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The Select-Sutter Micro-Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general surgery where coagulation of soft tissue is needed. This product is used with bipolar output of standard electrosurgical generators. The types of surgery intended are:

General sugery
Laparoscopic procedures
Endoscopic procedures
Laryngeal coagulation
Orthopedic coagulation
Thorascopic coagulation
Neurosurgical coagulation
Gynecological coagulation, (except for use in female sterilization)
Ear, Nose and Throat coagulation

The Micro-Bipolar Forceps Device is a laparoscopic and endoscopic device used for the grasping and general coagulation/cutting and pinpoint coagulation of tissue using electrosurgical energy under visualization. The device is used with bipolar outputs of electrosurgical generators and has reusuable probes for grasping/coagulation and pinpoint coagulation.

This 510(k) summary (K992760) describes the Select-Sutter Micro-Bipolar Forceps. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document provided is a 510(k) summary for a medical device cleared by the FDA. Such summaries primarily focus on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the manner you've requested for AI/software devices. For hardware devices like these electrosurgical forceps, the "proof" of meeting acceptance criteria typically comes from a series of engineering tests (e.g., electrical safety, mechanical strength, biocompatibility), which are usually referenced in the full 510(k) submission but not elaborated in the publicly available summary.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided text. The document describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not include performance data, study designs, or ground truth establishment relevant to an AI/software device evaluation.

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