(65 days)
Synthes 4.5 mm LCP Posterolateral Proximal Femur Plates are intended for treatment of fractures of the femur including: Basilar neck fractures such as Pauwels Type 3; fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, mutlifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed or transverse or with additional fracture of medial cortex; fractures of the proximal end of the femur combined with ipsilateral shaft fractures, metastatic fractures of the proximal femur; and also for use in fixation of osteopenic bone and fixation of non-unions or malunions.
Synthes 4.5 mm LCP Posterolateral Proximal Femur Plates are contoured to match the anatomy of the proximal femur. The plates feature a limited-contact profile and Combi holes (Dynamic Compression Plate holes combined with locking screw holes), which accept 4.5 mm cortex, 5.0 mm locking screws, 5.0 mm cannulated locking screws, 7.3 mm cannulated locking screws, and 7.3 mm cannulated conical screws. The plates are manufactured from stainless steel and titanium.
This document is for a medical device (a bone plate) and contains a 510(k) summary and an FDA clearance letter. It describes the device's technical specifications and intended use but does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request for the following information based only on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance analysis was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is typical for 510(k) submissions for Class II medical devices. This often relies on comparison of design, materials, and intended use, rather than extensive clinical performance studies. Performance data, if collected, would typically be for mechanical testing to ensure the device meets engineering specifications for strength, fatigue, etc., but these details are not provided in this 510(k) summary.
§ 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.