table 40b. Deming Regression Analysis between Software and Manual Measurements

	Contact Lens Group (n= 15)
	Epithelial Thickness						Stromal Thickness						Corneal Thickness
Parameter	intercept	intercept
CI lower	intercept
CI upper	slope	slope
CI lower	slope
CI upper	intercept	intercept
Cl lower	intercept
CI upper	slope	slope
CI lower	slope
CI upper	intercept	intercept
CI lower	intercept
CI upper	slope	slope
CI lower	slope
CI upper
C_2	-2.3	-12.7	8.2	1.04	0.83	1.25	0.4	-20.4	21.3	1.00	0.95	1.04	6.5	-10.1	23.1	0.98	0.95	1.01
T_2_5	5.4	-3.7	14.6	0.89	0.71	1.06	6.2	-18.4	30.7	0.99	0.94	1.04	-1.4	-21.3	18.6	1.01	0.97	1.04
ST_2_5	5.3	-2.3	12.9	0.89	0.75	1.04	-1.4	-28.9	26.1	1.01	0.95	1.06	-11.5	-25.5	2.6	1.03	1.00	1.05
S_2_5	2.8	-0.5	6.0	0.95	0.89	1.01	-10.7	-27.1	5.6	1.03	0.99	1.06	-14.3	-32.6	4.0	1.03	1.00	1.06
SN_2_5	3.3	-0.8	7.4	0.94	0.86	1.02	-6.7	-21.6	8.3	1.02	0.99	1.05	-6.3	-15.2	2.5	1.02	1.00	1.03
N_2_5	5.2	2.9	7.6	0.91	0.86	0.95	-0.4	-7.9	7.1	1.00	0.99	1.02	-5.7	-16.6	5.2	1.01	0.99	1.03
IN_2_5	2.7	-5.4	10.9	0.96	0.79	1.12	-10.1	-23.4	3.1	1.02	1.00	1.05	-8.7	-16.5	-0.9	1.02	1.00	1.03
I_2_5	1.7	-6.1	9.5	0.97	0.81	1.12	-4.3	-15.0	6.4	1.01	0.99	1.03	-4.3	-13.0	4.3	1.01	0.99	1.03
IT_2_5	3.8	-6.3	13.9	0.93	0.74	1.12	3.6	-5.7	12.8	0.99	0.98	1.01	-4.1	-18.0	9.7	1.01	0.98	1.04
T_5_7	6.4	-10.9	23.8	0.88	0.54	1.21	9.0	-9.7	27.7	0.98	0.95	1.02	-5.9	-16.2	4.5	1.01	0.99	1.03
ST_5_7	1.6	-12.9	16.0	0.97	0.68	1.25	4.2	-28.1	36.4	0.99	0.93	1.05	-10.4	-33.5	12.6	1.02	0.98	1.06
S_5_7	2.7	-5.7	11.1	0.95	0.78	1.11	10.6	-23.5	44.7	0.98	0.92	1.05	6.2	-23.9	36.4	0.99	0.94	1.04
SN_5_7	0.3	-6.2	6.9	1.00	0.87	1.13	1.4	-8.3	11.1	1.00	0.98	1.02	-6.7	-30.7	17.3	1.01	0.97	1.05
N_5_7	7.5	3.1	12.0	0.87	0.78	0.96	-5.1	-11.2	1.1	1.01	1.00	1.02	-10.3	-20.5	-0.2	1.02	1.00	1.04
IN_5_7	5.6	-0.8	11.9	0.92	0.80	1.04	-9.3	-18.3	-0.3	1.02	1.00	1.03	-7.0	-23.7	9.7	1.01	0.98	1.04
I_5_7	-5.7	-11.5	0.1	1.11	1.01	1.22	4.0	-9.1	17.2	0.99	0.97	1.02	4.1	-8.4	16.6	0.99	0.97	1.02
IT_5_7	6.1	-27.0	39.2	0.90	0.26	1.53	32.5	-42.0	106.9	0.94	0.79	1.08	21.4	-43.9	86.7	0.96	0.84	1.08
T_7_9	2.3	-13.1	17.7	0.96	0.65	1.26	-5.6	-22.0	10.8	1.01	0.98	1.04	-26.6	-38.2	-14.9	1.05	1.03	1.07
ST_7_9	1.6	-22.1	25.4	0.93	0.46	1.40	13.0	-42.6	68.6	0.98	0.89	1.08	-12.8	-51.0	25.4	1.02	0.96	1.09
S_7_9	-6.3	-22.9	10.2	1.10	0.77	1.43	-31.8	-51.7	-11.9	1.06	1.03	1.09	-36.3	-80.2	7.5	1.06	1.00	1.13
SN_7_9	-2.5	-12.1	7.1	1.02	0.84	1.21	-12.1	-117.9	93.7	1.03	0.85	1.20	-4.7	-121.1	111.6	1.01	0.83	1.19
N_7_9	6.3	0.2	12.5	0.88	0.77	1.00	20.6	-1.9	43.0	0.96	0.93	1.00	20.5	-11.4	52.4	0.97	0.92	1.02
IN_7_9	-0.8	-8.9	7.3	1.04	0.88	1.19	11.2	-31.5	53.9	0.98	0.90	1.06	16.5	-26.4	59.3	0.97	0.90	1.05
I_7_9	-9.6	-24.8	5.5	1.18	0.90	1.47	-3.4	-17.2	10.4	1.01	0.98	1.03	15.7	5.4	26.0	0.98	0.96	0.99
IT_7_9	10.5	-16.9	37.8	0.81	0.28	1.34	69.9	-86.7	226.5	0.87	0.58	1.16	59.2	-128.8	247.2	0.90	0.58	1.22

