(164 days)
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.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.