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The steerable guiding sheath, model Destino Twist is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements

Steerable Guiding Sheath, model Destino Twist

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Destino twist, steerable guiding sheath." This type of document is a regulatory approval, not a scientific study report describing acceptance criteria and device performance data from a specific study. Therefore, the requested information about acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies cannot be extracted from the provided text.

The document only states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices for its intended use, which is for the introduction of diagnostic and therapeutic devices into the human vasculature. It does not contain any specific performance data or a study description to support these claims.

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