(77 days)
To fold and deliver ALCON® qualified ACRYSOF® Acrylic foldable intraocular lenses into the eye for replacement of the human crystalline lens.
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Duckworth & Kent Ltd. Cartridge Lens Delivery System. Model DK7797". It states that the device is substantially equivalent to a legally marketed predicate device, but it does not include details about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any other specifics related to a study proving the device meets acceptance criteria.
The letter focuses on regulatory approval based on substantial equivalence, not on the detailed results of a performance study.
§ 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.