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The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System is indicated for:
-The non-surgical removal of emboli and thrombi from blood vessels.
-Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of three main components packaged separately:
● Aspiration Guide Catheter
● FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and 15-18 mm)
● Retraction Aspirator
The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The hand-lever operated Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever Catheter with thrombus into the Aspiration Guide Catheter to capture clot and restore blood flow.

The provided text describes a 510(k) premarket notification for the Inari Medical FlowTriever Retrieval/Aspiration System. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the text:

1. Table of Acceptance Criteria and the Reported Device Performance

The document states that "Test results demonstrated that all acceptance criteria were met," and "This testing FlowTriever demonstrated compliance with relevant product specifications." However, it does not explicitly list the specific quantitative acceptance criteria for each test or the exact performance values achieved. It only lists the types of tests performed.

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

The document does not specify the exact sample sizes used for each non-clinical test. The data provenance is non-clinical testing, meaning it involves engineering and bench testing, not patient data. Therefore, concepts like country of origin for data or retrospective/prospective studies do not apply in this context.

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

This information is not applicable as the study described is non-clinical testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation of outcomes. The "ground truth" here is adherence to engineering specifications and performance standards.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3. The testing involves objective measurements against predefined specifications, not subjective human assessment requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (embolectomy catheter), not an AI-driven diagnostic or assistive system that would involve human readers. Clinical testing was explicitly stated as "not required for the determination of substantial equivalence."

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

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

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on established product specifications, engineering standards, and the intended use of the device. The tests were designed to verify that the modified device met these predefined criteria.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this non-clinical engineering and performance testing for a physical medical device. This is not an AI/machine learning study.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System is indicated for:

-The non-surgical removal of emboli and thrombi from blood vessels.
-Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of three main components packaged separately: Aspiration Guide Catheter (AGC), FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and 15-18 mm), Retraction Aspirator.

The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The hand-lever operated Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever Catheter with thrombus into the Aspiration Guide Catheter to capture clot and restore blood flow.

The provided text describes a 510(k) premarket notification for the FlowTriever Retrieval/Aspiration System. However, it does not include detailed acceptance criteria or a comprehensive study report with quantified performance metrics to address all aspects of your request.

Based on the available information, here's what can be extracted:

Acceptance Criteria and Device Performance:

The document states that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use." However, the specific quantitative acceptance criteria and the actual reported device performance (e.g., success rates, flow rates, pressure tolerances) are not provided in this summary. The table below lists the types of tests performed, implying their successful outcome met an unstated acceptance criterion for each.

Study Details:

The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This means that the information you've requested regarding test sets, ground truth establishment, expert involvement, and MRMC studies is not applicable to the non-clinical testing presented here.

Therefore, for your specific questions:

1. A table of acceptance criteria and the reported device performance: This is partially addressed above, with implied "Met" for performance as no quantitative values are given.
2. Sample size used for the test set and the data provenance: Not applicable, as clinical testing was not performed. The non-clinical tests would have internal sample sizes (e.g., N units tested for leakage), but these are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as clinical testing was not performed, and thus no expert ground truth was established for a test set in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no clinical test set.
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, as no clinical study or AI component is described. The device is a physical medical device (embolectomy catheter).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, the device is a physical catheter system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be engineering specifications and standards (e.g., a specific leakage rate is acceptable, a certain tensile strength is required).
8. The sample size for the training set: Not applicable, no AI algorithm is involved that would require a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, this 510(k) submission relies on non-clinical (bench and physical) testing to demonstrate substantial equivalence to a predicate device, rather than clinical efficacy studies with human subjects or AI performance evaluations.

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