(232 days)
The 308nm Excimer System (model: XECL-308E) is an Ultraviolet Light Emitting Medical Device. It is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. It is to be used on intact skin only.
The 308nm Excimer System (model: XECL-308E)is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma on all skin types (I-VI). The system including a main body, power line, handpiece holder, XeCl lamp, handpiece, and output light window adapter. The handpiece includes a contains light emitting diodes (LEDs), which create an array of narrowband UVB light centered at a wavelength mainly between 308±2 nm. The device should be operated by a professional doctor in the hospital for the treatment.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML-driven medical device.
The document is a 510(k) summary for the "308nm Excimer System" (model: XECL-308E), which is an Ultraviolet Light Emitting Medical Device. It describes the device's indications for use, its comparison to predicate devices, and lists various electrical safety and electromagnetic compatibility standards it complies with (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62304 for software).
However, none of the details you requested regarding acceptance criteria, device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information for an AI/ML device are present. The device described here is a physical medical device (an excimer lamp), not an AI/ML software device.
§ 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.