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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.

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.

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for "Sunglasses". It confirms the device's substantial equivalence to previously marketed devices and permits its marketing.

However, the letter does not contain any information regarding:

1. Acceptance criteria and reported device performance: This document does not detail any specific performance metrics or testing results for the sunglasses beyond stating they are intended to protect eyes from bright sunlight.
2. Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for any study evaluating the device's performance.

The document primarily focuses on regulatory approval based on substantial equivalence, not on a detailed scientific study demonstrating specific performance metrics against pre-defined acceptance criteria.

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