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The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated for:
• The non-surgical removal of soft thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.

The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include a clot reservoir, a funnel loading tool, and a 60 cc syringe. The ClotTriever Catheter consists of four pre- assembled polymeric coaxial catheters terminating in an expandable coring element and thrombus collection bag. At the proximal end of the catheter is a handle used to enable tensioning of the coring element. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque.

The ClotTriever Thrombectomy System underwent non-clinical testing to demonstrate substantial equivalence to its predicate device, specifically ClotTriever Thrombectomy System (K173470). The device is used for the non-surgical removal of soft thrombi and emboli from blood vessels and for the injection/aspiration of fluids in the peripheral vasculature.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text lists numerous tests conducted to ensure the device's performance meets established specifications. For each test, the "reported device performance" is a blanket statement indicating that: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use."

Without specific numerical or qualitative results for each individual test, a detailed table with specific acceptance criteria and performance metrics cannot be generated. However, the types of tests conducted serve as proxies for the acceptance criteria for various aspects of the device's functionality and safety.

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

The provided information focuses on non-clinical testing (e.g., bench testing, mechanical tests). There is no information provided regarding a "test set" in the context of patient data.

• Sample Size: Not applicable for a clinical test set as no clinical testing was performed for this submission. For the non-clinical tests, specific sample sizes are not explicitly stated for each test, but it is implied that sufficient samples were used to meet the verification and validation requirements.
• Data Provenance: Not applicable for a clinical test set. For the non-clinical tests, the data provenance is from the manufacturer's (Inari Medical) internal testing.

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

This information is not applicable as the submission states: "Clinical testing was not required for the determination of substantial equivalence." Therefore, no clinical ground truth was established by experts for a test set in this context.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring expert adjudication was utilized.

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

An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This implies no human-in-the-loop performance evaluation or comparison with AI assistance.

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

This information is not applicable. The ClotTriever Thrombectomy System is a physical medical device (catheter system), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.

7. The Type of Ground Truth Used

For the non-clinical testing conducted, the "ground truth" used was established product specifications, engineering standards, and the performance of the predicate device (K173470). In other words, the device's performance was compared against predetermined acceptance criteria derived from its design requirements and the known characteristics of equivalent devices.

8. The Sample Size for the Training Set

This information is 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

This information is not applicable for the same reason as point 8.

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The Retraction Aspirator is intended to be used with the FlowTriever Retrieval/Aspiration System to facilitate the simultaneous aspiration and withdrawal of the FlowTriever Catheter into the Guide Catheter.

The Retraction Aspirator facilitates the simultaneous aspiration and withdrawal of the FlowTriever Catheter into the Guide Catheter. The hand-lever operated Retraction Aspirator, with its integrated clutch, is fitted with a vacuum syringe and collection container. Operating the Retraction Aspirator lever simultaneously retracts the FlowTriever Catheter into the Guide Catheter and aspirates fluid.

The provided text is a 510(k) summary for the Inari Medical Retraction Aspirator, stating that it is substantially equivalent to a previously cleared device (K143563) and that no changes have been made to the device, its design, technology, materials, or manufacturing processes. Therefore, no new performance data or acceptance criteria are presented for this specific 510(k) (K152097). Instead, it refers back to the non-clinical test results submitted for K143563.

Based on the provided document, the following information can be extracted regarding the device and its assessment:

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

Since the current submission (K152097) explicitly states "No changes have been made to the Retraction Aspirator since the original clearance on February 3, 2015 (K143563). The device design, technology, materials, processes, etc. have not been changed with this application," and "Non-clinical test results for the Retraction Aspirator were submitted in premarket notification K143563. No changes have been made to the device therefore additional testing was not necessary," no new acceptance criteria or reported performance is included in this document. The assessment relies on the prior clearance.

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

• Sample Size for Test Set: Not specified in this document. The document refers to non-clinical test results from the original clearance (K143563).
• Data Provenance: Not specified in this document. The document refers to non-clinical test results from the original clearance (K143563).

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/Not specified. The assessment for this device relies on non-clinical testing rather than expert-based ground truth from clinical studies.

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

• Not applicable/Not specified. The assessment for this device relies on non-clinical testing.

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 device is an embolectomy catheter, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. "Clinical testing was not required for the determination of substantial equivalence."

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

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

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

• For the non-clinical testing referenced from K143563, the ground truth would typically be based on established engineering and material science metrics, such as mechanical strength, fluid dynamics, biocompatibility, and manufacturing quality control. Specific types are not detailed in this document.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable. This is a physical medical device, not an AI model.

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