(183 days)
The FlexitSystem® plates and screws system is indicated for proximal tibial and distal femoral osteotomies.
The FlexitSystem® Knee osteotomy system range consists of metallic surgical devices intended to maintain opening and closing wedge osteotomies of the proximal tibia and distal femur. They are available in several lengths and shapes. A FlexitSystem® Knee osteotomy system consists of: -A Neosteo plate; -Neosteo screws that are locked into the plate. All the implants are made of titanium alloy. Fixation of the plate is ensured by the threading of the holes in the plate and the corresponding threads on the screws for a complete fixation of the implant.
The provided text is a 510(k) Summary for the FlexitSystem® Knee Osteotomy System. It details the device, its intended use, and the comparisons made to predicate devices to demonstrate substantial equivalence.
However, the provided document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance study results. The document pertains to a traditional medical device (metallic surgical implants) and the testing performed is mechanical testing, not clinical studies involving AI or human reader performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML-based device because the provided text does not contain any information about such a device or study.
The questions in your prompt are specifically designed for the evaluation of AI/ML-driven medical devices, which typically involve assessing diagnostic accuracy, reader performance, and ground truth establishment. The FlexitSystem® is a surgical implant, and its evaluation focuses on mechanical properties and material equivalence to existing devices.
If you have a different document related to an AI/ML device, please provide that.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.