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Indicated for alignment, stabilization of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and for arthrodesis. This includes transverse fractures, oblique fractures, spiral fractures, segmental fractures, open fractures, open fractures, pathologic fractures, metaphyseal fractures with bone loss, prophylactic fixation of impending fractures, pseudoarthrosis of the tibial shaft, bone transport, nonunions, and corrective osteotomies.

The new Affixus Tibial Nailing System is part of a long bone nailing system that offers an implant design to treat a range of tibial fractures from simple to complex, with versatile locking options. These intramedullary nails offer specific anatomical features designed to aid in insertion, while also offering options to address both proximal and distal fractures. The proximal end of the nail features four screw holes while the distal end contains five. Both the proximal and distal ends offer oblique screw positions to provide maximum fracture stability and/or facilitate capture of distal fragments, as needed. The nails are intended to be used with 4.0 and 5.0mm non-locking screws and the system offers optional end caps that can be inserted into the top of the nail following implantation. The implants shall be offered in a sterile configuration. The system is to be used with a series of instrumentation to aid during the preparation and implantation of the nail, screws and end caps.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification for the "Affixus Tibial Nailing System," a medical device used for bone fixation.

The document focuses on demonstrating substantial equivalence of the Affixus Tibial Nailing System to previously cleared predicate devices. It describes the device, its intended use, indications for use, materials, design features, and sterilization, highlighting their similarity to the predicate devices.

While it mentions non-clinical performance testing (static and fatigue construct strength testing), this testing was conducted to demonstrate that the new device "withstood greater static load as well as fatigue load compared to the predicate device." This is a comparison for substantial equivalence, not a demonstration against pre-defined acceptance criteria for device performance as would be detailed in a clinical or specific performance study.

The document explicitly states: "Clinical Tests - None provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as these details are not present in the provided text.

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