Search Results

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.

Ask a specific question about this device