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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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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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