(302 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence in detecting and displaying uterine activity compared to TOCO and IUPC | "The study provided evidence that the EUM 100Pro performed substantially equivalently to the legally marketed predicate devices for detecting and displaying uterine activity in women at term gestation in active labor." Physicians independently evaluated tracings from EUM, TOCO, and IUPC, annotating contractions and commenting on interpretability. The outcomes of this physician evaluation led to the conclusion of substantial equivalence. |
| Interpretability of tracings | Physicians were asked to "comment on the interpretability of the tracing." While no specific metric is provided, the overall conclusion of substantial equivalence suggests satisfactory interpretability. |
| Total number of uterine contractions detected | Physicians were asked to "indicate the total number of uterine contractions on the tracing." The conclusion of substantial equivalence implies that the EUM 100Pro's detection of total contractions was comparable to the predicate devices. |
| Electrical, EMC, EMI compliance to IEC 60601-1 and IEC 60601-2-40 | The device "passed the requirements." |
| Biocompatibility of materials (electrodes) | The electrodes "have been cleared for the intended use under K990356." |
Study Details
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 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).