(24 days)
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 an FDA 510(k) clearance letter for "Momo Design Sunglasses" and an "Indications For Use" statement. It does not contain information regarding
acceptance criteria, study details, device performance data, sample sizes, expert qualifications, or ground truth establishment for an AI/device study.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them, as this information is not present in the provided 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.