(88 days)
The DePuy Fracture and Fusion Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe. humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [> 12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
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The provided text is a 510(k) summary for a medical device (DePuy Fracture and Fusion Plating System) seeking clearance from the FDA. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and preclinical data.
Crucially, this document does NOT contain information about acceptance criteria, device performance studies (like a standalone or MRMC study), sample sizes, ground truth establishment, or expert involvement as would be typical for an AI/CAD-related approval.
This is a traditional medical device (implants for bone fixation) that relies on engineering principles, materials science, and comparative analysis with existing devices, not on data-driven AI algorithms that require performance metrics like sensitivity, specificity, or AUC against a ground truth.
Therefore, I cannot provide the requested information because it is not present in the provided text. The document clearly states:
- "The DePuy Fracture and Fusion Plating System is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data. No new issues of safety or efficacy have been raised."
This indicates that the clearance was based on equivalence to existing devices and preclinical testing (e.g., mechanical strength, biocompatibility), not on direct human performance or AI algorithm performance evaluation.
§ 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.