Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The F15A series fetal and maternal monitor can monitor multiple physiological parameters of the fetus/mother in real time. F15A series can display, store, and print patient information and parameters, provide alarms of fetal and maternal parameters, and transmit patient data and parameters to Central Monitoring System.

F15A series fetal and maternal monitors mainly provide following primary feature:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The provided FDA 510(k) clearance letter and summary for the Fetal & Maternal Monitor (F15A, F15A Air) do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

The document focuses primarily on demonstrating substantial equivalence to a predicate device (Edan Instruments, Inc., F9 Express Fetal & Maternal Monitor, K173042) through comparison of intended use, technological characteristics, and conformance to various safety and performance standards. It mentions "functional and system level testing to validate the performance of the devices" and "results of the bench testing show that the subject device meets relevant consensus standards," but it does not specify quantitative acceptance criteria for each individual physiological parameter (e.g., FHR accuracy, SpO2 accuracy) nor the specific results of those tests beyond stating that they comply with standards.

Specifically, the document does not include information on:

• A table of acceptance criteria with specific quantitative targets for each parameter and the reported device performance values against those targets. It only states compliance with standards.
• Sample sizes used for a "test set" in the context of clinical performance evaluation (it mentions "bench testing," but this is typically laboratory-based and doesn't involve patient data in a "test set" sense for AI/algorithm performance validation).
• Data provenance for such a test set (e.g., country of origin, retrospective/prospective).
• Number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or human reader improvement data with AI assistance.
• Standalone (algorithm-only) performance, as this is a monitoring device, not a diagnostic AI algorithm.
• Type of ground truth (beyond "bench testing" which implies engineered signals or controlled environments).
• Sample size for a training set or how ground truth for a training set was established. This device is a traditional medical device, not an AI/ML-driven diagnostic or interpretative algorithm in the way your request implies.

Therefore, based solely on the provided text, I can only address what is present or infer what is missing.

Here's a breakdown based on the available information:

Analysis of Acceptance Criteria and Performance Testing based on Provided Document

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (F9 Express Fetal & Maternal Monitor, K173042) by showing that the new device (F15A, F15A Air) has the same intended use and fundamentally similar technological characteristics, with any differences not raising new safety or effectiveness concerns.

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table with quantitative acceptance criteria for each physiological parameter (e.g., FHR accuracy, SpO2 accuracy) and the corresponding reported performance values obtained in testing. Instead, it states that the device was assessed for conformity with relevant consensus standards. For example, it lists:

• IEC 60601-2-37:2015: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (relevant for FHR).
• ISO 80601-2-61:2017+A1:2018: Particular requirements for basic safety and essential performance of pulse oximeter equipment (relevant for SpO2).
• ISO 80601-2-56:2017+A1:2018: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (relevant for TEMP).
• IEC 60601-2-27:2011: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (relevant for MECG/DECG).

Acceptance Criteria (Inferred from standards compliance): The acceptance criteria are implicitly the performance requirements specified within these listed consensus standards. These standards set limits for accuracy, precision, response time, and other performance metrics for each type of measurement.

Reported Device Performance: The document states: "The results of the bench testing show that the subject device meets relevant consensus standards." This implies that the measured performance statistics (e.g., accuracy, bias, precision) for each parameter fell within the acceptable limits defined by the respective standards. However, the specific measured values are not provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench Testing" which implies laboratory-based testing using simulators, controlled signals, or phantoms, rather than a "test set" involving patient data. There is no information provided regarding:

• Sample size (e.g., number of recordings, duration of recordings, number of simulated cases) for the bench tests for each parameter.
• Data provenance (e.g., country of origin, retrospective or prospective) as this is not a study involving patient data collection for performance validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable and not provided. For a traditional physiological monitor, ground truth for bench testing is typically established using:

• Calibrated reference equipment/simulators: e.g., ECG simulators to generate known heart rates, SpO2 simulators to generate known oxygen saturation levels.
• Physical standards/phantoms: e.g., temperature baths at known temperatures.
• Known physical properties: e.g., precise weights for pressure transducers.

