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The Materialise SurgiCase System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner. If is also intended as pre-operative software for simulating I evaluating implant placement and surgical treatment options.

The Materialise SurgiCase System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) summary for the Materialise SurgiCase System, focusing on demonstrating substantial equivalence to a predicate device (SimPlant). It describes the device's intended use and classification but does not include details of a study that proves the device meets specific acceptance criteria based on performance data. The FDA letter confirms the clearance based on substantial equivalence, not on a detailed performance study presented in this summary.

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