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The MultiClearXL Multiwavelength Targeted Phototherapy System ("MultiClearXL") is intended to provide phototherapeutic light to the body. The MultiClearXL is generally indicated to treat dermatological conditions. The MultiClearXL's specific indication is for use in UVB phototherapy and PUVA photochemistry to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma and for the use of visible blue/violet light to treat moderate inflammatory acne vulgaris.

The MultiClearXL is a computer controlled, high-intensity lamp intended for treatment of dermatological disorders by emitting a homogenous UV light dose in the UVB, UVA, and visible blue/violet light ranges. The desired dose of UVA or UVB or blue/violet light is selected using controls on the system front panel. The system consists of a console trolley, control console, illumination assembly, an extension arm (light guide and hand piece) and protective eyewear for the operator and patient.

This 510(k) premarket notification for the MultiClearXL Multiwavelength Targeted Phototherapy System does not contain the information requested in your prompt regarding acceptance criteria, study details, and performance data.

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting detailed clinical study results or acceptance criteria based on performance metrics. It primarily discusses the device's intended use, technological characteristics, and comparison to existing devices.

Therefore, I cannot populate the table or provide the requested study details. The document states:

• "The MultiClearXL has the same intended use and indications and similar principles of operation and technological characteristics as a combination of the predicate devices. The MultiClearXL's specific indications are specific indications for at least one of the predicate devices. Any minor differences between the MultiClearXL and its predicate devices raise no new issues of safety or effectiveness. Thus, the MultiClearXL is substantially equivalent to the predicate devices."

This indicates that the basis for approval is substantial equivalence to existing devices, not a new clinical study demonstrating specific performance against predefined acceptance criteria for the MultiClearXL itself.

Summary of missing information:

• Acceptance Criteria Table: No acceptance criteria or reported device performance metrics are provided.
• Sample size and data provenance for test set: Not mentioned.
• Number and qualifications of experts for ground truth: Not mentioned.
• Adjudication method for test set: Not mentioned.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone algorithm performance: Not applicable, as this is a phototherapy system, not an AI algorithm.
• Type of ground truth: Not applicable in the context provided.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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