(125 days)
The ALCON® UltraChopper is indicated to be used with an Ultrasonic Phacofragmentation Handpiece to separate a cataractous lens into smaller pieces.
The ALCON® UltraChopper tip is a modified ultrasonic tip that will be added to the existing ALCON® Phaco tip family. The ALCON® UltraChopper tip is of a similar size and shape as existing Alcon phaco tips and is made with the same material (Titanium 6AL-4V alloy) as the Alcon phaco tips currently used on the INFINITI® System and CONSTELLATION® System. The ALCON® UltraChopper tip will utilize existing packaging configurations and have the same shelf life as existing phaco tips. It can be used with the same ultrasonic handpieces (INFINITI®, INFINITI® NeoSonix® or INFINITI® OZil) currently used on the Alcon systems such as the INFINITI® System and CONSTELLATION® System.
To use the ALCON® UltraChopper as intended, no modification to the existing INFINITI® System and CONSTELLATION® System software is required.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document describes a 510(k) premarket notification for the ALCON® UltraChopper, a phacofragmentation tip. It includes:
- Device Description: What the device is, its materials, and compatibility with existing systems.
- Indications for Use: The intended purpose of the device.
- Brief Summary of Non-clinical test and Results: This section details biocompatibility evaluations and sterilization validation, stating that "Non-clinical testing has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate devices."
However, it does not provide specific acceptance criteria (e.g., performance metrics, thresholds) or detailed study results that would allow me to fill out the requested table and answer the specific questions about sample sizes, expert qualifications, adjudication methods, or comparative effectiveness studies. The primary purpose of this document is to establish substantial equivalence to predicate devices, not to present a detailed performance study against predefined acceptance criteria.
§ 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.