FEops HEARTguideTM, FEops HEARTguideTM ALPACA

FEops nv
FEops HEARTguideTM, FEops HEARTguideTM ALPACA Model Card
Product Details
Model Identifier
Manufacturer
FEops nv
Product
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
Version
Unknown
Date Cleared
06/06/2023
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
CT images
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as: • Segmentation of cardiovascular structures • Visualization and image reconstruction techniques: 2D review, MPR • Measurement and annotation tools • Reporting tools FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g., FEops HEARTguide™ Simulation Application cleared as K214066). The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment. FEops HEARTguide™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement.
Intended User
Qualified clinicians
Age
Unknown
Anatomy
Chest
Modality
CT
Output
• Segmentation of cardiovascular structures • Visualization and image reconstruction techniques: 2D review, MPR • Measurement and annotation tools • Reporting tools
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
Stand-Alone Performance
Standalone Model Performance
Reference Standard (Ground Truth)
Interpretation by Reviewing Clinician
No. of Cases
35
Age Range (Years)
50 - 92
Sex (%)
Female: 49
Male: 51
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
Not provided
Model Specificity
Not provided
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)
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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