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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 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

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.

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