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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.

This document is a 510(k) premarket notification for "Sunglasses" (K971385). It confirms the device is substantially equivalent to devices marketed prior to May 28, 1976. However, the provided document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment.

The document is a regulatory approval letter from the FDA, and it focuses on:

• Acknowledging the 510(k) submission.
• Determining substantial equivalence to a predicate device.
• Outlining the general controls and regulations applicable to the device.
• Confirming permission to market the device.
• Providing contact information for regulatory inquiries.
• Stating the intended use of the sunglasses.

Therefore, I cannot provide the requested information based on the provided text.

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