Dry Eye Group Agreement

Table 41a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Dry Eye Group (n= 18)
		Epithelial Thickness					Stromal Thickness				Corneal Thickness
Parameter	mean	SD	LOA
lower
bound*	LOA
upper
bound**	mean	SD	LOA
lower
bound*	LOA
upper
bound**	mean	SD	LOA
lower
bound*	LOA
upper
bound **
C_2	-0.3	1.0	-2.3	1.7	-2.4	1.1	-4.5	-0.3	-2.7	0.7	-4.1	-1.3
T_2_5	-0.2	1.6	-3.3	2.8	1.1	1.8	-2.4	4.5	0.8	0.8	-0.6	2.3
ST_2_5	-0.3	1.8	-3.9	3.2	2.2	1.7	-1.1	5.5	1.9	1.0	-0.1	3.8
S_2_5	0.3	1.5	-2.5	3.2	2.8	1.6	-0.4	6.0	3.1	1.3	0.6	5.6
SN_2_5	-0.1	1.8	-3.7	3.4	2.8	2.1	-1.4	7.0	2.7	1.1	0.6	4.7
N_2_5	-0.1	1.5	-3.1	2.8	1.9	1.5	-1.1	4.9	1.7	0.7	0.3	3.2
IN_2_5	0.1	1.6	-3.1	3.2	1.6	1.8	-1.9	5.0	1.6	0.9	-0.1	3.3
I_2_5	0.2	1.8	-3.3	3.7	1.2	1.9	-2.6	5.0	1.4	1.0	-0.6	3.5
IT_2_5	0.1	1.5	-2.8	3.0	0.5	1.4	-2.3	3.3	0.6	0.8	-1.0	2.2
T_5_7	0.7	2.9	-5.1	6.5	-1.4	4.8	-10.9	8.0	-0.7	4.3	-9.1	7.6
ST_5_7	0.4	2.7	-4.8	5.6	0.9	4.6	-8.2	10.0	1.3	3.6	-5.8	8.4
S_5_7	0.5	2.3	-4.0	5.0	1.8	4.6	-7.2	10.7	2.3	4.2	-6.0	10.6
SN_5_7	0.8	2.2	-3.6	5.1	0.0	2.3	-4.4	4.5	0.8	1.5	-2.2	3.8
N_5_7	0.6	1.8	-3.0	4.1	-0.3	2.0	-4.2	3.7	0.3	1.1	-1.8	2.4
IN_5_7	1.1	1.8	-2.4	4.5	-0.7	1.8	-4.3	2.8	0.3	0.9	-1.4	2.0
I_5_7	0.6	1.9	-3.0	4.3	0.2	1.8	-3.3	3.7	0.8	0.9	-1.0	2.5
IT_5_7	0.9	2.6	-4.2	6.0	-0.5	2.4	-5.3	4.2	0.3	2.1	-3.7	4.4
T_7_9	-0.2	4.0	-8.0	7.6	1.6	8.2	-14.5	17.8	1.4	7.4	-13.1	16.0
ST_7_9	-1.5	3.4	-8.2	5.2	4.9	5.6	-6.2	15.9	3.4	5.5	-7.4	14.2
S_7_9	-2.1	3.0	-7.9	3.7	7.4	9.2	-10.7	25.5	5.3	8.3	-11.0	21.6
SN_7_9	-0.6	2.8	-6.0	4.9	5.3	11.1	-16.5	27.1	4.7	10.0	-15.0	24.4
N_7_9	0.5	3.2	-5.7	6.7	0.1	4.9	-9.6	9.8	0.6	4.2	-7.6	8.8
IN_7_9	0.4	3.0	-5.4	6.3	0.3	4.1	-7.7	8.4	0.8	3.1	-5.3	6.8
I_7_9	-0.4	3.1	-6.6	5.7	1.6	3.4	-5.1	8.2	1.1	1.8	-2.5	4.7
IT_7_9	0.4	3.2	-5.9	6.7	1.3	5.6	-9.6	12.2	1.7	4.2	-6.6	10.0

