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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 (OB-GYN, MFM). 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 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 detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) Clearance Letter for Fetal EchoScan v1.1:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather presents the performance metrics achieved by the device in both standalone and reader studies. The implication is that these performance levels were deemed acceptable for clearance.

Table 1. Standalone Performance of Fetal EchoScan v1.1 for all suspicious radiographic findings Combined

Table 2. Reader Study Performance of Fetal EchoScan v1.1 for all suspicious radiographic findings Combined

Note: The numerical acceptance criteria for "high sensitivity" and "high specificity" are not explicitly defined in the provided document, but the reported performance values surpassed what was considered acceptable by the FDA for substantial equivalence.

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

• Test Set Sample Size (Standalone Testing): 877 clinically acquired fetal ultrasound exams.
• Test Set Sample Size (Reader Study): 200 exams.
• Data Provenance:
  • Country of Origin: U.S.A. and France.
  • Retrospective or Prospective: The document doesn't explicitly state whether the data was retrospective or prospective, but it mentions "clinically acquired" exams, which often implies retrospective use of existing data.

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

• Number of Experts: Three (3) pediatric cardiologists.
• Qualifications of Experts: Pediatric cardiologists. No further details on years of experience or board certification are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Majority voting among the three pediatric cardiologists.

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

• Was an MRMC study done? Yes.
• Effect Size of Human Readers' Improvement with AI vs. without AI assistance:
  • ROC AUC: Humans improved by +14.9% (from 0.825 unaided to 0.974 aided), with a p-value of 0.002.
  • Mean Sensitivity: Humans improved by +15.3% (from 0.782 unaided to 0.935 aided).
  • Mean Specificity: Humans improved by +21.1% (from 0.759 unaided to 0.970 aided).

6. Standalone Performance Study

• Was a standalone study done? Yes.
• Performance Metrics: Refer to Table 1 above. The AI system had a conclusive output rate of 98.8%. Sensitivity ranged from 0.977 to 0.987, and Specificity ranged from 0.963 to 0.977 for the detection of any suspicious findings, depending on how inconclusive outputs were treated.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus. Specifically, it was derived from a "truthing process in which three pediatric cardiologists assessed the presence or absence of each of the eight findings, and majority voting was used." This constitutes expert consensus.

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." However, the specific sample size for the training set is not provided in the clearance letter. It only mentions that the data used for standalone testing (877 exams) and the reader study (200 exams) were distinct from the training and validation data.

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." However, the methodology for establishing ground truth for the training set is not explicitly detailed in the provided text. It can be inferred that a similar expert review process would have been used, but no specific details are given.

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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 (OB-GYN, MFM). 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 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 device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds. Instead, it presents the performance of the device in various metrics and then concludes that these results demonstrate substantial equivalence. For the purpose of this request, I will infer the implied acceptance criteria from the reported performance and the conclusion of substantial equivalence.

Inferred Acceptance Criteria & Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Standalone Test Set: 877 clinically acquired fetal ultrasound exams.
• Sample Size for MRMC Test Set: 200 exams.
• Data Provenance: The data was collected from 11 centers in the U.S.A. and France. It was retrospectively collected as it refers to "clinically acquired fetal ultrasound exams".

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three (3) pediatric cardiologists.
• Qualifications of Experts: The document specifies "pediatric cardiologists" but does not provide details on their years of experience or other specific qualifications beyond their specialty.

4. Adjudication Method for the Test Set

• Adjudication Method: Majority voting. This means that if at least two out of the three pediatric cardiologists agreed on the presence or absence of a finding, that was established as the ground truth.

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

• Was an MRMC study done? Yes.
• Effect size of human readers improvement with AI vs. without AI assistance:
  • ROC AUC for any suspicious finding: +14.9% increase (from 0.825 unaided to 0.974 aided, p=0.002).
  • Mean Sensitivity for any suspicious finding: +15.3% increase (from 0.782 unaided to 0.935 aided).
  • Mean Specificity for any suspicious finding: +21.1% increase (from 0.759 unaided to 0.970 aided).

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes.
• The results are presented in Table 1, showing sensitivity and specificity for "Any suspicious findings" and each individual finding, calculated under two scenarios for inconclusive outputs.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus. Specifically, it was derived from a truthing process by three pediatric cardiologists using majority voting.

8. Sample Size for the Training Set

• The document states that "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 that the "ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing." However, similar to the training set sample size, it does not explicitly describe how the ground truth for the training set was established. It only details the ground truth establishment for the test sets (standalone and MRMC).

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