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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.

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