The Fundus AutoImager™ is an automated ocular fundus imaging device that allows for the rapid capture, storage, manipulation and transmission of images of the eye, especially the retina area, as an aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

Device Description

The Fundus AutoImager utilizes video cameras for alignment, focus and tracking of the patient's pupils and a high-resolution (1k x 1k) chargecoupled device (CCD) camera for focus and tracking of the fields of interest on the patient's fundus. The system acquires stereo pairs of images that are displayed on a video monitor. The operator can select for imaging in monochrome or color and the images can be stored to disk, printed, or sent to a remote location via the Internet.

AI/ML Overview

This document is a 510(k) Summary for the Fundus AutoImager™ by Visual Pathways, Inc. It describes the device, its intended use, technological characteristics, and claims of substantial equivalence to predicate devices. The review indicates that the 510(k) lacks detailed information typically required to fully respond to all points in your request. For many of the requested items, the document states that specific information was not provided or cannot be extracted.

Here's an analysis of the provided text against your requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in terms of accuracy, sensitivity, or specificity for the Fundus AutoImager™. Instead, the evaluation focuses on qualitative aspects and operational performance compared to predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance (as described in the document)
Image Quality: Quality of images obtained	Confirmed to produce images of comparable quality to the Zeiss FF450 fundus camera.
Ease of Operation: Minimal operator training and intervention.	Requires minimal operator training and intervention during the imaging process; improved performance through more automated, faster, and simpler operation.
Time Required for Imaging: Rapid capture of images.	Shorter time to access a single stereo pair of images; shorter time to acquire multiple field stereo imaging (e.g., diabetic retinopathy NIH standard, seven-field stereo imaging).
Safety: Patient and operator safety.	Presents no new issues in regard to patient or operator safety.
Substantial Equivalence: Similar intended use and technological characteristics to predicate devices.	Determined to be substantially equivalent to legally marketed predicate devices (Zeiss FF450 VISUPAC and Topcon Medical Systems' ImageNet Digital Ophthalmic Imaging System) in intended use, indications, and overall technological characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Approximately 130 patients.
Data Provenance:
- Country of Origin: Not explicitly stated, but the evaluation was directed by Stephen Fransen, M.D., Chief Scientific Officer of Inoveon Corp., Oklahoma City, OK, suggesting a US-based study.
- Retrospective or Prospective: The study describes acquiring multiple field images "on approximately one hundred thirty patients," which implies a prospective data collection rather than retrospective analysis of existing images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: At least one, Stephen Fransen, M.D. The text also mentions "Dr. Fransen and his team," which suggests more than one person was involved, but the exact number is not specified.
Qualifications of Experts: Stephen Fransen, M.D., is a board-certified ophthalmologist and retinal specialist. No specific experience length is mentioned for Dr. Fransen or his team.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe a formal adjudication method for establishing ground truth or resolving discrepancies. The evaluation was "directed" by Dr. Fransen, and he and his team "evaluated" the Fundus AutoImager and the images produced. This primarily indicates a single expert (or principal expert with a team) assessment rather than a formal adjudication process (e.g., multi-reader consensus, 2+1, 3+1).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes a comparative evaluation between the Fundus AutoImager™ and a predicate device (Zeiss FF450 fundus camera) regarding image quality and operational aspects. However, this was not an MRMC comparative effectiveness study designed to measure the improvement of human readers with AI assistance. The Fundus AutoImager™ itself is described as an "automated ocular fundus imaging device" that aids in diagnosing or monitoring diseases, but the study focuses on its performance in image acquisition and quality compared to another fundus camera, not on how its images improve human diagnostic performance. The effect size of human readers improving with AI vs. without AI assistance is therefore not addressed in this document.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This device is an imaging system (ophthalmic camera), not an AI algorithm intended for automated diagnosis or interpretation. The document describes the device's ability to capture, store, manipulate, and transmit images as an aid in diagnosing or monitoring diseases, implying human interpretation is still within the loop. Therefore, a standalone (algorithm only) performance study as commonly understood for AI diagnostics was not performed, as it's not applicable to this type of device based on the provided description.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for evaluating the images was based on the expert assessment/consensus of Stephen Fransen, M.D., a board-certified ophthalmologist and retinal specialist, and his team. The evaluation considered "the quality of images obtained" and their utility for diagnosis/monitoring.

