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The Piolax Hydrophilic Guidewire is indicated for use for introduction and positioning of catheters within the peripheral vasculature in vascular diagnostic and therapeutic applications, particularly for arterial and venous applications in the cardiac, cerebral, and abdominal regions. The Guidewire is contraindicated for use in coronary vessels.

The Piolax Hydrophilic Guidewire is a tapered wire. composed of stainless steel or Ni-Ti alloy that is coated with a hydrophilic polymer. The hydrophilic polymer is composed of polyvinyl pyrrolidone and benzoyl peroxide. The Guidewire is provided with one of three differently shaped hydrophilic polymer-coated tips (i.e., straight, angled, J-shaped). The standard wire diameters are 0.58 mm, 0.72 mm, 0.79 mm, and 0.86 mm. The range for length of guidewires is 450 to 3,000 mm.

This document is a 510(k) summary for the Piolax Hydrophilic Guidewire. It describes the device, its intended use, and performance data used to establish substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

Analysis of the Piolax Hydrophilic Guidewire 510(k) Summary

This document describes a medical device called the "Piolax Hydrophilic Guidewire" and seeks to demonstrate its substantial equivalence to a predicate device, the "Terumo Radifocus® Guidewire M". Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are essentially demonstrating that the new device is as safe and effective as the predicate device. The "study that proves the device meets the acceptance criteria" refers to the testing performed to support this claim.

It's important to note that a 510(k) submission generally relies on bench testing and comparisons to a predicate device, rather than extensive clinical studies with human participants, especially for devices like guidewires. Therefore, many of your requested items about human study design, expert ground truth, and MRMC studies will not be applicable or explicitly stated in this type of document.

1. A table of acceptance criteria and the reported device performance

The document doesn't present a formal table of acceptance criteria with corresponding performance in a typical clinical study sense. Instead, the acceptance criterion for the 510(k) is "substantial equivalence" to the predicate device. The performance data presented are results from specific engineering and biocompatibility tests, with the conclusion that they demonstrate this equivalence.

Conclusion stated: "The test results demonstrate that the Piolax Hydrophilic Guidewire is substantially equivalent to the Terumo Radiofocus® Guidewire." And "All tests demonstrated that the Piolax Hydrophilic Guidewire is biocompatible." Further, "Based on results of the above testing, Piolax concludes that the Piolax Hydrophilic Guidewire is as safe and as effective as Terumo's Radifocus® Guidewire."

Regarding the device described and the nature of the submission (510(k) for a guidewire), many of the detailed requests for clinical study specifics will not be present. Here's why and what can be extracted:

2. Sample size used for the test set and the data provenance

• Sample size: Not explicitly stated for each test beyond "the Piolax Hydrophilic Guidewire" implying multiple units were tested. The mechanical and biocompatibility tests are typically performed on a statistically relevant number of samples, but the exact count isn't provided in this summary.
• Data provenance (e.g. country of origin of the data, retrospective or prospective): The tests were conducted by Piolax (Japan) to support the FDA submission. These are prospective bench/lab tests designed for regulatory approval, not retrospective or prospective clinical studies on human populations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as the "ground truth" for mechanical and biocompatibility tests is based on established engineering standards and biological assay results, not expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert reviews of clinical cases (e.g., imaging studies), not for bench testing of medical devices.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI-assisted diagnostic device. It is a physical guidewire used in interventional procedures. MRMC studies are typically for evaluating diagnostic imaging systems or AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable, as this is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the mechanical performance tests (tensile strength, torque strength, torqueability, tip flexibility, coating adherence) would be quantitative measurements against predefined engineering specifications and/or direct comparison to the predicate device's performance data.
• The ground truth for biocompatibility tests (pyrogen, hemolytic, cytotoxicity, etc.) would be standardized laboratory assay results that determine if the leachates or materials cause adverse biological reactions, following established protocols (e.g., ISO 10993 series or specific USP standards).
• For shelf-life, the ground truth is stability testing data (e.g., accelerated or real-time aging studies) demonstrating that the device maintains its performance and safety characteristics over the claimed duration.

8. The sample size for the training set

• Not applicable. This is not a machine learning device. The "training set" concept is irrelevant here.

9. How the ground truth for the training set was established

• Not applicable.

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