(77 days)
The Numelock™ II System is intended for use in the temporary stabilization of long bone fractures.
The Numelock™ II System consists of a series of locking plates and screws for the internal fixation of long bone fractures. The plates are available in different styles and configurations to fit various anatomical sites. Each plate has holes for screw fixation and is pre-contoured to fit the anatomical profile of the different periarticular regions of long bones.
The provided document is a 510(k) premarket notification for the Numelock™ II System, a metallic bone fixation device. It describes the device and claims substantial equivalence to predicate devices, but it does not contain a study demonstrating that the device meets specific acceptance criteria related to numerical performance metrics.
Therefore, I cannot populate the requested table and answer the study-related questions as the information is not present in the provided text.
The document states:
- "Mechanical testing demonstrated comparable mechanical properties to the predicate devices." This is a very high-level statement and does not provide specific acceptance criteria, reported performance values, or any details about the study (sample size, methodology, ground truth, etc.).
In summary, the provided document does not contain the information required to answer your request about acceptance criteria and a study proving the device meets them.
§ 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.