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The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.

The ReVene Thrombectomy Catheter is a rotational venous thrombus extraction system for the treatment of vessels greater than 6mm diameter. The device is designed to be used in a medical catheter laboratory and allows for optional infusion of thrombolytic agents.

The device is compatible with a 10Fr introducer and includes a wire-braided cobalt chromium basket for thrombus disruption. A rotational thrombus-extractor, consisting of a helical coil housed inside a metal tube, is powered by an internal DC motor and batteries. The extractor runs the length of the catheter, and when activated, the coil rotates and is designed to macerate and transport thrombus from the basket to a collection container outside the body.

The main features of device are:

• . The thrombus disruption cage
• . The non-vessel contact thrombus extractor
• . The handle

The ReVene Thrombectomy Catheter is packaged as a single unit and is sterilized using ethylene oxide. The device is provided sterile, non-pyrogenic and is for single-use only.

This document is a 510(k) premarket notification for the "ReVene Thrombectomy Catheter" by Vetex Medical, Ltd. The information provided is for regulatory clearance based on substantial equivalence to a predicate device, not typically a study proving the device meets acceptance criteria of an AI/algorithm-based diagnostic device. The document describes various device performance tests for a mechanical thrombectomy catheter, an interventional medical device, not an AI or algorithm-based diagnostic tool.

Therefore, many of the requested criteria related to AI/algorithm development and validation (like sample size for training set, ground truth for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to this type of device submission.

However, I can extract the acceptance criteria and performance data for the mechanical thrombectomy catheter as described in the document, and highlight that this is not an AI/algorithm-based device study.

Here's a breakdown of the relevant information provided in the document:

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

The document states that "All tests met the pre-determined acceptance criteria" for various performance tests. It also specifies a primary performance endpoint for a clinical study.

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 (Clinical Trial): 19 subjects were enrolled and treated.
• Data Provenance: The document states it was a "multi-centre evaluation." While the country isn't explicitly stated for all centers, the submitter is Vetex Medical Ltd. from Galway, Ireland. The study was "prospective, non-randomized."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not an AI/algorithm-based diagnostic device where experts establish ground truth for images. The ground truth in the clinical study is based on direct observation of thrombus removal (SIR Grade Lysis) and adverse events by the treating clinicians/investigators. No specific number or qualification of experts for ground truth establishment is mentioned as it's not applicable in this context.

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

• Adjudication methods like 2+1 or 3+1 are typically for interpreting imaging data with multiple readers, which is not the primary focus here. For the clinical trial, the endpoint (SIR Grade II Lysis or greater and freedom from procedural adverse events) would have been assessed by the clinical investigators at each site, likely following pre-defined protocols. The document does not specify an adjudication method for this assessment.

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

• No, an MRMC comparative effectiveness study was not done. This is a thrombectomy catheter, not an AI assistance device for human readers.

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

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

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

• For the clinical study, the "ground truth" for efficacy was the Society of Interventional Radiology (SIR) Grade Lysis (a measurement of thrombus removal as assessed by imaging, presumably by the interventionalists) and freedom from procedural/device-related adverse events (outcomes data). For the animal study, it was also based on observed performance and safety.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm device that requires a training set.

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

• Not applicable.

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