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This device is intended to introduce up to an 0.038" wire guide into the peripheral vasculature. It is also used to introduce diagnostic and/or interventional devices able to pass through the ID of the introducer.

The device is utilized to gain access to the peripheral vasculature using the Seldinger technique. These introducer sets are comprised of either 4.0 French or 5.0 French outer introducer and 3.0 French inner dilator coaxial pair, a 21 gauge percutaneous entry needle, an 0.018 inch mandril wire guide with a distal coil tip, and a Check-Flo® Hemostasis Valve. These sets are supplied sterile and are intended for one-time use.

The provided text describes the Cook Incorporated Micropuncture® Pedal Access Set (K172980). It details the device's indications for use, its comparison to a predicate device, and the non-clinical testing performed to establish its substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily details non-clinical laboratory testing. For these tests, specific sample sizes are not explicitly stated, but the results indicate that the "predetermined acceptance criteria were met" for all tests. There is no information regarding country of origin or retrospective/prospective nature for these non-clinical tests.

The document does reference clinical literature to support the indications for use, stating:

• "These articles describe successful use of the subject device for pedal access in a total of 220 patients..."
• The articles listed are from the Journal of Endovascular Therapy, Fortschr Röntgenstr, and Annals of Vascular Surgery, suggesting an international (likely multi-country) provenance, and they are retrospective or prospective observational studies/case series rather than controlled trials focused specifically on this device's performance against pre-defined criteria. The specific nature (retrospective/prospective) would need to be gleaned from the individual articles, which are only referenced.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The primary evidence presented for substantial equivalence is based on non-clinical performance testing against established engineering standards (e.g., ISO standards), not on expert-adjudicated test sets or ground truth established by experts. The clinical literature cited involves patient outcomes from medical procedures, where the "ground truth" would be the clinical success or complications observed by the treating physicians, but this is used as supportive evidence for the indications for use, not as a test set for device performance itself.

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

Not applicable. This is for non-clinical testing against engineering standards.

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 not an AI-powered diagnostic or assistive tool for human readers. It is a physical medical device (catheter introducer set).

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

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

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

For the non-clinical tests, the "ground truth" is defined by the specific performance requirements outlined in the referenced ISO and other engineering standards. For instance, the "ground truth" for the tensile test is "no loosening or separation."

For the clinical literature cited, the "ground truth" is implicitly the outcomes data from the patient cases described in those publications (e.g., successful revascularization, complications, etc.), which support the general utility of pedal access.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve AI or machine learning models that require training sets.

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

Not applicable. This is a physical medical device and does not involve AI or machine learning models.

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