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The PowerWire Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater, including vessels with stents.

PowerWire Radiofrequency Guidewire is a sterile, single-use device used to deliver radiofrequency (RF) energy. It is shipped as a sterile device kit containing one (1) PowerWire RF Guidewire and one (1) RFP-100A Connector Cable (separately cleared under K230571) sealed in a double compartment pouch, which is then placed inside a shelf box and then an outer cardboard box. The device is sterilized using ethylene oxide.

The device consists of a core wire surrounded by a polymer insulation. The wire connects to a radiofrequency puncture generator at the proximal end via a connector cable (K230571) and has an active tip at the distal end to deliver radiofrequency energy.

The PowerWire Radiofrequency Guidewire must be used with an approved Baylis Radiofrequency Puncture Generator (Baylis RF Generator K122278) and RFP-100A Connector Cable (K230571). The connector cable connects the RFP-100A BMC Radiofrequency Puncture Generator (RFP-100A Generator) to the PowerWire RF Guidewire to enable radiofrequency (RF) power to be delivered from the Generator to a PowerWire RF Guidewire. The PowerWire Radiofrequency Guidewire delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) Electrode.

All models of the PowerWire Radiofrequency Guidewire have a usable length of 250cm and an outside diameter of 0.035". The various straight and curved distal configurations of the wires provide physicians with flexibility of choosing the most suitable guidewire for accessing target tissue in tortuous pathways in the body, with either straight or angled distal tips.

Once the occlusion is crossed, the PowerWire Radiofrequency Guidewire can act as a rail for balloon or stent catheters, or can be exchanged for other guidewires or devices cleared for peripheral interventional procedures. The PowerWire Radiofrequency Guidewire is designed to be compatible with most balloon and stent catheters approved for use in peripheral interventional procedures.

The provided FDA 510(k) summary for the PowerWire Radiofrequency Guidewire Kit (K232562) describes performance testing to demonstrate substantial equivalence to its predicate device (K101615). However, it does not detail acceptance criteria or specific study results in a format that directly addresses all your requested points for an AI/device performance study.

This document describes a medical device (a guidewire) and its physical and electrical characteristics, biocompatibility, and bench testing, rather than an AI algorithm's performance. Therefore, many of your questions regarding acceptance criteria and study design for AI performance are not directly applicable or answerable from this text.

I can, however, extract related information and highlight what is missing based on the document.

No AI/Algorithm Performance Study Described

It is important to note that this 510(k) summary does not describe a study involving an AI algorithm or software for diagnostic or therapeutic assistance. The device in question is a physical medical device (a guidewire) used for creating channels in occluded peripheral vessels. The "performance data" section focuses on physical, electrical, and biocompatibility testing of the guidewire itself, not on an algorithm's diagnostic accuracy or effectiveness.

Therefore, the following points address what can be inferred or what is explicitly missing from the provided text regarding your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device.

Reinterpretation for a Physical Device (PowerWire Radiofrequency Guidewire Kit)

If we interpret your request to apply to the physical device described, here's what we can gather:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct "acceptance criteria" table with numerical values. Instead, it lists the types of tests conducted to ensure the device performs "compared to the predicate device" and that it "does not raise new questions of safety or effectiveness." The implicit acceptance criterion for most tests would be equivalence or non-inferiority to the predicate, or compliance with relevant standards.

Missing: Specific quantitative acceptance criteria (e.g., "flexibility within X% of predicate," "tensile force > Y N") are not detailed in this summary. The general statement is "confirmed performance compared to the predicate device" or "compliance with standards."

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for each test. For physical device testing, "samples" typically refer to the number of guidewires tested, which is generally much smaller than patient data sets for AI.
• Data Provenance: Not applicable in the context of patient data for an AI study. The tests are benchtop, simulated use, and material characterization. "0-Day testing from the predicate device application (K101615) was leveraged for this device," suggesting some data was carried over.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This pertains to clinical evaluation or expert consensus for ground truth in diagnostic/AI studies, which is not described for a physical guidewire.

4. Adjudication Method

• Not Applicable: This relates to expert review processes for ground truth in diagnostic/AI studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: This is a study type for evaluating AI assistance in diagnostic tasks, which is not relevant to this physical device.

6. Standalone (Algorithm Only) Performance Study

• No: This is a study type for AI algorithm performance, not relevant to this physical device.

7. Type of Ground Truth Used

• For Physical Device Tests: The "ground truth" is typically defined by engineering specifications, accepted international standards (e.g., ISO, IEC), and the performance characteristics of the predicate device. For biocompatibility, it's the established safe biological response. For mechanical tests, it's the measured physical properties against established limits.

8. Sample Size for Training Set

• Not Applicable: No AI algorithm is described, so there is no "training set."

9. How Ground Truth for Training Set Was Established

• Not Applicable: No AI algorithm is described.

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