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BTI-Scan is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is indicated as a software interface and image segmentation system for the transfer of imaging information from a medical CT scanner. It is also indicated for use as a planning and simulation software for dental implant placement and surgical treatment.

BTI Scan is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical CT scanner. It is also intended as a pre-operative software for simulating / evaluating dental implant placement and surgical treatment options.

The provided text is a 510(k) summary for the BTI-Scan device, which describes its intended use, predicate device, and the FDA's clearance. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details on the study that proves the device meets specific criteria, as this information is not present in the provided document.

The document primarily focuses on establishing substantial equivalence to a predicate device (SimPlant System) and obtaining regulatory clearance based on that equivalence, rather than providing detailed performance study data.

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