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The Kerboull Cross is intended to be used to reconstruct the acetabulum in primary and/or revision total hip arthroplasty. Specifically, this device is used to reinforce the medial wall of the acetabulum to achieve stable fixation of the acetabular component in the presence of a deficient or weakened medial wall caused by severe inflammatory disease, fracture of the medial wall, or failed total hip arthroplasty.

The Kerboull Cross is a hemi-spherical, metal shell that incorporates several flanges and screw holes and is shaped to fit into the acetabulum. These devices are available in a range a outer diameters to fit varying anatomical requirements.

The provided text is a 510(k) summary for the Kerboull Cross Acetabular Reinforcement Shell. This historical document (from 1997) pertains to a physical medical device and does not contain information about software, artificial intelligence, or any studies involving AI/algorithms, ground truth, or expert review.

Therefore, I cannot provide a response to your request, as it asks for details relevant to AI/software performance studies that are not present in the given text.

The closest information available is:

• Substantial Equivalence: The device's substantial equivalence is based on its intended use, materials, design, and relative indications and contraindications to DePuy's Protrusio Cage (K962007). This is a regulatory pathway for physical devices, not a performance study as described in your request.
• Intended Use: The Kerboull Cross is intended to reconstruct the acetabulum in primary and/or revision total hip arthroplasty, specifically to reinforce the medial wall.

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