DS Core CBCT Anatomy

DS Core CBCT Anatomy is a cloud-based AI/ML software-as-a-medical-device that assists dental professionals in reviewing cone-beam computed tomography (CBCT) scans and digital impression (DI) intraoral scans. It automatically identifies anatomical structures, proposes a panoramic curve, segments teeth and jaws, detects the inferior alveolar nerve canal, and performs image registration to support diagnostic review and treatment planning for patients aged 12 and older with permanent dentition.

The device uses locked, machine-learning-based convolutional neural network (CNN) models for anatomical segmentation, keypoint detection, and automatic scan orientation. It operates as a backend API service without a graphical user interface. Like the predicates, it processes standard dental imaging data and generates assistive outputs; minor differences such as the panoramic curve proposal algorithm do not constitute new technological principles.

Not stated in this summary. The document mentions testing against predefined acceptance criteria and expert ground truth from U.S. licensed dentists but does not cite specific consensus standards such as ISO, IEC, or ASTM.