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The Fencer 308 Excimer Laser will be indicated for use the Psoriasis, vitiligo, atopic dermatitis and leukoderma.

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The provided text is a 510(k) clearance letter from the FDA for the Fencer 308 Excimer Laser. It states that the device is substantially equivalent to legally marketed predicate devices for the indications of use: psoriasis, vitiligo, atopic dermatitis, and leukoderma.

However, this document does not contain information about:

1. Acceptance criteria and reported device performance: The letter states substantial equivalence, but doesn't detail performance metrics or specific acceptance criteria.
2. Sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods for a test set, or details about a training set.
3. Whether MRMC or standalone performance studies were conducted, or any effect size of AI assistance.

Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement. These details would typically be found in the 510(k) submission itself, not in the clearance letter.

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