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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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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 Sublime™ Microcatheter is intended to access the peripheral vasculature in order to facilitate the placement and/or the exchange of guidewires. The Sublime Microcatheter is also intended to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The Sublime Microcatheter is a sterile, single-use, disposable intravascular catheter with an atraumatic distal tip and a proximal hub with a luer fitting. The Sublime Microcatheter is a single lumen support catheter, compatible with 014", 018", and 035" guide wire platforms and a 4F guide catheter. It has a working length of up to 200 cm, and both straight and angled tip configurations. The catheter has a stainless-steel braid supported construction with hydrophilic coating. The distal end of the catheter includes a radiopaque markerband to facilitate visualization under fluoroscopy.

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Sublime™ Microcatheter. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document pertains to a medical device (Microcatheter), not an AI/software device. Therefore, many of the typical questions for AI/software such as "Number of experts used to establish ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Training set sample size," and "How ground truth for training set was established" are not applicable in this context. The acceptance criteria and studies are for a physical medical device's performance characteristics.

Acceptance Criteria and Reported Device Performance

The document states that "All test results met documented acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed, implying that specific criteria were defined and met internally by the manufacturer.

Table 1: Acceptance Criteria and Reported Device Performance (as inferred from the text)

Study Details

As this is a physical medical device, the "study" primarily consists of design verification testing rather than clinical performance studies typically seen with diagnostic or AI devices. The goal is to demonstrate "substantial equivalence" to a predicate device based on performance characteristics.

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: The document does not specify the sample sizes used for each of the listed tests (e.g., number of catheters tested for flow rate, tensile strength, etc.).
   • Data Provenance: This would typically be from laboratory bench testing and simulated use, conducted by the manufacturer (Surmodics Inc.). The country of origin is implied to be the USA, as the company is based in Eden Prairie, Minnesota, and submitting to the US FDA. The testing is prospective in nature, as it's part of the premarket notification process for a new device.

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

   • This question is not applicable for this type of medical device clearance. "Ground truth" in this context refers to engineering specifications and performance standards established by the manufacturer and recognized industry standards (e.g., ISO standards for medical devices). The expertise would be in materials science, mechanical engineering, and quality control, rather than medical interpretation by radiologists.

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

   • This is not applicable for engineering bench testing. Adjudication methods are typically for human interpretation of medical images or clinical outcomes. Deviations from expected test results would be handled through a non-conformance process and investigation by engineers and quality personnel.

4. 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:

   • This is not applicable. This is a physical microcatheter, not an AI software. No human reader studies (MRMC) were conducted or required for this type of device clearance.

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

   • This is not applicable. This is a physical medical device, not an algorithm.

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

   • The "ground truth" (or more appropriately, the reference standard) for these tests is based on defined engineering specifications, performance standards (e.g., ISO standards for catheters), and validation methods for each physical characteristic (e.g., a calibrated flow meter for flow rate, a universal testing machine for tensile strength, a pressure gauge for burst testing). Biocompatibility is assessed against established biological safety standards.

7. The sample size for the training set:

   • This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established:

   • This is not applicable for the same reason as above.

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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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