(128 days)
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.
§ 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.