The Optim-Eyes 450 sunglasses are worn by persons to protect the eyes from bright sunlight, including 100% and UVB, and blue light up to 450 nanometers.

Device Description

The Optim-Eyes 450 are non-prescription sunglasses constructed of commonly used materials for sunglass and spectacle frames and lenses.

AI/ML Overview

The provided text describes the Optim-Eyes 450 Sunglasses, a non-prescription device. The information focuses on its regulatory classification, safety, and substantial equivalence, rather than detailed clinical acceptance criteria or a study proving those criteria.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Impact Resistance (Drop Ball Test)	All sunglass lots are drop ball tested in accordance with 21 C.F.R. § 801.410.
UVB Radiation Blockage	Meets and exceeds current ANSI Z80.3 UV standards for "high and prolonged use", blocking virtually 100% UVB radiation.
UVA Radiation Blockage	Meets and exceeds current ANSI Z80.3 UV standards for "high and prolonged use", blocking virtually 100% UVA radiation.
Blue Light Attenuation	Strongly attenuates short-wave blue light (up to 450 nanometers as per Indications For Use).

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

The document states "All sunglass lots are drop ball tested." This suggests a commitment to testing each manufacturing lot, which implies a sampling strategy rather than a single fixed test set size for regulatory submission. However, the exact sample size per lot or for the UV/blue light testing is not specified.

Regarding data provenance, the testing appears to be conducted by the manufacturer, Taylor/Fox Enterprises, L.L.C. The country of origin of the data is not explicitly stated, but the company is based in Santa Monica, CA, USA, and the submission is to the US FDA, implying testing was likely conducted in the US or under US-standardized conditions. The data is retrospective in the sense that it represents past testing, but it's part of an ongoing quality control process for manufacturing.

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

This section is not applicable to this device. For non-prescription sunglasses, "ground truth" is established through standardized physical and optical testing against regulatory and industry standards (like 21 C.F.R. § 801.410 for impact and ANSI Z80.3 for UV). It does not involve expert consensus on visual interpretations or diagnoses.

4. Adjudication method for the test set

This section is not applicable. As mentioned above, performance is assessed against objective physical and optical standards, not through expert adjudication of subjective interpretations.

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

An MRMC comparative effectiveness study is not applicable to this device. This type of study is relevant for diagnostic or screening devices where human readers (e.g., radiologists, pathologists) interpret images or data, often with AI assistance. Sunglasses are a protective device, not a diagnostic one.

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

This section is not applicable. This device is not an algorithm or an AI system. Its performance is inherent to its physical properties.

7. The type of ground truth used

The ground truth used for this device's safety and effectiveness claims is based on:

Regulatory Standards: 21 C.F.R. § 801.410 for impact resistance.
Industry Standards: ANSI Z80.3 UV standards for "high and prolonged use" for UV and likely blue light attenuation.
These are objective, measurable physical and optical properties as defined by established benchmarks, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of this device. A training set is used for machine learning algorithms, which are not involved here.

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

This section is not applicable for the same reason as point 8.

Summary

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K971875

Optim-Eyes 450 Sunglasses 510(k) Summary

JUN 1 3 1997

1. Device Name

Classification Name: Proprietary Name:

Sunglasses (non-prescription), Class I Optim-Eyes 450 sunglasses

Device Sponsor 2.

Taylor/Fox Enterprises, L.L.C. 626 Santa Monica Blvd., Suite 101 Santa Monica, CA 90401 310-624-6277

3. Description of the Device

The Optim-Eyes 450 are non-prescription sunglasses constructed of commonly used materials for sunglass and spectacle frames and lenses.

Safety and Effectiveness 4.

All sunglass lots are drop ball tested in accordance with 21 C.F.R. § 801.410.

The lenses meet and exceed current ANSI Z80.3 UV standards for "high and prolonged use", blocking virtually 100% both UVB and UVA radiation. In addition they strongly attenuate short-wave blue light.

Substantial Equivalence 4.

The Optim-Eyes 450 sunglasses are substantially equivalent to commercially available sunglass products, including the Blublocker sunglasses (K900382).

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 1997

Mr. Adam Taylor Taylor/Fox Enterprises L.L.C. c/o King & Spalding 1730 Pennsylvania Ave. N.W. Washington, D.C. 20006

Re: K971875 Trade Name: Optim-Eyes 450 Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: May 5, 1997 Received: May 20, 1997

Dear Mr. Taylor:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 I'lectronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Adam Taylor

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):

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Optim-Eyes 450 sunglasses Device Name:

indications For Use:

二

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The Optim-Eyes 450 sunglasses are worn by persons to protect the eyes from bright sunlight, including 100% and UVB, and blue light up to 450 nanometers.

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

Concurrence of CDRH, Office of Device Evaluation (ODB)

Am Williams

(Division Sign-Off)

Division of Ophthalmic Devices
Number K971875

Prescription Use (Pex 21 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.