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The Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.

This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA

The provided text is a 510(k) summary for the Rocket Medical plc IR™ Guidewires, dated November 2, 2004. This document is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/algorithm-based diagnostic or assistive device.

Instead, it pertains to a physical medical device (guidewires) and focuses on demonstrating substantial equivalence to a predicate device already on the market.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions you asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set sample size) are relevant to the evaluation of AI/machine learning devices, not a traditional physical medical device like guidewires in this context.

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