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I. Fetal Surveillance
A Corometrics 120 Series Monitor is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). Fetal movement detection and fetal heart rate alarm options (user selectable high/low and poor signal quality alarms or Spectra alerts) are available.

II. Maternal Monitoring
A Corometrics 120 Series Monitor is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured with these monitor configurations are summarized below.

NOTE: Maternal vital signs provided by the monitor should only be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms.

Blood Pressure. The monitor is intended for use in the non-invasive monitoring of maternal blood pressure (NBP). This monitor is not intended for use in neonatal or pediatric blood pressure monitoring.

Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of maternal functional oxygen saturation of arterial hemoglobin (MSpO2).

Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of the maternal heart/pulse rate. Additionally, a MECG waveform "snapshot" may be displayed and printed.

NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.

The 120 Series is intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms, and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment.

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a maternal/fetal monitor. It describes the device, its intended use, and a comparison to predicate devices, but it does not detail specific performance metrics, acceptance criteria, or any studies conducted to validate these criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used or their qualifications.
4. Adjudication method.
5. Information about an MRMC comparative effectiveness study or effect size.
6. Information about a standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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The 120 Series is intended for monitoring fetal and maternal vital signs: fetal heart rate; and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment.

The proprietary name of the modified device to be introduced into interstate commerce is the 120 Series Maternal/Fetal Monitor. Common names include: 120 Series, 120 MFM.

I am sorry, but the provided text does not contain the information required to populate the acceptance criteria and study details. The document is a 510(k) summary for the Corometrics 120 Series Maternal/Fetal Monitor, which was cleared in 1997. It describes the device's intended use and compares its technological characteristics to predicate devices. However, it does not include details about acceptance criteria, device performance metrics, sample sizes for testing or training, ground truth establishment, expert qualifications, or details of a comparative effectiveness study, which are typical for studies involving AI or complex statistical analysis for diagnostic accuracy.

The relevant section simply states: "The 120 Series has been extensively tested to meet its requirements and design." This is a general statement and does not provide specific details about the studies or acceptance criteria themselves.

Therefore, I cannot extract the requested information from this document.

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