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The LaborView ™ LV1000 Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.

The LaborView™ LV1000 Wireless Electrode System is a uterine activity (UA), maternal (MHR) and fetal (FHR) heart rate sensor replacement intended to interface with existing Philips Avalon fetal monitors in hospital delivery environments.

Labor View™ LV1000 Wireless Electrode System is comprised of an electrode array, a wireless transmitter ("Transmitter"), computational base station"), a power supply module, and adapters to connect to compatible fetal monitors. The electrode array is sensitive to changes in the electrical activity at the skin surface due to muscle contractions, maternal, and fetal ECG when placed on the expectant mothers abdomen. These signals are passed to the device, converted to a contraction curve, maternal heart rate (MHR), and fetal heart rate (FHR), and subsequently passed to the Philips monitor.

All the components of LaborView™ LV1000 Wireless Electrode System work together with the compatible fetal monitors to complete a system that can detect maternal contractions, MHR and FHR during labor. The fetal monitor, in turn, may interface to a central monitoring system in order to conveniently present contraction information to clinicians.

The provided text describes a 510(k) premarket notification for the LaborView™ LV1000 Wireless Electrode System, but it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria and a detailed study report for a novel AI device.

Therefore, the requested information on acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training data details is not available in the provided document.

The document discusses non-clinical testing which includes:

• Biocompatibility
• Software Verification (compliance with FDA guidance, but no specific performance metrics)
• Electrical Safety, EMC, and Wireless Capability (compliance with standards like ANSI/AAMI ES60601-1, IEC 60601-1-2014)
• Performance Testing (bench testing verifying performance to specifications, including Electrode Array, Transmitter, Base Station, Monitor Interface Cable, System Validation, EC13 Compliance Verification for Maternal Heart Rate (MHR), Comparative Testing, and Testing with compatible patient monitors).

While "Performance Testing" is mentioned, no specific acceptance criteria for these tests or the results demonstrating the device meets them are provided. The focus is on verifying compliance with design specifications and industry standards rather than a clinical performance study with predefined acceptance metrics for accuracy, sensitivity, or specificity.

In summary, based on the provided text, it is not possible to fill out the requested table or answer most of the detailed questions regarding acceptance criteria and performance study specifics for an AI device, as the document describes a 510(k) for a medical device (a wireless electrode system) that is seeking substantial equivalence to a predicate, not a performance study of a novel AI algorithm.

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PUREtrace™ is an electromyography (EMG) device that non-invasively measures intrapartum uterine activity. PUREtrace™ is indicated for use on women who are at term (≥37 completed weeks), in labor, with singleton pregnancies. The signal is acquired from surface electrodes that are placed on the maternal abdomen. PUREtrace™ is intended for use by healthcare professionals in a clinical setting.

PUREtrace is a device for registering the electrical activity of the uterine muscle (myometrium) of laboring patients. PUREtrace consists of a multi surface-electrode patch (Graphium patch) and a hardware module (PUREtrace module). The Graphium patch is applied to the abdomen of the patient and acquires the electromyography (EMG) signal of the uterine muscle (electrohysterography, EHG). During a contraction, a large number of uterine muscle cells contract in a controlled manner and the changes in potential can be measured as changes in electrical on the skin of the pregnant woman's abdomen. This signal is sent to the PUREtrace module, converted into a measure for uterine activity and subsequently sent to a compatible fetal monitor where it is displayed as a tocogram. PUREtrace is available in multiple variants with different output connectors to facilitate interfacing with various fetal monitors.

Here's a summary of the acceptance criteria and the study conducted for the PUREtrace™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. However, it implicitly uses the concept of "substantial equivalence" to a predicate device as the primary acceptance criterion. The performance is reported in terms of the device's ability to display uterine activity comparably to existing methods.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Study): 42 women initially enrolled. 40 uterine activity (UA) registrations with sufficient usable data were assessed for performance evaluation.
• Data Provenance: The document does not specify the country of origin of the data. The study was an "observational clinical study," suggesting prospective data collection for the purpose of the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Three individual clinical investigators.
• Qualifications of Experts: They are referred to as "clinical investigators." No specific qualifications like "radiologist with 10 years of experience" are provided.

