A multicenter study will be conducted to assess the role of the AI/ML technologies of Origin Medical EXAM ASSISTANT (OMEA) in interpreting first-trimester fetal ultrasound examinations (11 weeks 0 days - 13 weeks 6 days). The performance of the AI-based system will be compared against the ground truth provided by an independent reading panel of maternal-fetal medicine physicians.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
To assess whether the AI/ML technologies used in OMEA can achieve an acceptable sensitivity for identifying the diagnostic view
Timeframe: 11 weeks 0 days to 13 weeks 6 days
To assess whether the AI/ML technologies used in OMEA can achieve an acceptable sensitivity and consistency for verifying the quality criteria of a given image
Timeframe: 11 weeks 0 days to 13 weeks 6 days
To evaluate the performance of the OMEA AI/ML technologies with respect to facilitating the determination of quantitative measure of crown-rump length (CRL) and nuchal translucency (NT), complementary evaluations of agreement will be performed.
Timeframe: 11 weeks 0 days to 13 weeks 6 days