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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.

Device Description

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.

AI/ML Overview

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.

Performance Metric	Acceptance Criteria (Implied Non-inferiority)	EUM100Pro Performance	Doppler-based Fetal Monitor Performance (Reference)	Gold Standard (Fetal Scalp Electrode) Comparison
Percent of Interpretable FHR	Non-inferior to Doppler-based Fetal Monitor.	98.5% (95% CI [98.5%-99.6%])	96% (95% CI [95%-98.2%])	EUM showed "non-inferior results" compared to Doppler.
RMS error (vs. Gold Standard)	Lower RMS error compared to Doppler-based Fetal Monitor (indicating higher similarity to gold standard).	1.47 (from Bland Altman)	4.42 (from Bland Altman)	EUM is "more similar to gold standard fetal Scalp electrode measurement compared to Doppler."
Mean delta (vs. Gold Standard)	Lower mean delta compared to Doppler-based Fetal Monitor (indicating higher similarity to gold standard).	0.009 (95% CI [0.007-0.015])	0.232 (95% CI [0.227-0.256])	EUM is "more similar to gold standard fetal Scalp electrode measurement compared to Doppler."
Safety and Effectiveness Concerns	No new safety or effectiveness concerns compared to predicate/reference devices in terms of indications, patient population, environment, design, technology, and performance.	Document states "no differences" that raise concerns.	(Not explicitly a performance metric, but a safety/effectiveness claim)	(Based on a broader comparison beyond just FHR monitoring, as stated in the "Discussion of Differences" section.)

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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