4. Adjudication Method for the Test Set

The adjudication method appears to be individual blinded assessment and annotation. The text states: "The tracings were reviewed by three individual clinical investigators, who were blinded to the technology used and the study subjects corresponding with the tracings. The clinical investigators assessed the interpretability of the tracings. In addition, they annotated the tracings by marking all deflections they assessed to be uterine contractions." This implies each expert independently reviewed and marked contractions, and the overall "performance" was assessed based on these individual assessments, likely compared against a gold standard (TOCO and IUPC data). It does not explicitly mention a consensus or arbitration process among the three experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly described. The clinical study was designed to compare the PUREtrace™ device (which uses electromyography and processes the signal to display uterine activity) against established methods (tocodynamometry and intrauterine pressure catheter) and to assess its interpretability by human readers. The PUREtrace™ device itself is an "electromyography (EMG) device" that "converts [the EMG signal] into a measure for uterine activity and subsequently sent to a compatible fetal monitor where it is displayed as a tocogram." It's not presented as an AI-assisted human reading tool in this context, but rather a direct measurement and display device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment of the PUREtrace™ device was done in the clinical study. The device's output (the displayed tocogram derived from EMG) was directly compared against TOCO and IUPC readings, and its interpretability was assessed by clinical investigators. The device is intended to non-invasively measure and display uterine activity, and its "performance" in doing so was evaluated independently.

7. The Type of Ground Truth Used

The ground truth used for comparison in the clinical study was:

• Tocodynamometry (TOCO): An external method for monitoring uterine contractions.
• Intrauterine Pressure Catheter (IUPC): An invasive, more direct and typically considered gold standard method for measuring uterine contraction strength and frequency.

The study simultaneously monitored uterine activity with PUREtrace™, TOCO, and IUPC.

8. The Sample Size for the Training Set

The provided document does not specify a training set sample size. The description focuses on the clinical performance testing of the device rather than its development or machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not explicitly mentioned or described, the method for establishing its ground truth is not provided in this document.

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The LaborView LV1000™ Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.

The LaborView LV1000 is a uterine activity and maternal and fetal heart rate sensor replacement intended to interface to existing perinatal monitors in use in hospital delivery environments. LaborView is comprised of an electrode array, a wireless front-end ("Front-end"), computational back-end ("Back-end"), a power supply module, and optional adapters to connect to various perinatal monitors. The electrode array is sensitive to changes in electrical characteristics of the skin due to muscle contractions, maternal, and fetal ECG when placed on the expectant mother's abdomen. These signals are passed to LaborView, converted to a contraction curve and maternal heart rate (MHR), and fetal heart rate (FHR), and subsequently passed to the perinatal monitor. Note not all perinatal monitors support input of the MHR. Labor View includes the hardware and firmware necessary to convert the electrical signals obtained via the electrode array into contraction, MHR, and FHR curves. Labor View provides analog interfaces to the electrode array and the perinatal monitor but may also interface via USB to a data collection application running on a host PC. The Front-end mates to the electrode array, digitizes the signals and transmits the signals wirelessly to the Back-end component. The Back-end receives the signals from the Front-end. implements the digital signal processing to create the MHR, FHR and contraction curves, then transmits them via the monitor cable/interface to the existing perinatal monitor. A variety of connector adapters may exist between the Back-end and the perinatal monitor such that a single Back-end design can interface to a variety of perinatal monitor manufacturers and models. The LaborView system power is supplied via an isolated power supply or a rechargeable battery pack. All of the components of Labor View work together with the perinatal monitor to complete a system that can detect maternal contractions, MHR and FHR during labor. The perinatal monitor, in turn, may interface to a central monitoring system in order to conveniently present contraction information to clinicians.

Here's an analysis of the acceptance criteria and study findings for the LaborView LV1000, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a discrete table of "acceptance criteria" with numerical targets. Instead, it describes clinical testing comparing the LaborView LV1000's performance against established gold standards and its predicate device (Monica AN24) for various endpoints. The implication is that meeting or performing "as well as" these standards and the predicate serves as the acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Clinical Testing (Comparative Effectiveness Study): 107 subjects.
• Data Provenance: Prospective, non-randomized, multi-center study. The document does not specify the country of origin of the data, but given the FDA submission, it's highly likely to be U.S.-based or conducted under U.S. regulatory guidelines.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the "number of experts" used to establish ground truth or their specific qualifications (e.g., radiologist with 10 years of experience). However, the ground truth itself is established by medical devices:

• Uterine Activity (UA) Ground Truth: Intrauterine Pressure Catheter (IUPC) – this is considered the clinical "gold standard" for measuring uterine contractions.
• Clinical context: The study was conducted in a "clinical setting" by "healthcare professionals," implying that medical staff (e.g., obstetricians, nurses) were involved in patient care and data interpretation, but not explicitly for "ground truth adjudication" in the typical sense of expert reading.

