(190 days)
The DePuy Anatomic Locking Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia and fibula, particularly in osteopenic bone.
The DePuy Anatomic Locking Plating System is substantially equivalent to currently marketed devices.
This document is a 510(k) summary for the DePuy Anatomic Locking Plating System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria through a clinical study or a standalone algorithm performance study.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device performance study is not applicable to this 510(k) summary.
The 510(k) summary states:
- "The DePuy Anatomic Locking Plating System is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data." This indicates that equivalence was shown through non-clinical testing (e.g., mechanical tests, materials characterization), not a clinical study with performance metrics like sensitivity, specificity, or accuracy.
- "No new issues of safety or efficacy have been raised." This reinforces that the submission aims to show the device is as safe and effective as existing, legally marketed devices, not to establish new safety or efficacy profiles to meet specific performance criteria.
In summary, the provided document does not contain the information requested because it is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a predicate device rather than meeting specific pre-defined acceptance criteria through a new performance study.
§ 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.