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Intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in surgical procedures such as but not limited to orthopedic, arthroscopic, and spinal procedures.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the Arthro Kinetics Vesalius MR Generator. The document is a 510(k) premarket notification letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as classification, general controls, and compliance, but it does not detail any technical performance criteria or study results.

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The Arthro Kinetics' Endoscopic Spine System (Kinetics Interchangeable Spine System) is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy.

The Arthro Kinetics Endoscopic Spine System consists of an Endoscope, light source, light guide, sheaths, camera head, and camera control unit and is a reusable minimally invasive system that enables surgeons to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy. The outer sheath acts to facilitate suction / irrigation to the surgical site, serving as a cannula to provide an access portal for the endoscope to be inserted into the patient for viewing or the placing of manual surgical instruments. By inserting the endoscope into the outer sheath the surgeon will be able to view the operative site whilst being guided to the pain source by the ongoing feedback from the patient. The endoscope also has a working channel to allow surgical instruments to be inserted into the operative site.

This is not an AI/ML medical device. This document describes an "Arthro Kinetics Endoscopic Spine System," which is a physical medical device. The information provided in the prompt is for AI/ML medical devices. Therefore, I cannot extract the requested information.

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