Adravision Perio
Adra CorporationAdravision Perio is a semi-automated dental image processing software that assists dentists and dental hygienists in measuring mesial and distal bone levels from bitewing and periapical radiographs. The software provides suggested measurements and visual annotations to support clinical decision-making, improving the accuracy and efficiency of dental assessments for adults without primary teeth.
Intended Use
Adravision Perio is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs.
Technology
Adravision Perio is a Software as a Medical Device (SaMD) that utilizes machine learning to analyze bitewing and periapical dental radiographs, measure interproximal bone levels, and provide annotations to users. It supports various image formats (DICOM, JPEG, PNG, TIFF, BMP) and multiple web browsers.
Performance
Performance testing included software verification and validation, and bench testing against ground truth datasets. The device achieved high precision (91.0% bitewing, 84.8% periapical) and recall (94.0% bitewing, 89.3% periapical) in object key similarity assessments, and high sensitivity and specificity in length measurement assessments with low mean absolute error. Testing demonstrated robustness and reliability without adverse effects.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/14/2023
3 months - 2
FDA Approval
12/5/2023
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