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The indication for use are UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.

Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV laser system is a self-contained ultraviolet laser light source and optical energy delivery system that provides targeted energy to the treatment site while avoiding exposure to non-affected tissue. The light source is contained within the protective console. The complete system also includes a hand piece connected to the console via an articulating arm. Timing and dosing parameters and the user interface are controlled through a display on the console. The delivery system allows UV-B light to pass through the hand piece to selectively treat skin legions without exposure to the unwanted skin.

The provided text is a 510(k) Summary for a medical device, the PALLAS 308/311 Solid-State UV Laser System. It outlines the device's technical characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence for FDA clearance.

However, this document does not contain information about a study that proves the device meets specific acceptance criteria based on AI/algorithm performance, human reader improvement with AI assistance, or expert consensus on a test set. The performance data section refers to non-clinical tests (measurement of wavelength, output power, energy fluence) and compliance with various consensus standards related to electrical safety, electromagnetic compatibility, usability, risk management, and software validation for a laser system, not an AI-driven medical device.

Therefore, I cannot provide the requested information related to acceptance criteria and study details for an AI-driven device, as the provided document concerns a UV laser system and its substantial equivalence to a predicate device, based on engineering and safety standards, not AI-specific performance.

Specifically, the document does not mention:

• A table of acceptance criteria with reported device performance for an AI/algorithm.
• Sample sizes for a test set or data provenance for AI model validation.
• The number or qualifications of experts for ground truth establishment.
• Adjudication methods for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• The type of ground truth (e.g., pathology, outcomes data).
• Sample size for a training set or how its ground truth was established.

The "Performance Data" section details non-clinical tests of the laser's physical parameters and compliance with electrical and safety standards, which are typical for laser devices seeking 510(k) clearance via substantial equivalence.

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