(30 days)
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonumion or revision surgery.
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System consists of anatomically contoured, lowprofile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking Extremity Plating System (EPS) screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. Screws lengths are offered in 10-40mm for the 2.7mm diameter plate screws and in 10 – 60mm in 3.5mm and 4.0mm diameter plate screws. All components (implants and the associated instruments) are provided sterile and for single use only.
The provided document does not describe an AI/ML device or software. It pertains to the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System, which is a metallic bone fixation appliance used for surgical fusion in the foot.
Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable and cannot be extracted from this document. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, and engineering analysis for a physical medical implant.
§ 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.