(461 days)
OnyxCeph3™ software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph3™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data.
OnyxCeph3™ dental aligner software device is designed for the simulation and planning of orthodontic and maxillofacial surgical combination treatments, based on virtual models and CT / DVT volume data. OnyxCeph3™ is a software device that includes both 3D and 2D versions both suitable for dental facilities to use for orthodontic treatments.
The provided text is a K213263 510(k) summary for the OnyxCeph3™ device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document states that "Clinical testing has not been included and is not required to demonstrate substantial equivalence."
Therefore, I cannot provide the requested information from the given text.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).