(86 days)
UV phototherapy device is intended to be used for the treatment of psoriasis, vitiligo and atopic dermatitis (eczema). It is to be used on intact skin only. Patients shall use it at home under the guidance of the physician.
UV phototherapy device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and eczema. It is to be used on intact skin only. Patients shall use it at home under the quidance of the doctor.
Users can set UV irradiation dose through the controller, and confirm the light emission by pressing the start button. The controller will control the light emitting time of the set dose. The light emission will stop automatically after the UV irradiation dose reaches the set value.
The provided text is a 510(k) Summary for a UV Phototherapy Device. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.
The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It then lists several international standards (IEC and ISO) with which the device complies. However, it does not provide:
- A table of actual acceptance criteria (e.g., minimum efficacy rates, safety thresholds) for the device's clinical performance.
- The reported device performance against such criteria.
- Details about specific studies (clinical or non-clinical) that "prove" the device meets these criteria in terms of clinical outcomes for psoriasis, vitiligo, and atopic dermatitis.
- Information on sample sizes for test sets or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document focuses on substantiating equivalence to predicate devices primarily through technological comparison and compliance with electrical safety, EMC, and biocompatibility standards, rather than direct evidence of clinical efficacy meeting predefined acceptance criteria for the treatment of dermatologic conditions.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the studies and ground truth, as this information is not present in the provided text.
§ 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.