(90 days)
The Synthes MatrixRIB Fixation System is indicated for the fixation and stabilization of rib fractures, fusions and osteotomies of normal and osteoporotic bone.
The Synthes MatrixRIB Fixation System consists of bone plates, intramedullary (IM) splints and screws. All plates, IM splints and screws are manufactured from titanium alloy. The devices are provided sterile and non-sterile.
The provided text is a 510(k) summary for the Synthes MatrixRIB Fixation System, a medical device for fixing rib fractures. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Instead, it focuses on demonstrating substantial equivalence to predicate devices through mechanical tests and engineering analyses. This is a common pathway for medical devices seeking FDA clearance, where the focus is on showing the new device is as safe and effective as existing legally marketed devices, rather than conducting new clinical trials with acceptance criteria.
Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, training set details) because this information is not present in the provided document.
§ 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.