4. Adjudication Method for the Test Set

The document describes a comparative clinical study where the LaborView LV1000's performance was evaluated against a "gold standard" (IUPC) and a predicate device (Toco). It does not mention a human "adjudication method" in terms of multiple experts reaching consensus on an image or tracing interpretation for the test set. Instead, objective measurements from the gold standard device (IUPC) served as the direct reference for comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Was an MRMC study done? No, the document describes a comparative clinical study of the device against a gold standard and a predicate device, not a study evaluating human reader performance with and without AI assistance. The LaborView LV1000 is presented as a sensor replacement for existing monitors, providing data to human healthcare professionals, rather than an AI interpretation tool for human readers.
• Effect size of human readers improving with AI: Not applicable, as this was not an MRMC study focused on human reader improvement with AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the clinical comparative effectiveness study evaluates the LaborView LV1000's standalone performance in measuring FHR, UA, and MHR by comparing its outputs directly against gold standard measurements (IUPC for UA, and implied clinical standards for FHR/MHR, though FHR ground truth method isn't explicitly stated, likely Fetal Scalp Electrode - FSE, as mentioned as a comparison for the predicate). The device produces curves and measurements that are then displayed on existing perinatal monitors for healthcare professionals to interpret. The study aims to validate the accuracy of these generated measurements.

7. The Type of Ground Truth Used

• Uterine Activity (UA): Intrauterine Pressure Catheter (IUPC) – considered the gold standard for objective measurement of uterine contractions.
• Fetal Heart Rate (FHR): The document for the LaborView LV1000 comparison study notes "Comparison to Fetal Scalp Electrode (FSE) for Fetal Heart Rate" in the predicate comparison table, implying FSE would be the gold standard used or referenced for FHR.
• Maternal Heart Rate (MHR): ANSI / AAMI EC13 simulation (for bench testing) and likely standard clinical vital sign monitoring in the clinical study.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" sample size. This is a 510(k) submission for a medical device (sensor system), not primarily an AI algorithm. While it leverages digital signal processing, the submission focuses on validating the device's measurements against established clinical standards, not on training an AI model with a distinct dataset. If internal algorithmic parameters were optimized, details about that training would not typically be in this summary.

9. How the Ground Truth for the Training Set Was Established

Not applicable as a distinct "training set" for an AI algorithm (in the modern sense) is not described or the focus of this 510(k) summary. The "ground truth" discussed pertains to the clinical validation of the device's output against established medical measurement standards during testing.

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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).

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The EUM100Pro (Electro Uterine Monitor) is a transabdominal electromyography (EMG) monitor intended to non-invasively measure intrapartum uterine activity. The EUM100Pro acquires the signal from surface EMG electrodes placed on the patient abdomen.

The EUM100Pro is intended for use on women in term (>36 completed weeks of gestation) labor, with singleton pregnancies.

The EUM100Pro is intended for use by healthcare professionals in a clinical setting.

The EUM100Pro System is designed to present and record the electrical activity of the uterus. The activity is shown as graphs similar to the commonly use toco-dynamometer.

The EUM100Pro is built around an EN- 60950 certified computer. Analog signals are obtained from CE certified amplifier box from Delsys Inc., Boston, MA. Delsys also supply the input modules, power supply, electrodes and disposable stickers.

The system is comprised of a multi-channel surface electromyogram operative to sense electromyographic (EMG) activity, a three-dimensional position sensor and a personal computer providing data analysis, recording media and a graphical user interface.

Here's a summary of the acceptance criteria and study details for the EUM100Pro device, based on the provided text:

Acceptance Criteria and Device Performance

The provided text does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes the clinical study's purpose as providing "evidence that the EUM 100Pro performed substantially equivalently to the legally marketed predicate devices for detecting and displaying uterine activity."

