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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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Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages.

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.

Videa Perio Assist (VPA) software is a cloud-based AI-powered medical device for the automatic measurement of tooth interproximal alveolar bone level in dental radiographs. The device itself is available as an API (Application Programming Interface) behind a firewalled network. The device returns 1) a series of points with connecting lines measuring the mesial and distal alveolar bone levels associated with each tooth 2) this distance expressed in millimeters and/or as a percentage of the root length.

Videa Perio Assist is accessed by the trained professional through their image viewer. From within the image viewer the user can upload a radiograph to Videa Perio Assist and then review the results. The device outputs a line to identify these points which calculate the interproximal bone level.

The device output will show all applicable measurements from one radiograph regardless of the number of teeth present. If no teeth are present the device outputs a clear indication that there are no identifiable teeth to calculate the interproximal bone level.

The intended users of Videa Perio Assist are trained professionals such as dentists and dental hygienists.

The intended patients of Videa Perio Assist are patients 12 years and above with permanent dentition undergoing routine dental visits or suspected of having interproximal bone level concerns. Videa Perio Assist may only be used with patients with permanent dentition present in the radiograph.

Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided FDA 510(k) summary for Videa Perio Assist:

1. Table of Acceptance Criteria & Reported Device Performance

Videa Perio Assist underwent two primary types of testing: Bench Testing (focused on algorithm precision/recall) and Clinical Testing (focused on algorithm sensitivity, specificity, and accuracy for clinical measurements).

Bench Testing Acceptance Criteria & Performance (Per Tooth Landmark Detection)

Note: The document notes that for the periapical CEJ-ABL subgroup, precision was 79.1%, meaning it did not meet the acceptance criteria of >82% precision for this specific subgroup, however, this was attributed to difficulty in estimating obscured points on overlapping teeth.

Clinical Testing Acceptance Criteria & Performance (Per Interproximal Bone Level Measurement)

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Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions. Videa Caries Assist is indicated for use by board licensed dentists for the concurrent review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.

Videa Caries Assist (VCA) software is a cloud-based AI-powered medical device for the automatic detection of carious lesions 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 a bitewing image, the device returns a set of bounding boxes representing the carious lesions detected. VCA is accessed by the dental practitioner through their Dental Viewer. From within the Dental Viewer the user can upload a radiograph to VCA and then review the results. The device outputs a binary indication to identify the presence or absence of findings are present the device outputs the coordinates of the bounding boxes for each finding. If no findings are present the device outputs a clear indication that there are no carious lesions identified.

Here's a summary of the acceptance criteria and the study details for the Videa Caries Assist device, based on the provided document:

Acceptance Criteria and Device Performance

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