(49 days)
The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
The In2Bones USA LLC, CoLink™ Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
The In2Bones CoLink™ Afx Plating System is a system of plates and screws and surgical instruments used to treat traumatic fractures and osteotomies of the ankle. These subject devices are part of the overarching CoLink™ Plating System and will be commonly referred to as the CoLink™ Afx Plating System.
The provided text describes a medical device submission (K181113) for the CoLink™ Afx Plating System. However, this is a 510(k) summary for a bone fixation system, and not an AI/ML medical device. As such, it does not contain the specific information required to answer the questions about acceptance criteria for an AI/ML device, such as performance metrics like sensitivity, specificity, or AUC, nor information on training/test sets, ground truth establishment, or expert adjudication.
The document focuses on demonstrating substantial equivalence to predicate devices through:
- Indications for Use: The CoLink™ Afx Plating System is indicated for stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
- Materials: Made of Titanium Alloy and Commercially Pure Titanium.
- Geometry.
- Performance Testing: Static and fatigue four-point bend testing (ASTM F382) for plates, and torsional strength, insertion/removal torque, and axial pullout testing (ASTM F543) for screws.
Since the request is specific to AI/ML device evaluation criteria, and this document pertains to a traditional mechanical medical device, the information to directly answer the numbered questions is not present.
§ 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.