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The Alta® IM Rod System includes rods that are intended to provided temporary stabilization of femoral fractures. The new Alta rods are intended for use in stabilizing various types of fractures, osteotomies, malunions, and nonunions of the proximal, middle, and distal portions of the femur. TThey can be used in procedures such as femoral reconstruction, bone lengthening, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures and knee fusions. The rods are inserted into the intramedullary canal using either an antegrade or a retrograde approach.

The IM rods in Alta® IM Rod System consist of a family of curved, fluted rods, cross-locking screws and cap screws for intramedullary nailing of femoral, tibial and humeral shaft fractures. This Alta IM Rod line extension is a modification of the currently marketed Alta IM rods and screws cleared under various 510(k) notifications. These new components will retain the major design features of the previously cleared Alta IM rods and screws and will be made from titanium alloy.

The new femoral IM rods will have two anterior/posterior (A/P) proximal holes and two medial/lateral (M/L) distal holes for dynamic or static locking with cross-locking screws. The cap screws will be available in the standard, low profile and extended designs.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any such criteria. The document is a 510(k) summary for the Alta® Intramedullary Rod System, which outlines its intended use, materials, design, and its substantial equivalence to other marketed devices. It does not contain details about specific performance metrics, testing methodologies, sample sizes, or expert evaluations.

Therefore, I cannot provide the requested table or information regarding acceptance criteria and studies.

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