Insight BD
Siemens Healthineers
Product Details
Model Identifier
Manufacturer
Siemens Healthineers
Product
Insight BD
Version
Unknown
Date Cleared
02/06/2018
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
Xray Breast
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
Insight BD is a software application for the volumetric density assessment of digital x-ray images of the breast to aid health care professionals in the assessment of breast tissue composition. Insight BD is not a diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made visually by medical professionals.
Intended User
Medical professionals
Age
Unknown
Anatomy
Chest
Modality
MAM
Output
The assessment consists of generating and evaluating density maps where the value at each pixel represents the thickness of fibroglandular tissue above that pixel. From those density maps the software calculates quantitative values, namely � volume of fibroglandular tissue in the breast in cm� � breast volume in cm� � volumetric breast density in % � breast density grade The breast density grade is computed by thresholding of the volumetric breast density and conforms to BI-RADS� 5th Edition breast composition categories. The masking effect of dense fibroglandular tissue is automatically included in the results.
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
Unknown
Standalone Model Performance
Reference Standard (Ground Truth)
N/A
No. of Cases
N/A
Age Range (Years)
N/A
Sex (%)
- Female: N/A
- Male: N/A
- Unknown: N/A
Race (%)
- White: N/A
- Black or African American: N/A
- American Indian or Alaska Native: N/A
- Asian: N/A
- Native Hawaiian or Other Pacific Islander: N/A
- Unknown: N/A
Ethnicity (%)
- Hispanic or Latino: N/A
- Not Hispanic or Latino: N/A
- Unknown: N/A
Geographic Region (%)
- USA: N/A
- International: N/A
- Unknown: N/A
Output
N/A
Scanner Manufacturer(s)
N/A
Scanner Model(s)
N/A
No. of Sites
N/A
Model Accuracy
N/A
Model Sensitivity
N/A
Model Specificity
N/A
Reader Study Performance
No. of Readers
N/A
No. of Cases
N/A
No. of Sites
N/A
Output
N/A
Age Range (Years)
N/A
Sex (%)
- Female: N/A
- Male: N/A
- Unknown: N/A
Race (%)
- White: N/A
- Black or African American: N/A
- American Indian or Alaska Native: N/A
- Asian: N/A
- Native Hawaiian or Other Pacific Islander: N/A
- Unknown: N/A
Ethnicity (%)
- Hispanic or Latino: N/A
- Not Hispanic or Latino: N/A
- Unknown: N/A
Geographic Region (%)
- USA: N/A
- International: N/A
- Unknown: N/A
Scanner Manufacturer(s)
N/A
Scanner Model(s)
N/A
Model Accuracy
N/A
Model Sensitivity
N/A
Model Specificity
N/A
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
All
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)
Contact Information
Contact Information
Point of Contact Name
Unknown
Email
Unknown
Additional Details
Related Use Cases
Unknown