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The Diamondback 360°™ Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use in treating de novo or restenotic, calcified lesions in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The Diamondback 360°™ Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V shunts).

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a medical device called the "Diamondback 360° Orbital Atherectomy System."

While it confirms the device's clearance and provides indications for use, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts, adjudication methods for ground truth, or types of ground truth used in any studies.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set details.

This document is a regulatory approval letter, not a clinical study report or a technical performance specification document.

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