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The Progen™ short trochanteric nail is indicated for fixation of various types of stable and unstable neck, intertrochanteric, and peritrochanteric fractures.

The Progen™ long trochanteric nail is intended for fixation of stable femoral fractures occurring from the base of the femoral neck extending distally to a point approximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, and revisions.

The Progen™ long trochanteric nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, malunion, and revisions.

The Progen™ Trochanteric Nail System consists of temporary fixation intramedullary nails and their accompanying instrumentation designed for fracture fixation and stabilization of the femur. The implants are available in various lengths and diameters to accommodate a range of patient anatomy. Each of the intramedullary nails is secured by a sequence of screws that transect through holes in the proximal and distal sections of each nail.

The Progen™ Trochanteric Nail System consists of single-use intramedullary nails for stable and unstable neck, intertrochanteric, pertrochanteric, and subtrochanteric fractures and combinations of these fractures. The system consists of Nail, Lag Screw, Secondary Screw, Lag Cap, Locking Screws, Set Screws, and Nail End Cap. The nails and accompanying components are manufactured from titanium alloy (Ti-6Al-4V ELI). Additionally, the Nails and Lag Screws have a Type II anodized surface treatments.

The provided text describes the Progen™ Trochanteric Nail System, an intramedullary fixation rod system, and its substantial equivalence with predicate devices. However, this document does not contain information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.

The information provided relates to a traditional medical device (an intramedullary nail system), and the performance data section focuses on sterilization, shelf-life, biocompatibility, and mechanical testing in accordance with ISO and ASTM standards. There is no mention of an AI/ML component, clinical testing, or any metrics related to AI/ML device performance such as sensitivity, specificity, or accuracy.

Therefore, I cannot provide the requested table or answer the questions related to AI/ML device performance, ground truth, expert qualifications, or MRMC studies based on the provided text.

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