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510(k) Data Aggregation
(330 days)
Philips 50XM (K954351)
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 |
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(112 days)
Indicated for use by health care professionals whenever there is a need for measuring the noninvasive blood pressure and pulse rate of patients. It is intended for use in patient monitors for measurement of blood pressure and for calculation of pulse rate of adults, pediatrics, and neonates in health care facilities.
The picoNIBP OEM module is a complete noninvasive arterial blood pressure measurement component intended for use in patient monitors. The picoNIBP OEM module incorporates all hardware control and signal processing and also the algorithms to derive systolic, diastolic, and mean blood pressure as well as the pulse rate. The derived data is provided to the patient monitor that incorporates the picoNIBP OEM module.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets them with quantitative results. It primarily focuses on regulatory information, specifically a 510(k) summary for the Philips picoNIBP OEM module.
However, based on the information provided, here's what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Pass/Fail criteria were based on standards and on the specifications cleared for the predicate device. Test results demonstrated that the picoNIBP OEM module meets all reliability requirements and performance claims and showed substantial equivalence."
This indicates that specific performance metrics were tested against established standards and predicate device specifications. However, the actual numerical acceptance criteria and the reported device performance values are not present in the provided text.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Verification and validation testing activities were conducted," but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide any information about experts used for establishing ground truth or their qualifications. Given that this device measures non-invasive blood pressure, the ground truth would likely be established through comparison with a reference method (e.g., invasive arterial blood pressure monitoring) rather than expert consensus on images or interpretations.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. This type of study is more relevant for diagnostic imaging interpretation, not typically for physiological measurement devices like a blood pressure module.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
The text states: "The picoNIBP OEM module incorporates all hardware control and signal processing and also the algorithms to derive systolic, diastolic, and mean blood pressure as well as the pulse rate." It also mentions "accuracy determination." This implies that the device (which includes its algorithms) was tested for its standalone performance. However, no specific study details or quantitative results are provided. The phrase "Pass/Fail criteria were based on standards and on the specifications cleared for the predicate device" strongly suggests a standalone performance evaluation against defined metrics.
7. Type of Ground Truth Used:
While not explicitly stated, for non-invasive blood pressure devices, the typical ground truth used in performance studies involves comparison to a "gold standard" reference method, such as invasive arterial blood pressure measurement. It is possible that the "standards" mentioned in the text refer to internationally recognized protocols for NIBP accuracy testing (e.g., ISO 81060-2). The document does not explicitly state the type of ground truth.
8. Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide any information about a training set or how its ground truth was established.
Summary of what is present and what is missing:
| Information Requested | Presence in Document |
|---|---|
| 1. Table of Acceptance Criteria & Reported Performance | Partially Present (conceptually): States "Pass/Fail criteria were based on standards and on the specifications cleared for the predicate device" and that "Test results demonstrated that the picoNIBP OEM module meets all reliability requirements and performance claims." However, the actual numerical acceptance criteria and reported performance values are NOT provided. |
| 2. Test Set Sample Size & Data Provenance | Absent: No mention of sample size or data provenance (e.g., retrospective/prospective, country of origin). |
| 3. Number & Qualifications of Ground Truth Experts | Absent: No mention of experts for ground truth establishment. For NIBP, ground truth is typically a reference measurement, not expert consensus. |
| 4. Adjudication Method | Absent. |
| 5. MRMC Comparative Effectiveness Study & Effect Size | Absent: Not applicable for this type of device (physiological measurement vs. diagnostic interpretation). |
| 6. Standalone Performance Study | Implied/Present: The document states the device has "algorithms to derive systolic, diastolic, and mean blood pressure as well as the pulse rate" and that "accuracy determination" was part of testing. It confirms that the device "meets all reliability requirements and performance claims," which suggests standalone performance was evaluated. However, specific study details or quantitative results of this standalone performance are NOT provided. |
| 7. Type of Ground Truth Used | Implied: Likely comparison to a "gold standard" reference method (e.g., invasive blood pressure) based on industry standards for NIBP accuracy, but not explicitly stated in the document. |
| 8. Training Set Sample Size | Absent: No mention of a training set. The device reuses an existing NIBP algorithm from a predicate device, suggesting the algorithm was already developed and validated within the predicate. |
| 9. How Training Set Ground Truth Was Established | Absent: No mention of a training set. The device reuses an existing NIBP algorithm from a predicate device, suggesting the algorithm was already developed and validated within the predicate. Therefore, this device's submission focuses on demonstrating substantial equivalence, not necessarily on a de novo algorithm development and training process within this specific 510(k). |
In essence, the provided 510(k) summary serves as a regulatory document affirming that the picoNIBP OEM module has undergone verification and validation testing to demonstrate substantial equivalence to predicate devices, and that it met internal and standard-based "Pass/Fail criteria." However, it lacks the detailed study methodology and quantitative performance data that would typically be found in a comprehensive clinical study report.
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