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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 Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm in diameter.

The Surmodics Pounce™ 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, the Funnel Catheter, and cleaning tool accessories. The system contains radiopaque components to conduct the procedure and is intended to be introduced through appropriately sized 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 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 of the funnel using the slider button on the integrated handle.

The provided document describes the Pounce™ Thrombectomy System, specifically the Pounce LP Thrombectomy System, for which Surmodics Inc. sought 510(k) clearance (K231022). This submission is for modifications to an existing predicate device (Pounce™ Thrombectomy System, K220501) to extend its use to smaller vessels.

The document explicitly states: "No clinical studies were required for the Pounce Thrombectomy System."

Therefore, the following information regarding acceptance criteria, device performance, and study details is not available in the provided text, as the clearance was based on bench testing and a determination of substantial equivalence to a predicate device, rather than a clinical study demonstrating performance against specific acceptance criteria.

However, based on the provided information, we can infer some aspects relevant to a hypothetical acceptance criteria and the type of study conducted (bench testing) to support the device's substantial equivalence.

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

Since no clinical study was performed and the clearance was based on substantial equivalence to a predicate, there isn't a table of clinical acceptance criteria and device performance in the traditional sense for this submission. The "acceptance criteria" here would be the successful completion of various bench tests demonstrating that the modified device performs similarly to the predicate and meets engineering specifications.

Study that proves the device meets the acceptance criteria:

The study that "proves the device meets the acceptance criteria" in this context is the Performance Bench Testing listed on page 5 of the document. These tests evaluated mechanical properties, device functionality, material integrity, and compatibility with the intended use environment.

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

• Sample Size: The document does not specify the sample sizes used for each of the bench tests.
• Data Provenance: Not applicable. These were bench tests, not clinical data from patients. They would have been conducted within Surmodics Inc. (an American company) or contracted labs.
• Retrospective or Prospective: Not applicable, as these were non-clinical, controlled bench tests.

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. For bench testing, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, rather than expert clinical consensus.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical trial endpoints or image interpretation where human judgment is involved. Bench tests rely on objective measurements and established pass/fail criteria.

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. No clinical studies were required or performed for this submission. The device is a mechanical thrombectomy system, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI improvement.

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

Not applicable. The device is a mechanical thrombectomy system, not an algorithm.

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

Not applicable for the bench testing. The "ground truth" for each bench test was defined by the specified engineering requirements and performance parameters that the device was designed to meet, often in accordance with ISO or ASTM standards.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. See point 8.

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