(25 days)
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.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).