(14 days)
Riviera Sunglasses are intended to be worn by a person to protect the eyes from bright, but do not provide for refractive correction.
Sunglasses, Nonprescription, Class I 886.5850, 86HQY
The provided text is a 510(k) clearance letter from the FDA for "Riviera Sunglasses." This document outlines the agency's determination of substantial equivalence for the device. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter is a regulatory document confirming that the sunglasses are substantially equivalent to pre-amendment devices and can be marketed. It does not delve into the detailed technical or clinical validation studies that would typically define acceptance criteria and prove performance for a more complex medical device.
Therefore, I cannot provide the requested information based on the input text.
§ 886.5850 Sunglasses (nonprescription).
(a)
Identification. 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.