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AUTOBAHN® EVO Femoral Nails are indicated for long bone fracture fixation in skeletally mature patients, specifically femoral fracture fixation, which may include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, supracondylar fractures, including those with intra-articular extension, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures, fractures proximal to a total knee arthroplasty, fractures distal to hip joint, nonunions and malunions, poly trauma patients, fractures in the morbidly obese, fractures involving osteopenic and osteoporotic bone, compound and simple shaft fractures, proximal, metaphyseal, and distal shaft fractures, segmental fractures, closed supracondylar fractures, fractures involving femoral condyles, comminuted fractures with bone loss, and periprosthetic fractures. In addition, the AUTOBAHN® EVO Antearade Nails are intended for use in adolescents (12-21 years) in which the growth plates have fused.

The AUTOBAHN® Nailing System is a family of intramedullary nails, screws and washers designed to be used for internal bone fixation. The AUTOBAHN® EVO implants include femoral nails (antegrade and retrograde) and locking screws available in various lengths and diameters to accommodate a wide range of patient anatomy; the nails are secured with locking screws. Washers and nuts are also available. Devices are manufactured from titanium allov, cobalt chrome allov, and stainless steel.

The provided document describes a 510(k) premarket notification for the AUTOBAHN® EVO Femoral Nails and does not contain information about acceptance criteria or a study proving that an AI/device meets such criteria.

The document is a regulatory submission for a medical device (intramedullary fixation rod) and focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing and comparison of technological characteristics. It does not involve AI, image analysis, or performance metrics typically associated with AI/ML device evaluations. Therefore, I am unable to extract the requested information based on the provided text.

The information sought in your request, such as a table of acceptance criteria, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details, are all relevant to the evaluation of AI/ML-based medical devices, which this document does not concern.

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