SUNGLASSES by ELEGANCE OPTICAL MANUFACTORY, LTD.

This document is a letter from the FDA regarding a 510(k) premarket notification for "Sunglasses." It primarily addresses the regulatory status and substantial equivalence of the device, rather than providing a study on performance against acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be gathered:

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

Cannot be extracted. The document is a regulatory approval letter, not a device performance study report. It does not list any specific acceptance criteria or performance metrics for the sunglasses.

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

Cannot be extracted. No test set or data provenance is mentioned as this is not a study report.

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)

Cannot be extracted. No ground truth establishment or expert involvement for a test set is discussed.

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

Cannot be extracted. No adjudication method is mentioned.

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

Cannot be extracted. This document predates widespread AI development for medical devices and does not describe any MRMC studies or AI involvement. The device is "Sunglasses," not an AI-powered diagnostic tool.

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

Cannot be extracted. No algorithm or standalone performance is discussed.

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

Cannot be extracted. No ground truth for performance evaluation is mentioned. The "ground truth" implied by the 510(k) process is the existence of legally marketed predicate devices that the new device is substantially equivalent to.

8. The sample size for the training set

Cannot be extracted. No training set is mentioned.

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

Cannot be extracted. No training set or its ground truth establishment is discussed.

Summary:

This document is solely an FDA 510(k) clearance letter confirming that "Sunglasses" manufactured by Elegance Optical Mfy. Ltd. are substantially equivalent to pre-amendments devices. It does not contain any information regarding performance studies, acceptance criteria, test sets, or ground truth establishment.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1997

Elegance Optical Mfy. Ltd. C/o Ms. Esther Lai International Development Group, Inc. 401 Broadway, Suite 613 New York, NY 10013

Re: K973934 Trade Name: Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: October 8, 1997 Received: October 15, 1997

Dear Mr. Lai:

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, Olisting 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- Ms. Lai

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): X973934

vice Name: Sunglasses

Indications For Use:

Intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amwilliams

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. K973934

Pription Use ( 1 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 886.5850 Sunglasses (nonprescription).

(a)
Identification. Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.