(734 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided document. The study aims to demonstrate that the SureCALL® uterine EMG technology detects uterine contractions as well as conventional tocodynamometry. | The three-way clinical study and the follow-up MRMC study demonstrate that the SureCALL® uterine EMG technology detects uterine contractions as well as conventional tocodynamometry. The document notes that the technology infrequently presents low amplitude deflections that may appear to be contractions but do not correspond to uterine contractions. It states that this difference is unlikely to have an adverse impact on clinical outcomes in full term laboring patients, implicitly suggesting the performance is acceptable for its intended use despite some false positives. |
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.
§ 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).