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The Thrombus Retrieval System is intended for the non-surgical removal of thrombi and emboli from the arterial peripheral vasculature.

The Pounce™ Thrombus Retrieval System is a percutaneous catheter system designed to facilitate mechanical thrombus removal in the peripheral arterial vasculature. The system is comprised of three separate components; a 5Fr Basket Delivery Catheter, a Basket Wire Assembly and a Trumpet Assembly. The system also includes a Basket Loading Tool accessory for loading the Basket Wire Assembly into the Basket Delivery Catheter. The system contains the necessary radiopaque components to conduct the procedure and the system should be introduced through a minimum 7Fr guide sheath.

This document describes the Surmodics Pounce™ Thrombus Retrieval System, a medical device intended for the non-surgical removal of thrombi and emboli from the arterial peripheral vasculature. The information provided is from a 510(k) summary submitted to the FDA. The following aims to extract details regarding acceptance criteria and the study proving the device meets them, based solely on the provided text.

Based on the provided FDA 510(k) summary, the Pounce™ Thrombus Retrieval System underwent various performance bench tests, packaging tests, biocompatibility tests, and an animal study to demonstrate substantial equivalence to its predicate devices. The document explicitly states that "All test results met documented acceptance criteria and/or included justification of values."

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

The document does not explicitly present a table of specific numerical acceptance criteria alongside corresponding numerical reported device performance for each test. Instead, it states that "All test results met documented acceptance criteria and/or included justification of values," indicating qualitative compliance. The tests performed are listed, implying that the device successfully met the undisclosed acceptance criteria for each.

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 does not specify the sample sizes used for each of the bench tests, packaging tests, or biocompatibility tests. It also does not provide details on the data provenance for these tests, such as country of origin or whether they were retrospective or prospective.

For the animal study, it states: "The Thrombus Retrieval System device was subjected to an acute animal GLP study to evaluate and confirm the substantially equivalent performance and safety of the Pounce Thrombus Retrieval System device use within an arterial vasculature system." However, the number of animals or specific details of the study design (e.g., prospective) are not mentioned.

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)

The document makes no mention of experts being used to establish ground truth for any of the tests, nor does it specify their qualifications. The tests conducted (bench, packaging, biocompatibility) are typically objective engineering and scientific evaluations that do not rely on expert consensus for "ground truth" in the same way clinical image interpretation might. The animal study would involve veterinary professionals, but their specific roles in establishing "ground truth" are not detailed.

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

The document does not describe any adjudication methods used for the test set. This is consistent with the nature of the tests performed, which are primarily objective and do not typically involve human interpretation needing adjudication.

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

No multi-reader, multi-case (MRMC) comparative effectiveness study was done. The document explicitly states: "No Clinical data is being submitted for the Thrombus Retrieval System." This device is a mechanical thrombus retrieval system, not an AI-assisted diagnostic or interpretative tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

This question is not applicable as the Pounce™ Thrombus Retrieval System is a physical medical device for mechanical thrombus removal, not an algorithm or AI system. Therefore, standalone algorithm performance without human-in-the-loop is not relevant.

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

The types of "ground truth" used for the various tests are inherent to the nature of those tests:

• Performance Bench Testing: Engineering specifications, material properties, and functional design requirements serve as the ground truth. For example, a "burst" test would have an acceptance criterion for the pressure it withstands, which is its engineered breaking point.
• Packaging Testing: Compliance with ISO 11607-1 standards and internal design specifications for package integrity.
• Biocompatibility Tests: Compliance with ISO 10993-1 series standards for biological safety, with established limits for various toxicological endpoints.
• Sterilization Evaluation: Compliance with ISO 11135 standards for ethylene oxide sterilization.
• Animal Testing: Physiological and histological assessments in an animal model to evaluate device performance and safety in a living system. The "ground truth" here would be the biological response and observable effects.

8. The sample size for the training set

This question is not applicable. This device is a physical medical device, not a software algorithm that requires a training set.

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

This question is not applicable as there is no training set for a physical medical device.

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