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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 is a 510(k) premarket notification letter from the FDA for "Sunglasses" (K971087). This document confirms that the device is substantially equivalent to a predicate device and can be marketed subject to general controls.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt regarding a study proving the device meets acceptance criteria.

The document is a regulatory approval letter, not a study report. Therefore, I cannot generate the requested table and study description based on the input provided.

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