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The Peripheral ROTAPRO is intended for percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.

The Peripheral ROTAPRO Rotational Atherectomy System consists of an Advancer pre-connected to a Catheter. The advancer functions as a guide for the sliding elements that control burr advancement and the catheter portion of the device guides the burr through the vasculature to the treatment site. The Peripheral ROTAPRO devices are provided sterile and non-pyrogenic unless the package has been opened or damaged. It is intended for one procedure use only.

The provided text describes a 510(k) premarket notification for the "ROTAPRO Rotational Atherectomy System," a medical device, and not an AI/ML software or a diagnostic device. Therefore, the acceptance criteria and study details requested in the prompt, such as those related to AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert consensus, and MRMC studies, are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device (Rotablator™ Rotational Atherectomy System with Peripheral RotaLink Plus™) through bench testing and comparison of technological characteristics.

Instead, I can outline the performance data presented to support the substantial equivalence:

Device Performance Study Details (Non-AI/ML)

As this is a mechanical medical device, the "acceptance criteria" are related to functional performance tests and comparisons to a predicate device, rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document describes "bench testing" which implies engineering tests on device units, not a dataset of patient images or clinical cases. The "sample size" would refer to the number of devices or components tested. This specific number is not explicitly stated in the provided text.
• Data Provenance: The tests are conducted by the manufacturer (Boston Scientific Corporation). The data comes from internal testing.

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

• Not applicable. This device is mechanical. Ground truth would relate to physical measurements and engineering specifications, not expert interpretation of medical images or diagnoses.

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

• Not applicable. Adjudication methods are relevant for subjective human interpretations, typically in diagnostic studies. Bench testing relies on objective, measurable performance characteristics.

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 is a mechanical device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a hardware device; there is no "algorithm only" performance to evaluate in this context.

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

• The "ground truth" for this device's performance would be the established engineering specifications, material properties, and functional parameters that the device is designed to meet. This is determined by the manufacturer's design requirements and industry standards, verified through bench testing.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI/ML model where a "training set" of data is used.

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

• Not applicable. As above, no training set for an AI/ML model.

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