(123 days)
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.
| Feature / Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (LaborView LV1000) |
|---|---|---|
| Uterine Activity (UA) - Interpretability (PPA) | Non-inferiority to Toco (external tocodynamometer) when compared to IUPC (intrauterine pressure catheter) gold standard. | PPA calculated for each patient. (Specific value not provided, but implies non-inferiority was met.) |
| Uterine Activity (UA) - Sensitivity (Contraction Detection) | Non-inferiority to Toco in detecting contractions within +/- 30 seconds, compared to IUPC. | Proportion of contractions detected within +/- 30 seconds calculated. (Specific value not provided, but implies non-inferiority was met.) |
| Uterine Activity (UA) - Timing Accuracy | Non-inferiority to Toco in timing of corresponding contractions, compared to IUPC. | Difference in timing calculated. (Specific value not provided, but implies non-inferiority was met.) |
| Biocompatibility | Compliance with ISO 10993-1 (cytotoxicity, sensitization, irritation) for surface contact, skin, limited duration. | Found to be non-reactive per ISO 10993-1 testing. |
| Electrical / EMC / EMI | Compliance with ANSI/AAMI/ES 60601-1, IEC 60601-1-2, and Wireless Coexistence requirements. | Performed as intended, meeting requirements of the standards, considered safe. |
| Bench Testing | Verification of performance to specifications; compliance with ANSI/AAMI EC13 for Maternal Heart Rate (MHR). | Met its performance specifications and requirements. |
| Usability | Potential users able to complete tasks (sensor array placement, interpretation of device feedback, removal) successfully. | All participants able to complete all tasks successfully. |
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.
§ 884.2720 External uterine contraction monitor and accessories.
(a)
Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.(b)
Classification. Class II (performance standards).