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The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.

The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vascular.

The Cleaner™ Rotational Thrombectomy System is a percutaneous infusion system that utilizes a rotating sinusoidal wire to increase the dispersion of delivered solution. The devices employ mechanical rotation of a flexible "S" shaped dispersion wire at 4000 RPM which creates a fluid vortex within the treatment site. Contrast media and physician specified solutions, including thrombolytics, may be infused through the catheter lumen to a side hole at the distal end. The dispersion wire uses mechanical rotation to allow the infused solution to penetrate the clot increasing the effectiveness of the treatment. Any residual clot can be aspirated through an introducer sheath prior to restoration of flow. The distal soft tip is a radiopaque a-traumatic tip on the distal end of the dispersion wire. The devices are sterile and single-use disposable.

This FDA 510(k) summary for the Cleaner™ Rotational Thrombectomy System does not include specific acceptance criteria or a detailed study description with performance metrics in numerical form. It refers to general "bench testing and animal studies" and "performance testing" to support substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or expert involvement as these are not present in the provided document.

However, I can extract information related to the types of studies conducted and general conclusions:

1. A table of acceptance criteria and the reported device performance
Not provided in the document. The document states: "Results of bench testing and animal studies demonstrate Cleaner™ Rotational Thrombectomy System is as safe and effective as the legally marketed predicate device." However, no specific performance metrics or acceptance criteria are listed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in precise detail. The document mentions "A GLP animal study was conducted" but does not specify the number of animals or the species used, or the country of origin. It's prospective by nature of being an animal study.

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)
Not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.

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
Not applicable. This device is a mechanical thrombectomy system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for physical intervention, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the animal study, the ground truth would be based on direct observation of vessel patency and potentially pathology/histology of the treated vessels. The document states "The animal testing show the Cleaner Rotational Thrombectomy System successfully restores patency to occluded vessels." This implies visual assessment of vessel patency as the outcome.

8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established
Not applicable. This is a physical device, not a machine learning algorithm.

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