Specification
Device Description
The Windows™ software OnyxCeph³™ is a network application developed by Image Instruments for the use of digital 2D and 3D image data for measurement, consultation, documentation and processing purposes in orthodontics.
OnyxCeph³™ is not an image archiving or document management, or communication system. It is also not intended to be used for making diagnoses.
However, it does include features (measurement functions on digital images) that can be used to verify diagnostic assessments. For this reason, Image Instruments classifies and labels the software as medical device software (SaMD).
This labeling (e.g. by the CE mark) refers exclusively to the measurement functionality provided in the Digitize module in accordance with the medical purpose specified by the manufacturer in the instructions for use.
The 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. The information provided in the context of clinical use can only be used to support independently made diagnostic assessments in accordance with the intended purpose. read more
Indications 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 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. 
Medical Purpose / Intended Use
The OnyxCeph³™ software is intended for the medical purpose of digitally measuring patient images in the Digitize module in order to verify diagnostic statements derived from other procedures in connection with the assessment of clinically relevant (classified as disease or disability) dental and jaw misalignments based on the measurement results displayed in the results table of this module.
The software may only be used for this purpose by qualified personnel. Clinical decisions must not be based primarily or exclusively on the evaluation results provided by the software.
Performance Data
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 use of the software requires the proper registration and productive activation of the software by the user. Non-productively activated versions of the software only serve to familiarise the user with its use or for testing purposes.
Program Versions | Modules
| Topic | Content |
|---|---|
| Program Versions | Available program versions |
| Version Featurelist | Program version comparison |
| Module List | Module List |
| Module Windows | Module Windows |
Release Information
Specialist prerequisites
All image managementt and image evaluation 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 Types
| Topic | Content |
|---|---|
| Image Types 2D | Pre-defined 2D image types |
| Image Types 3D | Pre-defined 3D image types |