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The Brivant guide wires are intended for use in the coronary and peripheral vasculature.

The Brivant Guidewire is a disposable medical device designed for single use only. It consists of a 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over the distal coil segment in a progressive fashion. The Brivant Guidewire is produced in lengths of 175, 195 and 300cm and is available in either silicone or hydrophilic coatings. The profile of the reduced section is varied to provide a range of products of mixed stiffness.

The provided document describes a 510(k) premarket notification for the "Brivant Guidewire," a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials or studies analyzing AI performance. Therefore, the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, ground truth methods, MRMC studies, and standalone AI performance is not applicable to this submission.

The document states that "Performance testing involving the following testing has been completed tensile strength, torque strength, torque response, coating performance, radiopacity, packaging qualification (including accelerated aging), sterilization, tip flexibility, catheter compatibility testing and biocompatibility testing in compliance with ISO 10993-1 has been successfully completed. The successful tests demonstrated the Brivant Guidewires consistently performed within their design parameters, are safe and effective and perform as well as the predicate devices."

This indicates that internal engineering and bench testing was conducted to ensure the device met its design specifications and relevant safety standards, allowing it to perform "as well as the predicate devices" in terms of functional effectiveness. However, no specific acceptance criteria thresholds or reported performance values from these tests are detailed in the summary. The "study" here refers to this suite of non-clinical performance and safety tests, not a clinical trial involving human patients or an AI performance evaluation.

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