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The ClotTriever Thrombectomy System is indicated for:

• · The non-surgical removal of 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 including deep vein thrombosis (DVT).

The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever XL Catheter is intended for vessels 10 to 28 mm in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the 16Fr ClotTriever Sheath ("ClotTriever Sheath"), Protrieve Sheath and the ClotTriever XL Catheter ("Catheter"), each packaged separately.
The ClotTriever XL Catheter is a coaxial catheter assembly with a distal coring element and collection bag for retrieving thrombus. The proximal handle controls the expansion of the collection bag via the inner catheter. The outer shaft constrains the coring element and collection bag prior to deployment. Stopcocks and Luer connectors are provided for de-airing the ClotTriever XL Catheter shafts.
To aid in fluoroscopic visualization, the distal tip is radiopaque and radiopaque marker bands are located on the intermediate catheter to identify the proximal end of the coring element, and on the outer catheter to identify the distal end of ClotTriever XL outer catheter.

This document is a 510(k) summary for the Inari Medical ClotTriever XL Catheter (41-102). It describes a labeling correction to the Instructions for Use (IFU) for the device. As such, the submission focuses on verifying that the labeling changes do not alter performance or safety, rather than providing extensive de novo performance data.

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

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "In accordance with the design failure modes and effects analysis, design validation testing was only performed on the attributes impacted by the IFU modifications." This suggests that the acceptance criteria for the "Simulated Use – Clot Burden" and "Simulated Use – Tensile Testing" would have been established based on ensuring the device continues to function as intended and safely, despite the labeling changes. However, the specific numerical or qualitative criteria for these tests are not detailed in the provided text. The conclusion of substantial equivalence implies that these criteria were met.

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

Due to the nature of this submission being a labeling correction rather than a new device submission or significant modification, the concept of a "test set" for performance evaluation in the typical sense (e.g., a clinical trial cohort or a dataset for AI model testing) is not directly applicable.

• Sample Size for Non-Clinical Testing: Not explicitly provided for the "Simulated Use – Clot Burden" and "Simulated Use – Tensile Testing." These tests would have used an appropriate number of devices to demonstrate reproducibility and robustness, but the specific count is not mentioned.
• Data Provenance: The non-clinical testing was conducted by Inari Medical, Inc. The data is prospective for this specific submission, as it was generated to support the labeling updates. No information is provided regarding country of origin for the data, but it would typically be conducted in the country of the manufacturer (USA, in this case).

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

This question is not applicable to this submission. The device is a physical medical device (catheter) for thrombus removal, not an AI or diagnostic device that requires expert-established ground truth on a test set. The validation for this submission focuses on non-clinical performance and safety based on changes to the instructions for use.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI-powered clinical decision support systems where human readers interpret medical data. The ClotTriever XL Catheter is a therapeutic device, and this particular submission concerns a labeling correction, not a comparative effectiveness study of the device itself.

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

No, a standalone performance study was not done. This question is primarily relevant for AI algorithms. The ClotTriever XL Catheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing ("Simulated Use – Clot Burden" and "Simulated Use – Tensile Testing"), the "ground truth" would be established by engineering specifications, design requirements, and industry standards for device performance and safety. For example, for tensile testing, the ground truth would be breaking strength exceeding a specified threshold. For simulated clot burden, the ground truth would be successful and complete removal of simulated clots according to a predefined metric. This differs from expert consensus, pathology, or outcomes data which are relevant for diagnostic or AI-based devices.

8. The Sample Size for the Training Set

This question is not applicable. The ClotTriever XL Catheter is a physical medical device, not an AI algorithm that requires a training set.

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

This question is not applicable for the same reasons as point 8.

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