8. The sample size for the training set

The document describes a clinical evaluation of the performance of the Fundus AutoImager and does not mention a separate "training set" in the context of an AI model development. The device is a hardware imaging system with automated features, not a conventional machine learning model that undergoes training on a large dataset. Therefore, the sample size for a training set is not applicable or not provided in this context.

9. How the ground truth for the training set was established

Since no training set for an AI model is described or applicable to the device as presented, information on how its ground truth was established is not provided.

Summary

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Visual Pathways, Inc. www.vispath.com

334 White Spar Road Prescott, AZ 86303

p 928.778.5002 f 928.778.5004

7 2002 NOV

Pathw A New Vision in Eye Care

APPENDIX D

510(k) Summary

This summary of premarket notification safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92(c).

Date Prepared:	August 1, 2002
Applicant:	Visual Pathways, Inc.334 White Spar RoadPrescott, AZ 86303-4238(928) 778-5002 – Voice(928) 778-5004 – FAX
Contact:	Mr. Gary F. Buck(928) 778-5002 – Voice(928) 778-5004 - FAX
Registration:	K020888
Device Name:	Proprietary Name—Fundus AutoImager™Common Name—AC Powered Ophthalmic CameraClassification Name—Ophthalmic Camera (21 CFR 886.1120)

Note: This classification name is in accordance with FDA's publication
"Classification Names for Medical Devices and In-Vitro Diagnostic
Products" (FDA 95-4246). In addition, 21 CFR 886.1120 is cited in this
publication as the corresponding regulation.Legally Marketed Device for Claiming Substantial Equivalence:

Manufacturer	Device Name	510(k) Number
Carl Zeiss Jena GmbH	FF450(plus) VISUPAC	K011877
Topcon Medical Systems	ImageNet Digital OphthalmicImaging System	K870039

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Visual Pathways, Inc.

APPENDIX D

The Fundus AutoImager™ is an automated ocular fundus imaging device Intended Use: that allows for the rapid capture, storage, manipulation and transmission of images of the eye, especially the retina area, as an aid in diagnosing or monitoring diseases of the eye that may be observed and photographed. The Fundus AutoImager requires minimal operator training and intervention during the imaging process. It is intended for use with patients for whom examination of the fundus for pathologies is requested.

The Fundus AutoImager is designed as a film-less imaging system, utilizing a high-resolution digital camera that allows for convenient storage and transmission of images.

The Fundus AutoImager utilizes video cameras for alignment, focus and Device Description: tracking of the patient's pupils and a high-resolution (1k x 1k) chargecoupled device (CCD) camera for focus and tracking of the fields of interest on the patient's fundus. The system acquires stereo pairs of images that are displayed on a video monitor. The operator can select for imaging in monochrome or color and the images can be stored to disk, printed, or sent to a remote location via the Internet.

All of the aligning and focusing procedures are performed using barely visible infrared illumination. With such illumination, the patient's pupils do not constrict and for all but patients with unusually small natural pupils, no artificial dilation is required.

Technological Characteristics/Substantial Equivalence:

The indications or intended uses of the Visual Pathways. Inc. Fundus AutoImager and legally marketed predicate devices such as the Zeiss FF450 VISUPAC system (K011877) and Topcon Medical Systems' ImageNet Digital Ophthalmic Imaging System (K870039) are intended to capture and store images of the retina taken by a fundus camera. The Fundus AutoImager is an automated imaging device that is intended to capture, store, manipulate and transmit images of the fundus. The Fundus AutoImager requires minimal operator training and intervention during the imaging process. It is intended for use for patients for whom examination of the fundus for pathologies is requested. Some predicate devices are likewise comprised of fundus cameras and computer hardware and software systems intended to capture, store, manipulate and transmit images of the fundus. Thus, the Fundus AutoImager ophthalmic camera has the same intended use and indications as the predicate devices.

