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The peripheral Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.

The Rotablator® Rotational Angioplasty system uses a high speed, rotating, diamondcoated burr to ablate occlusive material and restore luminal patency. The burr spins at 140.000-190.000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The Rotablator System with Exchangeable Catheter comprises four main components: advancer, catheter with diamond-coated burr, console and foot pedal, and guide wire.

The provided text is a 510(k) summary for a medical device modification (Rotablator® Angioplasty System). It describes the device, its intended use, and states that it is substantially equivalent to a predicate device based on comparison of intended uses, designs, and testing.

However, the document does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or any statistical performance metrics typically found in a clinical study report or detailed device validation. The text focuses on regulatory approval based on substantial equivalence to a predicate device rather than detailing de novo performance testing results with predefined acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the necessary data is not present in the given input. The document explicitly states:

• "The proposed Rotablator system is considered to be substantially equivalent to the previously marketed Rotablator system based on a comparison of the intended uses and designs and results of the testing and evaluations performed."
• There's no mention of a clinical study, sample sizes, ground truth establishment, or expert reviews for this specific submission.

To answer your request, I would need a document that presents the results of specific performance tests, validation studies, or clinical trials that define acceptance criteria and then report how the device performed against them.

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