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Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:

• Stabilization of soft tissues and fractures
• Polytrauma/multiple orthopedic trauma
• Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
• Arthrodeses and osteotomies with soft tissue problems; failures of total joints
• Neutralization of fractures stabilized with limited internal fixation
• Non-unions/septic non-unions
• Intra-operative reductions/stabilization tool to assist with indirect reduction
• Unilateral rectilinear bone segment transport or leg lengthening

The Synthes Large External Fixation, MR Conditional consists of previously cleared clamps, rods, Schanz screws and Steinmann pins. Synthes will also offer Sterile Packaged Large External Fixation Kits, MR Conditional. These kits contain previously cleared external fixation devices and manual surgical instruments.

The provided text is a 510(k) summary for the Synthes Large External Fixation, MR Conditional device. It details the device's technical specifications, indications for use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot provide the requested table and study details based on the given input. The document focuses on regulatory approval based on equivalence rather than detailed performance study reporting.

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