Therefore, the implicit acceptance criteria are based on demonstrating substantial equivalence to predicate devices (Tocodynamometry - TOCO and Intrauterine Pressure Catheter - IUPC) in detecting and displaying uterine activity, as assessed by physicians.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 43 women.
   • Data Provenance: The text does not specify the country of origin. It indicates the study was "conducted a clinical study enrolling 43 women at term gestation in active labor." The context suggests this was a prospective clinical study as women were enrolled specifically for this evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Three (3) physicians.
   • Qualifications: The text only states "three physicians." No specific qualifications (e.g., years of experience, specialty) are provided.

3. Adjudication method for the test set:

   • The physicians "evaluated independently" and were "masked to the technology used to acquire the tracings." They were asked to annotate contractions and indicate the total number. The text does not explicitly state an adjudication method like 2+1 or 3+1 for discrepancies. It implies that the individual assessments of these three physicians, when compared across the different tracing types (EUM, TOCO, IUPC), formed the basis for concluding substantial equivalence.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not reported. This study assessed the standalone performance of the EUM100Pro device (which incorporates an algorithm) in comparison to established methods (TOCO and IUPC) as interpreted by physicians. The focus was on the device's ability to generate signals comparable to existing methods, rather than on improving human reader performance with aid.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, a standalone evaluation of the EUM100Pro's output was done. The EUM100Pro is described as generating "graphs similar to the commonly use toco-dynamometer," and these tracings were presented to physicians for interpretation. The study was designed to show the device's performance in detecting and displaying uterine activity itself, which is a standalone function of the algorithm and hardware. The physicians then interpreted these device-generated tracings.

6. The type of ground truth used:

   • The ground truth was established by expert consensus/interpretation of established predicate technologies (Tocodynamometry - TOCO and Intrauterine Pressure Catheter - IUPC) and the EUM100Pro's own output, all compared simultaneously. The study design implicitly uses the TOCO and IUPC as the "established" or "reference" methods against which the EUM100Pro's output is compared, with expert physician interpretation serving as the ultimate arbiter of what constitutes a contraction on any of the tracings.

7. The sample size for the training set:

   • The document does not provide any information about a separate training set or its sample size. The clinical study described appears to be a validation or test set. Without information on an AI/ML component that requires explicit training, details about a training set are not included.

8. How the ground truth for the training set was established:

   • As no information on a training set is provided, the method for establishing its ground truth is also not stated.

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The SureCALL® Labor Monitor® is a transabdominal electromyography (EMG) monitor intended to measure uterine activity. It is intended for use on pregnant women who are at term (>36 completed weeks), with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.

The SureCALL® Labor Monitor® is a transabdominal electromyography monitor. The device consists of a Signal Conditioning Module specifically designed to collect, filter, and amplify the electromyographic (EMG) signal and a separate Control System to analyze, record, and display the EMG signal. In addition, the device has the option to record and display the input from standard FDA-cleared fetal heart rate sensor, intrauterine pressure catheter, and maternal heart rate sensor or tocodynamometers transducer device, alongside the EMG signal traces. The Signal Conditioning Module contains electronic components designed to receive a physiological signal from a set of Ag/AgCI surface electrodes placed on the subject's abdomen and amplify and filter the signal. The optional fetal heart rate, intrauterine pressure catheter, and maternal heart rate or tocodynamometer's signals originating and collected from FDA-cleared devices pass through the Signal Conditioning Module without modification. The Control System consists of an off-the-shelf laptop computer with a LabVIEW based program designed to collect, record and display electrical signals in a meaningful and easily quantifiable format.

Here is the information describing the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

Acceptance Criteria and Device Performance

Study Information:

1. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample size for the "comprehensive clinical study" or the "multi-reader study."
   • The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions the "new indications for use were substantiated by a comprehensive clinical study and a follow-up multi-reader study."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document mentions a "multi-reader study" but does not specify the number of readers (experts) or their qualifications.

3. Adjudication method for the test set:

   • The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the "multi-reader study."

4. 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:

   • A "multi-reader study" was conducted.
   • However, the document does not describe a comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. The multi-reader study results report sensitivity, extra event rate, and individual agreement among readers in "preterm patients" – implying evaluation of the device output itself by readers, not the device's assistance to readers in interpretation of other data. It does not provide an effect size for human reader improvement with AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The "comprehensive clinical study" compares the SureCALL® Labor Monitor® (implicitly, its algorithm's output) against a tocodynamometer (TOCO), suggesting a standalone evaluation of the device's ability to detect uterine contractions. The results (e.g., 95% agreement with TOCO, peak difference) reflect the device's performance directly.

