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The Cleaner™ Plus 18F 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™ 18F 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 an aspiration control and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the external vacuum reservoir with pump known as the Aspiration Canister.

The system is inserted percutaneously into the vessel using an introduction catheter, the system Aspiration Catheter and Dilator may be placed over-the-wire to the site of thrombus. The device macerates intra-lumen and wall adherent thrombus with a maceration wire. The macerated thrombus is removed from the vessel using an aspiration system. The aspiration of the clot can be performed simultaneous or independently.

Additionally, the device may be used for infusion of thrombolytics and/or contrast media. Once thrombus resolution is achieved, the device is removed from the patient and discarded.

The provided text describes information about the Cleaner™ Plus 18F Thrombectomy System, a medical device, and the basis for its FDA clearance through a 510(k) premarket notification (K233909). The information primarily focuses on establishing substantial equivalence to a predicate device (K211798), rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, many of the requested items related to AI/ML device study design (e.g., sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable or cannot be extracted from this document, as it concerns a mechanical thrombectomy system, not an AI/ML-driven device.

However, I can provide the available information regarding the device's performance assessment and the basis for its clearance.

Acceptance Criteria and Device Performance (Non-AI/ML Medical Device)

The document does not present a table of numerical "acceptance criteria" in the same way one might find for an AI/ML model's performance metrics (e.g., AUC, sensitivity, specificity thresholds). Instead, the acceptance criteria for this medical device are qualitative, based on established industry standards, guidance, and the successful outcome of various performance and safety tests demonstrating substantial equivalence to a predicate device.

The "reported device performance" refers to the successful completion and meeting of predefined parameters for each test, indicating the device performs as intended and is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical device, not an AI/ML system, the "acceptance criteria" are the successful completion of various tests and the demonstration of substantial equivalence. The "reported device performance" refers to the outcomes of these tests.

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

• Sample Size for Test Set: Not explicitly stated numerically as a "test set" in the context of an AI/ML model for classification or prediction. The "test set" here refers to the actual physical devices (or components) used for the various in-vitro and in-vivo performance and safety tests. The specific number of devices/samples tested for each individual performance test (e.g., tensile strength, kink testing) is not provided in this summary.
• Data Provenance:
  • In-vitro Performance Testing: Conducted by the manufacturer (Argon Medical Devices, Inc.)
  • Biocompatibility Testing: Leveraging data from predicate device (K211798) and a comparator device (K232679). These studies were performed under Good Laboratory Practices (GLP) in compliance with FDA GLP, 21 CFR Part 58.
  • Animal Studies: Conducted as part of the submission to demonstrate safety and performance. (Specific country/institution not mentioned, implied to be part of the submission package leveraged by the manufacturer).
  • Retrospective or Prospective: All tests described are prospective, conducted specifically for this submission.

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

• Not applicable for this type of device. The "ground truth" for a mechanical device like this is established through engineering and scientific measurement, and observable biological/physical outcomes, rather than expert interpretation of images or clinical data. Device performance is measured against established physical and safety parameters.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in scenarios where human interpretation of complex data (like medical images) is being used to establish ground truth or evaluate diagnostic performance. For a mechanical device, performance is evaluated against objective, measurable criteria and laboratory test results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is relevant for AI/ML devices where reader performance (e.g., radiologists, pathologists) is being evaluated with and without AI assistance. This document describes a mechanical device.

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

• Not applicable. This relates to AI/ML algorithm performance.

7. The Type of Ground Truth Used

• Objective Engineering & Biological Measurements: The ground truth for this device is based on:
  • Physical/Dimensional conformity: Verified dimensions and visual appearance.
  • Functional performance: Successful operation during simulated use, aspiration and maceration efficiency, tensile strength, torque, kink resistance, etc.
  • Biocompatibility: Established through ISO standards and GLP-compliant testing results (e.g., absence of cytotoxicity, sensitization, irritation).
  • Biological safety and effectiveness (animal studies): Observable clinical and histological outcomes in vivo (e.g., vessel patency, absence of thromboembolism, rupture, hemorrhage).
  • Compliance with industry standards: Meeting parameters set forth in standards like IEC 60601.

8. The Sample Size for the Training Set

• Not applicable. This document describes a mechanical device, not an AI/ML model that requires a "training set."

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

• Not applicable. As there is no AI/ML training set, this question is not relevant.

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