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The Corometrics Fetal Movement Detection (FMD) Kit is intended to detect gross fetal body movements and fetal body movements with associated limb movement. Corometrics defines "gross fetal body movement" as the extension, flexion, or rolling over of the fetal trunk about the longitudinal axis of the body and associated limb movements." Movement of the extremities alone may not be detected. Fetal eye movements will not be detected.

The FMD Kit is a modular hardware/software kit that can be installed in a Corometrics Fetal Monitor. The FMD Kit provides the ability to automatically detect fetal movement via pulse Doppler ultrasound and to display the duration of such events on the fetal monitor's recorder strip chart as horizontal bars along the time scale (time axis) of the heart rate scale.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them, beyond a general statement of "equivalent performance." The FMD Kit's submission is a 510(k) for a modified device, primarily comparing it to a predicate device, the Hewlett-Packard Fetal Movement Profile (FMP) Option.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics. It indicates that the Corometrics Fetal Movement Detection (FMD) Kit demonstrates equivalent performance to the Hewlett-Packard Fetal Movement Profile (FMP).

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

The document mentions "clinical evaluations were performed" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This type of study is not mentioned. The FMD Kit is not an "AI" device as understood in modern terms, and its function is automatic detection, not an aid to human interpretation that would necessitate an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is designed for automatic detection of fetal movement. The "bench testing and clinical evaluations" mentioned would implicitly be testing the algorithm's standalone performance in detecting fetal movement. However, no specific details or results of such a standalone study are provided. The comparison is made against a predicate device, suggesting its performance is evaluated in the context of its intended function which is automatic detection.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used. Given the nature of fetal movement detection, potential ground truths could include:

• Real-time observation by medical staff (e.g., nurses, doctors).
• Simultaneous use of another established method for fetal movement detection.
• Correlation with other physiological signs.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is consistent with a 510(k) submission for a device that predates modern machine learning/AI techniques that typically involve explicit training sets. The device likely uses rule-based or signal processing algorithms rather than learned models.

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

As no training set is mentioned, this information is not applicable/provided.

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