DS Core Diagnosis

DS Core Diagnosis is a cloud-based dental imaging software that allows dentists to view, interact with, and analyze various types of digital patient media (2D and 3D images, photos) in a single viewer. It includes standard image viewing tools (annotation, rotation, contrast adjustment, brightness, magnification) and a machine learning-enabled panoramic curve proposal feature for patients aged 12 and older with permanent dentition that suggests an optimal panoramic curve along the dental arch from CBCT scans, which users can then adjust and review.

DS Core Diagnosis is cloud-based software, whereas the predicate (Sidexis 4) is desktop-based downloaded software. The subject device does not include image acquisition capability, while the predicate does. Both offer fundamental image viewing settings (brightness, contrast, zoom, gamma). Critically, the subject device's panoramic curve proposal feature is AI/ML-enabled using a Convolutional Neural Network model, whereas the predicate's panoramic curve proposal is not AI/ML-enabled. Both devices allow manual review and adjustment of the proposed panoramic curve.

Not stated in this summary.

Both devices serve the same core purpose—providing a platform for qualified professionals to review and diagnose digital patient images. The panoramic curve proposal success rate (PCPSR) testing showed 99% success on combined datasets with lower bound 95% CI of 95.42%, and expert clinical evaluation achieved a 92.5% pass rate for clinical acceptability. Although the subject device uses AI/ML for its panoramic curve proposal while the predicate does not, this difference does not affect safety and effectiveness because users retain full autonomy to adjust and review any proposed curve. The cloud-based architecture and absence of image acquisition are differences that do not impact the device's core diagnostic support function. System validation and usability testing with clinicians passed all tests, supporting equivalence in intended use and fundamental functionality.