The Overjet Charting Assist is a software system that helps dental professionals analyze 2D dental X-rays by detecting natural dental structures like tooth anatomy and numbering, as well as restorative dental work such as crowns and implants. It supports clinicians by automating dental chart creation from images, aiding in more precise and efficient dental assessments.
Overjet Charting Assist is a Medical Image Management and Processing System intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. It assists dental professionals in producing dental charts based on image analysis from bitewing, periapical, and panoramic radiographs for patients ages 5 and above.
The system uses AI-based image analysis to detect specific dental structures on 2D dental radiographs (bitewing, periapical, panoramic). It includes a Predetermined Change Control Plan (PCCP) for iterative algorithm updates based on real-world data to reduce false positives and negatives. Algorithm modifications are applied manually and undergo verification and validation before release, with no continuous learning in the field.
No additional performance testing was conducted for this updated device apart from the existing data from the predicate device. Performance assessments follow previously established acceptance criteria to ensure safety and effectiveness. If modifications fail performance evaluation, they are not implemented.
No predicate devices specified
Submission
6/11/2024
FDA Approval
8/27/2024
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