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The EUM100Pro (Electro Uterine Monitor) is a transabdominal electromyography (EMG) monitor intended to non-invasively measure intrapartum uterine activity and fetal heart rate (FHR). The EUM100Pro acquires the signal from surface EMG electrodes placed on the patient abdomen.

The EUM100Pro is intended for use on women (>36 completed weeks of gestation) in labor, with singleton pregnancies.

The EUM100Pro is intended for use by healthcare professionals in a clinical setting.

The EUM100Pro (electro uterine monitor) System is designed to present and transmit via RS232 protocol the electrical activity of the uterus and fetal heart rate. The data is shown and displayed as graphs (uterine activity and FHR) and similar to the commonly use toco-dynamometer / Doppler monitors.

The EUM100Pro is built around an EN 60950 certified computer.

Here's an analysis of the acceptance criteria and the study used to validate the EUM 100Pro device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds (e.g., "sensitivity must be >X%"). Instead, it focuses on demonstrating non-inferiority of the EUM100Pro compared to a Doppler-based Fetal Monitor, using a fetal scalp electrode as the gold standard.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 33 women
• Data Provenance: The document does not explicitly state the country of origin. It mentions "a clinical study was completed," implying a prospective study setting where subjects were enrolled for this specific study. Given the manufacturer's address (Israel), it's plausible the study was conducted there or in a comparable clinical research environment. It is a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used to establish the ground truth. The gold standard for FHR measurement was a fetal scalp electrode connected to a Philips HP 50 XM, which is an objective measurement tool rather than relying on expert interpretation for ground truth.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method in the context of expert review or consensus for the test set. The ground truth was established by an objective medical device (fetal scalp electrode), so adjudication by human experts was not necessary for the FHR data itself.

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

No, a multi-reader, multi-case comparative effectiveness study was not explicitly described. The study focused on the standalone performance of the EUM100Pro as a device for FHR and uterine activity monitoring, comparing its readings directly against a gold standard and a reference device, rather than evaluating human reader performance with or without AI assistance. The EUM100Pro is a monitoring device, not an AI interpretation tool in the context of this summary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was conducted. The EUM100Pro device's FHR measurements were directly compared against the gold standard (fetal scalp electrode) and a reference device (GE/Corometrics 170 Doppler ultrasound cardiograph). The performance metrics (percent of interpretable FHR, RMS error, mean delta) directly reflect the device's output.

7. The Type of Ground Truth Used

The primary ground truth for the FHR measurement was data from a fetal scalp electrode connected to a Philips HP 50 XM (described as the "gold standard"). This is an objective physiological measurement.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is a 510(k) summary for a substantial equivalence determination, and the clinical study described is a validation study (test set) for the FHR feature on the EUM100Pro. It's possible that the device's algorithms for FHR detection were developed using other datasets or prior knowledge, but this information is not included in this summary. The summary focuses on the comparative clinical performance for regulatory clearance.

9. How the Ground Truth for the Training Set Was Established

Since information regarding a training set is not provided, how its ground truth was established is also not described in this document.

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The EUM100Pro (Electro Uterine Monitor) is a transabdominal electromyography (EMG) monitor intended to non-invasively measure intrapartum uterine activity. The EUM100Pro acquires the signal from surface EMG electrodes placed on the patient abdomen.

The EUM100Pro is intended for use on women in term (>36 completed weeks of gestation) labor, with singleton pregnancies.

The EUM100Pro is intended for use by healthcare professionals in a clinical setting.

The EUM100Pro System is designed to present and record the electrical activity of the uterus. The activity is shown as graphs similar to the commonly use toco-dynamometer.

The EUM100Pro is built around an EN- 60950 certified computer. Analog signals are obtained from CE certified amplifier box from Delsys Inc., Boston, MA. Delsys also supply the input modules, power supply, electrodes and disposable stickers.

The system is comprised of a multi-channel surface electromyogram operative to sense electromyographic (EMG) activity, a three-dimensional position sensor and a personal computer providing data analysis, recording media and a graphical user interface.

Here's a summary of the acceptance criteria and study details for the EUM100Pro device, based on the provided text:

Acceptance Criteria and Device Performance

The provided text does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes the clinical study's purpose as providing "evidence that the EUM 100Pro performed substantially equivalently to the legally marketed predicate devices for detecting and displaying uterine activity."

Therefore, the implicit acceptance criteria are based on demonstrating substantial equivalence to predicate devices (Tocodynamometry - TOCO and Intrauterine Pressure Catheter - IUPC) in detecting and displaying uterine activity, as assessed by physicians.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 43 women.
   • Data Provenance: The text does not specify the country of origin. It indicates the study was "conducted a clinical study enrolling 43 women at term gestation in active labor." The context suggests this was a prospective clinical study as women were enrolled specifically for this evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Three (3) physicians.
   • Qualifications: The text only states "three physicians." No specific qualifications (e.g., years of experience, specialty) are provided.

3. Adjudication method for the test set:

   • The physicians "evaluated independently" and were "masked to the technology used to acquire the tracings." They were asked to annotate contractions and indicate the total number. The text does not explicitly state an adjudication method like 2+1 or 3+1 for discrepancies. It implies that the individual assessments of these three physicians, when compared across the different tracing types (EUM, TOCO, IUPC), formed the basis for concluding substantial equivalence.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not reported. This study assessed the standalone performance of the EUM100Pro device (which incorporates an algorithm) in comparison to established methods (TOCO and IUPC) as interpreted by physicians. The focus was on the device's ability to generate signals comparable to existing methods, rather than on improving human reader performance with aid.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, a standalone evaluation of the EUM100Pro's output was done. The EUM100Pro is described as generating "graphs similar to the commonly use toco-dynamometer," and these tracings were presented to physicians for interpretation. The study was designed to show the device's performance in detecting and displaying uterine activity itself, which is a standalone function of the algorithm and hardware. The physicians then interpreted these device-generated tracings.

6. The type of ground truth used:

   • The ground truth was established by expert consensus/interpretation of established predicate technologies (Tocodynamometry - TOCO and Intrauterine Pressure Catheter - IUPC) and the EUM100Pro's own output, all compared simultaneously. The study design implicitly uses the TOCO and IUPC as the "established" or "reference" methods against which the EUM100Pro's output is compared, with expert physician interpretation serving as the ultimate arbiter of what constitutes a contraction on any of the tracings.

7. The sample size for the training set:

   • The document does not provide any information about a separate training set or its sample size. The clinical study described appears to be a validation or test set. Without information on an AI/ML component that requires explicit training, details about a training set are not included.

8. How the ground truth for the training set was established:

   • As no information on a training set is provided, the method for establishing its ground truth is also not stated.

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