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510(k) Data Aggregation
(330 days)
The Monica AN24 is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA). The AN24 acquires and displays the FHR & MHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) and maternal ECG (mECG) signal. Using the same surface electrodes, the AN24 also acquires and displays the UA tracing from the uterine electromyography (EMG) signal. The AN24 is indicated for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.
The AN24 maternal-fetal monitor is intended for use by healthcare professionals in a clinical setting.
The Monica AN24™ is a small, battery-powered device for L&D surveillance of fetal well-being. The AN24™ is designed to passively monitor Fetal Heart Rate (FHR)), maternal heart rate (MHR) and Uterine Activity (UA) during pregnancy and can be used at any time from > 36 completed weeks gestation in laboring patients. The AN24™ is suitable for singleton pregnancies only.
The Monica AN24 is a small, battery powered electrophysiological monitor (specifically fetal ECG, maternal ECG and uterine EMG). The electrical signals are passively monitored on three channels using five electrodes placed on the pregnant abdomen in specific locations. From these electrical signals the Fetal Heart Rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA) are continuously extracted and displayed in the same standard format as the predicate device.
Here's an analysis of the Monica AN24 device's acceptance criteria and study, based on the provided 510(k) summary:
Monica AN24 Device Acceptance Criteria and Study Analysis
The Monica AN24 is an intrapartum maternal-fetal monitor. This 510(k) summary focuses on demonstrating the substantial equivalence of the Monica AN24's Maternal Heart Rate (MHR) monitoring capability to a predicate SPO2 pulse oximeter (Philips M1191A). The FHR and UA monitoring capabilities had previously been cleared (K101801).
1. Table of Acceptance Criteria and Reported Device Performance
The study aimed to demonstrate non-inferiority of the Monica AN24's MHR monitoring compared to the predicate SPO2 pulse oximeter.
| Acceptance Criterion (Null Hypothesis of Inferiority, Alternative Hypothesis of Non-Inferiority) | Reported Device Performance (Monica AN24 vs. Predicate SPO2) | Outcome |
|---|---|---|
| Reliability: Success Rate Ratio (Lower limit of CI > 0.8) | Mean SR Ratio (AN24/SPO2): 1.16 CI: 1.08 - 1.21 | Met |
| Accuracy: RMS Error (Upper limit of 95% CI for RMS error < 7 BPM) | Combined RMS error (AN24 vs. SPO2): 4.49 BPM CI: 3.46 - 5.52 BPM Upper limit of 95% CI: 5.381 BPM (from conclusion) | Met |
| Correlation between AN24 and SPO2 MHR traces | Mean: 0.90 CI: 0.87 - 0.93 | N/A (Secondary) |
| 95% Limits of Agreement | -11.47 bpm to +11.62 bpm | N/A (Descriptive) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (for MHR study): 33 women (from the initial 60 enrolled women). This specific study focuses on MHR data.
- Data Provenance: The study was conducted at two clinical sites: QHC, New York, and Temple University, Philadelphia, in the USA. The study was prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth for the MHR study was established by a predicate SPO2 pulse oximeter (Philips M1191A) connected to a series 50 fetal monitor. The study does not mention the use of human experts to establish ground truth for MHR. Instead, it relies on the established accuracy and reliability of the predicate medical device.
4. Adjudication Method for the Test Set
Since the ground truth for MHR was established by a predicate medical device (SPO2 pulse oximeter) and not human experts, there was no adjudication method described or necessary in the traditional sense (e.g., 2+1, 3+1). The AN24's MHR readings were directly compared to the SPO2 readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for the MHR monitoring capability. The study evaluates the performance of the AN24 device itself against a predicate device, not the improvement of human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation was conducted. The study directly compares the MHR outputs of the Monica AN24 device (algorithm only, as it's an automated measurement) against the outputs of the predicate SPO2 pulse oximeter. There is no human intervention in the MHR measurement process for either device in this comparative study.
7. The Type of Ground Truth Used
The ground truth for the MHR was the measurement from a predicate medical device: a SPO2 pulse oximeter (Philips M1191A) known to produce an MHR trace. Additionally, maternal heart rate was monitored by a pulse oximeter as part of the overall study design.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This type of submission (510(k) for a device with established underlying technology for FHR/UA and comparing a new MHR method) usually focuses on validation rather than demonstrating the development of a novel algorithm from scratch. It's possible the MHR algorithm in the AN24 was developed using internal data not disclosed in this summary, or it relies on well-established ECG signal processing techniques that don't require training in the machine learning sense. The clinical study described here is for validation/testing purposes.
9. How the Ground Truth for the Training Set Was Established
As no separate training set is explicitly mentioned or detailed, the method for establishing its ground truth is also not provided in this summary.
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