Search Results

This sunlamp product is intended exclusively for cosmetic tanning of the human skin, for one person at a time, at the age of 18 or above.

The primary technical components of sunlamp products are artificial sources of UV radiation and a mechanical structure. Different UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification for sunlamp products, which primarily focuses on substantial equivalence to predicate devices and regulatory compliance rather than outlining detailed acceptance criteria, specific study designs, or performance metrics typically associated with medical device efficacy studies.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample sizes for test sets, data provenance, or details on training sets.
3. Information about experts establishing ground truth or adjudication methods.
4. Details of multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
5. The type of ground truth used (e.g., pathology, outcomes data).

The document is about sunlamp products and their regulatory clearance, not about an AI or algorithmic device.

Ask a specific question about this device