(140 days)
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.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”