(27 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 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.
§ 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.