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Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams.

When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings:

• overriding artery
• septal defect at the cardiac crux
• abnormal relationship of the outflow tracts
• enlarged cardiothoracic ratio
• right ventricular to left ventricular size discrepancy
• tricuspid valve to mitral valve annular size discrepancy
• pulmonary valve to aortic valve annular size discrepancy
• cardiac axis deviation

Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views.

Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians. It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams.

Fetal EchoScan is not intended for use in multiple pregnancies, cases of fetal heterotaxy and postnatal ultrasound exams.

Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect suspicious cardiac radiographic findings for further review by trained and qualified physicians. Fetal EchoScan is intended to be used as an adjunct to the interpretation of the second-trimester fetal anatomic ultrasound exam performed between 18 and 24 weeks of gestation, for pregnant women aged 18 or more.

Here's a breakdown of the acceptance criteria and study details for the Fetal EchoScan (v1.2) device, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance (Standalone Study)

The document primarily provides performance data from a standalone study, which implies these are the acceptance criteria met by the device.

The document does not explicitly state the pre-defined target values for these metrics, but the presented data demonstrates the device's performance against the ground truth.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Standalone Study Test Set): 877 clinically acquired fetal ultrasound exams.
• Data Provenance: The data was acquired from 11 centers in the U.S.A. and France. The data is retrospective, as it refers to "clinically acquired fetal ultrasound exams."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Three (3)
• Qualifications of Experts: Pediatric cardiologists.

4. Adjudication Method for the Test Set

• Adjudication Method: Majority voting. Three pediatric cardiologists assessed the presence or absence of each of the eight findings, and majority voting was used to establish the reference standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? Yes, a fully-crossed MRMC study was conducted.
• Effect Size of Human Readers' Improvement with AI vs. without AI assistance:
  • ROC AUC for detection of any suspicious radiographic finding:
    • AI-aided: 0.974 (95% CI 0.957-0.990)
    • Unaided: 0.825 (95% CI 0.741-0.908)
    • Increase in AUC: +14.9% (0.149, statistically significant with p=0.002)
  • Mean Sensitivity for any claimed suspicious finding:
    • AI-aided: 0.935 (0.892-0.978)
    • Unaided: 0.782 (0.686-0.878)
    • Increase in Sensitivity: +15.3%
  • Mean Specificity for any claimed suspicious finding:
    • AI-aided: 0.970 (0.949-0.991)
    • Unaided: 0.759 (0.630-0.887)
    • Increase in Specificity: +21.1%

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes, "Standalone testing" was explicitly performed and described. The results are presented in the "Table 1. Sensitivity and Specificity (with 95% CI) of Fetal EchoScan..." section.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (majority voting by three pediatric cardiologists).

8. Sample Size for the Training Set

• The document states, "The ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing," but it does not explicitly provide the sample size for the training set.

9. How the Ground Truth for the Training Set Was Established

• The document states, "The ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing."
• Similar to the test set, it is highly probable that the ground truth for the training set was established through a robust expert review process, likely involving pediatric cardiologists. However, the specific details of the training set's ground truth establishment are not provided in this document. It only confirms that the truthing process for the test set was "conducted independently of the Fetal EchoScan device."

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