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Intended Use: The 3 CCD HD ENDOCAM 5550 has been designed for video endoscopy and can be used for both diagnostic and therapeutic interventions. In conjunction with video recorders, video printers and other video devices it can be used for recording and storing video images.

Indications and field of Use: The 3 CCD Endocam is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, gynecologic, laparoscopic, urologic, sinuscopic, plastic, and as an accessory for microscopic surgery.

The 3 CCD HD Endocam 5550 consists of a camera control unit and a connectable camera head. The camera head connects to an endoscope for High Definition visualization during minimally invasive surgical procedures.

The camera controller provides outputs for video monitoring, video recording, and connecting to the RWMIC-NET Operating Room Control System.

The provided text describes the Richard Wolf 3 CCD HD Endocam 5550, an endoscopic video camera system. It highlights its intended use, technological characteristics, and claims of substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, performance metrics, or details of a study proving the device meets acceptance criteria in the format typically used for evaluating the performance of AI/ML-driven medical devices.

The text only mentions that "Bench testing of specifications were verified / validated and software validation was performed to assure safe and effective operation / control of the software functions." It also explicitly states, "No clinical data was required to confirm safety and effectiveness."

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the provided document.

The document discusses the regulatory clearance process for a traditional medical device (an HD endoscopic camera system) based on substantial equivalence to existing predicate devices, rather than a novel AI/ML algorithm requiring rigorous performance evaluation against specific clinical or quantitative acceptance criteria through detailed studies.

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