(7 days)
The intended function of the UV-B ultraviolet lamp is therapy for Psoriasis and Vitiligo.
Philips PL-S 9W/12/2P UV-B
Watts - 9
Volts - 60
Base - G23
Length - max OAL - 167 mm
This document is a 510(k) Summary Statement for the Philips PL-S 9W/12/2P UV-B lamp, which is intended for therapy for Psoriasis and Vitiligo. It is a submission to the FDA for market clearance and confirms substantial equivalence to previously marketed predicate devices.
This document does not describe acceptance criteria for an AI/ML device, nor does it present the results of a study to prove a device meets such criteria.
The document states that the Philips PL-S 9W/12/2P UV-B lamp is substantially equivalent to existing predicate devices (TL20W/12/RS, TL40W/12/RS, TL100W/12 UV B) because, while dimensionally different, they have "substantially equivalent outputs." This implies that the acceptance criteria for this device are met by demonstrating that its UV-B output characteristics are comparable to those of already approved lamps for the indicated therapies.
Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria and a study to prove a device meets those criteria, as this information is not present in the provided text. The document is concerned with demonstrating substantial equivalence based on output, rather than performance against pre-defined acceptance criteria for a new type of device or AI/ML product.
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.