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The SellaS® is intended for use in : Dermatological procedures requiring the coagulation of soft tissue;

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I am sorry, but based on the provided text, I cannot provide the requested information. The document is a clearance letter from the FDA for a device named "SellaS®," indicating it is substantially equivalent to a legally marketed predicate device.

The letter does not include any information about:

• Acceptance criteria: It does not define specific performance metrics the device needs to meet.
• A study proving device performance: It does not describe any studies, their methodologies, results, or the metrics used to evaluate the device.
• Sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is purely a regulatory letter granting market clearance based on substantial equivalence, not a performance report or a summary of a clinical study.

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