(29 days)
The intended use of the miCOR System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.
Not Found
The provided text is an FDA 510(k) clearance letter for the miCOR System Lens Fragmentation System. This document, while indicating the device's clearance for market and its intended use, does not contain any information regarding specific acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information in the table or the subsequent numbered points based solely on the text provided. The document focuses on regulatory compliance and the determination of substantial equivalence, not on the detailed technical study results.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.