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EndoAssist is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use.

A few examples of the more common endoscopic surgeries are laparoscopic*

cholecystectomy hernia repair fundoplication splenectomy appendectomy hemicolectomy sympathectomy lymph node dissection hysterectomy gastric banding qastric by pass nephrectomy radical prostatectomy anterior spinal fusion, decompression fixation wedge resection lung biopsy pleural biopsy , internal mammary artery dissection for coronary artery bypass coronary artery bypass grafting where endoscopic visualization is indicated examination of the evacuated cardiac chamber during performance of valve replacement or repair.

• In this context "laparoscopic" is taken to embrace the use of a rigid endoscope in any part of the body

EndoAssist is a head-controlled Endoscopic camera manipulator. It is intended for use in minimally invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery and allows the surgeon directly to control movements of a rigid endoscope by head gestures.

I'm sorry, but without a dedicated study section detailing performance data, acceptance criteria, and ground truth establishment, I cannot fulfill your request for a table of acceptance criteria, device performance, and study information. The provided document is a 510(k) summary for the EndoAssist device, which primarily focuses on device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.

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