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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 for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath comprises a reinforced 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 the funnel loading tool and a Large Bore 60 cc syringe. The ClotTriever Catheter comprises reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.

This document is a 510(k) summary for the Inari Medical ClotTriever Thrombectomy System. It outlines the FDA's determination of substantial equivalence for a modified version of the device.

Based on the provided text, the device in question is not an AI/ML powered device. It's a physical medical device designed for the non-surgical removal of thrombi and emboli. Therefore, the questions related to AI/ML device performance, such as acceptance criteria based on AI metrics, sample sizes for test/training sets for AI, expert adjudication, MRMC studies, and standalone algorithm performance, are not applicable to this document.

The document states:

• "Non-Clinical Testing: Non-clinical testing was not required to support the change to the Indications for Use."
• "Clinical Testing: The CLOUT registry clinical data supporting this labeling change was previously submitted in the ClotTriever Thrombectomy System 510(k) (K193462, cleared on September 9, 2020). No additional clinical data was deemed necessary to determine substantial equivalence of the subject and predicate devices."

This means that the current 510(k) submission (K210190) is for a labeling change (specifically, removing "chronic clot" from a contraindication) for an already cleared device, and no new performance testing (clinical or non-clinical) was conducted or required for this specific submission. The substantial equivalence determination is based on the previously submitted data for K193462.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device from this document. The document describes a traditional medical device and a submission for a minor labeling modification.

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