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The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.

The Xpert Knee range consists of plates and screws designed for the fixation of fractures, nonunions and malunions of the proximal tibia in adults. The plates and screws of the Xpert Knee range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use. The instruments of the Xpert Knee range will be provided non sterile for sterilization by health care professionals prior to use. Materials: CP Titanium grade 4 (conform to ASTM F67 and ISO 5832-2) for the plates, and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3) for the screws. Function: The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.

I apologize, but the provided FDA 510(k) clearance letter for the "Xpert Knee" device does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially not in the context of an AI/algorithm-based medical device.

The document primarily focuses on:

• Identity of the device: Xpert Knee, a metallic bone fixation appliance (plates and screws).
• Intended Use: Fixation of fractures, non-unions, and malunions of the proximal tibia in adults.
• Substantial Equivalence: Comparing the Xpert Knee to legally marketed predicate devices (other bone plates and screws) based on material, design, and indications for use.
• Non-clinical testing: Mechanical tests (static and dynamic tests on plates, pullout and torsional tests on screws) to demonstrate performance against the predicate devices.
• Lack of clinical studies: Explicitly states "No clinical studies were performed."

The categories you've asked about (acceptance criteria for algorithms, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are all highly relevant to the evaluation of AI or software-as-a-medical-device (SaMD). The Xpert Knee, as described in this 510(k), is a physical medical device (implants), not an AI software. Therefore, the information you're looking for about AI performance is not present in this document.

To answer your request, I would need a 510(k) (or similar regulatory document) for an AI/algorithm-based device.

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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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