Table of Contents
The standalone Windows™ software OnyxCeph³™ provides software tools to digitally perform analog image-based in-house workflows in orthodontic facilities. To the extent that these workflows output measurement information, their accuracy shall at least match the accuracy of the corresponding analog workflows.
The tools developed for this purpose shall be flexibly configurable and combinable in order to digitally map a wide variety of orthodontic in-house workflows and thus generate a general benefit in the form of savings, facilitation and improvement.
In addition to this general benefit, the application of the software enables a clinical benefit exclusively in the form of deriving metric information from case-relevant 2D and 3D image data and is therefore classified as a medical device.
The OnyxCeph³™ software does not make treatment decisions or provide treatment recommendations. The software itself and its outputs cannot be used directly on patients or for their treatment. According to the intended purpose, the measured values provided within the scope of clinical use can only be used to back up independently made treatment decisions.
Medical Purpose | Indication for Use
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 dental applications by qualified staff only. Clinical decisions cannot be motivated exclusively or even mainly on evaluation results provided by the software.
The correct function of the software requires the use of the most up to date program version (release).
The availability of a new program version is displayed by a release update button top right in the program main window if online connected. Alternatively, the update information has to be checked on the product website www.onyxceph.com on a regular base.
The intended medical purpose requires a correct registration and activation of the software by the user. Unauthorized trial versions can only be used to become familiar with the application acc. to its user interface and functionality but do not represent a medical product so far.
Program Versions | Modules
|Program Versions||Available program versions|
|Version Featurelist||Program version comparison|
|Module List||Module List|
|Module Windows||Module Windows|
All measurement, simulation, and image processing tools provided by OnyxCeph³™ merely serve to assist you in finding a diagnosis. All diagnosis and possible treatments must be based on clinical knowledge and experience. OnyxCeph³™ does not lay claim to replace the diagnosis of the physician.
Additionally, it is pointed out that the results obtained by the measuring functions of OnyxCeph³™ can only be correctly calculated on condition of the object to be evaluated being digitally imaged in the focal plane without distortion. This has to be secured by means of appropriate calibration of the image acquisition process or suitable correction of the digitally recorded images.
The propriety of the used algorithms for 2D and 3D measurements on data sets can be verified by both test images which can be loaded from the root directory of the installation medium and download installation zip file. Both test images have to be classified as image type NoType (2D) resp. NoType (3D) and analyzed by the Calibration analysis. The error of each such measurement should be within the standard deviation displayed in column norm value.
Image and Tracing Types
|Image Types 2D||Pre-defined 2D image types|
|Tracing Types 2D||Available tracing types|
|Image Types 3D||Pre-defined 3D image types 3D|
|Tracing Types 3D||Available tracing types 3D|