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Visual Pathways, Inc.

APPENDIX D

The same technological characteristics of the Fundus AutoImager are also present in many legally marketed ophthalmic cameras.

The Fundus AutoImager and the predicate devices have similar general principles of operation and technological characteristics. Each of the devices is an ophthalmic camera. The user views the patient's retina through a fundus camera. A light source is used to illuminate the retina and the images formed are captured by the camera. The images are then digitized and stored. Successive images are taken to permit viewing a larger area of the retina. With some predicate devices, the stored images may be viewed on a monitor.

The technological differences between the Fundus AutoImager and its predicate devices are the degree of automation of the Fundus AutoImager ophthalmic camera, including its auto-pupil alignment and focus, autofundus alignment and focus, auto-retinal field accession, and auto-image collection and mosaicing. The Fundus AutoImager also differs from some of the predicate devices in its image storage system and the media on which the images may be captured, that is, digital electronic display versus film or printed image. However, these differences do not raise any new questions of safety or effectiveness. The Fundus AutoImager uses dedicated cameras and an automated illumination system for imaging the pupil and the fundus. Predicate devices use fundus cameras that rely upon manual targeting, focusing and image capture.

Based on the reasons provided, the Fundus AutoImager is substantially equivalent to legally marketed predicate devices.

Per 21 CFR Section 807.92(b)(3), we have clinically evaluated the Conclusions: performance of the Fundus AutoImager™, in conjunction with our marketing partner Inoveon Corp., Oklahoma City, OK and their Chief Scientific Officer, Stephen Fransen, M.D. Dr. Fransen, a board certified ophthalmologist and retinal specialist, directed the evaluation, comparing the performance characteristics of the Fundus AutoImager with the Zeiss FF450 fundus camera. The evaluation, among other things, considered the quality of images obtained, ease of operation, time required to access a single stereo pair of images, time to acquire multiple field stereo imaging (such as the diabetic retinopathy NIH standard, sever field stereo imaging), safety of patient and operator. Dr. Fransen and his team acquired multiple field images on approximately one hundred thirty patients. This number included both dilated and undilated conditions. From their evaluation of the Fundus AutoImager and the images produced, we have confirmed that the Fundus AutoImager is a product that incorporates some novel designs in both software and hardware to achieve

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Visual Pathways, Inc.

improved performance through more automated, faster and simpler operation. The comparison of the Fundus AutoImager with predicate devices demonstrates substantial equivalence with those devices. At the same time, the Fundus AutoImager presents no new issues in regard to patient or operator safety, or effectiveness.

Signed:

Date: 5/7/02

JAMAIRO

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized graphic that resembles a bird in flight, but upon closer inspection, it is composed of three human profiles facing to the right.

Enod and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

NOV 7. 2002

Visual Pathways, Inc. c/o Gary F. Buck 334 White Spar Road Prescott. AZ 86303

Re: K020888

Trade/Device Name: Fundus AutoImager™ Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: August 8, 2002 Received: August 9, 2002

Dear Mr. Buck:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Gary F. Buck

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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PreMarket Notification 510(k) Fundus AutoImager™ Visual Pathways, Inc.

STATEMENT OF INDICATIONS FOR USE

This device will also bear the prescription legend: "Caution: Federal law restricts the use of this device on the order of a physician."

Prescription Use
(Per 21 CFR 801.109)

Miklo Nicolas

vision of Ophthalmic Ear, Nose and Throat Devises

510(k) Number _

KU2CS88

Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.