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The 7 mm Extended Length Endoscope with Dissection Tip is indication of a surgical cavity and dissection in endoscopic procedures and other minimally invasive surgical procedures allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients requiring endoscopic tissue separation of the extraperitoneal or subcutaneous extremity and thoracc space. Extremity procedures include tissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The 7 mm Endoscope is a reusable product which consists of a stainless steel shaft housing optical and illumination components. The proximal end has an eyepiece for camera adapter attatchment, and a light post for light cable connection; the camera adapter and light cable are not included with the 7 mm Endoscope. The 7 mm Endoscope is supplied non-sterile, and must be cleaned and sterilized prior to each use.

This appears to be a 510(k) summary for a medical device (7 mm Extended Length Endoscope), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data for a novel AI/software component.

Therefore, the requested information regarding acceptance criteria, a specific study proving device meets acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment methods for an AI/software device cannot be extracted from the provided text.

The document discusses the device's technological characteristics, indications for use, and reprocessing methods. It states that "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the previously cleared 7 mm Extended Length Endoscope." However, it does not provide the specific acceptance criteria for these in-vitro tests, the detailed performance results, or any of the other information typically associated with AI/software performance studies.

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance studies for an AI/software device. This document is for a traditional medical device demonstrating substantial equivalence.

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