LOA lower bound = mean-1.96xSD

40

Image /page/40/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 orange at the bottom and fades to yellow at the top. The circle is not complete, with a gap at the top left.

Table 41b. Deming Regression Analysis between Software and Manual Measurements

	Dry Eye Group (n= 18)
			Epithelial Thickness				Stromal Thickness						Corneal Thickness
Parameter	intercept	intercept
CI lower	intercept
CI upper	slope	slope
CI lower	slope
CI upper	intercept	intercept
CI lower	intercept
CI upper	slope	slope
CI lower	slope
CI upper	intercept	intercept
CI lower	intercept
CI upper	slope	slope
CI lower	slope
CI upper
C_2	-1.6	-6.6	3.3	1.02	0.93	1.12	0.6	-3.3	4.4	0.99	0.99	1.00	-0.8	-13.4	11.8	1.00	0.97	1.02
T_2_5	5.3	0.3	10.3	0.89	0.80	0.99	-5.2	-22.0	11.5	1.01	0.98	1.05	-4.0	-8.1	0.2	1.01	1.00	1.02
ST_2_5	-0.2	-9.7	9.4	1.00	0.81	1.18	-0.2	-7.8	7.4	1.00	0.99	1.02	0.0	-4.9	5.0	1.00	0.99	1.01
S_2_5	-4.1	-11.0	2.8	1.08	0.95	1.22	2.4	-7.4	12.3	1.00	0.98	1.02	1.2	-9.1	11.5	1.00	0.99	1.02
SN_2_5	-8.6	-23.8	6.6	1.16	0.88	1.44	8.0	-3.3	19.3	0.99	0.97	1.01	2.6	-5.2	10.3	1.00	0.99	1.01
N_2_5	-10.6	-17.7	-3.5	1.20	1.06	1.33	5.8	-7.0	18.6	0.99	0.97	1.02	0.4	-4.0	4.8	1.00	0.99	1.01
IN_2_5	-2.6	-11.7	6.5	1.05	0.88	1.22	2.0	-14.0	17.9	1.00	0.97	1.03	-4.6	-11.6	2.5	1.01	1.00	1.02
I_2_5	-3.4	-8.9	2.0	1.07	0.96	1.17	-5.7	-17.9	6.4	1.01	0.99	1.04	-4.5	-10.5	1.4	1.01	1.00	1.02
IT_2_5	-2.1	-7.3	3.0	1.04	0.95	1.14	-7.1	-11.3	-2.8	1.02	1.01	1.02	-6.1	-14.3	2.1	1.01	1.00	1.03
T_5_7	4.0	-14.3	22.2	0.94	0.58	1.29	5.5	-83.5	94.5	0.99	0.81	1.16	30.1	-35.8	95.9	0.95	0.83	1.06
ST_5_7	-8.4	-38.2	21.5	1.17	0.60	1.73	-34.9	-112.6	42.8	1.07	0.92	1.21	-21.3	-86.9	44.3	1.04	0.92	1.15
S_5_7	-6.0	-22.0	9.9	1.13	0.82	1.43	-25.7	-95.0	43.6	1.05	0.92	1.17	-30.0	-99.5	39.4	1.05	0.94	1.17
SN_5_7	0.6	-14.6	15.8	1.00	0.72	1.29	5.0	-6.0	16.1	0.99	0.97	1.01	-1.7	-15.8	12.4	1.00	0.98	1.03
N_5_7	-1.9	-13.1	9.3	1.05	0.84	1.25	-2.4	-20.7	16.0	1.00	0.97	1.04	-7.3	-21.3	6.8	1.01	0.99	1.04
IN_5_7	-0.4	-11.0	10.1	1.03	0.83	1.22	6.2	-2.3	14.6	0.99	0.97	1.00	-3.5	-11.4	4.3	1.01	0.99	1.02
I_5_7	0.0	-11.7	11.7	1.01	0.79	1.23	-6.7	-13.6	0.3	1.01	1.00	1.03	-0.2	-6.6	6.2	1.00	0.99	1.01
IT_5_7	-1.0	-22.2	20.2	1.03	0.64	1.43	-10.8	-25.8	4.2	1.02	0.99	1.05	1.3	-9.3	11.9	1.00	0.98	1.02
T_7_9	-1.5	-22.6	19.5	1.03	0.62	1.43	-8.8	-99.3	81.6	1.02	0.85	1.19	26.7	-25.6	79.0	0.96	0.87	1.05
ST_7_9	4.8	-8.2	17.8	0.88	0.64	1.12	13.4	-16.9	43.8	0.99	0.93	1.04	33.6	-9.3	76.4	0.95	0.89	1.02
S_7_9	-4.4	-21.3	12.5	1.05	0.73	1.37	24.4	-30.3	79.2	0.97	0.89	1.06	10.2	-29.7	50.1	0.99	0.94	1.05
SN_7_9	2.4	-6.4	11.2	0.94	0.78	1.11	-37.8	-131.4	55.9	1.07	0.92	1.23	-56.7	-157.6	44.2	1.09	0.94	1.25
N_7_9	-8.3	-23.3	6.7	1.16	0.89	1.44	-14.3	-46.9	18.4	1.02	0.97	1.08	-34.9	-61.5	-8.2	1.06	1.01	1.10
IN_7_9	-7.6	-27.1	11.9	1.15	0.78	1.52	3.2	-13.1	19.5	0.99	0.97	1.02	-13.2	-28.7	2.3	1.02	1.00	1.05
I_7_9	-7.6	-25.3	10.1	1.13	0.81	1.45	2.4	-10.4	15.1	1.00	0.98	1.02	-1.3	-8.6	6.0	1.00	0.99	1.02
IT_7_9	3.1	-30.3	36.5	0.95	0.33	1.57	-15.1	-42.4	12.2	1.03	0.98	1.08	-1.3	-17.1	14.4	1.01	0.98	1.03

