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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 Condylar Head Add-on System is an adjustable height add-on system for use with the 2.4 mm Locking Reconstruction Plate System and MatrixMANDIBLE Plate System. It consists of a condylar head, 2 screws, and one of four (4) fixation plates, each with a different screw hole spacing that determines the height of the condylar head.

The provided documents do not contain information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, adjudication methods, or MRMC comparative effectiveness studies.

The documents are a 510(k) summary and an FDA clearance letter for the "Synthes (USA) Condylar Head Add-on-System - Modification". These documents focus on establishing substantial equivalence to a predicate device, an existing Synthes Condylar Head Add-on-System.

Specifically, the 510(k) summary states that "Documentation is provided which demonstrates the Synthes (USA) Condylar Head Add-on-System - Modification to be substantially equivalent to other legally marketed devices such as: Synthes (USA) Condylar Head Add-on-System." This implies that the device's acceptance is based on its similarity to an already approved device, rather than a new study proving specific performance metrics against defined acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

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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.

Ask a specific question about this device