Videa Perio Assist
VideaHealth, Inc.Videa Perio Assist is an AI-powered software that helps dentists and dental hygienists measure and visualize bone levels between teeth using bitewing and periapical dental X-rays. It provides precise measurements that support evaluations related to periodontal health but is not meant to replace full clinical diagnosis.
Intended Use
Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, dentists and dental hygienists.
Technology
Videa Perio Assist is a cloud-based AI-powered medical device available as an API. It automatically returns measurement points and lines indicating mesial and distal alveolar bone levels on dental radiographs as distances or percentages of root length. It integrates with existing image viewers and supports various image formats including DICOM, rvg, png, tiff, jpg, jpeg, and dex.
Performance
Performance testing included software verification and validation for a moderate level of concern, bench testing on 996 radiographs and 16,131 landmarks with precision and recall above 82%, and clinical testing on 189 radiographs showing sensitivity above 88% and specificity above 87% for most measurements. Generalizability testing confirmed consistent performance across various intraoral sensor manufacturers and patient age groups, with minor exceptions that did not affect clinical safety or efficacy.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/26/2022
3 months - 2
FDA Approval
2/6/2023
Other devices from VideaHealth, Inc.
- Videa Dental Assist2023 • 510K
- Videa Caries Assist2022 • 510K
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