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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 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.

The provided text describes the ClotTriever Thrombectomy System, its indications for use, and a clinical study (CLOUT Registry) conducted to support changes to its indications. However, the document does not contain a table of acceptance criteria and the device performance against those specific criteria. It outlines the results of a clinical registry and concludes that these results support the changes to the Indications for Use.

Therefore, many of the requested details cannot be fully extracted from the provided text. I will answer based on the information available and explicitly state when information is not present.

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

The document does not explicitly present a table of predefined acceptance criteria for the device's performance in a clinical study. Instead, it describes clinical outcomes observed in the CLOUT Registry, which are then used to justify the expanded Indications for Use.

Note: These are observed outcomes from a registry study, not a pre-defined set of acceptance criteria with corresponding thresholds. The document implies these results were sufficient to demonstrate substantial equivalence for the expanded indications.

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 (Test Set):
  • 133 patients (for procedural and acute data across 16 sites).
  • 98 patients (for 30-day follow-up data).
• Data Provenance:
  • Study Type: Clinical Registry (CLOUT Registry). Registries are typically prospective, collecting real-world data over time. The description "real-world patient outcome information" supports this.
  • Country of Origin: Not explicitly stated in the provided text, but the FDA submission suggests it was likely a multi-center study, possibly within the United States or including international sites. The absence of specific country details means it cannot be determined from this document.

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)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document only mentions "core lab Marder scores" were used for thrombus removal assessment, implying expert review by a central laboratory, but details about the experts' number or qualifications are not provided.

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

The document does not provide details about the adjudication method used for the clinical data in the CLOUT Registry. It mentions "core lab Marder scores," which suggests a centralized assessment, but not the specific adjudication process (e.g., number of readers, conflict resolution).

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

The provided text describes a clinical study of a thrombectomy device, not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and was not performed/reported for this device.

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

This question is also not applicable as the device described (ClotTriever Thrombectomy System) is a physical medical device for thrombus removal, not a standalone algorithm.

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

The ground truth for the effectiveness and safety of the device was established primarily through:

• Clinical Outcomes Data: This includes direct patient outcomes, such as rates of thrombus removal (quantified by "core lab Marder scores"), incidence of major adverse events, changes in Post-Thrombotic Syndrome (PTS) incidence, and improvements in various quality of life scores (Villalta, rVCSS, EQ-5D, NPRS).

8. The sample size for the training set

The document describes a clinical registry (CLOUT Registry), which is an observational study collecting real-world data. It does not refer to a "training set" in the context of device development or machine learning. The 133 patients (with 98 having 30-day follow-up) represent the study population for evaluating the device's performance, not a training set for an algorithm.

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

As there is no mention of a "training set" in the context of this device or study, this information is not applicable. The ground truth for the efficacy and safety of the device was established through the objective clinical data collected in the CLOUT Registry, as detailed in point 7.

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