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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 text describes a 510(k) submission for "Sunglasses" (K971707) and the FDA's determination of substantial equivalence. However, it does not contain the specific information required to answer your questions about acceptance criteria, device performance, study details, or ground truth establishment.

This document is a regulatory approval letter, not a technical report or clinical study summary. It confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed but does not provide details about performance testing or validation studies with specific metrics.

Therefore, I cannot populate the table or provide answers to the questions based solely on the provided text.

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