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GuideMia Ortho+ software system is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design option (Custom metal bands, export of models, Indirect Bonding) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of treatment. It can be further used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

None of the export models from the software are expected to be CAD/CAM milled.

The use of the Ortho+ system requires the users to have the necessary domain training and knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

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The provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies for a device. The document is an FDA 510(k) clearance letter for the "Guidemia Ortho+" software system. It confirms the substantial equivalence of the device but does not detail any performance studies.

Therefore, I cannot provide the requested information based on the given text.

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The GuideMia system is intended as software interface to transfer DICOM images generated by CT scanners, an image segmentation system to create dental anatomies from scan images, and a preoperative software for simulating/evaluating dental implant placement and surgical treatment options.

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This document is a 510(k) clearance letter from the FDA for a device called "GuideMia Software System". It does not contain information about the acceptance criteria and study results for the device. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given input document. If you have a different document that details the acceptance criteria and study that proves the device meets them, please provide it.

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