(142 days)
The Velocity Advantage would be used by a physician in conjunction with standard vitrectomy equipment to cut and remove vitreous and other intraocular tissue.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Velocity Advantage" device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.
The letter primarily confirms that the device is substantially equivalent to a predicate device and can therefore be marketed. It lists the device name, a brief indication for use, and regulatory information.
Therefore, I cannot extract the requested information from this document.
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.