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The Liger Medical HTU-110 is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe.

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The provided document is limited to a 510(k) clearance letter for a medical device called the "Liger Medical HTU-110," which is a gynecologic electrocautery device. This type of document typically focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or comprehensive clinical study data in the way one would find for a significantly novel or AI-powered device.

Therefore, the document does not contain information to address the posed questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) clearance letter confirms that the device is "intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe." The clearance is based on the device being substantially equivalent to legally marketed predicate devices, meaning its performance characteristics are deemed similar enough to existing devices that it does not raise new questions of safety and effectiveness. The specifics of how that equivalence was demonstrated (e.g., through bench testing confirming electrical output, temperature control, etc.) are usually in the full 510(k) submission, which is not provided here.

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