DTX Studio Clinic 3.0
Nobel Biocare ABDTX Studio Clinic 3.0 is an AI-powered software tool designed to assist dentists in detecting dental conditions such as caries, bone loss, periapical radiolucency, root canal filling deficiencies, discrepancy at the margin of restorations, and calculus from intraoral radiographs. It supports review of bitewing and periapical radiographs in patients aged 15 and older, providing highlighted areas of suspicion to aid clinical assessment and diagnosis.
Intended Use
DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings including caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at margin of an existing restoration and bone loss. It is indicated for use by dentists for concurrent review of bitewing and periapical radiographs of permanent teeth in patients 15 years or older.
Technology
The device uses an AI-powered Focus Area Detection algorithm based on supervised machine learning to automatically detect and highlight multiple dental findings on intraoral radiographs, outputting bounding boxes for review and diagnostic confirmation by the dentist.
Performance
Performance validation included standalone testing on 452 intraoral radiographs with expert-labeled findings and a clinical multi-reader, multi-case study involving 30 dentists. Standalone sensitivity ranged from 0.68 to 0.95 across finding types, with a mean Dice overlap of 53.5% to 71.9%. Clinical study showed significant improvement in diagnostic accuracy with AI assistance (8.7% overall AUC increase, p<0.001), and improved sensitivity for all dental findings.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/1/2022
9 months - 2
FDA Approval
3/28/2023
Other devices from Nobel Biocare AB
- DTX Studio Clinic (4.0)2023 • 510K
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