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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) premarket notification letter from the FDA regarding "Sunglasses" (K972246). This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

The letter states that the device is substantially equivalent to legally marketed predicate devices and thereby permits its marketing. It primarily addresses regulatory classifications, general controls, and compliance with manufacturing practices.

Therefore, I cannot provide the requested information based on the content of these pages. The document is strictly a regulatory approval letter, not a study report or technical specification.

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