Second Opinion® CS
Pearl Inc.
Product Details
Model Identifier
Manufacturer
Pearl Inc.
Product
Second Opinion® CS
Version
Unknown
Date Cleared
06/12/2025
FDA Submission No.
Category
CADe
Model Characteristics
Inclusion Criteria
Periapical radiographs of permanent teeth in patients 12 years of age or older
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
Second Opinion® CS is a computer aided detection ("CADe”) software to aid in the detection and segmentation of caries
in periapical radiographs.
It is designed to aid dental health professionals to review periapical radiographs of permanent teeth in patients 12 years of
age or older as a second reader.
Intended User
Dental health professionals
Age
Adult and Pediatric
Anatomy
Head
Modality
XRAY
Output
The device detects and segments caries in periapical radiographs, providing an overlay of segmented contours and a detailed analysis of the lesion's overlap with dentine and enamel, presented as a percentage.
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
1,250
Age Range (Years)
12 - 75
Sex (%)
Female: 50
Male: 44
Unknown: 5
Male: 44
Unknown: 5
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: 100
Output
Caries present: 32
Scanner Manufacturer(s)
Carestream;Kodak
Scanner Model(s)
Unknown
No. of Sites
Unknown
Model Accuracy
Unknown
Model Sensitivity
88%
Model Specificity
Not provided
Reader Study Performance
No. of Readers
21
No. of Cases
330
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
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
Predicate Device(s)
Unknown
Contact Information
Contact Information
Point of Contact Name
Unknown
Email
Unknown
Additional Details
Related Use Cases
Unknown