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The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids. including thrombolytics, in the peripheral venous vasculature.

The Cleaner Plus™ Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the-wire device placement.

The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes system controls, and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the Aspiration Canister.

The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the therapeutic site. The dilator and guidewire are removed, and the Maceration Wire, using the Peel-Away introducer is advanced through the hemostasis valve of the Aspiration Catheter to the therapeutic site and connected to the handpiece. To complete the system, the provided Aspiration Canister is connected to the handpiece to provide aspiration. The Handpiece provides controls to turn on/off maceration and/or the application of suction. Like the current Cleaner15/CleanerXT devices, mechanical thrombectomy will be achieved by rotating a flexible stainless-steel maceration wire powered by a motor inside the handpiece. The aspiration source is provided to aspirate macerated clot from the distal portion of the device through the handpiece and captures the macerated clot in the Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the pump, and LEDs that indicate the level of the vacuum.

The provided text describes the evaluation of a medical device, the Cleaner Plus™ Thrombectomy System, for substantial equivalence to predicate devices, as part of an FDA 510(k) submission. This document is a regulatory submission, and as such, it focuses on non-clinical data (bench-top and animal studies) rather than clinical study data involving human patients or complex AI performance metrics.

Therefore, many of the requested points related to AI performance, human reader studies (MRMC), data provenance, expert consensus on ground truth, and training data for AI models are not applicable to this type of medical device submission.

Here's an analysis of the acceptance criteria and study information provided, focusing on what is relevant in this context:

1. Table of Acceptance Criteria and Reported Device Performance

The document details non-clinical performance tests that were conducted and states that the device "were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not explicitly list quantified acceptance criteria for each test or detailed performance results in a table format. Instead, it lists the types of tests performed.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each bench-top test (e.g., number of wires tested for fatigue). For the animal study, the sample size is not explicitly stated, but it is implied to be sufficient for regulatory assessment.
• Data Provenance: The studies are described as "non-clinical" (bench-top and animal studies) performed to support the 510(k) submission. The location or specific country of origin for these non-clinical tests is not detailed, but they are conducted under "Good Laboratory Practices (GLP) in compliance to FDA GLP, 21 CFR Part 58," indicating they are intended for a US regulatory submission. They are inherently "prospective" in that they are designed and executed for device evaluation rather than analyzing existing data.

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

This is not applicable. This submission concerns a physical medical device, not an AI/imaging diagnostic device requiring human expert ground truth for interpretation of images or other data. The "ground truth" for these tests are objective measurements of device performance, material properties, and biological responses in laboratory and animal models.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) where there may be disagreement among readers on findings. For physical device testing, the "ground truth" is established by the test procedures themselves and objective measurements.

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

This is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists). This submission is for a mechanical thrombectomy system.

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

This is not applicable. There is no AI algorithm being evaluated for standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this device evaluation is established through:

• Bench-top test results: Objective measurements of physical properties, mechanical performance, and system functionality (e.g., wire tensile strength, catheter kink resistance, pump vacuum performance).
• Biocompatibility test results: Laboratory analyses demonstrating the device's biological safety according to established ISO standards.
• Animal study observations: Histological findings, gross observations related to vessel integrity, and assessments of thromboembolism. These are based on established pathological and physiological evaluations in an animal model.

8. The Sample Size for the Training Set

This is not applicable. This is not an AI/ML device, so there is no "training set."

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

This is not applicable. As there is no AI/ML component, there's no training set or associated ground truth for it.

In summary: The provided document is a 510(k) summary for a physical medical device. The "acceptance criteria" discussed relate to the successful completion of a battery of non-clinical (bench-top and animal) tests, demonstrating the device's safety and performance characteristics are substantially equivalent to marketed predicate devices. The study design and reporting reflect the requirements for physical device clearance, rather than those for AI/ML-driven diagnostic tools.

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