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The PL-980 laser and collimated handpiece will be indicated for ablation, vaporizing, excision, incision, and coagulation of soft tissue encountered in dermatology and plastic surgery, including but not limited to vascular lesions such as telangiectasia and angiomas.

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This document is a 510(k) clearance letter from the FDA for a medical device (Sheaumann PL-980 laser). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms substantial equivalence to a predicate device based on the indications for use.

Therefore, I cannot provide the requested information from the provided text.

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The PL-1064 laser, collimated handpiece will be indicated for ablation, vaporizing, excision, incision, and coagulation of soft tissue encountered in dermatology, plastic surgery, and podiatry including but not limited to plantar warts, periungual and subungual warts and telangiectasia.

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The provided document is a 510(k) premarket notification letter from the FDA regarding a laser surgical instrument (Sheaumann PL-1064). This type of document primarily confirms that the FDA has reviewed the device and determined it to be "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

Crucially, this document DOES NOT contain the details of the performance study or acceptance criteria. The FDA's 510(k) clearance process relies on the manufacturer demonstrating substantial equivalence, which often involves testing but the specific results and methodology of those tests are typically not included in the public-facing clearance letter. They are part of the detailed submission made by the manufacturer to the FDA.

Therefore, I cannot provide the requested information from the given text. The information requested (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are all specifics of a performance study that are not present in this regulatory correspondence.

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