Better Diagnostics Caries Assist (BDCA) Version 1.0
Better Diagnostics AI CorpBetter Diagnostics Caries Assist (BDCA) Version 1.0 is an AI-powered software tool that helps dentists automatically identify and mark areas of tooth decay (caries) on dental x-rays (bitewing and periapical). It provides visual annotations to support the dentist's diagnosis, improving the accuracy and efficiency of caries detection but does not replace clinical judgment or complete review.
Intended Use
Better Diagnostics Caries Assist is a radiological, automated, concurrent read, CADe software intended to identify and localize carious lesions on bitewings and periapical radiographs acquired from patients aged 18 years or older, for use by board licensed dentists.
Technology
BDCA v1.0 includes four main software components: a web-based presentation layer for viewing AI annotations, APIs for integration with Dental Practice Management Systems, a business layer that manages image flow and annotation display, and cloud-hosted computer vision models performing image processing to detect carious lesions and output bounding boxes. The AI provides binary detection and localizes lesions with bounding boxes on dental x-rays (bitewing and periapical).
Performance
Performance testing included standalone and clinical multi-reader multi-case (MRMC) studies. BDCA v1.0 achieved high sensitivity and specificity (>88% sensitivity and >99% specificity) in detecting caries at both the surface and image levels on bitewing and periapical images, surpassing FDA performance goals. Clinical reader studies with 29 dentists showed significant improvements in diagnostic accuracy, with statistically significant increases in sensitivity and specificity when using BDCA assistance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/14/2024
9 months - 2
FDA Approval
3/11/2025
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