Search Results

Surgiform Anatomical Malar implants can be used by surgeons in a unique surgical procedure designed to restore or enhance a patients facial appearance. The implants can be used for aesthetic or reconstructive procedures. The implants can be inserted into a "pocket" created by means of a standard intraoral surgical incision. The implants can elevate and reposition sagging skin and can also fill the hollows and depressions caused by gravity and time. The implants can also be used by surgeons to restore a patients natural appearance as a result of severe facial trauma.

Not Found

I am sorry, but the provided text does not contain the necessary information to answer your questions regarding acceptance criteria and study details for the Surgiform Anatomical Malar device. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It specifies general information about regulatory approval, but it does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

Ask a specific question about this device

Ask a specific question about this device