(131 days)
For Plastic and Reconstructive Surgery
The Surgiform Technology Ltd.'s S.F.A.M. implant is intended for augmentation or repair of the soft tissues of the facial area. The product is available in sheets or strands of the following sizes: Sheets: Length 5-100mm, Width 5-100mm, Thickness 0.2-0.4mm. Strands: 5-15cm, OD-1.0-4.0mm.
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer, indicating that their device (Surgiform Augmentation Material) has been found substantially equivalent to a legally marketed predicate device.
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. It is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the requested information from this text.
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.