(276 days)
The Biomet Forerunner™ Plating System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand, and middle foot bones. This 510(k) expands the indications for use to the forefoot, and adds specific indications for midfoot/forefoot procedures:
- Treatment of fractures and fracture-dislocations of the midfoot/forefoot
- Malunions
- Non-unions
- Joint fusions/arthrodesis
- Corrective osteotomies for deformities
These procedures in the midfoot/forefoot may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
The Biomet Forerunner" Plating System is an internal fixation system consisting of various sized plates and screws. The plates and screws are fabricated from Ti-6Al-4V.
The provided text describes a 510(k) premarket notification for the Biomet Forerunner Plating System, which is a metallic bone fixation device. This specific submission expands the indications for use of the system to include the forefoot and adds specific midfoot/forefoot procedures.
However, the document is a regulatory submission describing a device and its intended use, rather than a study evaluating its performance against specific acceptance criteria. The FDA's review concludes that the device is "substantially equivalent" to predicate devices, meaning it does not raise new issues of safety or effectiveness compared to existing, legally marketed devices.
Therefore, the requested information regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), and training set information is not present in this document.
The "Summary of Technologies" section states: "The technological characteristics of the Forerunner" Plating System are the same as, or similar to, the predicate devices." This implies that the device's performance would be considered similar to the predicate devices, which have already been deemed safe and effective.
In summary, this document does not contain the information required to populate the table or answer the specific questions about acceptance criteria and a study proving device performance, as it is a substantial equivalence claim for a physical medical device, not an AI/software 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.