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Overjet Caries Assist (OCA) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. 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.

Overjet Caries Assist (OCA) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. 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. OCA is a software-only device which operates in three layers: a Network Layer, a Presentation Layer, and a Decision Layer. Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Layer and results are pushed to the dashboard, which are in the Presentation Layer. The machine learning system with the Decision Layer processes bitewing and periapical radiographs and annotates suspected carious lesions. It is comprised of four modules: - Image Preprocessor Module - Tooth Number Assignment Module - Caries Module - Post Processing

The Overjet Caries Assist (OCA) is a radiological, automated, concurrent read, computer-assisted detection software intended to aid in the detection and segmentation of caries on bitewing radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or that takes into account other relevant information from the image, patient history, and actual in vivo clinical assessment.

Overjet Caries Assist (OCA) is a radiological automated concurrent read computer-assisted detection (CAD) software intended to aid in the detection and segmentation of caries on bitewing radiographs. The device provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete clinician's review or their clinical judgment that takes into account other relevant information from the image or patient history. OCA is a software-only device which operates in three layers - a Network Layer, a Presentation Layer, and a Decision Layer (as shown in the data flow diagram below). Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Layer and results are pushed to the dashboard, which are in the Presentation Layer. The Machine Learning System within the Decision Layer processes bitewing radiographs and annotates suspected carious lesions. It is comprised of four modules: - Image Classifier The model evaluates the incoming radiograph and predicts the ● image type between Bitewing and Periapical Radiograph. This classification is used to support the data flow of the incoming radiograph. As part of the classification of the image type any non-radiographs are classified as "junk" and not processed. These include patient charting information, or other non-bitewing or periapical radiographs. OCA shares classifier and Tooth Number modules with the Overjet Dental Assist product cleared under K210187. - . Tooth Number Assignment module - This module analyzes the processed image and determines what tooth numbers are present and provides a pixel wise segmentation mask for each tooth number. - Caries module - This module outputs a pixel wise segmentation mask of all carious lesions using an ensemble of 3 U-Net based models. The shape and location of every carious lesion is contained in this mask as the carious lesions' predictions. - Post Processing The overlap of tooth masks from the Tooth Number . Assignment Module and carious lesions from the Caries Module is used to assign specific carious lesions to a specific tooth. The Image Post Processor module annotates the original radiograph with the carious lesions' predictions.

Overjet Dental Assist 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. 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.

Overjet Dental Assist developed by Overjet Inc, 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. Overjet Dental Assist is a cloud native Software as a Medical Device that allows users to automate the measurement of interproximal bone levels for bitewing and periapical radiographs, review associated radiographs, view annotations, modify annotations.