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The In2Bones USA LLC, CoLink® Plating System / CoLink® View Plating System / CoLink® Mini 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 USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal.

The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metatarsals, and phalanges).

The In2Bones CoLink® Plating System / CoLink® View Plating System / CoLink® Mini Plating System and Fracture and Correction System are previously cleared plate and screws systems. The scope of this submission is to add a new packaging system for the previously cleared screws. The screws are all made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V). The implants are MR conditional.

This document is a 510(k) Premarket Notification from the FDA regarding orthopedic plating and screw systems. It does not describe an AI/ML medical device or a study proving that an AI/ML device meets acceptance criteria. The document explicitly states that the submission's scope is to "add a new packaging system for the previously cleared screws" and mentions that the products are "identical in indications, materials and geometry." The "Performance Testing" section lists validations related to sterilization, packaging, shelf life, and biocompatibility, which are standard for physical medical devices, not AI/ML performance.

Therefore, I cannot extract the requested information about acceptance criteria or a study proving an AI/ML device meets them from this document. The provided text does not contain any information related to AI/ML device performance, ground truth establishment, expert adjudication, or MRMC studies.

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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.

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