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Femoral/recon antegrade nails and retrograde nails are indicated for shaft fractures including severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; bone lengthening shortening femur reconstruction following turnor resection and grafting. fractures in osteoporotic bone: severely comminuted shaft fractures, pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed supracondylar fractures; and prophylactic nailing of impending pathologic fractures.

Additional indications for the femoral/recon antegrade include: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures.

Additional indications for retrograde nails include: severely comminuted supracondylar fractures with or without difficult intra-articular extension, fractures that require opening the knee joint to stabilize the femoral condylar segment. Also, fractures above total knee implants.

The TriMax Nail System is intended to be removed upon fracture healing.

The TriMax Nail System includes femoral nails and screws. All components are manufactured from stainless steel.

This document, "Summary of Safety and Effectiveness TriMax Nail System," describes a medical device, the TriMax Nail System, and its substantial equivalence to other systems. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The document is a traditional 510(k) summary for a medical implant (nail system) from 1996. It focuses on:

• Substantial Equivalence: Comparing the TriMax Nail System to existing, legally marketed predicate devices, a common pathway for medical device approval.
• Device Description: What the device is made of and its components.
• Indications for Use: The medical conditions the device is intended to treat.
• Mechanical Testing: Confirmation that the physical implant can withstand "normal in vivo loading."

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC/standalone studies because this document is not about an AI/ML powered medical device and does not present data in that format.

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