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

The Surmodics™ Pounce™ XL Thrombectomy 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 delivery catheter, a basket wire and a funnel catheter. The system also includes a basket loading tool accessory for loading the basket wire into the delivery catheter. The system contains the necessary radiopaque components to conduct the procedure and the system should be introduced through a minimum 7 Fr guide sheath.

The Delivery Catheter is flexible and designed to deliver the Basket Wire to the location of the thrombus. Incorporated in the catheter is a radiopaque marker band located at the distal tip.

The Basket Wire is comprised of two distal self-expanding baskets mounted on a core wire for capturing thrombus. The distal capture baskets have integral radiopaque markers mounted on the struts of the basket for basket visibility under fluoroscopy.

The Funnel Catheter is used for thrombus collection and retrieval in conjunction with the Basket Wire. The Funnel Catheter is comprised of an inner funnel catheter and an outer delivery catheter. The two catheters work together to allow unsheathing and sheathing of the slider button on the integrated handle.

The provided text is a 510(k) summary for the Surmodics Pounce XL Thrombectomy System. This document outlines the device's technical specifications, indications for use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. It does not describe a study involving human-in-the-loop performance with AI assistance, nor does it detail a standalone AI algorithm performance study. The device described is a mechanical thrombectomy system, not an AI-powered diagnostic or therapeutic device.

Therefore, many of the requested details, such as "acceptance criteria," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone study," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not applicable to this document as they pertain to the evaluation of AI/ML-based medical devices or diagnostic studies, not the mechanical thrombectomy system described here.

The document focuses on the mechanical performance and biocompatibility of the device, comparing it to existing predicate devices.

However, I can extract the information relevant to the mechanical device's acceptance criteria and the summary of studies performed to prove it meets them, based on the provided text.

Here's a breakdown of the requested information, adapted to what is present in the document:

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

The document states: "All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." It lists the types of tests conducted but does not provide the specific numerical acceptance criteria or the numerical results for each test. Instead, it offers a high-level statement of compliance.

Summary of Studies Performed (Relevant to mechanical device performance):

The device was evaluated through the following tests, with all results meeting documented acceptance criteria:

• Dimensional evaluations
• Radiopacity
• Tensile Strength
• Freedom from leakage
• Hub/Luer connector compatibility
• Removal Force
• Radial Force
• Kink Resistance
• Torque Strength
• Ancillary Device Compatibility
• Atraumatic Surfaces
• Simulated Use
• Basket Wire Fatigue
• Biocompatibility

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

The document does not specify sample sizes for any of the performance or bench tests (e.g., how many devices were tested for tensile strength or fatigue). It also does not discuss "data provenance" in the context of clinical data (e.g., country of origin, retrospective/prospective) because these are benchmarking/engineering tests of a physical device, not clinical trials or AI model validation studies.

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

Not applicable. "Ground truth" in this context would refer to engineering specifications and performance benchmarks, not expert medical consensus on imaging or clinical outcomes, as this is a mechanical device, not an AI system. The "experts" would be the engineers and technicians performing the tests and comparing results against design specifications.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical trials or expert review of data (e.g., radiology reads) to resolve discrepancies in interpretation. These are bench tests against engineering specifications.

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 a mechanical thrombectomy device, not an AI-powered diagnostic or assistance tool for human readers.

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

Not applicable. This relates to AI algorithm performance.

7. The type of ground truth used

For the mechanical device performance tests, the "ground truth" would be established engineering specifications, design requirements, and recognized industry standards for medical device performance (e.g., biocompatibility standards, tensile strength requirements for catheters).

8. The sample size for the training set

Not applicable. This refers to the training of an AI model, which is not the subject of this document.

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

Not applicable, for the same reason as above.

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