Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

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.

Inclusion Criteria:

• ultrasound examinations conducted during the second trimester of the pregnancy
• fetus between 18 and 24 weeks of gestational age
• mothers 18 years old or older

Exclusion Criteria:

• exams corresponding to multiple pregnancy
• fetal heterotaxy
• exams not containing video clips with interpretable 4-chamber (4C), Left Ventricular Outflow Tract (LVOT) or Right Ventricular Outflow Tract (RVOT) standard views