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510(k) Data Aggregation
(146 days)
MONICA HEALTHCARE LTD.
The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.
The Novii Patch is an accessory to the Novii Pod that connects directly to the Novii Pod and contains the surface electrodes that attach to the abdomen.
The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.
The Novii Pod maternal-fetal monitor and its accessories are intended for use by healthcare professionals in a clinical setting
The Monica Novii Pod Fetal-Maternal Monitor is designed as an ambulatory device for the monitoring of a pregnant mother. The monitor enables the abdominal electrophysiological signal to be picked up from three different positions on the maternal abdomen using the 5 electrodes on the Monica Novii Patch. The monitor filters the abdominal signals, converts the abdominal electrophysiological data into a digital format and then processes it in real time to extract the fetal heart rate, maternal heart rate and uterine activity. The result of the processing is transmitted via the Bluetooth connection to the Monica Novii CTG Interface device that is a Monica Approved accessory to the Monica Novii Pod.
Here's a breakdown of the acceptance criteria and the studies that prove the Monica Novii Wireless Patch System meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides acceptance criteria for non-clinical tests (Data Transfer Validation and Data Extraction Validation).
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Non-Clinical Testing | |||
| Data Transfer Validation | Bias difference for Fetal Heart Rate (FHR) | Less than 1 BPM | Demonstrated compliance (implies bias difference was |
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(330 days)
MONICA HEALTHCARE LTD.
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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(34 days)
MONICA HEALTHCARE
The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.
The Monica IF24 CTG Interface Device is an interface device that allows an AN24 to send data to a standard Fetal Monitor. 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 IF24 CTG Interface Device is a small, low-voltage device that receives the monitored parameters from the Monica AN24 Fetal Monitor and converts the wireless digital signal to analogue for inputting into a CTG Monitor. It has a touch screen for:
- Selection of the appropriate CTG monitor
- Calibration with the CTG Monitor
- Display AN24 battery power
- Display Bluetooth connectivity between the AN24 & IF24
The Monica IF24 CTG Interface Device is an accessory designed to interface the wireless output of the Monica AN24 Fetal Monitor with a standard CTG (Cardiotocography) Fetal monitor. This allows signals collected by the AN24 to be displayed, printed, and potentially sent to a central network via the CTG monitor.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on non-clinical testing and substantial equivalence rather than explicit performance metrics with acceptance criteria for clinical efficacy. The acceptance criteria are broadly implied as compliance with relevant voluntary standards and accurate data reception/transmission.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety (Compliance with EN60601-1) | "The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Electrical Safety." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were EN60601-1 electrical safety." |
| EMC (Electromagnetic Compatibility) (Compliance with EN60601-1-2, FCC CFR47) | "The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: EMC." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were EN60601-1-2 EMC, FCC CFR47 EMC." |
| Material Safety/Biocompatibility (Compliance with ISO10993) | "The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Material Safety." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were ISO10993 Biocompatibility." |
| Software Validation (Compliance with EN 62304) | "The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Software Validation." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were EN 62304 Software." |
| Usability (Compliance with IEC 62366) | "The Monica IF24 CTG Interface Device and Accessories comply with voluntary standards. The standards were employed in the following areas: Usability." "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were IEC 62366 Usability." |
| Quality Management System (Compliance with ISO13485) | "The non clinical tests used voluntary standards to demonstrate that the Monica IF24 CTG Interface Device is as safe and effective in performance to the predicate device, the main standards employed were ISO13485 QMS." |
| Accurate data reception and transmission | "The Monica IF24 CTG Interface Device accurately receives and transmits the correct data." (Demonstrated through "software validation and performance bench testing"). |
| Substantial Equivalence to predicate devices | "The conclusions drawn from the nonclinical tests, performance tests and the validation demonstrate that the Monica IF24 CTG Interface Device is substantially equivalent to the legally marketed predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a "test set" in the context of clinical data for the IF24 device. The regulatory submission is primarily based on non-clinical tests (electrical safety, EMC, material safety, software validation, usability, and performance bench testing) to demonstrate substantial equivalence to predicate devices (Monica AN24, Philips Avalon CTS).
- Sample Size for Test Set: Not applicable or not specified in terms of patient data. The testing involves engineering and software validation tests.
- Data Provenance: Not applicable in terms of patient data. The testing is described as non-clinical and performance bench testing, likely conducted in a laboratory or engineering environment. The manufacturer is Monica Healthcare Ltd, based in Nottingham, UK.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. Given the non-clinical nature of the testing described, it's unlikely that "experts" (e.g., radiologists) in the typical sense for medical image interpretation were used for establishing ground truth for a clinical test set. The experts involved would likely be engineers, software testers, and regulatory compliance specialists responsible for executing and evaluating the non-clinical tests.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of an adjudication method for a clinical test set because the provided information focuses on non-clinical and bench testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through non-clinical testing of the interface device itself, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The concept of "standalone performance" as typically applied to an AI algorithm making a diagnosis or performing a task without human intervention doesn't directly apply here. The Monica IF24 is an interface device; its "performance" is in accurately receiving and transmitting data, not in making clinical interpretations. The "algorithm" in this context refers to the software controlling the device's functionality (e.g., conversion of wireless digital signal to analog), which was validated through "software validation and performance bench testing" to ensure accurate data handling.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" would be established by:
- Compliance with published standards: For electrical safety, EMC, material safety, software, usability, and QMS, the ground truth is simply adherence to the requirements outlined in the specified standards (e.g., EN60601-1, IEC 62366).
- Expected data values/behavior: For "accurate data reception and transmission," the ground truth would be the known input data values from the AN24 and the expected output values and waveform fidelity on the CTG monitor, verified through performance bench testing.
8. The Sample Size for the Training Set:
Not applicable. The Monica IF24 is an interface device, not an AI model that requires a training set in the conventional sense of machine learning for classification or prediction tasks. The software involved handles data conversion and communication, which is validated, not "trained."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no mention of a training set for an AI model.
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(220 days)
MONICA HEALTHCARE
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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