(103 days)
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.
Videa Perio Assist (VPA) software is a cloud-based AI-powered medical device for the automatic measurement of tooth interproximal alveolar bone level in dental radiographs. The device itself is available as an API (Application Programming Interface) behind a firewalled network. The device returns 1) a series of points with connecting lines measuring the mesial and distal alveolar bone levels associated with each tooth 2) this distance expressed in millimeters and/or as a percentage of the root length.
Videa Perio Assist is accessed by the trained professional through their image viewer. From within the image viewer the user can upload a radiograph to Videa Perio Assist and then review the results. The device outputs a line to identify these points which calculate the interproximal bone level.
The device output will show all applicable measurements from one radiograph regardless of the number of teeth present. If no teeth are present the device outputs a clear indication that there are no identifiable teeth to calculate the interproximal bone level.
The intended users of Videa Perio Assist are trained professionals such as dentists and dental hygienists.
The intended patients of Videa Perio Assist are patients 12 years and above with permanent dentition undergoing routine dental visits or suspected of having interproximal bone level concerns. Videa Perio Assist may only be used with patients with permanent dentition present in the radiograph.
Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided FDA 510(k) summary for Videa Perio Assist:
1. Table of Acceptance Criteria & Reported Device Performance
Videa Perio Assist underwent two primary types of testing: Bench Testing (focused on algorithm precision/recall) and Clinical Testing (focused on algorithm sensitivity, specificity, and accuracy for clinical measurements).
Bench Testing Acceptance Criteria & Performance (Per Tooth Landmark Detection)
| Metric | Acceptance Criteria (Overall) | VPA Performance (Bitewing) | VPA Performance (Periapical - Overall) | VPA Performance (Periapical - CEJ-ABL subgroup) |
|---|---|---|---|---|
| Recall | > 82% | 94.4% | 91.9% | N/A (Not reported specifically for this subgroup for recall) |
| Precision | > 82% | 84.3% | N/A (Not reported overall for periapical) | 79.1% (Did not meet criteria for this subgroup) |
Note: The document notes that for the periapical CEJ-ABL subgroup, precision was 79.1%, meaning it did not meet the acceptance criteria of >82% precision for this specific subgroup, however, this was attributed to difficulty in estimating obscured points on overlapping teeth.
Clinical Testing Acceptance Criteria & Performance (Per Interproximal Bone Level Measurement)
| Metric | Acceptance Criteria (Overall) | VPA Performance (Bitewing) | VPA Performance (Periapical - All) | VPA Performance (Periapical - CEJ->ABL subgroup) | VPA Performance (Periapical - CEJ->RT subgroup) | VPA Performance (Periapical - ABL->RT subgroup) |
|---|---|---|---|---|---|---|
| Sensitivity | > 82% | 92.8% (Met) | 88.3% (Met) | Met | Met | Met |
| Specificity | > 81% | 89.4% (Met) | 87.0% (Met) | Did not meet (for this subgroup) | Met | Met |
| Mean Absolute Error |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).