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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prenatal ultrasound examinations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device-Aided performances | Device | Determination of the presence of the 8 findings suspicious of CHD by readers, aided by the device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Sensitivity and specificity for both reading conditions for the presence of any suspicious finding |
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Inclusion Criteria:
Exclusion Criteria:
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Ultrasound examinations conducted during the second trimester of the pregnancy, containing interpretable 4-chamber, LVOT and ROVT standard views of the fetal heart
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Gardella, PhD | Chief Technical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MFM Associates, PLLC | New York | New York | 10128 | United States |
no sharing of the IPD is planned
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Device-Unaided performances | Other | Determination of the presence of the 8 findings suspicious of CHD by readers, unaided by the device |
|
Sensitivity and specificity for both reading conditions (aided vs unaided by the device) for identification of each finding. |
| 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. | 1 month |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |