(33 days)
The Paradigm Phaco Tip is intended to be used in conjunction with an ultrasonic handpiece for ophthalmic surgery to remove cataract tissue.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Phacopak" (also referred to as "Phaco Tip"). It explicitly states that the device is substantially equivalent to legally marketed predicate devices.
However, this document DOES NOT contain any information regarding acceptance criteria, device performance, sample sizes for testing, ground truth establishment, expert qualifications, adjudication methods, or results from any studies (standalone or MRMC comparative effectiveness).
The letter is a regulatory approval document and focuses on the administrative aspects of substantial equivalence, not the detailed technical data that would be found in a study report.
Therefore, I cannot fulfill your request for the acceptance criteria and study details based on the provided text. The requested information is simply not present in these documents.
§ 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.