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Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize the following features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older. Suspected Dental Findings: Caries, Attrition, Broken/Chipped Tooth, Restorative Imperfections, Pulp Stones, Dens Invaginatus, Periapical Radiolucency, Widened Periodontal Ligament, Furcation, Calculus. Historical Treatments: Crown, Filling, Bridge, Post and Core, Root Canal, Endosteal Implant, Implant Abutment, Bonded Orthodontic Retainer, Braces. Normal Anatomy: Maxillary Sinus, Maxillary Tuberosity, Mental Foramen, Mandibular Canal, Inferior Border of the Mandible, Mandibular Tori, Mandibular Condyle, Developing Teeth, Erupting Teeth, Non-matured Erupted Teeth, Exfoliating Teeth, Impacted Teeth, Crowding Teeth.

Videa Dental Assist (VDA) software is a cloud-based AI-powered medical device for the automatic detection of the features listed in the Indications For Use statement in dental radiographs. The device itself is available as a service via an API (Application Programming Interface) behind a firewalled network. Provided proper authentication and an eligible bitewing, periapical or panoramic image, the device returns a set of bounding boxes representing the suspect dental finding, historical treatment or normal anatomy detected. VDA is accessed by the dental practitioner through their dental image viewer. From within the dental viewer the user can upload a radiograph to VDA and then review the results. The device outputs a binary indication to identify the presence of findings for each indication. If findings are present the device outputs the number of findings by finding type and the coordinates of the bounding boxes for each finding. If no findings are present the device outputs a clear indication that there are no findings identified for each indication. The device output will show all findings from one radiograph regardless of the number of teeth present.

Here's a breakdown of the acceptance criteria and study details for the Videa Dental Assist device, as provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that all listed sensitivity, specificity, and AFROC FOM results met their acceptance criteria, but generally does not explicitly list the specific numerical acceptance criteria. For the purpose of this table, "Met Acceptance Criteria" will be used when the text indicates it.

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