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Citieffe External Fixator ST.A.R 90 F4 ELBOW is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:

• Fracture dislocation with ligaments instability;
• Comminuted intra-articular fractures;
• Post traumatic reconstruction for joint stiffness.
  Citieffe External Fixator ST.AR. 90 F4 KNEE is intended for use in the treatment of bone conditions leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

ST.A.R.90 F4 External Fixation Screws With Hydroxyapatite

I apologize, but the provided text from the FDA 510(k) summary for K150661 does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) or machine learning (ML) models such as sample sizes for test/training sets, expert qualifications, or comparative effectiveness studies.

The document is a standard FDA clearance letter for a medical device (external fixation screws) and focuses on regulatory compliance and substantial equivalence to predicate devices, not on the performance evaluation of a diagnostic AI system against specific clinical acceptance criteria.

Therefore, I cannot fulfill your request for that specific information based on the text provided.

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