Clinical experts are not involved in establishing ground truth for bench performance of these types of physiological measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable and not provided. Adjudication methods are relevant for human expert review of complex clinical data (e.g., medical images for AI validation) to establish a consensus ground truth. For bench testing of physiological monitors, ground truth is objectively determined by calibrated instruments or defined physical parameters.

5. 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

This is not applicable and not provided. An MRMC study is typically performed to evaluate the diagnostic accuracy of AI-assisted human interpretations versus unassisted human interpretations for AI-driven diagnostic devices. The Fetal & Maternal Monitor is a physiological monitoring device, not an AI-assisted diagnostic imaging or interpretation system. It measures and displays physiological parameters; it does not provide AI-driven assistance for human "readers" to interpret complex clinical information.

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

The device is a monitor that directly measures physiological parameters. It is not an "algorithm only" device in the sense of an AI model providing a diagnostic output. Its performance (e.g., FHR accuracy) is its standalone performance, as it directly measures these parameters. The document states "functional and system level testing to validate the performance of the devices," which would represent this type of standalone performance for the measurement functionalities. However, specific quantitative results are not given, only compliance with standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained in point 3, the ground truth for bench testing of physiological monitors is established using calibrated reference equipment/simulators and physical standards.

8. The sample size for the training set

This is not applicable and not provided. This device is a traditional physiological monitor, not a machine learning model that requires a "training set." Its algorithms for parameter measurement are based on established physiological principles and signal processing techniques, not on statistical learning from large datasets.

9. How the ground truth for the training set was established

This is not applicable and not provided for the same reasons as point 8.

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

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

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

The EUM100Pro (electro uterine monitor) System is designed to present and transmit via RS232 protocol the electrical activity of the uterus and fetal heart rate. The data is shown and displayed as graphs (uterine activity and FHR) and similar to the commonly use toco-dynamometer / Doppler monitors.

The EUM100Pro is built around an EN 60950 certified computer.

Here's an analysis of the acceptance criteria and the study used to validate the EUM 100Pro device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds (e.g., "sensitivity must be >X%"). Instead, it focuses on demonstrating non-inferiority of the EUM100Pro compared to a Doppler-based Fetal Monitor, using a fetal scalp electrode as the gold standard.

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

• Sample Size: 33 women
• Data Provenance: The document does not explicitly state the country of origin. It mentions "a clinical study was completed," implying a prospective study setting where subjects were enrolled for this specific study. Given the manufacturer's address (Israel), it's plausible the study was conducted there or in a comparable clinical research environment. It is a prospective study.

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

The document does not specify the number of experts used to establish the ground truth. The gold standard for FHR measurement was a fetal scalp electrode connected to a Philips HP 50 XM, which is an objective measurement tool rather than relying on expert interpretation for ground truth.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method in the context of expert review or consensus for the test set. The ground truth was established by an objective medical device (fetal scalp electrode), so adjudication by human experts was not necessary for the FHR data itself.

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, a multi-reader, multi-case comparative effectiveness study was not explicitly described. The study focused on the standalone performance of the EUM100Pro as a device for FHR and uterine activity monitoring, comparing its readings directly against a gold standard and a reference device, rather than evaluating human reader performance with or without AI assistance. The EUM100Pro is a monitoring device, not an AI interpretation tool in the context of this summary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was conducted. The EUM100Pro device's FHR measurements were directly compared against the gold standard (fetal scalp electrode) and a reference device (GE/Corometrics 170 Doppler ultrasound cardiograph). The performance metrics (percent of interpretable FHR, RMS error, mean delta) directly reflect the device's output.

