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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 text, there is no information available about acceptance criteria, device performance, or any studies conducted to prove such criteria.

The provided text is a 510(k) clearance letter from the FDA for a product named "Sunglasses." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.

The document does not contain any technical specifications, performance metrics, clinical study design, or results. It is a regulatory approval document, not a scientific report detailing device performance.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets those criteria, as that information is not present in the provided input.

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