Search Results

The Ultraviolet Phototherapy Device 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).

Ultraviolet Phototherapy Device

This FDA 510(k) clearance letter is for a physical device, an Ultraviolet Phototherapy Device, and not for an AI/software as a medical device (SaMD).

Therefore, the document does not contain any information about:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• Any study proving AI model performance.
• Data provenance, sample sizes, expert qualifications, or adjudication methods for an AI test set.
• Multi-Reader Multi-Case (MRMC) studies for AI.
• Standalone AI performance.
• Training set details for an AI model.

The clearance is based on substantial equivalence to existing predicate devices, which primarily relies on technological characteristics, indications for use, and safety/performance data typical for physical medical devices (e.g., electrical safety, EMC, photobiological safety, performance of the UV light output).

In summary, none of the requested information regarding acceptance criteria and studies for an AI/SaMD can be extracted from this document, as it pertains to a traditional physical medical device.

Ask a specific question about this device