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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 text is related to a 510(k) premarket notification for "Venneto Sunglasses." This type of regulatory document, particularly for Class I devices like sunglasses, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with acceptance criteria, human-in-the-loop performance, or AI assistance.

Therefore, the input does not contain information about:

• Acceptance criteria and reported device performance in a table format.
• Sample sizes for test sets, data provenance, ground truth establishment, or training sets.
• The number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance studies.
• The type of ground truth used (pathology, outcomes data, etc.).

The document solely confirms that the Venneto Sunglasses are classified as a Class I device and are substantially equivalent to pre-amendment devices, allowing them to be marketed under general controls.

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