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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:

1. Treatment of fractures and fracture-dislocations of the midfoot/forefoot
2. Malunions
3. Non-unions
4. Joint fusions/arthrodesis
5. 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.

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