(213 days)
Second Opinion® BLE is a radiological automated image processing software device intended to identify and display bone level measurements in bitewing and periapical radiographs. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
It is designed to aid dental health professionals to review bitewing and periapical radiographs of permanent teeth in patients 12 years of age or older as a concurrent and second reader.
Second Opinion BLE is a radiological automated image processing software device intended to identify and display bone level measurements in bitewing and periapical radiographs. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
It is designed to aid dental health professionals to review bitewing and periapical radiographs of permanent teeth in patients 12 years of age or older as a concurrent and second reader.
Second Opinion BLE consists of three parts:
- Application Programing Interface ("API")
- Machine Learning Modules ("ML Modules")
- Client User Interface (UI) ("Client")
The processing sequence for an image is as follows:
- Images are sent for processing via the API
- The API routes images to the ML modules
- The ML modules produce detection output
- The UI renders the detection output
The API serves as a conduit for passing imagery and metadata between the user interface and the machine learning modules. The API sends imagery to the machine learning modules for processing and subsequently receives metadata generated by the machine learning modules which is passed to the interface for rendering.
Second Opinion BLE uses machine learning to detect bone level measurements. Images received by the ML modules are processed yielding detections which are represented as metadata. The final output is made accessible to the API for the purpose of sending to the UI for visualization. Detected bone level measurements are displayed as linear overlays atop the original radiograph which indicate to the practitioner which regions contain which detected potential conditions that may require clinical review. The clinician can toggle over the image to highlight a potential condition for viewing.
Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA clearance letter for Second Opinion® BLE:
Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance (Bitewing Images) | Reported Device Performance (Periapical Images) |
|---|---|---|---|
| Precision (for interproximal bone levels) | > 82% | 87% (95% CI: 86%, 88%) | 87% (95% CI: 85%, 89%) |
| Recall (for interproximal bone levels) | > 82% | 91% (95% CI: 90%, 92%) | 87% (95% CI: 85%, 89%) |
| Mean Absolute Difference (CEJ-bonecrest measurement) |
§ 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).