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The Supracondylar Nail is intended for use in fixation of various types of fractures of the supracondylar or distal region of the femur as well as for proximal fractures in conjunction with supracondylar fractures.

The Supracondylar Nail is a cannulated rod designed to be inserted through the condylar notch in order to fix fractures of the femur. The nail is available in 9 through 13 mm diameters with varying lengths. Each nail contains multiple distal and proximal holes/slots for insertion of locking screws with a cone-shaped head for ease of insertion. The nail is fluted for revasularization. Longer length nails are curved. The holes/slots accept cortical screws for locking of the nail.

The provided text describes a medical device called the "Supracondylar Intramedullary Nail" and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of performance metrics for an AI/ML algorithm.

The document discusses:

• Device Description: A cannulated rod for fixing femur fractures.
• Intended Use: Fixation of supracondylar or distal femur fractures.
• Performance Data: Physical testing (four-point bend testing) of the nail's bending strength and rigidity compared to predicate devices.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

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