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The Vesalius Essential device and its accessories are intended for resection, ablation and coagulation of soft tissues and haemostasis of blood vessels in surgical procedures in orthopedic, arthroscopic, neurosurgery, ENT, and spinal procedures.

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I am sorry, but the provided document does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Vesalius" electrosurgical device, detailing its regulation, classification, and indications for use. It does not include acceptance criteria, performance data, details of specific studies, sample sizes, or ground truth establishment methods for device performance.

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The Vesalius, models Vesalius MCNplus and QUANTUM and accessories are intended for resection, ablation and coagulation of soft tissues and haemostasis of blood vessels in surgical procedures in orthopaedic, arthroscopic, neurosurgery, ENT, and spinal procedures.

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I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a medical device called "Vesalius". It outlines the regulatory approval of the device for certain surgical procedures but does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or specific study methodologies such as MRMC studies or standalone algorithm performance.

Therefore, I cannot generate the table or answer the specific questions about the device's acceptance criteria and the study proving it meets them based on the given input.

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