Post-LRS Group Agreement

Table 42a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Post-Laser Refractive Surgery Group (n= 19)
	Epithelial Thickness				Stromal Thickness				Corneal Thickness
Parameter	mean	SD	LOA lower bound*	LOA upper bound**	mean	SD	LOA lower bound*	LOA upper bound**	mean	SD	LOA lower bound*	LOA upper bound**
C_2	0.4	1.2	-2.1	2.8	-3.9	1.8	-7.4	-0.5	-3.5	1.0	-5.5	-1.5
T_2_5	1.4	2.1	-2.7	5.6	0.3	2.3	-4.2	4.8	1.7	1.4	-1.1	4.6
ST_2_5	1.1	2.2	-3.3	5.5	1.8	2.4	-2.9	6.5	2.9	1.6	-0.1	6.0
S_2_5	1.1	2.0	-2.8	5.0	3.1	2.1	-0.9	7.2	4.2	1.9	0.5	7.9
SN_2_5	0.8	2.1	-3.3	4.9	3.1	2.0	-0.8	6.9	3.9	1.4	1.1	6.7
N_2_5	0.7	1.9	-3.1	4.5	2.2	1.9	-1.4	5.9	2.9	1.6	-0.3	6.2
IN_2_5	1.0	1.8	-2.6	4.6	1.6	2.0	-2.4	5.6	2.6	1.6	-0.6	5.8
I_2_5	1.3	1.7	-2.1	4.7	1.2	1.8	-2.4	4.7	2.5	1.4	-0.3	5.3
IT_2_5	1.6	1.8	-1.9	5.0	0.2	2.0	-3.8	4.1	1.7	1.5	-1.1	4.6
T_5_7	1.1	4.0	-6.6	8.9	-1.2	4.5	-10.1	7.8	0.0	1.5	-3.0	2.9
ST_5_7	0.4	3.1	-5.7	6.5	1.1	4.1	-7.1	9.2	1.5	2.1	-2.7	5.7
S_5_7	1.3	3.6	-5.8	8.4	1.2	4.2	-7.0	9.4	2.5	2.0	-1.3	6.4
SN_5_7	1.4	2.9	-4.3	7.1	-0.6	3.2	-6.9	5.8	0.8	2.7	-4.5	6.1
N_5_7	1.4	2.7	-3.8	6.6	-0.4	2.7	-5.7	5.0	1.1	1.4	-1.6	3.7
IN_5_7	1.5	2.5	-3.3	6.3	-0.3	2.9	-6.0	5.4	1.2	1.5	-1.8	4.2
I_5_7	1.0	2.9	-4.7	6.7	1.1	3.8	-6.4	8.7	2.1	1.7	-1.2	5.5
IT_5_7	0.9	2.7	-4.3	6.2	-0.4	3.4	-7.0	6.3	0.6	1.4	-2.3	3.4
T_7_9	-1.3	4.2	-9.4	6.9	1.8	7.5	-12.9	16.5	0.5	5.2	-9.7	10.7
ST_7_9	-1.0	4.5	-9.9	7.9	3.6	9.5	-15.1	22.3	2.6	7.4	-11.9	17.1
S_7_9	-0.5	5.1	-10.4	9.4	4.2	13.7	-22.7	31.1	3.7	12.6	-20.9	28.3
SN_7_9	-0.3	4.2	-8.5	7.9	2.5	7.5	-12.2	17.2	2.2	6.7	-10.9	15.3
N_7_9	1.1	3.3	-5.5	7.6	0.7	5.4	-9.9	11.2	1.8	4.3	-6.7	10.2
IN_7_9	0.3	3.7	-7.0	7.6	1.0	5.9	-10.6	12.6	1.3	4.6	-7.6	10.3
I_7_9	-0.2	3.4	-6.7	6.4	2.0	5.4	-8.5	12.6	1.9	3.8	-5.6	9.3
IT_7_9	-0.3	4.0	-8.2	7.5	1.9	5.6	-9.1	12.8	1.6	3.7	-5.8	8.9

