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The ROVO Mechanical Thrombectomy Device is indicated for the removal and thrombi from vessels in the peripheral vasculature.

The ROVO Mechanical Thrombectomy Device is indicated for the removal of soft emboli and thrombi from vessels in the peripheral vasculature. It consists of a ROVO Driver, a ROVO Locking Aspiration Syringe, and a ROVO Catheter. The ROVO Driver handpiece was designed to work with an off-the-shelf catheter manufactured by Merit Medical Systems, Inc (K121051 and K132409) and an off-the-shelf locking aspiration syringe (K163597) also manufactured by Merit Medical Systems, Inc. Both the catheter and syringe are private labeled with the ROVO system name.

The ROVO Catheter is maneuvered under fluoroscopic observation to the location of the target thromboemboli utilizing the surgeon's preferred vascular access procedure. Once in the desired location, the ROVO Driver handpiece with the ROVO Locking Syringe is attached to the catheter. Squeezing of the handpiece rotates the distal tip of the ROVO Driver. This rotation ensures the thromboemboli is loosened and the catheter tip is fully exposed to the vessel to completely capture and aspirate the thromboemboli. Rotation does not happen when the trigger is released. Aspiration of the emboli/thrombi happens upon release of the Locking Syringe, independent of the catheter rotation. During aspiration, the surgeon can continue to pull the trigger and move the catheter as needed to capture the target thromboemboli.

The provided text describes a medical device called the ROVO Mechanical Thrombectomy Device and its 510(k) clearance. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy, as your specific questions imply (e.g., effect size of human readers with AI, standalone algorithm performance, ground truth establishment for test/training sets).

This document focuses on the substantial equivalence of a physical medical device (mechanical thrombectomy device) to existing predicate devices, primarily through non-clinical performance data and a comparison of technological characteristics. Clinical testing was explicitly stated as not necessary for the determination of substantial equivalence in this context.

Therefore, many of your requested details regarding AI/ML device performance and testing methodology cannot be extracted from this document.

Here's what can be answered based on the provided text:

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

The document lists various non-clinical tests performed on the device components but does not provide specific acceptance criteria or quantitative performance results for these tests. It only states that these tests were "evaluated for" or "completed by Merit Medical Systems".

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document focuses on non-clinical engineering and biological tests, not data from human subjects or retrospective/prospective studies.

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)

This information is not applicable and not provided. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic or AI/ML-driven devices, which this is not.

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

This information is not applicable and not provided for the same reasons as above.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done, as explicitly stated: "Clinical testing was not necessary for the determination of substantial equivalence." This device is a mechanical thrombectomy device, not an AI-assisted diagnostic tool.

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

This is not an AI/ML or algorithm-based device, so a standalone algorithm performance study was not conducted.

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

No "ground truth" of this nature was established, as the device's substantial equivalence was determined through non-clinical performance testing and comparison to predicate devices, not through diagnostic accuracy studies.

8. The sample size for the training set

This information is not applicable and not provided, as this is not an AI/ML device.

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

This information is not applicable and not provided, as this is not an AI/ML device.

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