The accuracy of cephalometric landmark identification for malocclusion classification is essential for diagnosis and treatment planning. Identifying these landmarks is often complex and time-consuming for orthodontists. An AI model for classification was recently developed. This model was investigated based on current regulatory considerations as a result of the strict regulations on software systems and the lack of information on artificial intelligence (AI) requirements in this publication. The platform developed by the ITU/WHO for AI is used to assess the models of the application. The auditing procedure assessed the development process concerning medical device regulations, data protection regulations, and ethical considerations. Upon that, the major tasks during the development were evaluated, such as qualification, annotation procedure, and data set attributes. The AI models were investigated under consideration of technical, clinical, regulatory, and ethical considerations. The risk to the patient and user's health can be considered low according to the International Medical Device Regulators Forum (IMDRF) definition. This application facilitates the decision and planning of malocclusion treatment based on lateral cephalograms without cephalometric landmarks. It is comparable with common standards in orthodontic diagnosis.
Keywords: AI-Audit; Cephalometric landmarks; Regulation.
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