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The 611 Ankle Fusion Nail is intended to immobilize tibiotalar and subtalar joints of the ankle in order to obtain the fusion of these joints and to decrease pain as compared to the preoperative condition.

The immobilization of the ankle with the 611 Ankle Fusion Nail is indicated in the following cases:

• Severe defects of the ankle and subtalar joints and/or deformations with/without instability,
• Avascular necrosis of the talus,
• Traumatic or post-traumatic involvement of the ankle and subtalar joints,
• Degenerative pathologies: primary or post-trauma osteoarthritis, rheumatoid polyarthritis.
• Revision of the arthrodesis or revision of the total ankle prosthesis,
• Neuroarthropathy or neuropathic deformation of the ankle/Charcot Foot.

The 611 Ankle Fusion Nail consists of an Ankle nail associated with locking screws as well as a plug. The Ankle nails are available in variety of diameters and angulations. The plug screwed into the threaded end of the nail is to prevent bone ingrowth. The locking screws are self-tapping screws.

All components of the 611 Ankle Fusion Nail are single use devices. The Ankle nail and plug are delivered sterile. The locking screws are delivered non sterile with the instrumentation.

The provided text describes a medical device, the "611 Ankle Fusion Nail," and its substantial equivalence to predicate devices, but it does not contain information related to software or AI performance.

Therefore, I cannot provide an answer based on the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment that would typically apply to an AI device. The document focuses on regulatory approval for a physical orthopedic implant.

Here's why the AI-specific questions cannot be answered from this document:

• No AI Device: The "611 Ankle Fusion Nail" is a physical intramedullary fixation rod made of titanium alloy for ankle arthrodesis. It is not an AI or software-based device.
• No Performance Metrics for AI: The "acceptance criteria" discussed in the document relate to the physical and mechanical properties of the nail (e.g., fatigue testing), material equivalence, and intended use equivalence with predicate devices. There are no sensitivity, specificity, AUC, or other AI performance metrics.
• No Study for AI Performance: The "study" mentioned is "Fatigue testing" (page 3), which is a non-clinical test for a physical implant, not a study evaluating AI diagnostic or decision-making accuracy.
• No Test/Training Sets or Ground Truth for AI: Since there's no AI component, there are no test sets, training sets, data provenance, expert ground truth establishment, or adjudication methods relevant to AI performance.
• No MRMC Study: There's no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study as the device is not an AI-assisted diagnostic tool.

In summary, the provided text describes the regulatory clearance process for a physical medical device and does not contain any information about its performance as an AI device.

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