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The Radifocus® Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

The Radifocus® Glidewire Advantage (0.014") consists of a Nickel Titanium alloy core wire. A polyurethane and hydrophilic coating is applied to the distal portion of the wire while a PTFE coating is applied to the proximal portion. The wire distal segment comes in an angled configuration. The Radifocus® Glidewire Advantage (0.014") diameter wire contains a distal radiopaque spring coil. The wire is package in a plastic holder contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into a needle or catheter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Radifocus® Glidewire Advantage (0.014"), structured according to your request.

Please note: The provided document is a 510(k) Summary for a medical device (a guide wire), which focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments. It does not describe a study involving human readers, AI, or advanced clinical outcomes data, as would be typical for an AI/ML-driven diagnostic device. Therefore, several of your requested sections will be answered as "Not applicable" or by indicating that the information is not present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for many of these tests were "Test method developed in-house" or based on FDA Guidance documents for similar devices. For biocompatibility, the acceptance criteria are generally to be "Non-cytotoxic," "Non-hemolytic," etc. The document explicitly states that the tests were "performed and passed," indicating adherence to their established criteria. For the in-house developed tests, specific quantitative acceptance criteria are not provided in this summary, but the results indicate successful performance.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of wires tested for torque, friction, etc.). It refers to "tests performed" and methods, implying a sufficient number of samples were used to generate statistically meaningful results for each test.
• Data Provenance: The tests are described as "bench tests" and "biocompatibility testing." This is laboratory-generated data, not patient data from a specific country or origin in the traditional sense. It's prospective in the sense that the tests were deliberately conducted to assess the new device.

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

Not applicable. This submission describes bench and biocompatibility testing, which do not typically involve experts establishing ground truth in the same way clinical studies or image-based diagnostic evaluations do. The "ground truth" for these tests are the established physical/chemical properties or biological reactions according to the specified standards or in-house methods.

4. Adjudication method for the test set

Not applicable. As this involves bench and biocompatibility testing against defined standards, there is no need for expert adjudication. The results are objective measurements or observations interpreted against pre-defined criteria.

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 device is a physical medical instrument (a guide wire), not an AI-enabled diagnostic tool.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

The ground truth used for performance testing was based on:

• In-house developed test methods and their established specifications.
• Relevant FDA Guidance documents (e.g., "Coronary and Cerebrovascular Guidewire Guidance - January 1995," "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PCTA) Catheters").
• International Standards for biocompatibility (e.g., ISO 10993 series, ASTM F756-08, USP35).
• Risk analysis performed according to ISO 14971, which helps define acceptance criteria.

8. The sample size for the training set

Not applicable. This refers to a physical medical device submission, not an AI/ML model that requires a training set.

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

Not applicable. No training set was used for this device.

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