Intended Use

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 their clinical judgment that takes into account other relevant information from the image, patient history, and actual in vivo clinical assessment.

Technology

Overjet Caries Assist (OCA) is a software-only automated detection tool with a three-layer architecture: Network Layer (interfaces with clinic), Decision Layer (machine learning model for caries detection), and Presentation Layer (dashboard for user interaction). It uses an ensemble of three U-Net based models for pixel-wise segmentation of carious lesions on bitewing radiographs and assigns detected lesions to specific teeth through a post-processing module.

Performance

Performance testing included standalone algorithm testing and clinical reader studies demonstrating improved dentist sensitivity in caries detection by over 15%, with an overall sensitivity of 72.0% and specificity of 98.1% at the lesion level. Clinical evaluation showed an increase in reader sensitivity from 57.9% to 76.2% when assisted by the software, with a statistically significant increase in diagnostic performance (AFROC AUC increase).

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/10/2021

    9 months
  • 2

    FDA Approval

    5/10/2022

Other devices from Overjet, Inc.

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