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ORskin Blue is intended for incision, vaporization, ablation, hemostasis, and coagulation of soft tissue.

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I apologize, but the provided text is a 510(k) clearance letter from the FDA for a device named "ORskin Blue," a laser surgical instrument. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding a study proving the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements. It does not provide the technical or clinical study data you are asking for. Therefore, I cannot extract that information from this document.

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