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The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.

The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 45 to 135 cm.

The provided document is a 510(k) summary for the VascuPuncture™ PICC Guidewire, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one would see for a novel AI/software medical device.

Therefore, much of the requested information cannot be extracted directly from this document. However, I will fill in what can be inferred or stated based on the nature of a 510(k) submission for a guidewire.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (guidewire), acceptance criteria and performance are typically related to physical and functional characteristics demonstrating equivalence to existing, legally marketed predicate devices. The document explicitly states:

"Functional and performance characteristics are demonstrated through equivalence with the predicate device and testing of representative device samples."

However, specific quantitative acceptance criteria (e.g., tensile strength > X, lubricity < Y) and their corresponding reported performance values are not provided in this 510(k) summary. The summary concludes that the device is "substantially equivalent to the predicate devices in terms of functional design, indications for use, principles of operation and performance characteristics."

Therefore, I cannot populate a table with numerical acceptance criteria and reported performance based on this document.

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

The document mentions "testing of representative device samples." However, it does not specify the sample size for any test set or the provenance of any data (e.g., country of origin, retrospective/prospective). This information would typically be found in detailed test reports, not in the 510(k) summary itself.

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

This question is not applicable to the type of device and submission described. For a guidewire, "ground truth" would not be established by experts interpreting data in the same way it would be for an AI diagnostic device (e.g., interpretation of medical images). Performance is assessed through engineering and biocompatibility testing.

4. Adjudication method for the test set

Not applicable for a physical medical device like a guidewire. Adjudication methods are relevant for subjective assessments, typically by experts, which are not detailed here.

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/software device, and no human-in-the-loop studies are mentioned or expected for a guidewire.

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

Not applicable. This is not an AI/software device.

7. The type of ground truth used

For a physical medical device like a guidewire, "ground truth" is established through:

• Engineering specifications and standards: Performance such as tensile strength, kink resistance, lubricity, torqueability, flexibility, etc., are measured against pre-defined engineering requirements and industry standards.
• Biocompatibility testing: Results of biological assessments (e.g., cytotoxicity, sensitization, irritation) are compared against established safety benchmarks.
• Comparison to predicate devices: The "ground truth" for substantial equivalence often involves demonstrating that the new device performs similarly or meets the same safety and effectiveness profiles as legally marketed predicate devices.

The document refers to "biocompatibility is demonstrated through equivalence with legally marketed predicate devices and the result of ICPMS and prior biocompatibility testing." This indicates the use of biocompatibility test results as a form of ground truth for that aspect.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The document mentions "testing of representative device samples," which implies a test set for performance verification, but not a training set.

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

Not applicable, as there is no training set for this device.

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