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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. Better Diagnostics Caries assist is indicated for use by board licensed dentists. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history or actual in vivo clinical assessment.

Better Diagnostics Caries Assist (BDCA) Version 1.0 is a computer-aided detection (CADe) software designed for the automated detection of carious lesions in Bitewings and periapical dental radiographs. This software offers supplementary information to assist clinicians in their diagnosis of potentially carious tooth surfaces. It is important to note that BDCA v1.0 is not meant to replace a comprehensive clinical evaluation by a clinician, which should consider other pertinent information from the image, the patient's medical history and clinical examination. This software is intended for use in identifying carious lesions in permanent teeth of patients who are 18 years or older. BDCA v1.0 does not make treatment recommendations or provide a diagnosis. Dentists should review images annotated by BDCA v1.0 concurrently with original, unannotated images before making the final diagnosis on a case. BDCA v1.0 is an adjunct tool and does not replace the role of the dentist. The CAD generated output should not be used as the primary interpretation by the dentists. BDCA v1.0 is not designed to detect conditions other than the following: Caries. BDCA v1.0 comprises four main components: - Presentation Layer: This component includes "AI Results Screen" a web-based interface (user interface) that allows users to view AI marked annotations. This is a custom code provided by Better Diagnostics AI Corp to Dental PMS customers. User Interface uses Angular.js and node.js technology to show images on the "AI Results Screen". System can process PNG, BMP and JPG format images. All images are converted into JPEG format for processing. Computer Vision Models returns AI annotations and co-ordinates to the business layer. Business layer sends coordinates to the presentation layer and bounding boxes are drawn on the image using custom code written in Angular.js and node.js. Dentists can view, accept or reject the annotations based on his evaluation. Better Diagnostics AI provides UI code to customers e.g. dental practice management software and imaging firms for utilization of BCDA v1.0 software. - Application Programming Interface (API): APIs are a set of definitions and protocols for building and integrating application software. It's sometimes referred to as a contract between an information provider and an information user. BDCA v1.0 APIs connect the Dental PMS with the business layer. API receives images input from Dental PMS and passes it to the business layer. It also receives annotations and co-ordinates from the business layer and passes it to the presentation layer hosted by Dental PMS. - Business Layer: Receives image from the API Gateway and passes it to computer vision models. It also receives the bounding boxes coordinates from the model and retrieves images from the cloud storage. It sends all information to the "AI Results screen" to display rectangle bounding boxes. - Computer Vision Models (CV Models): These models are hosted on a cloud computing platform and are responsible for image processing. They provide a binary indication to determine the presence of carious findings. If carious findings are detected, the software will output the coordinates of the bounding boxes for each finding. If no carious lesions are found, the output will not contain any bounding boxes and will have a message stating "No Suspected: Caries Detected" AI models have three parts: - Pre-Processing Module: Standardization of image to specific height and width to maintain consistency for AI model. Finds out the type of image including IOPA, Bitewings or other types. BDCA v 1.0 can only process Bitewings and IOPA images for patients over age 18. All other types of images will be rejected. - Core Module: This module provides carious lesion annotations and co-ordinates to draw bounding boxes. - Post-Processing Module: includes cleanup process to remove outliers/incorrect annotations from the images.