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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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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 designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy System consists of ClotTriever 13 Fr and 16 Fr Sheaths, Protrieve Sheath, ClotTriever Catheter, ClotTriever BOLD Catheter, and the ClotTriever XL Catheter, each packaged separately.
The ClotTriever Catheter, ClotTriever BOLD Catheter, and the ClotTriever XL Catheter are comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Three ports terminating in two stopcocks and a luer lock connection are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the ClotTriever Sheaths, Protrieve Sheath, and ClotTriever Catheters have radiopaque distal tips. The ClotTriever XL Catheter is intended for vessels 10 to 28 mm in the peripheral vasculature.

The ClotTriever XL Catheter is an accessory to the ClotTriever Thrombectomy System and is used for non-surgical removal of thrombi and emboli from blood vessels. It is also used for the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel within the peripheral vasculature, including deep vein thrombosis (DVT).

Here's an overview of the acceptance criteria and study information for the ClotTriever XL Catheter based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each non-clinical test. It mentions that "verification and validation tests were identified to support the substantial equivalence" and that "test results demonstrated that all acceptance criteria were met."

The provenance of the data is from non-clinical testing conducted by Inari Medical, Inc. The nature of these tests (e.g., mechanical, simulated use, biocompatibility) implies laboratory-based testing rather than patient data. Therefore, the data would be considered prospective from a testing perspective, as the tests were conducted specifically for this submission. There is no information about country of origin, but it is typically assumed to be where the manufacturer is based (USA).

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

Since this submission is based on non-clinical testing (mechanical, performance, and biocompatibility), there is no mention of "experts" in the context of establishing ground truth for a test set based on patient data (e.g., radiologists, pathologists). The "truth" for these tests is based on predefined engineering and scientific specifications, and compliance with standards like ISO 10993-1.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation is based on objective, quantifiable non-clinical test results against established specifications, not subjective interpretation of medical images or patient outcomes.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to support substantial equivalence." This means the submission did not involve studies comparing human readers' performance with and without AI assistance, as the device is a medical instrument (catheter), not an AI diagnostic tool.

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

Not applicable. The ClotTriever XL Catheter is a medical device for clot removal, not an algorithm or AI system. Its performance is evaluated through physical and biological testing, not through standalone algorithm performance metrics.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on engineering specifications, established industry standards (e.g., ISO 10993-1 for biocompatibility), and pre-defined performance benchmarks relevant to the safe and effective operation of the catheter. For the animal safety evaluation, the ground truth would be based on in-vivo observations of safety and functional performance.

8. The Sample Size for the Training Set

Not applicable. The ClotTriever XL Catheter is a physical medical device and does not involve AI algorithms that require a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

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