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The CUSA Excel Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including Neurosurgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery.

The CUSA Excel Ultrasonic Surgical Aspirator System (CUSA) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Excel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). A tip has been added to the CUSA Excel system to enable it to abrade bone. Testing was completed to demonstrate that the tip will abrade bone. The tip is manufactured from the same materials as in the other CUSA Excel tips.

The provided text is a 510(k) summary for the Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity), sample sizes for test sets or training sets, expert qualifications, adjudication methods, or results from comparative effectiveness studies.

The text simply states: "Testing was completed to demonstrate that the tip will abrade bone." This is a general statement and does not provide quantified performance data or details of a study that would establish specific acceptance criteria.

Therefore, I cannot fulfill the request to provide the detailed information required for the table and all the numbered points because the provided document does not contain this type of performance study data.

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