(30 days)
The Synthes (USA) Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
The Synthes (USA) Sternal Fixation System consists of machined titanium plates, a quick-release pin and 3.0 mm locking screws. The plates utilize screw fixation to create the construct.
I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, a study, sample sizes, experts, adjudication methods, multi-reader multi-case studies, standalone performance studies, or ground truth.
The document is a 510(k) summary and an FDA clearance letter for the Synthes (USA) Sternal Fixation System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing the detailed study design and results typically found in a clinical trial report.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.