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The Stryker Sidne™ System is indicated for use with compatible endoscopic and general surgery devices. The Stryker Sidne™ System can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope fendoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectorny, laparoscopic hemia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder anthroscopy, small joint anthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectorny, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The Stryker Sidne™ System is a medical device that is designed to allow the surgeon to control the state, selection, and settings of the surgical equipment it Is networked with. Sidne™ is compatible with existing devices that are HERMES OR Control Center compatible. The intent of the Sidne™ Control Center is to allow for voice control of medical device settings by the surgeon or operating room personnel, thereby eliminating the need for manual operation of those devices compatible with Sidne™ , or relying upon verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.

I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called the "Sidne™ System" (formerly "Merdoc™ System"). This document primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance.

It does not contain the specific information requested regarding:

• Acceptance criteria and reported device performance in a table.
• Details of a study proving the device meets acceptance criteria.
• Sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set information.

The document discusses the device's indications for use, its function as a control system for surgical equipment, and its conformity to voluntary standards. However, it does not provide details about clinical studies or performance metrics often associated with AI/ML device evaluations.

Therefore, I cannot fulfill your request for a table of acceptance criteria and study details based on the provided text.

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