Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious radiographic findings in fetal heart ultrasound video clips recorded during 2nd trimester anatomic ultrasound examinations conducted during the second trimester of the pregnancy.
Study Type
OBSERVATIONAL
Enrollment
200
Determination of the presence of the 8 findings suspicious of CHD by readers, aided by the device
Determination of the presence of the 8 findings suspicious of CHD by readers, unaided by the device
MFM Associates, PLLC
New York, New York, United States
AUC of the ROC curve for the presence of any suspicious finding
AUC of the ROC curve for both reading conditions (aided vs unaided by the device) derived from the identification of any suspicious radiographic finding
Time frame: 1 month
AUC of the ROC curve for the presence of each suspicious finding
AUCs of the ROC curve for both reading conditions (aided vs unaided by the device) for identification of each finding.
Time frame: 1 month
Sensitivity and specificity for both reading conditions for the presence of any suspicious finding
Sensitivity and specificity for both reading conditions (aided vs unaided by the device) for identification of each finding.
Time frame: 1 month
Sensitivity and specificity for both reading conditions for the presence of each suspicious finding
Sensitivity and specificity for both reading conditions for the presence of each suspicious finding.
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.