(84 days)
The Synthes Locking Distal Radius Plating System is intended for fixation of complex intra- and extraarticular fractures and osteotomies of the distal radius and other small bones.
The Synthes Locking Distal Radius Plating System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the distal end of the radius.
The provided text describes the regulatory clearance for the "Synthes Locking Distal Radius Plating System" and does not contain information about acceptance criteria for device performance or a study that proves the device meets those criteria, as it relates to performance metrics for an AI/ML device.
The document is a 510(k) premarket notification summary from the FDA, indicating that the device has been found substantially equivalent to a predicate device. This process focuses on the safety and effectiveness profile relative to existing devices, and typically involves:
- Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics and indications for use.
- Bench Testing: Mechanical, material, and sometimes biological (biocompatibility) tests to ensure the device meets engineering specifications and is safe for its intended use.
- No Clinical Trials (often): For 510(k) clearances, extensive clinical trials proving novel clinical efficacy are often not required if substantial equivalence can be demonstrated through other means.
Therefore, I cannot extract the requested information based on the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set, data provenance, or number of experts.
- Adjudication method.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
This is expected as the Synthes Locking Distal Radius Plating System is a surgical implant (a physical device), not an AI/ML-driven diagnostic or prognostic tool that would typically involve the types of performance studies and metrics requested.
§ 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.