(63 days)
The Synthes (USA) 2.4mm LCP Wrist Plate is intended for colles' and distal radius fractures with dorsal angulation of the distal fragment.
The 2.4 mm LCP Wrist Plate is a pre-contoured plate which is positioned dorsolaterally on the distal radius and affixed to the second metacarpal to span the wrist. A low profile construct is maintained by incorporating a 2.6 mm thickness, and a width of 7.5 mm. The plate has combination and DCU holes which accept 2.4 mm cortex and 2.4 mm locking screws. The plate is made out of Stainless Steel with tapered ends and is 170 mm in length.
The provided text is a 510(k) summary for the Synthes (USA) 2.4 mm LCP Wrist Plate. This document describes a medical device, its intended use, and its substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices in the US.
However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory filing, not a clinical or performance study report.
Therefore, I cannot provide the requested information, specifically:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method: Not present.
- MRMC comparative effectiveness study: Not present. This device is a bone fixation plate, so an MRMC study related to AI assistance would not be applicable.
- Standalone performance study: Not present.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
The document discusses the device's name, classification, predicate device, description, and intended use for regulatory purposes, concluding with an FDA letter finding substantial equivalence. There are no performance metrics or study details to extract for the questions asked, as these are typically found in separate performance reports or clinical data submissions, not in a 510(k) summary itself for this type of device.
§ 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.