LOA lower bound = mean-1.96xSD

41

Image /page/41/Picture/0 description: The image contains the logo for Optovue. The logo consists of a stylized orange circle on the left side, with a gap in the upper left quadrant. To the right of the circle, the word "OPTOVUE" is written in gray, sans-serif font. The logo is simple and modern in design.

Table 42b. Deming Regression Analysis between Software and Manual Measurements

Post-Laser Refractive Surgery Group (n= 19)
	Epithelial Thickness						Stromal Thickness						Corneal Thickness
Parameter	intercept	intercept
CI lower	intercept
Cl upper	slope	slope
CI lower	slope
CI upper	intercept	intercept
CI lower	intercept
CI upper	slope	slope
CI lower	slope
CI upper	intercept	intercept
Cl lower	intercept
Cl upper	slope	slope
CI lower	slope
Cl upper
C_2	-4.5	-8.1	-0.9	1.09	1.02	1.15	-10.1	-17.0	-3.2	1.02	1.00	1.03	-6.8	-11.1	-2.5	1.01	1.00	1.02
T_2_5	-5.6	-14.8	3.6	1.12	0.96	1.29	-2.9	-17.1	11.3	1.01	0.98	1.04	1.1	-7.7	9.9	1.00	0.98	1.02
ST_2_5	-5.1	-12.1	1.8	1.11	0.98	1.24	-1.6	-9.2	5.9	1.01	0.99	1.03	5.1	-2.0	12.1	1.00	0.98	1.01
S_2_5	-4.3	-12.1	3.4	1.10	0.95	1.25	-2.7	-22.6	17.2	1.02	0.97	1.06	10.3	0.3	20.3	0.99	0.97	1.01
SN_2_5	-5.2	-12.6	2.1	1.11	0.97	1.25	4.9	-22.8	32.7	1.00	0.94	1.05	13.3	6.3	20.4	0.98	0.97	1.00
N_2_5	-4.6	-14.2	5.0	1.10	0.92	1.27	4.8	-16.5	26.1	1.00	0.95	1.04	11.6	3.5	19.8	0.98	0.97	1.00
IN_2_5	-2.1	-11.3	7.2	1.05	0.89	1.21	24.6	-4.3	53.6	0.96	0.89	1.02	2.5	-4.4	9.4	1.00	0.99	1.01
I_2_5	-4.5	-9.5	0.6	1.10	1.01	1.19	11.0	-36.2	58.2	0.98	0.88	1.08	5.6	-2.0	13.2	0.99	0.98	1.01
IT_2_5	-2.6	-8.6	3.4	1.07	0.96	1.18	-21.1	-75.8	33.6	1.05	0.93	1.16	1.8	-6.4	9.9	1.00	0.98	1.02
T_5_7	-24.2	-54.4	6.0	1.47	0.91	2.03	-14.8	-62.2	32.6	1.03	0.93	1.12	2.0	-9.2	13.2	1.00	0.98	1.02
