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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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(220 days)
The Monica AN24 is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR) and uterine activity (UA). The AN24 acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) 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) from the fetal electrocardiogram (fECG) and Uterine Activity (UA) from the Electrohysterogram (EHG) 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 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) and Uterine Activity (UA) are continuously extracted and displayed in the same standard format as the predicate device.
Here's a breakdown of the acceptance criteria and the study details for the Monica AN24 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct thresholds in the document, but rather implied by the non-inferiority comparison to the predicate device and the reported outcomes from the clinical study. The study aimed to demonstrate that the Monica AN24 is at least as accurate and reliable as the predicate device. Therefore, the "acceptance criteria" can be inferred as performance greater than or equal to the predicate device for each metric.
| Metric | Implied Acceptance Criteria (relative to Predicate) | Reported Monica AN24 Performance | Reported Predicate Performance (Philips 50XM) |
|---|---|---|---|
| Fetal Heart Rate (FHR) Interpretability (PPA) | ≥ 72% | 85% | 72% |
| FHR Accuracy (RMS Error) | ≤ 12 bpm | 5 bpm | 12 bpm |
| Uterine Activity (UA) Interpretability (PPA) | ≥ 67% | 97% | 67% |
| UA Sensitivity Accuracy (Sensitivity for Contractions) | ≥ 55% | 89% | 55% |
| UA Timing Accuracy (Mean Timing Difference for Contractions) | ≤ 3.3 seconds lag | 2.5 seconds lag | 3.3 seconds lag |
2. Sample Sizes and Data Provenance
- Test Set (Clinical Study):
- Total Subjects Enrolled: 60 women.
- Evaluable Data Subjects: 34 subjects.
- FHR Study Subjects: 33 women.
- UA Study Subjects: 30 women.
- Data Provenance: The study was conducted at two clinical sites: QHC, New York, and Temple University, Philadelphia. This indicates prospective data collection in the USA.
- Training Set Sample Size: Not explicitly stated. The document describes a "clinical equivalence trial" and a "subsequent Multi-Reader-Multi-Case (MRMC) study," which are generally used for validation/testing.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Four.
- Qualifications of Experts: Board Certified Obstetricians. (Specific years of experience are not mentioned).
4. Adjudication Method (Test Set)
- Uterine Activity (UA): The uterine activity data was "independently reviewed in a Multi-Reader Study by four Board Certified Obstetricians who independently indicated on randomized trace segments." The results were "averaged" to establish the ground truth for UA. This aligns with a form of consensus-based adjudication, likely an average or 4/4 agreement model, though the exact decision rule isn't specified beyond "average of 4 board certified obstetricians."
- Fetal Heart Rate (FHR): The ground truth for FHR was established directly by the "Direct fetal Scalp ECG (second Phillips Series 50XM device)," which served as the gold standard. No expert adjudication was mentioned for FHR.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Yes, a "Multi-Reader-Multi-Case (MRMC) study" was integral to the evaluation of Uterine Activity (UA).
- Effect Size of Human Readers' Improvement with AI vs. without AI assistance: The document focuses on the performance of the device itself (Monica AN24 or predicate) compared to the gold standard, with human readers involved in establishing the ground truth for UA and in reviewing "False Positives." It does not describe a comparative effectiveness study where human readers interpret tracings with and without AI assistance to measure reader improvement. The MRMC study in this context refers to multiple readers evaluating the output of different devices (Monica AN24, TOCO, IUPC) to derive ground truth and compare device performance.
6. Standalone (Algorithm Only) Performance Study
- Yes, the study primarily assessed the standalone performance of the Monica AN24 device (algorithm only), comparing its output directly against established gold standards (fetal scalp ECG for FHR, IUPC for UA). The metrics (PPA, RMS error, sensitivity, timing accuracy) are all measures of the device's inherent performance.
7. Type of Ground Truth Used
- Fetal Heart Rate (FHR): Direct fetal Scalp ECG (from a second Philips Series 50XM device). This is a direct physiological measurement considered the gold standard.
- Uterine Activity (UA): Intrauterine Pressure Catheter (IUPC) (from a Philips Series 50XM device), with expert consensus from four Board Certified Obstetricians used to interpret the tracings and mark contractions. This is a combination of direct physiological measurement and expert consensus/adjudication.
8. Sample Size for the Training Set
- The document does not explicitly state the sample size used for training the Monica AN24 device's algorithms. The described study is a clinical equivalence trial used for validation of the device's performance against a gold standard and a predicate, not for training.
9. How Ground Truth for the Training Set was Established
- The document does not provide information on how ground truth was established for the training set, as the focus is on the clinical validation study for regulatory submission.
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