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The Power Wire Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater.

The present device, PowerWire Radiofrequency Guidewire consists of a core wire surrounded with a polymer insulation. The wire connects to a radiofrequency puncture generator at the proximal end via a connector cable, and has an active tip at the distal end to deliver radiofrequency energy. The changes made to the device include changes in active tip geometry and material and addition of more radiopaque bands.

The PowerWire Radiofrequency Guidewire is designed to be compatible with most balloon and stent catheters approved for use in peripheral interventional procedures.

The provided text describes a 510(k) summary for the PowerWire Radiofrequency Guidewire. This document primarily focuses on establishing substantial equivalence to a predicate device and detailing non-clinical performance and safety testing. It does not describe a study involving device performance against acceptance criteria in the context of a diagnostic or AI-enabled device, nor does it involve human readers, ground truth establishment by experts, or AI performance metrics.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone AI performance, or ground truth types as these concepts are not present in the provided text.

The document is a regulatory submission demonstrating the safety and performance of a new version of a guidewire by comparing it to an existing cleared device through a series of non-clinical (bench and biocompatibility) tests. These tests evaluate the physical, electrical, and biological properties of the device against established standards and internal criteria to ensure it performs as intended and is as safe as the predicate device.

Key takeaway based on the provided text: The submission focused on demonstrating substantial equivalence of the new PowerWire Radiofrequency Guidewire to a previously cleared version using a battery of non-clinical tests. This is a common approach for device modifications where clinical efficacy has already been established for the predicate.

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