ST_5_7	-11.6	-25.9	2.6	1.22	0.97	1.48	-0.4	-22.7	22.0	1.00	0.96	1.04	0.7	-8.5	10.0	1.00	0.99	1.02
S_5_7	-9.3	-17.1	-1.4	1.20	1.07	1.34	-30.0	-67.0	7.0	1.06	0.99	1.13	2.9	-8.1	13.8	1.00	0.98	1.02
SN_5_7	4.0	-8.8	16.8	0.95	0.71	1.19	-26.9	-53.1	-0.7	1.05	1.00	1.10	2.1	-26.1	30.3	1.00	0.95	1.04
N_5_7	-6.3	-22.9	10.3	1.14	0.83	1.46	-15.7	-49.8	18.5	1.03	0.97	1.09	-0.3	-10.3	9.7	1.00	0.99	1.02
IN_5_7	-1.7	-12.3	8.9	1.06	0.86	1.25	-8.4	-68.0	51.2	1.01	0.91	1.12	0.8	-8.5	10.0	1.00	0.98	1.02
I_5_7	-14.7	-32.4	3.0	1.28	0.96	1.60	-17.8	-43.7	8.0	1.03	0.98	1.08	5.8	-4.3	16.0	0.99	0.98	1.01
IT_5_7	-17.2	-40.8	6.3	1.33	0.90	1.76	-57.4	-155.1	40.3	1.11	0.91	1.30	1.4	-11.6	14.4	1.00	0.98	1.02
T_7_9	-1.5	-59.9	57.0	1.00	-0.13	2.14	-10.5	-55.9	34.9	1.03	0.95	1.11	-13.7	-44.0	16.6	1.02	0.97	1.07
ST_7_9	-5.1	-49.0	38.8	1.08	0.21	1.95	-9.6	-55.7	36.5	1.02	0.94	1.10	-7.5	-44.7	29.7	1.02	0.96	1.08
S_7_9	-32.2	-86.2	21.8	1.64	0.52	2.75	16.0	-60.6	92.6	0.97	0.83	1.11	-9.2	-95.1	76.8	1.02	0.89	1.15
SN_7_9	1.5	-14.3	17.4	0.96	0.65	1.28	3.4	-58.2	65.1	1.00	0.89	1.11	-31.4	-70.0	7.2	1.05	0.99	1.11
N_7_9	-10.6	-26.6	5.4	1.22	0.92	1.51	26.6	-15.3	68.4	0.95	0.88	1.03	-32.8	-71.1	5.6	1.05	0.99	1.11
IN_7_9	1.4	-15.4	18.3	0.98	0.67	1.29	45.4	-29.8	120.6	0.92	0.78	1.05	-14.5	-32.0	3.0	1.03	1.00	1.05
I_7_9	10.6	-4.7	25.8	0.80	0.52	1.08	-31.0	-74.8	12.9	1.07	0.98	1.15	14.5	-2.7	31.7	0.98	0.95	1.01
IT_7_9	13.6	-17.3	44.5	0.73	0.14	1.32	-49.6	-116.0	16.9	1.10	0.97	1.22	-6.8	-23.9	10.2	1.01	0.99	1.04

Keratoconus Group Agreement

Table 43a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Keratoconus Group (n= 16)
			Epithelial Thickness				Stromal Thickness		Corneal Thickness
Parameter	mean	SD	LOA
lower
bound*	LOA
upper
bound **	mean	SD	LOA
lower
bound*	LOA
upper
bound**	mean	SD	LOA
lower
bound*	LOA
upper
bound**

