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The Hydrophilic Coating Guide Wire is designed to direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular interventions.

The Hydrophilic Coating Guide Wire consists of a Nickel-Titanium alloy core wire; a polymer jacket (Polyurethane containing Tungsten for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The guide wire is provided sterile (EtO) and is intended for single use only.

This document is a 510(k) Premarket Notification from Suzhou Hengrui Disheng Medical Co., Ltd. for their "Hydrophilic Coating Guide Wire." It seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific performance criteria for an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, and sample sizes for training/test sets (as they pertain to AI/ML) is not available in this document.

This submission is for a medical device (a guide wire) and primarily focuses on its physical characteristics, materials, intended use, and non-clinical performance testing to show it's equivalent to existing devices. It does not involve any AI/ML component.

Consequently, I cannot fill in the table or answer the questions related to AI/ML performance. The document only reports on the substantial equivalence of the physical guide wire device to predicate devices.

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