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The Next Generation Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile duct, cystic, pancreatic, and right and left hepatic ducts.

Radius Medical Technologies, Inc. has developed a line of Endoscopic guidewires ranging in sizes of 0.025" to 0.035" diameter and lengths of 260 cm to 450 cm (in standard and stiff body types). The wires will be offered with a 5 cm radiopaque distal tip (angled and straight). The wires are constructed of a solid nitinol core wire, which tapers at its distal end. A shrink jacket surrounds the core over the entire length except the distal most 5 cm. A radiopaque tube covers the distal 5 cm. Single striped bands of ink are placed circumferentially onto the jacket and spaced in 1 cm intervals beginning at the 6 cm location and continuing to the 40 cm location from the distal tip. Multiple ink bands are used to delineate the 10, 15, and 20 cm locations. A coating is applied over the tip portion of the guidewire.

This document is a 510(k) premarket notification for the Radius Medical Technologies Next Generation Guidewire and does not contain information regarding an acceptance criteria table, device performance metrics, detailed study designs, or AI/ML components. Therefore, I cannot provide the requested information.

The document primarily focuses on:

• Regulatory information: Device classification, regulation numbers, product codes, and substantial equivalence determination.
• Device description: Physical characteristics, materials, and sizing of the guidewire.
• Intended use: To guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures.
• Predicate devices: Comparison to existing legally marketed guidewires.
• Performance testing (general statement): Mentions various tests performed (distal tip tensile, torqueability, tip flexibility, coating adherence/integrity, and electrical resistance) but does not provide specific acceptance criteria or detailed results.

There is no mention of an AI/ML component, expert ground truth, sample sizes for AI model training/testing, or MRMC studies in this document.

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