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The Insertion Tool is used to facilitate the introduction of a guidewire during general intravascular procedures.

The Insertion Tool is a sterile accessory device indicated to facilitate the introduction of a guidewire into the lumen of a guiding catheter, without damage to the guidewire's distal tip.

It is designed to accommodate guidewires with diameters from 0.010" to 0.018" and is composed of a rigid funnel known as the hub which is attached to a stainless steel hypotube. The interior of the hub is designed to allow a guidewire with multiple bends at the distal tip to be directed easily into the smaller diameter stainless steel hypotube.

This document is a 510(k) summary for an "Insertion Tool" and does not relate to an AI/ML device. Therefore, the requested information about acceptance criteria, study details, human-in-the-loop performance, and training/test set specifics for an AI/ML model is not applicable and cannot be extracted from the provided text.

The document describes a medical device, its intended use, and comparison to predicate devices, focusing on design verification and validation through bench tests. There is no mention of AI/ML algorithms or their performance in this submission.

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