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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) clearance letter for "Sunglasses" (non-prescription) and an "Indications For Use" statement. It does not contain information about acceptance criteria for a medical device or a study proving that a device meets such criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given text.

The document primarily focuses on:

• Device: Sunglasses (non-prescription)
• Regulatory Classification: Class I, Product Code 86 HQY
• Indication for Use: To protect eyes from bright sunlight, not for refractive corrections, usually available over-the-counter.
• Regulatory Decision: Substantially equivalent to pre-amendment devices, subject to general controls.

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