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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.

The provided text is a 510(k) clearance letter from the FDA for "Sunglasses." This document is a regulatory approval for the device and does not contain any information about acceptance criteria, device performance studies, or clinical trial details.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study information
6. Standalone performance information
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The letter focuses on the substantial equivalence determination to a legally marketed predicate device, allowing the sunglasses to be marketed. It confirms that the device meets the definition of sunglasses (nonprescription) intended for protection from bright sunlight, as per the "Indications For Use" statement.

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