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The Estremo Citieffe Nailing System is indicated for femoral fracture fixation, which may include the following:

• · diaphyseal femoral fractures;
• · supra-condylar femoral fractures:
• · corrective osteotomies;
• · pseudoarthrosis:
• non-unions and mal-unions.

The Estremo Citieffe Nailing System is indicated for tibial fracture fixation, which may include the following:

• · diaphyseal tibial fractures;
• · corrective osteotomies;
• · pseudoarthrosis;
• · non-unions and mal-unions.

The Estremo Citieffe Nailing System is indicated for tibiotalocalcaneal arthrodesis.

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This document is an FDA 510(k) clearance letter for the Estremo Citieffe Nailing System, which is an intramedullary fixation rod for fracture fixation. It is NOT an AI/ML medical device submission.

As such, the document does not contain the information required to answer the prompt. The prompt asks for details about a study that proves an AI/ML device meets acceptance criteria, including:

• A table of acceptance criteria and reported device performance (for an AI/ML device, this would typically involve metrics like sensitivity, specificity, AUC, etc.)
• Sample size for the test set and data provenance
• Number and qualifications of experts for ground truth
• Adjudication methods
• MRMC study details and effect size
• Standalone AI performance
• Type of ground truth used
• Training set sample size and ground truth establishment

None of this information is present in the provided FDA 510(k) clearance letter for a physical medical implant (nailing system). The letter confirms the device's substantial equivalence to a predicate device based on its indications for use and general controls, but it does not describe an AI/ML algorithm's performance study.

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