(97 days)
Synthes 3.5mm Quadrilateral Surface Plates are indicated for quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates.
Synthes 3.5mm Quadrilateral Surface Plates consist of metallic plates pre-shaped to fit the quadrilateral surface of the pelvis. The plates are provided in short, standard, and long versions
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a medical device (Synthes 3.5mm Quadrilateral Surface Plates).
It includes information such as:
- Sponsor and device name
- Classification and predicate device
- Device description and indications for use
- A determination of substantial equivalence by the FDA
However, it does not detail:
- Specific acceptance criteria (e.g., performance metrics, thresholds)
- Any study design, test set characteristics, expert qualifications, adjudication methods, or results of performance testing that would demonstrate conformance to such criteria.
Therefore, I cannot fulfill your request for the table and study details based on the given input.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.