Videa Dental Assist

VideaHealth, Inc.
Videa Dental Assist Model Card
Product Details
Model Identifier
Manufacturer
VideaHealth, Inc.
Product
Videa Dental Assist
Version
Unknown
Date Cleared
12/15/2023
FDA Submission No.
Category
CADe
Model Characteristics
Inclusion Criteria
Dental Radiographs
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
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
Intended User
Trained dental professionals such as dentists and dental hygienists
Age
Adult and Pediatric
Anatomy
Head
Modality
XRAY
Output
The device outputs a binary indication to identify the presence or absence 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.
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
Unknown
Age Range (Years)
Unknown
Sex (%)
  • Female: Unknown
  • Male: Unknown
  • Unknown: Unknown
Output
Unknown
Race (%)
  • White: Unknown
  • Black or African American: Unknown
  • American Indian or Alaska Native: Unknown
  • Asian: Unknown
  • Native Hawaiian or Other Pacific Islander: Unknown
  • Unknown: Unknown
Ethnicity (%)
  • Hispanic or Latino: Unknown
  • Not Hispanic or Latino: Unknown
  • Unknown: Unknown
Geographic Region (%)
  • USA: Unknown
  • International: Unknown
  • Unknown: Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
Model Performance
Study Type
Performance Testing Type
Both
Standalone Model Performance
Reference Standard (Ground Truth)
Interpretation by Reviewing Clinician
No. of Cases
1,445
Age Range (Years)
3 - 61
Sex (%)
Female: 18
Male: 17
Unknown: 64
Race (%)
  • White: Unknown
  • Black or African American: Unknown
  • American Indian or Alaska Native: Unknown
  • Asian: Unknown
  • Native Hawaiian or Other Pacific Islander: Unknown
  • Unknown: Unknown
Ethnicity (%)
  • Hispanic or Latino: Unknown
  • Not Hispanic or Latino: Unknown
  • Unknown: Unknown
Geographic Region (%)
  • USA: Unknown
  • International: Unknown
  • Unknown: Unknown
Output
Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
No. of Sites
35
Model Accuracy
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
Reader Study Performance
No. of Readers
26
No. of Cases
378
No. of Sites
25
Output
Unknown
Age Range (Years)
3 - 61
Sex (%)
Male: 21
Unknown: 54
Race (%)
  • White: Unknown
  • Black or African American: Unknown
  • American Indian or Alaska Native: Unknown
  • Asian: Unknown
  • Native Hawaiian or Other Pacific Islander: Unknown
  • Unknown: Unknown
Ethnicity (%)
  • Hispanic or Latino: Unknown
  • Not Hispanic or Latino: Unknown
  • Unknown: Unknown
Geographic Region (%)
  • USA: Unknown
  • International: Unknown
  • Unknown: Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
Model Accuracy
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
Unknown
Slice Thickness
Unknown
Contrast Use
Unknown
MRI Field Strength
Unknown
Reconstruction Kernel Used
Unknown
Alternative Choices
Alternative Choices
Previous Version(s)
Unknown
Contact Information
Contact Information
Point of Contact Name
Unknown
Email
Unknown
Additional Details
Related Use Cases
Unknown
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