(79 days)
The Implantech ePTFE Facial Implants are intended for implantation to augment or reconstruct underdeveloped areas of the face. The devices are available in various chin, nasal, malar and carving block three dimensional shapes all which may be additionally carved to allow the surgeon to further shape the device should additional shaping be desired.
The Implantech ePTFE Facial Implants are intended for implantation to augment or reconstruct underdeveloped areas of the face. The devices are available in various chin, nasal, malar and carving block three dimensional shapes all which may be additionally carved to allow the surgeon to further shape the device should additional shaping be desired.
The provided text is an FDA 510(k) clearance letter for the Implantech ePTFE Facial Implants. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.
Therefore, I cannot provide the requested table and information based on the input text. The letter is a regulatory approval document, not a detailed study report.
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.