The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.

Device Description

The subject device is a diagnostic and therapeutic contact lens system used for eye fundus examination and therapy of intraocular abnormalities. The lens is one element made from PMMA (polymethylmethracryalate). The lens is a sterile, disposable, single use device.

AI/ML Overview

This document is a 510(k) summary for a medical device called "Volk Disposable Vitrectomy Lenses." A 510(k) submission is typically for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way AI/ML devices often require.

Therefore, many of the requested elements for an AI/ML device study – like acceptance criteria in terms of performance metrics (sensitivity, specificity), expert involvement for ground truth, sample sizes for test/training sets, or MRMC studies – are not applicable to this type of traditional medical device submission.

The "study" here is a comparison with predicate devices to demonstrate substantial equivalence, not a clinical performance study as one would expect for AI/ML.

Here's a breakdown of what can be extracted based on the provided document:

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

Acceptance Criteria: The primary "acceptance criterion" for a 510(k) is demonstrating "substantial equivalence" in design, intended use, materials, and sterile presentation (if applicable) to one or more legally marketed predicate devices. There are no explicit performance metrics (e.g., accuracy, sensitivity, specificity) stated as acceptance criteria in this document because it's a contact lens, not a diagnostic algorithm.
Reported Device Performance: The document asserts that the Volk Disposable Vitrectomy Lenses are "substantially equivalent in design, material, classification, and intended use" to the predicate devices. The "performance" being demonstrated is the functional equivalence of the lens for its intended diagnostic and therapeutic use.

Acceptance Criterion (Implicit for 510(k))	Reported Device Performance
Substantial Equivalence in:	Demonstrated substantial equivalence based on:
- Indication for Use	- Indications for use are nearly identical or very similar to predicates.
- Design	- Designs include flat, wide field, and 30° prism, similar to predicates.
- Materials	- PMMA, same as predicates.
- Sterility	- EO Sterilized, same as one predicate (Ocular Disposable Vitrectomy Lenses) and different from another (Volk Quadraspheric Fundus Lens) which was non-sterile, but this difference is addressed by the "disposable" aspect of the new device.

2. Sample size used for the test set and the data provenance

Not Applicable. This is not an AI/ML device or a clinical performance study involving a "test set" in the context of data. The "test" here is a comparison of device specifications to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. See point 2. Ground truth establishment for a diagnostic algorithm is not relevant for this device.

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

Not Applicable. See point 2.

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

Not Applicable. This is not a software device involving human readers or AI assistance.

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

Not Applicable. This is a physical contact lens, not an algorithm.

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

Not Applicable. There is no "ground truth" in the AI/ML sense. The "ground" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not Applicable. See point 2.

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

Not Applicable. See point 2.

In summary: The provided document describes a 510(k) submission for a traditional medical device (a contact lens). The "study" referenced is a comparison to predicate devices for substantial equivalence, not a performance study of an AI/ML diagnostic or therapeutic algorithm. Therefore, the questions designed for AI/ML device evaluation are largely not applicable.

Summary

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Volk Optical, Inc.

510(k) SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

11:10 PM

March 7, 2005 Date:

Volk Optical, Inc. Submitter: 7893 Enterprise Drive Mentor, Ohio 44060 (440) 942-6161

Contact Person:

Michaeleen Dom

Official Correspondent:

Richard E. Lippman, O.D., F.A.A.O. Vice President Ophthalmic Product Regulatory Affairs R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road Suite 30 Rockville, Maryland 20850 (240) 683-3738

Device Name:

Trade Name:	Volk Disposable Vitrectomy Lenses
Common Name:	Vitrectomy contact lens
Classification Name:	Lens, Contact- Diagnostic
Device Classification:	21 CFR 886.1385Class II
Product Code:	HJK

Device Description:

Intended Use:

Substantial Equivalence:

The Volk Disposable Vitrectomy Lenses are substantially equivalent in design, material, classification, and intended use to vitrectomy lenses cleared for marketing by Ocular Instruments, Inc. (K012096), and Volk Optical, Inc. (K943125). See chart below.

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Volk Optical, Inc.

Comparison	Volk Contact &Laser DiagnosticLenses (currentapplication)	Volk QuadrasphericFundus Lens(K943125)	Ocular DisposableVitrectomy Lenses(K012096)
Indication forUse	Diagnostic contactlens for eye fundusexaminations anduse in the therapy ofintraocularabnormalities	Diagnostic contactlens for eye fundusexaminations anduse in the therapy ofintraocularabnormalities	Visualizastion of theocular fundus, vitreousand retinal structuresduring vitrectomysurgeries.
Design	Various designsinclude the flat, widefield and 30° prism.	Various designsinclude the flat, widefield and 30° prism	Various designs includethe flat, wide field and30° prism.
Materials	PMMA	PMMA	PMMA
Sterility	EO Sterilized	Non-sterile	EO Sterilized

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle.

Public Health Service

MAR 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Volk Optical, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. Official Correspondent for Volk Optical, Inc. R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Rd., Suite 30 Rockville, MD 20850

Re: K050623

Trade/Device Name: Volk Disposable Vitrectomy lenses Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) diagnostic contact lens Regulatory Class: Class II Product Code: HJK Dated: March 9, 2005 Received: March 10, 2005

Dear Dr. Lippman:

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 - Richard E. Lippman, O.D., F.A.A.O.

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), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE STATEMENT

510(k) Number (if known)

K050623

Sales and the same

. . .

Device Name:

Volk Disposable Vitrectomy Lenses

Indications for Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

: 2 .

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W.C. Brown, Ph.D.

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

K050623 510(k) Number.

Regulation Number and Section

§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.

(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.