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The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a Laparoscopic Instrument and Electrode Tips. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations it must comply with.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval document, not a study report.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them based on the provided text.

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