C_2	-0.4	1.9	-4.2	3.4	-3.4	1.9	-7.2	0.5	-3.8	2.2	-8.1	0.6
T_2_5	-0.2	3.9	-7.9	7.5	1.3	3.3	-5.2	7.8	1.1	2.6	-4.0	6.2
ST_2_5	1.0	3.0	-4.9	6.8	3.4	2.9	-2.3	9.2	4.4	3.3	-2.1	10.9
S_2_5	1.0	2.4	-3.7	5.8	4.8	3.1	-1.4	10.9	5.8	4.2	-2.4	14.1
SN_2_5	0.7	2.6	-4.4	5.7	4.5	3.1	-1.6	10.6	5.2	4.1	-2.8	13.1
N_2_5	0.8	2.4	-3.9	5.6	3.7	2.9	-2.0	9.3	4.5	3.9	-3.2	12.2
IN_2_5	0.3	3.8	-7.3	7.8	4.0	4.8	-5.4	13.5	4.3	3.4	-2.4	11.0
I_2_5	-0.5	4.6	-9.5	8.6	1.5	7.6	-13.3	16.3	1.0	5.7	-10.2	12.3
IT_2_5	-0.6	4.3	-8.9	7.8	-1.5	9.7	-20.4	17.4	-2.1	10.5	-22.6	18.4
T_5_7	0.5	4.4	-8.1	9.1	-2.1	5.8	-13.5	9.2	-1.6	5.8	-13.0	9.7
ST_5_7	1.2	3.5	-5.7	8.2	1.5	4.1	-6.5	9.5	2.8	3.7	-4.6	10.1
S_5_7	1.1	3.1	-5.0	7.2	3.6	7.2	-10.4	17.7	4.8	6.8	-8.5	18.0
SN_5_7	1.3	3.2	-4.9	7.6	1.8	6.5	-10.9	14.5	3.2	5.4	-7.4	13.8
N_5_7	1.3	2.8	-4.1	6.7	-0.8	5.2	-11.0	9.4	0.5	5.3	-9.8	10.8
IN_5_7	1.5	2.7	-3.7	6.7	-0.9	9.3	-19.2	17.4	0.6	10.0	-19.1	20.2
I_5_7	1.0	3.8	-6.4	8.4	-2.1	5.8	-13.4	9.3	-1.1	6.2	-13.3	11.1
IT_5_7	0.7	4.9	-9.0	10.4	-6.5	12.2	-30.5	17.5	-5.8	11.6	-28.5	16.8
T_7_9	0.6	3.6	-6.5	7.7	4.9	14.2	-22.9	32.6	5.5	13.7	-21.4	32.3
ST_7_9	0.2	4.0	-7.7	8.0	1.9	11.4	-20.4	24.2	2.1	11.3	-20.0	24.2
S_7_9	0.0	4.0	-7.8	7.8	-1.0	16.0	-32.3	30.3	-1.0	14.5	-29.5	27.5
SN_7_9	0.9	4.7	-8.2	10.0	2.3	11.0	-19.3	23.9	3.2	9.8	-16.0	22.3
N_7_9	0.8	4.3	-7.7	9.2	-0.1	6.1	-12.0	11.8	0.7	4.5	-8.1	9.5
IN_7_9	0.3	3.8	-7.1	7.7	0.0	12.1	-23.8	23.7	0.3	10.9	-21.2	21.7
I_7_9	0.5	4.2	-7.6	8.7	5.5	13.2	-20.4	31.4	6.0	12.3	-18.1	30.2
IT_7_9	0.8	4.5	-8.0	9.6	2.3	18.8	-34.6	39.1	3.1	16.8	-29.9	36.1

LOA lower bound = mean-1.96xSD

42

Image /page/42/Picture/0 description: The image shows the text 'K180660' in a simple, sans-serif font. The text is presented in a clear and legible manner. The number appears to be a product or lot number.

Image /page/42/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 semi-circular shape that transitions from orange to yellow. The semi-circle is open on the left side, creating a crescent shape.

