WINSTATION RETINAL IMAGER by OPHTHALMIC IMAGING SYSTEMS

The WinStation Retinal Imager™ has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segment (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.

Device Description

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AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria and study details you've requested regarding a medical device. The document is a 510(k) clearance letter from the FDA for the "WinStation Retinal Imager," dated October 23, 1998. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE), a clinical study report, or similar regulatory submission details that would include:

Acceptance criteria and device performance: These are typically defined metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, along with the reported performance values from a study.
Sample size and data provenance: Details about the number of cases/patients used in testing and where the data came from (e.g., country, retrospective/prospective).
Number and qualifications of experts for ground truth: Information about the specialists who established the correct diagnoses or measurements, including their experience levels.
Adjudication method for ground truth: How disagreements among experts were resolved (e.g., majority vote, senior expert decision).
MRMC comparative effectiveness study: If human reader performance with and without AI assistance was evaluated, and the effect size measured.
Standalone performance: The performance of the algorithm without human intervention.
Type of ground truth: How the true status of a condition was determined (e.g., pathology, clinical follow-up, expert consensus).
Training set sample size: The number of data points used to train the AI model.
Ground truth establishment for training set: How the correct labels were assigned to the training data.

The current document only provides the FDA clearance, trade name, regulatory class, product code, and a general statement of indications for use, without any performance data or study design details.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 1998

Mr. Steven R. Verdooner President Ophthalmic Imaging Systems, Inc. 221 Lathrop Way Suite I Sacramento, CA 95815

Re: K982689 Trade Name: WinStation Retinal Imager Regulatory Class: II Product Code: 86 HKI Dated: September 29, 1998 Received: September 30, 1998

Dear Mr. Verdooner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Steven R. Verdooner, President

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

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

Enclosure

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510(k) Number (if known):K982689 · · · ¹ ¹ · ·------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
WinStation Retinal ImagerDevice Name: _________________________________________________________________________________________________________________________________________________________________Status Canada Career Station Company Company Come of Children

Indications For Use:

STATEMENT OF INDICATIONS FOR USE

The WinStation Retinal Imager™ will be operated by doctors and technicians in ophthalmic and optometric offices and other locations that are under the direction of a licensed physician in which it is appropriate to perform ocular imaging procedures. Fundus photography and slit lamp imaging is the standard of care for documentation of the patient's eye.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Denis L. McCarthy

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number .

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.