(78 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 a 510(k) premarket notification letter from the FDA for a device described as "Sunglasses." This type of document is a letter confirming substantial equivalence to a predicate device, which means the device "Sunglasses" meets the general controls provisions of the Act.
However, the provided text does NOT contain information regarding:
- Detailed acceptance criteria for the device's performance.
- A study proving the device meets specific acceptance criteria.
- Any quantitative performance metrics.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Types of ground truth.
- How ground truth was established for training or testing.
The document is a regulatory approval letter for a Class I medical device (sunglasses), which generally have lower regulatory hurdles and typically do not require extensive performance studies as seen with higher-risk medical devices or AI/software as a medical device (SaMD). The letter simply states the device is substantially equivalent to legally marketed predicate devices for its intended use: "to protect the eyes from bright sunlight but not to provide refractive corrections."
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving performance based on the provided text. The information requested (acceptance criteria table, study details, sample sizes, expert qualifications, ground truth methods, etc.) is typically found in the 510(k) submission itself or related clinical/performance studies, which are not part of this FDA clearance letter.
§ 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.