DS Core CBCT Anatomy
Dentsply SironaDS Core CBCT Anatomy is an AI-powered cloud software that helps dental professionals by automatically detecting and labeling anatomical structures, segmenting teeth, jaws, and nerve canals, and aligning dental scans. It streamlines diagnosis and treatment planning using CBCT and intraoral images, enhancing workflow efficiency for dental clinicians.
Intended Use
DS Core CBCT Anatomy is a cloud-based AI/ML-enabled software as a medical device, used as a backend API to aid dental professionals by analyzing Digital Impression (DI) and CBCT (DX) scans for diagnostic review and treatment planning. It identifies anatomical structures, segments teeth, jaws, and nerve canals, proposes panoramic curves, and assists in registration and comparison of dental images for patients aged 12 and older with permanent dentition.
Technology
The software employs neural network (CNN) models and automated algorithms to detect, segment, and register anatomical structures in CBCT and intraoral (DI) scans. It operates as a cloud-based service accessed through an API and integrates into dental clinical workflows, providing automatic visualizations and comparisons without replacing clinician oversight.
Performance
Performance testing included algorithm accuracy for segmentation, detection, and nerve canal localization tasks across diverse patient datasets, meeting all acceptance criteria. Tooth detection sensitivity was 99.37%, and jaw segmentation sensitivities exceeded 98%. Subgroup analysis showed consistent performance across age and imaging factors. All primary and co-primary endpoints for segmentation and detection accuracy were met.
Predicate Devices
No predicate devices specified
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