(78 days)
Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
The Synthes (USA) Condylar Head Add-on System is an adjustable height system intended for use with Synthes' 2.4 mm Locking Reconstruction Plate (LRP) System. The system consists of an elliptical shaped condylar head, four different fixation plates which allow the surgeon to adjust the height of the condylar head, and two fixation screws for mounting the condylar head and fixation plate onto a 2.4 mm locking reconstruction plate.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Synthes (USA) Condylar Head Add-on System, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than performance studies or clinical trials.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance based on the given information.
§ 872.4770 Temporary mandibular condyle reconstruction plate.
(a)
Identification. A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for treatment of temporomandibular joint disorders.(b)
Classification. Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.