(72 days)
The DePuy Synthes 2.4mm LCP Straight Wrist Plate is intended for Colles' and distal radius fractures with dorsal angulation of the distal fragment.
The 2.4mm LCP Straight Wrist Plate is designed for distal radius fractures with severe comminution requiring prolonged fixation, as an alternative to external fixation. Applied to the dorsal aspect of the wrist, the plate restores length and neutralizes loads on the consolidating fracture fragments.
The provided text describes a 510(k) premarket notification for a medical device, specifically the DePuy Synthes 2.4mm LCP Straight Wrist Plate. However, this document is a letter from the FDA regarding the substantial equivalence of a new version of an existing device (a sterile-packaged version) to an already cleared predicate device.
Crucially, this document states that "Clinical data was not necessary for the determination of substantial equivalence." This means that there was no clinical study, algorithm performance evaluation, or human reader study performed for this specific submission to demonstrate the device's efficacy or safety. The acceptance criteria and performance data typically requested for AI/ML-based medical devices or devices requiring clinical evidence are therefore not present in this document.
The "acceptance criteria" here refers to the FDA's regulatory criteria for determining substantial equivalence, not performance metrics of a device in a study. The "study that proves the device meets the acceptance criteria" in this context is the non-clinical performance testing that verifies the sterile packaging does not affect safety or performance, and the comparison to the predicate device.
Therefore, I cannot provide the detailed information requested in your prompt as it pertains to clinical performance and AI/ML model evaluation. The document specifically indicates that such data was not required for this particular submission.
§ 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.