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The General Surgery Indications for Use for the Athos laser are modified as follow: General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, and treatment of leg veins. The Athoscan and Constans Cooling System are indicated for use with the Athos laser for indications for which the laser has been cleared.

The Athos laser emits a beam of coherent light at 1064 microns which is delivered to the Athos handpieces, the Athoscan, or the Constans Cooling System through fiber optics. The Athoscan increases the efficiency of treating large areas of skin (during hair removal) and the Constans Cooling System reduces reduce pain and the risk of thermal damage by cooling the skin during laser treatment.

The provided text is a 510(k) summary for the Athos laser and its accessories. It states explicitly:

"Performance Data: None required."

This indicates that the submission did not include any studies or performance data to establish acceptance criteria or demonstrate device performance against such criteria. The basis for substantial equivalence was primarily through comparison with predicate devices and a modification of indications for use.

Therefore, I cannot provide the requested information as it is not present in the provided document. Many of the questions in your prompt (e.g., sample size, ground truth, expert qualifications, MRMC study, standalone performance) relate to performance studies, which were explicitly stated as "None required" for this 510(k) submission.

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