7. The Type of Ground Truth Used

The primary ground truth for the FHR measurement was data from a fetal scalp electrode connected to a Philips HP 50 XM (described as the "gold standard"). This is an objective physiological measurement.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is a 510(k) summary for a substantial equivalence determination, and the clinical study described is a validation study (test set) for the FHR feature on the EUM100Pro. It's possible that the device's algorithms for FHR detection were developed using other datasets or prior knowledge, but this information is not included in this summary. The summary focuses on the comparative clinical performance for regulatory clearance.

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

Since information regarding a training set is not provided, how its ground truth was established is also not described 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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Avalon Fetal/Maternal Monitor FM20:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM30:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM40:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

Avalon Fetal/Maternal Monitor FM50:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

The legally marketed Philips Avalon fetal/maternal monitors FM20. FM30. FM40. and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal electrocardiography (ECG) wave, maternal noninvasive blood pressure (NIBP), oxygen saturation (SpO2) with pulse rate and temperature, during antepartum testing and labor and delivery.

The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters:

• Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
• Fetal Movement Profile -
• Uterine activity via external Toco -
• -Maternal nulse rate
• -Maternal Heart Rate via maternal ECG
• Noninvasive blood pressure (NBP) -
• Maternal temperature -
• Pulse oximetry (maternal SpO2) -

The Avalon Fetal/Maternal Monitor FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters:

• One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
• -Uterine activity via intrauterine pressure (IUP)
• -Maternal ECG (MECG) wave

*) Note: maximum three fetal heart rates can be monitored.

The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters:

• Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
• Fetal Movement Profile -
• Uterine activity via external Toco -
• -Maternal Pulse Rate
• Maternal Heart Rate via maternal ECG -
• -Noninvasive blood pressure (NBP)
• -Maternal temperature
• -Pulse oximetry (maternal SpO2)

The Avalon Fetal/Maternal Monitor FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters:

• One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
• Uterine activity via intrauterine pressure (IUP) -
• -Maternal ECG (MECG) wave

*) Note: maximum three fetal heart rates can be monitored.

This document describes the Philips Avalon Fetal/Maternal Monitors (FM20, FM30, FM40, and FM50) with software revision J.30.

The document does not explicitly list acceptance criteria in a table format with reported device performance alongside it. Instead, it states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices" and that "The test results are passed and showed substantial equivalence."

1. A table of acceptance criteria and the reported device performance:

Based on the provided text, a specific table of acceptance criteria and reported device performance is not explicitly given. The document generally states that the device "passed" tests based on the specifications of predicate devices.

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

The document mentions "Bench testing included the use of previously recorded patient raw signals and traces." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

The document does not provide information regarding the number of experts, their qualifications, or how they established ground truth for any test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not describe any adjudication method used for a test set.

5. 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:

This document describes a medical device for monitoring physiological parameters, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

The document describes performance verification and validation. While software testing was performed ("Software verification and validation testing were conducted"), it primarily focuses on the device's functionality and safety in relation to its predicate devices, rather than a standalone algorithm performance in a diagnostic context. The device is a "monitor" and its modifications are related to interfaces and measuring capabilities. There is no explicit mention of a standalone algorithm-only performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document mentions "previously recorded patient raw signals and traces" were used for bench testing. The quality and origin of these 'raw signals' as ground truth are not further specified beyond being "previously recorded."

8. The sample size for the training set:

The document does not mention a training set as this is not an AI/machine learning device in the typical sense that would require a distinct training set.

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

As no training set is discussed, information on how ground truth was established for it is not applicable and not provided.

Summary of Acceptance Criteria and Study:

The primary "acceptance criteria" appear to be meeting the specifications cleared for the predicate devices, and the "study" involved a series of non-clinical verification and validation activities.

