(39 days)
The CUSA Shear Tip, an accessory of the CUSA EXcel Ultrasonic Surgical Aspirator System, is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
The CUSA Shear Tip is an additional tip that is used with CUSA EXcel system to fragment fibrous tissue. The distal end of the CUSA Shear Tip has a series of opposing angled lands, instead of a flat surface. This pattern promotes refracted longitudinal waves propagating in greatly different directions at the interface to coupled tissue. No changes to the console, handpiece or suction/irrigation system were needed.
The provided text outlines a 510(k) summary for the CUSA Shear Tip, an accessory to an ultrasonic surgical aspirator system. However, it does not contain the specific details required to answer your request regarding acceptance criteria and a study proving the device meets those criteria.
The document states: "Performance testing has been completed to demonstrate that the CUSA Shear Tip can better fragment fibrous tissue." This is a general statement and lacks all the specific information you've asked for.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or any other details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as none of that information is present in the provided text.
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