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

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 with a preloaded loading tool, and the Funnel Catheter. The system contains radiopaque components to conduct the procedure and is intended to be introduced through a minimum 7Fr guide sheath.

The Delivery Catheter is a flexible 5Fr catheter 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 and sheathing of the funnel using the slider button on the integrated handle.

This document is a 510(k) premarket notification for the Surmodics Pounce™ Thrombectomy System. It outlines the device's description, indications for use, and a comparison to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format, nor does it present device performance against specific targets for efficacy. Instead, it describes a series of bench tests conducted to demonstrate substantial equivalence to the predicate device after modifications. The reported performance is a qualitative statement of meeting these testing requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for the bench tests. The tests are described as "design verification" and "biocompatibility testing." These are typically laboratory-based engineering tests, not clinical studies involving human or animal subjects. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) as it applies to clinical data is not relevant here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This report details bench testing, not a study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

No. The document explicitly states: "No clinical studies were required for the Pounce Thrombectomy System." Therefore, no MRMC study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a medical instrument (thrombectomy system), not an AI algorithm, so standalone performance in that context is not relevant.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the bench testing, the "ground truth" would be the engineering specifications and established standards for performance and biocompatibility for medical devices. The device was tested against these predefined criteria to ensure it met the necessary performance characteristics and was safe for its intended use, demonstrating substantial equivalence to its predicate.

8. 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.

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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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