(161 days)
The Virilis Penile Prostheses are intended for implantation into the corpora cavernosa of the penis in patients who are diagnosed as having erectile dysfunction. The prosthesis is implanted to provid adequate penile rigidity for vaginal penetration.
Virilis Penile Prostheses
I am sorry, but the provided text is a 510(k) clearance letter and an "Indications For Use" statement. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to a study that proves the device meets acceptance criteria.
The document states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This process confirms that the new device is as safe and effective as a legally marketed device; it does not involve a study to demonstrate performance against specific acceptance criteria in the way a clinical trial or performance study would.
Therefore, I cannot provide the requested information based on the input text.
§ 876.3630 Penile rigidity implant.
(a)
Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.(b)
Classification. Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”