(261 days)
The intended use of the xPORT S Lens Fragmentation System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation, as well as ancillary functions such as vitreous aspiration and cutting
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I am sorry, but the provided text from the FDA 510(k) clearance letter for the Carl Zeiss Meditec xPORT S Lens Fragmentation System does not contain any information regarding acceptance criteria, device performance studies, or details about AI model validation.
The document is a standard 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices for its indicated use (fragmentation and removal of cataracts, etc.). It outlines the regulatory classification, product codes, and general controls the device is subject to.
Therefore, I cannot provide the details you requested because the source material does not contain that information. To answer your request, I would need a document that describes the clinical performance testing, validation studies, or technical specifications of an AI-powered medical device.
§ 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.