Videa Caries Assist
VideaHealth, IncVidea Caries Assist is a cloud-based AI software that helps dentists detect dental caries by analyzing bitewing X-ray images. It automatically highlights areas with possible carious lesions, aiding dentists in diagnosis and improving accuracy, thereby supporting better patient care.
Intended Use
Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions for the concurrent review of bitewing radiographs acquired from adult patients aged 22 years or older.
Technology
Cloud-based AI-powered software that uses supervised deep learning to automatically detect and localize carious lesions from bitewing X-ray images. Operated via API within a firewalled network, it outputs bounding boxes indicating lesion locations to dental practitioners via their dental viewer.
Performance
The device underwent bench and clinical evaluation showing good standalone lesion detection performance with an AFROC figure of merit of 0.74 and improved reader performance in a clinical study with statistically significant improvement in detection accuracy (p<0.0001) compared to unaided reads.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/6/2021
4 months - 2
FDA Approval
4/21/2022
Other devices from VideaHealth, Inc
- Videa Dental Assist2023 • 510K
- Videa Perio Assist2023 • 510K
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