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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.

The provided document is a 510(k) clearance letter from the FDA for non-prescription sunglasses. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as typically required for medical device performance evaluation.

This letter primarily focuses on the device's classification and its substantial equivalence to pre-amendment devices, allowing it to be marketed. It does not delve into the technical performance details or the studies conducted to establish that performance.

Therefore, I cannot provide the requested information based only on the input text. The information requested (acceptance criteria, study details, expert involvement, etc.) would be found in the 510(k) submission itself, not in the clearance letter.

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