(86 days)
The DePuy Locking Anatomic & Composite Plating System is intended for fixation of fractures, osteotomies and non-unions of the fibula, malleolus, metatarsals and metacarpals, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna and distal tibia, particularly in osteopenic bone.
The DePuy Locking Anatomic & Composite Plating System is substantially equivalent to currently marketed devices.
The provided text is related to a 510(k) premarket notification for a medical device called the "DePuy Locking Anatomic & Composite Plating System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested regarding:
- Acceptance criteria and reported device performance (in a table format).
- Sample sizes used for test sets, data provenance, and ground truth establishment details for a study proving acceptance criteria.
- Number of experts, their qualifications, and adjudication methods for establishing ground truth.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
- Ground truth type, training set sample size, and ground truth establishment for a training set.
The document is a regulatory approval notice based on the substantial equivalence of the new device to existing predicate devices, primarily demonstrated through pre-clinical data, not clinical performance studies against specific acceptance criteria.
Key information present in the document:
- Device Name: Locking Anatomic & Composite Plating System
- Intended Use: For fixation of fractures, osteotomies, and non-unions of various bones (fibula, malleolus, metatarsals, metacarpals, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna, and distal tibia), especially in osteopenic bone.
- Summary of Substantial Equivalence: "The DePuy Locking Anatomic & Composite 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 type of 510(k) submission relies on demonstrating that the new device has "technological characteristics... similar to the predicate devices including design and material" and that pre-clinical data supports its equivalence, rather than setting and meeting specific performance acceptance criteria in a clinical 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.