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Indicated for coagulation of tissue These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

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The provided text describes an FDA 510(k) clearance letter for an electrosurgical device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

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The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. Substantial equivalence generally means that the new device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness, and the data submitted show that the device is as safe and effective as the predicate device. However, the details of how this substantial equivalence was demonstrated through specific studies or acceptance criteria are not present in this clearance letter.

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