Overjet Calculus Assist

Overjet, Inc.
Overjet Calculus Assist Model Card
Product Details
Model Identifier
Manufacturer
Overjet, Inc.
Product
Overjet Calculus Assist
Version
Unknown
Date Cleared
12/16/2022
FDA Submission No.
Category
CADe
Model Characteristics
Inclusion Criteria
Dental xray images
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
Overjet Calculus Assist (OCalA) is a radiological automated concurrent-read computer-assisted detection software intended to aid in the detection of interproximal calculus deposits on both bitewing and periapical radiographs. The Overjet Calculus Assist surrounds suspected calculus deposits with a bounding box. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of containing calculus deposits. 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 or patient history. The system is to be used by professionally trained and licensed dentists.
Intended User
Dentist
Age
Adult
Anatomy
Head
Modality
XRAY
Output
Calculus detection on radiograph resulting in bounding box outline of suspected calculus
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)
Unknown
No. of Cases
618
Age Range (Years)
Unknown
Sex (%)
  • Female: Unknown
  • Male: Unknown
  • Unknown: 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
Output
Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
No. of Sites
Unknown
Model Accuracy
Unknown
Model Sensitivity
74
Model Specificity
99
Reader Study Performance
No. of Readers
14
No. of Cases
614
No. of Sites
Unknown
Output
Unknown
Age Range (Years)
Unknown
Sex (%)
  • Female: Unknown
  • Male: Unknown
  • Unknown: 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 Accuracy
Unknown
Model Sensitivity
Bitewing: reader sensitivity improved from 74.9% (95% CI: 68.3%, 80.2%) to 84.0% (95% CI: 78.8%, 88.2%) unassisted vs assisted Periapical: reader sensitivity improved from 74.7% (95% CI: 69.9%, 79.0%) to 84.4% (95% CI: 78.8%, 89.2%) unassisted vs assisted
Model Specificity
Bitewing: reader specificity decreased from 98.8% (95% CI: 98.7%, 99.0%) to 98.6% (95% CI: 98.4%, 98.9%)unassisted vs assisted Periapical: reader specificity decreased from 98.1% (95% CI: 97.8%, 98.4%) to 98.0% (95% CI: 97.7%, 98.4%)unassisted vs assisted
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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