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The Alians Elbow Locking Plating System is intended for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults

The Alians Elbow Locking Plating system consists of plates and screws, designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.

The implants of the Alians Elbow Locking Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.

The instruments of the Alians Elbow Locking Plating System range will be provided non sterile for sterilization by health care professionals prior to use or sterile.

Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F 136 and/or ISO 5832-3). The implants of the Alians Elbow Locking Function: Plating System are intended for the fixation of fractures and osteotomies of the distal humerus and the proximal ulna in adults.

This document is a 510(k) premarket notification for a medical device called the "Alians Elbow Locking Plating System." As such, it does not contain any information regarding acceptance criteria or a study proving that an AI-driven device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: Fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
• Design: Plates and screws.
• Materials: Titanium alloy Ti-6Al-4V.
• Mechanical Safety and Performance: Evaluated through engineering analysis (bending strength, bending stiffness, removable support).
• Lack of Clinical Studies: Explicitly states "No clinical studies were performed."

Therefore, I cannot provide the requested information about acceptance criteria or an AI-driven device study from this document. The provided text is for a traditional medical implant device, not an AI or software-as-a-medical-device product.

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