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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.

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