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The PaxWire Occlusion Balloon System is indicated for temporary flow occlusion in the iliofemoral artery.

The PaxWire™ Occlusion Balloon System (PaxWire System) is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures. The PaxWire System consists of an occlusion catheter with a distal atraumatic stainless-steel J-tip, a compliant Chronoprene balloon, an 80 cm working length stainless steel shaft with a maximum 0.035" diameter proximal to the balloon, and an internal valve on the proximal end of the catheter. The effective length of the Pax Wire System is 99 cm with the inflation handle attached. The balloon can be inflated up to 12 mm for temporary flow occlusion in the iliofemoral artery. The balloon includes radiopaque markers located at each end of the balloon to aid positioning during fluoroscopy. The internal valve can be manually opened to control balloon inflation. The system also includes an inflation handle, a 10 cc Prep Syringe, and a 3 cc Inflation Syringe.

The PaxWire Occlusion Balloon System is indicated for temporary flow occlusion in the iliofemoral artery. The provided text describes the 510(k) summary for this device, outlining its comparison to predicate devices and the performance data submitted to support its substantial equivalence. However, the document does not contain specific acceptance criteria, reported device performance metrics against those criteria, or a detailed study description with sample sizes, ground truth provenance, expert qualifications, or adjudication methods.

The document primarily focuses on listing the types of tests conducted:

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

• This information is not provided in the document. The document lists the types of tests performed but does not state the predetermined acceptance criteria for each test or the specific quantitative results achieved by the device against these criteria.

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

• This information is not provided in the document. The document mentions "bench testing" and "biocompatibility testing" but does not specify sample sizes for any of these tests or details about data provenance.

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)

• This information is not applicable/provided. The testing reported is primarily bench and biocompatibility testing, not studies requiring expert interpretation or ground truth establishment in a clinical context.

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

• This information is not applicable/provided. As above, the nature of the testing described does not involve adjudication of clinical data.

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

• This information is not applicable. The device described is a physical medical device (occlusion balloon system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.

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

• This information is not applicable. See point 5.

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

• This information is not applicable/provided. For the bench and biocompatibility tests performed, compliance with technical specifications and safety standards would be the "ground truth," but the specifics of how these were defined or measured are not detailed in the document.

8. The sample size for the training set

• This information is not applicable/provided. The device is not an AI algorithm that requires a training set.

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

• This information is not applicable/provided. See point 8.

In summary, the provided FDA 510(k) summary details the device's indications for use, its description, and the types of non-clinical tests (biocompatibility and bench tests) conducted to demonstrate substantial equivalence to predicate devices. However, it lacks the specific quantitative results, acceptance criteria, study methodologies, and details about human-reader involvement or AI elements that would be required to answer most of the questions posed.

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