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The System 12 Constrained Acetabular Liners are intended to be used with the various components of the System 12 Hip System in the replacement of the acetabulum and femoral head bearing surface secondary to degenerative joint disease, trauma, or failed previous prosthesis. These constrained liner components provide the surgeon with an alternative method in treating the total hip replacement patient who chronically dislocates.

A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

This 510(k) submission is a line extension intended to add System 12 Constrained Acetabular Liners to the System 12 Hip System.

This document is a 510(k) premarket notification for a medical device, the System 12 Constrained Acetabular Liners. It provides information regarding the device's intended use, description, and its substantial equivalence to predicate devices. However, this submission does not contain information about acceptance criteria, device performance, or any studies involving human readers or AI algorithms as requested in your prompt. The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, often through design concepts and mechanical properties, rather than detailed clinical performance studies in the way an AI/software device would.

Therefore, I cannot fulfill the request to describe acceptance criteria and associated studies for the System 12 Constrained Acetabular Liners based on the provided text. The document does not contain the necessary information regarding:

• Acceptance criteria and reported device performance (Table 1)
• Sample size and data provenance for test sets
• Number and qualifications of experts for ground truth
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth used
• Sample size and ground truth establishment for a training set

The provided text describes a physical implantable medical device (hip component) and its regulatory submission, not a diagnostic AI/software device.

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