Verification and Validation Activities Included:

• Biocompatibility testing (Cytotoxicity, Irritation, Delayed Type Hypersensitivity, Chemical characterization)
• Testing of new or impacted hazards from risk management analysis
• Software performance and regression verification and validation
• Performance and regression verification testing of wireless functionality
• Verification according to applicable EMC, safety, and performance standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-37, ISO 80601-2-56, ISO 80601-2-61, IEC 62304, AAMI ANSI ISO 10993-1)
• Bench testing using previously recorded patient raw signals and traces.

The conclusion states that these non-clinical tests demonstrated that the modified devices are "as safe, as effective, and perform as well or better as the predicate devices" and "do not introduce new questions concerning the safety or effectiveness." No clinical studies were deemed necessary.

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The single-use disposable, non-sterile Koala TOCO is intended for use in conjunction with standard fetal monitors for the evaluation of relative external uterine activity during antepartum and intrapartum periods in a clinical setting.

The Koala IUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring.

The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.

The Koala TOCO is a single-use tocodynamometer that is a transducer pressure-sensing device that can detect the changes in a mother's abdomen as her uterus tightens during a contraction. The device detects how often contractions occur and the length of each.

The Koala TOCO device is a pneumatic tocodynamometer that comprises a guard-ring with a thin elastic membrane stretched across a shallow depression in the center of the guard-ring. The elastic membrane traps a small volume of air in the depression. The air volume beneath the membrane of the Koala TOCO is connected via a low volume air channel to a pressure transducer in the Koala IUP/TOCO Reusable Cable. The operational response of the Koala TOCO is substantially equivalent to that of the standard guard-ring TOCO. This requires that the Koala TOCO have essentially the same physical shape, guard-ring area and pressure sensing area of the predicate devices. The pressure sensing area will present resistance to applied pressure. In other words, the displacement of air in the elastic membrane mimics the compression of the strain gauge of the guard-ring TOCO.

The Koala IUP/TOCO Reusable Cable can be used for intrauterine pressure monitoring with the Koala Intrauterine Pressure Catheter. The Koala TOCO and the Koala IUP/TOCO Reusable Cable are compatible with Philips and Corometrics monitors.

The provided text describes a 510(k) summary for the Koala TOCO and Koala IUP/TOCO Reusable Cable. This submission focuses on establishing substantial equivalence to a predicate device through non-clinical testing. Crucially, it explicitly states "Not Applicable" for clinical testing. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria from a clinical perspective.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not Available. The provided document does not specify quantitative acceptance criteria or performance metrics for the device in a clinical context. The non-clinical testing focused on establishing substantial equivalence in terms of design, materials, and specific physical/electrical characteristics compared to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. Since no clinical study was performed, there is no test set or data provenance from a clinical perspective. The non-clinical tests would have involved specific test samples (e.g., of materials, components), but the sample sizes for these are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No clinical test set or ground truth established by experts is mentioned, as no clinical study was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No clinical test set was used.

5. 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

• Not Applicable. This device is a physical medical device (tocodynamometer and cable), not an AI-powered diagnostic system. No MRMC study or AI-related effectiveness is discussed.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable for clinical ground truth. The substantial equivalence claim is based on non-clinical testing, comparing technological characteristics (e.g., physical dimensions, materials, sensing technology) to a predicate device. The "ground truth" for these tests would be established engineering standards, material specifications, and performance against defined test parameters for the device itself, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

• Not Applicable.

Summary of available information:

The 510(k) summary explicitly states "Not Applicable" for clinical testing. The device's acceptance is based on demonstrating substantial equivalence to an existing predicate device (FeatherLite™ Tocodynamometer - K013477) through non-clinical performance testing.

The non-clinical testing included:

• Predicate comparison testing
• Simulated use testing
• Hardware testing
• Electrical performance testing
• Biocompatibility testing according to ISO 10993-1
• Intrauterine pressure catheter (IUPC) compatibility testing

The conclusion is that the differences between the proposed device and the predicate device (minor differences in visual appearance, weight, sensing technology, and transducer location) are minor and do not impact safety and effectiveness, thus supporting substantial equivalence.

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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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