(60 days)
The CoLink® Mfx Plating System is intended for stabilization of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries, in both pediativ and adult patients.
The CoLink® Mfx Plating System is a line extension to the current CoLink® plating system offerings. The CoLink® Mfx Plating System has eight plate styles: 1st TMT Plates, 1st/2nd Lisfranc Plates, 2nd/3rd Lisfranc Plates, an NC Plate, a Medial Column TNC Plate, a Medial Column NCM Plate, and a Medial Column Bridge Plate. The plates and associated screws are manufactured from Titanium Alloy (ASTM F136).
The provided text describes a 510(k) premarket notification for a medical device called the CoLink Mfx Implant System. It does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML-driven medical device.
Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices through engineering analysis and performance testing of a physical implant system. The "performance testing" mentioned is mechanical testing (four-point bend testing per ASTM F382) to compare the subject plates to predicate plates, and also references previous validations for sterilization, biocompatibility, shelf life, and pyrogenicity for the broader CoLink® Afx System.
Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or studies related to AI/ML performance because the provided text is for a physical orthopedic implant and not an AI/ML-based device.
§ 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.