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The TRACKER Plus Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, and calcaneus. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The TRACKER Plus Kyphoplasty System consists of the balloon catheter, cement dispenser kit, and cement mixing system. The cement dispenser kit and the cement mixing system are intended to be used with the balloon catheter, but are sold separately.

The provided text does not contain information about an AI/ML device or a study involving such a device. The document is a 510(k) premarket notification for a medical device called the "TRACKER Plus Kyphoplasty System," which is a system used for the reduction of fractures and/or creation of a void in cancellous bone.

Therefore, I cannot provide a response to your request, as it pertains to AI/ML device acceptance criteria and studies, and this document describes a traditional medical device (kyphoplasty system) that does not incorporate AI/ML capabilities.

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