Differences

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--- en:specification [2024/03/21 16:11] – onyxadmin
+++ en:specification [2024/04/09 12:35] (current) – [Product Description] onyxadmin
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-===== Product Description =====
+===== Device Description =====
 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.\\
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 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.\\
-</WRAP>
+\\
-<WRAP formalbox>
 =====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. [[indication_for_use|{{:link.png|read more}}]]\\
-</WRAP>
 \\
-<WRAP formalbox>=====Medical Purpose=====
+=====Medical Purpose=====
 OnyxCeph³™ is a software only device and 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 who have received dedicated training for use of the software.\\
 Clinical decisions cannot be motivated exclusively or even mainly on evaluation results provided by the software.\\
 The classification as a medical device cannot be transferred to treatment measures or the manufacture of orthodontic appliances, even if these take into account the calculation results of the software. [[indication_for_use|{{:link.png|read more}}]]\\
-</WRAP>
 \\
 ===== Performance Data =====