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The guidewire is intended to facilitate the introduction of intravascular devices for use in the coronary and/or peripheral vasculature during diagnostic and interventional procedures.

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The provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) clearance letter from the FDA to Oscor Inc. for a Guidewire, Pursuer Series. It states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. The enclosure is an "Indications for Use Statement" which describes the intended use of the guidewire but does not include any performance metrics or study details.

Therefore, I cannot provide the requested information based on the given input.

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