6. The type of ground truth used:

   • For the "comprehensive clinical study," the ground truth for uterine contraction detection appears to be established via comparison with the tocodynamometer (TOCO). The study directly compares the SureCALL® measurements (RMS) to those from a TOCO device.
   • For the "multi-reader study," the ground truth against which reader performance (sensitivity, extra event rate, agreement) was judged is not explicitly stated but is implicitly the interpretation of the SureCALL® event detections, possibly against some established clinical standard or another reference. The document refers to "SureCALL® event rate" and "individual agreement" which suggests readers are evaluating events identified by the device.

7. The sample size for the training set:

   • The document does not provide any information on the sample size used for a training set. The context suggests that the SureCALL® Labor Monitor® [K090145] was an existing device, and K130002 is for new indications, rather than a completely new algorithm requiring new training.

8. How the ground truth for the training set was established:

   • The document does not provide any information on how ground truth for a training set was established.

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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.

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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.

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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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.

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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The SureCALL® EMG Labor Monitor® is a transabdominal electromyography (EMG) monitor intended to measure intrapartum uterine activity. It is intended for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.

The SureCALL® EMG Labor Monitor® is a transabdominal electromyography monitor. The device consists of a Signal Conditioning Module specifically designed to collect. filter, and amplify the electromyographical (EMG) signal and a separate Control System to analyze, record, and display the EMG signal. In addition, the device records and displays the input from standard FDA-cleared maternal heart rate sensor, fetal, heart rate sensor, intrauterine pressure catheter and tocodynamometer transducer devices, along side the EMG signal traces. The Signal Conditioning Module contains electronic components designed to receive a physiological signal from a set of Ag/AgCl surface electrodes placed on the subject's abdomen and amplify and filter the signal. The heart rate, intrauterine pressure, and/or tocodynamometer signals originating and collected from FDA-cleared devices pass through the Signal Conditioning Module without modification. The Control System consists of an off-the-shelf laptop computer with a LabVIEW based program designed to collect, record and display electrical signals in a meaningful and quantifiable format.

This document unfortunately does not contain explicit acceptance criteria for the SureCALL® EMG Labor Monitor®. It describes the device, its intended use, and the studies conducted, but it does not provide specific quantitative thresholds (e.g., "sensitivity must be >90%") that the device needed to meet to be considered effective.

Therefore, I cannot populate the "Acceptance Criteria" column in the table below. However, I can still provide the reported device performance and other requested information based on the provided text.

Acceptance Criteria and Study Details for SureCALL® EMG Labor Monitor®

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 20 women
• Data Provenance: The study was conducted at "three clinical sites," implying a prospective clinical study in an unspecified country (likely the US, given the FDA submission).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number or qualifications of experts used to establish ground truth or evaluate tracings in the initial "three-way clinical study." However, for the follow-up Multi-Reader Multi-Case (MRMC) study, it refers to "clinician judgment" and "readers" but does not specify the number or their qualifications.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (such as 2+1 or 3+1) for establishing ground truth or resolving discrepancies among readers in either the initial three-way study or the MRMC study. It mentions the "varied" nature of "clinician judgment on individual deflections," indicating a lack of formal adjudication method for those specific deflections and highlighting the subjectivity.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? Yes, a "second study" was conducted using "multi-reader-multi-case (MRMC) methodology where each reader read all three tracings."
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable. This was a comparative study between SureCALL® EMG, tocodynamometry, and IUPC, not a study to evaluate human reader improvement with AI assistance. The MRMC study evaluated the relative False Positive (FP) rate for SureCALL® and tocodynamometry but concluded that clinician judgment varied too widely to generalize the comparison of FP rates.

6. Standalone (Algorithm Only) Performance Study

The document does not explicitly detail a separate standalone (algorithm only without human-in-the-loop) performance study. The studies described involve the device's output (tracings) which are then interpreted. The device implicitly performs the "detection of uterine myoelectric activity" and "analysis" (via the Control System's LabVIEW program), but its performance is always discussed in the context of interpretation by clinicians or comparison to other monitoring methods.

7. Type of Ground Truth Used

• Ground Truth Type: Intrauterine Pressure Catheter (IUPC) was used as the 'gold standard' for measuring uterine activity.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. The description focuses solely on the clinical studies used for validation.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, this information is not provided.

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