(32 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 a 510(k) clearance letter from the FDA for "Non-prescription Sunglasses." This type of document is a regulatory approval, not a scientific study or a report detailing device performance and acceptance criteria.
Therefore, the input document does not contain any information related to:
- Acceptance criteria and reported device performance (in a table or otherwise)
- Sample size or data provenance for a test set
- Number/qualifications of experts for ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document simply states that the FDA has reviewed the 510(k) submission and determined the device (non-prescription sunglasses) is "substantially equivalent" to predicate devices, thus allowing it to be marketed. The "Indications For Use" section defines what the device is and its purpose, but not performance metrics or studies.
§ 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.