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The EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection of tissue.

The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral procedures restricted to benign and malignant tumors classified as Tl and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by sicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The 8mm Monopolar Scissors of this submission are for use only with the Intuitive Si System (Endoscopic Instrument Control System),

The 8mm Monopolar Curved Scissors Instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument with the patient tissue. This instrument is reusable and is provided non-sterile.

8mm Monopolar Curved Scissor Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for grecision when operating in a minimally invasive environment. EndoWrist 8mm Monopolar Curved Scissor Instruments, when used with the IS3000 system, are designed to support rapid and precise suturing, dissection and tissue manipulation in surgical procedures.

The provided text is related to the FDA 510(k) clearance for the "8mm Monopolar Curved Scissors" and discusses its substantial equivalence to predicate devices. However, it does not describe acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

The document focuses on the physical medical device (surgical scissors) and its continued substantial equivalence after an extended useful life (additional 10 reuse cycles). The "Performance Data" section lists various engineering and safety tests typical for a surgical instrument, such as Biocompatibility, Validation of Reprocessing, Functional Performance Testing, and Electrical Safety Testing. These are not performance metrics for an AI/ML algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) because the document describes the clearance of a non-AI/ML physical medical device.

To answer your request, the input document would need to be a 510(k) summary (or similar regulatory document) for an AI/ML-driven medical device, which would typically include sections on algorithm performance, clinical validation studies, and the establishment of ground truth for AI model evaluation.

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