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Mechanical cutting and electrosurgical coagulation of tissue during the performance of laparoscopic and general surgical procedures.

The device is a Class II medical device. The Everest LP Bipolar Scissors and Gyrus LP Scissors are a modification to the predicate device cleared under K904993. The Bipolar Bipolar LP Scissors are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The scissors blades are electrically isolated from each other enabling one blade to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation and mechanical cutting during surgical procedures is similar to the predicate device cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.

The provided text is a 510(k) summary for the Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors. It discusses the device's substantial equivalence to a predicate device and its intended use. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects like sample sizes, expert ground truth, or AI performance that your request asks for.

The document states:

"The Bipolar Bipolar LP Scissors are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The scissors blades are electrically isolated from each other enabling one blade to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation and mechanical cutting during surgical procedures is similar to the predicate device cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices."

"In conclusion, as the design, materials of construction, function and intended use of the Modified LP Bipolar Scissors is similar to that of the predicate devices currently cleared, Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent."

This indicates that the device was cleared based on substantial equivalence to an existing predicate device (K904993), rather than requiring a new clinical performance study with specific acceptance criteria as you've outlined. The FDA's 510(k) process often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, without necessarily requiring new, extensive clinical trials for every submission, especially for modifications that don't alter fundamental technology.

Therefore, I cannot populate the table or answer the specific questions you've posed because the provided text does not contain that type of detailed study information. The clearance was based on the premise that the device is "substantially equivalent" to one already on the market, implying that its performance would be similar, and thus, specific performance metrics and studies to prove them are not detailed in this summary.

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