CEREC Ortho Software

CEREC Ortho Software is designed to transform image data from intra-oral and desktop scanners into 3D virtual dental models, facilitating orthodontic data acquisition and detailed modeling analyses such as Bolton, Nance, and Moyers, with outcomes exportable for orthodontic appliance design. The software leverages digital image processing to create these patient-specific models, and its performance, including measurement accuracy and adherence to IEC 62304 software standards, has been substantiated through non-clinical testing.

CEREC Ortho Software is a stand-alone software application designed to utilize images acquired from handheld intra-oral 3D cameras and desktop laboratory scanners to create 3D virtual dental models. These digital models of the patient's intra-oral anatomy serve as functional equivalents to traditional physical dental models. The software facilitates the segmentation and editing of these 3D virtual models and allows for various analyses, including measurement and jaw analysis tools such as Bolton, Nance, and Moyers analyses, which can be used in secondary orthodontic treatment planning. The primary purpose of these models is for data acquisition and modeling analysis relevant to orthodontic patients and conditions. The 3D model data and the finalized analyses produced by the CEREC Ortho Software can be exported to an orthodontic laboratory or directly to orthodontic appliance manufacturers to aid in the design of orthodontic appliances. Unlike its predicate device, the 3Shape Ortho System™, the CEREC Ortho Software does not incorporate functionalities for orthodontic treatment simulation or the virtual design of orthodontic appliances itself; its intended use is a subset focused on model creation and analysis. Non-clinical performance testing was conducted to verify the accuracy of the software's measurement functions and the trueness and precision of optical impressions produced using compatible CEREC optical impression systems. Furthermore, the software underwent validation in conformity with IEC 62304 for medical device software lifecycle processes.

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• Q1. What is the quantitative accuracy and precision of the 3D virtual models generated by CEREC Ortho Software when compared to traditional physical plaster models or models from the predicate device, 3Shape Ortho System™?; Beyond Bolton, Nance, and Moyers analyses, what is the full spectrum of specific measurement tools and analytical capabilities offered by the software, and are there any plans for future expansion?; How does the CEREC Ortho Software address potential inaccuracies or artifacts present in the input scan data acquired from various compatible intra-oral cameras and desktop scanners, and what are the recommended best practices for data acquisition to ensure optimal 3D model quality?; Given that the software exports data for orthodontic appliance design but does not perform the design itself, does it incorporate any features for basic tooth setup simulations or alignment visualizations before exporting the models and analysis data?; What specific non-clinical tests were conducted to evaluate the robustness and reliability of the segmentation and editing tools for the 3D virtual digital models under diverse and challenging anatomical variations?