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The FuseForce™ Flex Dynamic Compression System is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.

The FuseForce™ Flex Dynamic Compression System consists of bone staple implants with two-leg and four-leg configurations. The system features low-profile and wide bridges, as well as multiple leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant and instruments for implantation. The implant is designed to provide compression to facilitate bone fusion.

This looks like a 510(k) summary for a medical device called the FuseForce™ Flex Dynamic Compression System. This document does not pertain to the performance of an AI/ML device, but rather a physical bone staple system.

Therefore, the requested information for an AI/ML study, such as acceptance criteria table, sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, is not applicable and cannot be extracted from this document.

The document discusses the substantial equivalence of the FuseForce™ Flex Dynamic Compression System to a predicate device based on non-clinical evidence (performance testing and engineering analysis) and states "N/A" for clinical evidence.

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