Table 43b. Deming Regression Analysis between Software and Manual Measurements

Keratoconus Group (n= 16)
			Epithelial Thickness						Stromal Thickness			Corneal Thickness
Parameter	intercept	intercept
CI lower	intercept
CI upper	slope	slope
CI lower	slope
CI upper	intercept	intercept
CI lower	intercept
CI upper	slope	slope
CI lower	slope
CI upper	intercept	intercept
CI lower	intercept
CI upper	slope	slope
CI lower	slope
CI upper
C_2	-5.2	-8.8	-1.7	1.09	1.02	1.16	-12.4	-16.6	-8.1	1.02	1.01	1.03	-16.2	-27.8	-4.7	1.03	1.00	1.05
T_2_5	-8.7	-26.2	8.7	1.17	0.85	1.48	-5.1	-13.5	3.3	1.01	0.99	1.03	-12.3	-29.2	4.5	1.03	0.99	1.06
ST_2_5	-5.0	-15.2	5.1	1.11	0.94	1.28	-3.2	-10.7	4.4	1.01	0.99	1.03	-8.5	-25.1	8.2	1.02	0.99	1.06
S_2_5	-0.5	-12.9	11.9	1.03	0.79	1.26	1.5	-5.8	8.9	1.00	0.99	1.02	-6.4	-33.6	20.9	1.02	0.97	1.07
SN_2_5	-5.8	-27.3	15.6	1.12	0.74	1.49	2.0	-4.1	8.1	1.00	0.99	1.01	-0.4	-36.8	35.9	1.01	0.95	1.07
N_2_5	-4.2	-19.2	10.8	1.09	0.83	1.35	4.1	-3.7	12.0	1.00	0.98	1.01	-2.4	-43.7	39.0	1.01	0.94	1.09
IN_2_5	-3.3	-10.1	3.5	1.06	0.93	1.20	-0.9	-8.9	7.2	1.01	0.99	1.02	15.1	-14.4	44.6	0.98	0.92	1.03
I_2_5	1.1	-36.1	38.2	0.97	0.26	1.69	-0.9	-8.1	6.3	1.00	0.99	1.02	8.1	-27.1	43.3	0.99	0.92	1.05
IT_2_5	-0.3	-27.6	27.0	1.00	0.45	1.54	-2.9	-10.5	4.7	1.01	0.99	1.02	-32.2	-96.4	32.0	1.06	0.94	1.18
T_5_7	-7.1	-35.6	21.3	1.14	0.61	1.68	-0.7	-22.1	20.8	1.00	0.96	1.04	-21.0	-62.7	20.6	1.04	0.96	1.11
ST_5_7	-17.8	-43.0	7.4	1.36	0.88	1.83	-4.7	-19.0	9.6	1.01	0.98	1.04	-3.1	-27.7	21.6	1.01	0.97	1.05
S_5_7	-8.1	-50.2	34.0	1.17	0.39	1.96	-20.8	-45.5	3.8	1.04	1.00	1.08	-28.5	-74.4	17.4	1.05	0.98	1.13
SN_5_7	0.8	-92.9	94.5	1.01	-0.69	2.71	-11.2	-28.9	6.4	1.02	0.99	1.05	-26.3	-62.8	10.3	1.05	0.99	1.11
N_5_7	0.4	-20.5	21.2	1.02	0.65	1.39	-5.3	-23.7	13.0	1.01	0.98	1.04	-15.9	-58.7	27.0	1.03	0.96	1.10
IN_5_7	4.5	-8.0	17.1	0.95	0.73	1.16	-0.4	-16.2	15.4	1.00	0.97	1.03	-8.9	-80.4	62.5	1.02	0.90	1.13
I_5_7	-7.4	-28.1	13.3	1.15	0.79	1.51	11.4	-15.1	37.8	0.98	0.93	1.03	-14.0	-36.7	8.7	1.02	0.99	1.06
IT_5_7	3.7	-37.0	44.3	0.94	0.19	1.70	6.5	-14.4	27.4	0.99	0.94	1.03	-57.1	-152.3	38.0	1.10	0.93	1.26
T_7_9	5.0	-14.0	23.9	0.92	0.57	1.27	-19.8	-69.7	30.1	1.04	0.95	1.13	4.7	-61.8	71.3	1.00	0.89	1.11
ST_7_9	5.0	-34.2	44.2	0.91	0.13	1.68	-22.5	-63.7	18.8	1.04	0.97	1.12	4.7	-54.5	63.8	1.00	0.90	1.09
S_7_9	-56.6	-115.7	2.5	2.13	0.94	3.32	-47.3	-113.1	18.6	1.08	0.97	1.19	35.2	-42.6	113.0	0.94	0.82	1.07
SN_7_9	13.0	-72.3	98.3	0.77	-0.80	2.35	-5.1	-61.4	51.1	1.01	0.92	1.10	15.9	-48.4	80.2	0.98	0.88	1.08
N_7_9	20.8	2.5	39.2	0.64	0.32	0.96	-31.6	-78.2	15.0	1.06	0.98	1.13	25.8	-4.6	56.2	0.96	0.91	1.01
IN_7_9	8.3	-30.3	46.9	0.86	0.18	1.53	-21.6	-38.3	-4.9	1.04	1.01	1.07	52.4	-21.7	126.6	0.92	0.79	1.04
I_7_9	-1.8	-18.4	14.8	1.04	0.76	1.32	10.8	-13.1	34.8	0.98	0.94	1.03	-35.6	-88.6	17.3	1.07	0.98	1.16
IT_7_9	-3.9	-32.6	24.7	1.09	0.58	1.59	-11.8	-44.0	20.3	1.02	0.97	1.08	-50.2	-102.9	2.6	1.09	1.00	1.18

Conclusion

The modified Avanti device and its RTVue XR Avanti and RTVue CAM predicate devices are identical in design and intended use. The results from the software, non-clinical and clinical performance testing demonstrate that the Avanti device with software modification is as safe and effective as its predicate devices.