(367 days)
The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
308nm Excimer System is an ultratraviolet light system designed to be used in Dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate specific ultraviolet light at wavelenath of 308 nm. It displays the treatment parameters. Users can set the device and fluence on the control touch screen and determine the machine's state and function under the help of colour-coded indicator light.
The provided document is an FDA 510(k) premarket notification for a medical device (308nm Excimer System) and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics typically associated with AI/ML-based medical devices or diagnostic tools.
This document primarily focuses on establishing "substantial equivalence" of the 308nm Excimer System to a legally marketed predicate device (GME ExSys 308) for treating psoriasis and vitiligo. The "tests" mentioned are bench testing for electrical safety, electromagnetic compatibility, and general safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57) and software lifecycle processes (IEC 62304). These are regulatory compliance tests, not performance studies as would be conducted for a diagnostic device's accuracy or an AI algorithm's effectiveness in a clinical context.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance in the context of accuracy, sensitivity, specificity, or clinical utility as would be applicable to an AI device. The document does not describe such a study.
The questions you asked are relevant for AI/ML medical devices where performance benchmarks and clinical validation studies are crucial. This document, however, describes a light therapy device where the primary regulatory hurdle is demonstrating equivalence to an existing device, not proving a new clinical efficacy or diagnostic accuracy.
§ 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.