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Sniper Elite™ Hydrophilic Guidewires are designed for use in angiographic procedures to introduce/position catheters and interventional devices within the vasculature.

The Sniper Elite™ Hydrophilic Guidewire is constructed from a super elastic, Nitinol core wire. A plastic cladding is applied over the Nitinol core, with a hydrophilic coating covering the plastic cladding. The polymer cladding is impregnated with a radiopacive agent and a platinum/8% tungsten coil is located in the distal tip for enhanced contrast under fluoroscopy.

The provided document describes the Sniper Elite™ Hydrophilic Guide Wire and its substantial equivalence to a predicate device. However, it does not contain information about a study with acceptance criteria to demonstrate device performance in the context of an AI/ML powered device. The document is for a traditional medical device (guidewire) and focuses on engineering and material-based performance tests for substantial equivalence, not AI/ML performance.

Therefore, I cannot provide the requested information for an AI/ML device because the provided text is not about an AI/ML device.

To provide a complete answer regarding an AI/ML device, the input document would need to describe:

• An AI/ML component or function within the device.
• Specific performance metrics related to the AI/ML component (e.g., sensitivity, specificity, AUC).
• Details of a clinical or bench study designed to evaluate the AI/ML performance against defined acceptance criteria.

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