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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™ 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 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.

The Basket Delivery Catheter is a flexible 5Fr catheter designed to deliver the Basket Wire Assembly to the location of the thrombus.

The Basket Wire Assembly is comprised of two distal self-expanding baskets mounted in series on a wire for capturing thrombus.

The Trumpet Assembly is used for thrombus collection and retrieval. The Trumpet Assembly is made of an inner trumpet catheter and an outer trumpet delivery catheters work together to allow deployment and retraction of the trumpet feature.

The provided text describes a 510(k) premarket notification for the Pounce™ Thrombectomy System, which is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. This is not the type of device (e.g., an AI/Machine Learning diagnostic or assistive device) that would typically have acceptance criteria presented in the format requested, nor would it involve the detailed study design (sample sizes, expert adjudication, MRMC studies, ground truth establishment for AI models) as outlined in the prompt's requirements.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Pounce™ Thrombectomy System K192814) by showing that a revised contraindication (for a smaller native vessel size) did not impact safety or effectiveness.

Therefore, I cannot fulfill the request as formatted, because the provided text does not contain the information relevant to a study proving a device meets acceptance criteria related to AI/ML performance, human reader improvement with AI assistance, or detailed ground truth methodologies for training and test sets.

Instead, the document states:

• Nonclinical Performance Testing Summary: "Test results demonstrated that all pre-defined acceptance criteria were met. Therefore, conforms to established product specifications and intended use and no new questions of safety and effectiveness were raised."

  • This indicates that internal acceptance criteria, likely related to engineering performance (e.g., basket cage radial force, simulated use), were met, but these are not the type of clinical performance criteria (e.g., sensitivity, specificity, AUC) typically associated with AI/ML devices that would involve large human reader studies.

• Clinical Data: "No clinical data was required to demonstrate substantial equivalence."

  • This explicitly states that a clinical study (like the one implied by the prompt's questions) was not necessary for this 510(k) submission, as substantial equivalence was demonstrated through nonclinical bench testing and prior animal testing information from the predicate device.

To directly answer the prompt's specific questions using the available information, where possible:

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

   • The document states: "Test results demonstrated that all pre-defined acceptance criteria were met."
   • The specific criteria mentioned are:
     • Basket Cage Radial Force
     • Thrombectomy System Simulated Use
   • No quantitative performance values or a detailed table are provided in this regulatory summary.

2. Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set data from human subjects or images were used for this substantial equivalence determination. The "test set" in this context refers to non-clinical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert consensus on medical images) was not established for this device's submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to clinical image interpretation by multiple readers, which was not part of this submission.

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. An MRMC study was not performed, as implicitly stated by "No clinical data was required."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a thrombectomy system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of clinical images and human interpretation. For the non-clinical tests, "ground truth" would be the engineering specifications and performance targets for the device's physical function.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring ground truth for a training set.

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