(300 days)
Folding and injection of Chiron Softex LI61U lens implant into the eye using a Chiron Microsert IC-5BU disposable cartridge.
Not Found
This document is a 510(k) premarket notification letter from the FDA to Duckworth & Kent, Ltd. regarding their Lens Delivery System DK7782-1. This is approval for a Class I medical device, which is considered low risk and does not typically require extensive clinical data or performance studies in the same way that software algorithms or higher-risk devices do.
As such, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and human reader studies is not present in this type of regulatory document for this specific device. These requirements are usually associated with devices where clinical performance and accuracy are key to safety and effectiveness, such as diagnostic AI tools.
Therefore, I cannot extract the requested information from the provided text.
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.