(90 days)
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).
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (Corometrics FMD Kit) |
|---|---|---|
| Detection method | Same as predicate (Pulse Doppler Ultrasound Technique) | Pulse Doppler Ultrasound Technique |
| Detection of gross body movements | Same as predicate (Yes, via ultrasound transducer) | Yes |
| Annotation method | Same as predicate (Annotated by bar/dot) | Annotated by bar/dot |
| Annotation by spike waveform | Same as predicate (No) | No |
| Optional function | Same as predicate (Yes) | Yes |
| Overall Performance | Equivalent to Hewlett-Packard Fetal Movement Profile (FMP) | Verified equivalent performance |
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.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).