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The RF Tunneler Wire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater.

The RF Tunneler Wire consists of a core wire surrounded with a polymer insulation. The wire connects to a perforation generator at the proximal end via a connector cable, and has an active tip at the distal end to delivery RF energy.

The RF Tunneler Wire is designed to be compatible with most balloon and stent catheters approved for use in peripheral interventional procedures.

The provided text describes the 510(k) summary for the Baylis RF Tunneler Wire, including its intended use, comparison to predicate devices, and some bench testing. However, it does not contain information about clinical studies, acceptance criteria, or specific performance metrics related to human or AI performance.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through design, function, and bench testing, rather than reporting on a clinical trial with specific performance outcomes against predefined acceptance criteria.

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