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The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors) are indicated for use by trained healthcare professionals in non-invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are intended for use in clinical and hospital-type facilities.

Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications:

1. Single or twin fetal heart rates by means of ultrasound
2. Uterine activity externally sensed
3. Fetal movement maternally sensed and externally via ultrasound
4. Maternal heart rate and oxygen saturation via pulse oximetry
5. Maternal non-invasive blood pressure

Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications:

1. Single or twin fetal heart rates by means of ultrasound and/or FECG
2. Maternal heart rate via ECG electrodes
3. Uterine activity externally or internally sensed
4. Fetal movement maternally sensed and externally via ultrasound
5. Maternal heart rate and oxygen saturation via pulse oximetry
6. Maternal non-invasive blood pressure

The Sonicaid Team3 is a mains / battery powered multi-function fetal monitor designed for use in clinical and hospital environments during antepartum and intrapartum phases of pregnancy.

The Sonicaid Team3 is designed for use at the bedside; there is a wall mounting bracket available as well as a trolley for fixed or transportable use. The unit may also be used free-standing on a work surface.

The units are powered either from local mains electrical supply or an optional internal rechargeable battery.

The Sonicaid Team3 fetal monitors include the following:

• 8.4" Color LCD Display with LED backlighting.
• Touch screen user interface.
• Monitoring of up to two fetal heart rates via independent ultrasound transducers.
• Monitoring of maternal uterine activity via external tocodynamometer (Toco) or internal intra-uterine pressure (IUP) transducers.
• Monitoring of maternal oxygen saturation (SpO2) and heart rate via pulse oximetry sensor.
• Monitoring of maternal Non-Invasive Blood Pressure . (NIBP).
• Monitoring of fetal heart rate via ECG.
• Maternal heart rate (eMHR).
• Capture of maternally sensed fetal movements via a cabled switch.
• Chart printout via (optional) inbuilt thermal printer
• Data output via RS232.

The provided text describes the acceptance criteria and study for a medical device (Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors) in the context of an FDA 510(k) submission. However, it does not contain information about acceptance criteria in terms of numerical performance thresholds (e.g., specific accuracy, sensitivity, or specificity targets for the physiological parameters being monitored). Instead, it primarily focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and various types of engineering and performance testing.

Therefore, the following information is extracted based on the provided text, and where specific details are not present, it will be noted.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of numerical "acceptance criteria" and "reported device performance" in the typical sense of a clinical performance study with specific metrics like sensitivity, specificity, or accuracy targets. Instead, it demonstrates performance through compliance with recognized standards and various engineering and functional tests. The implied acceptance criterion is "demonstrating substantial equivalence to the predicate device" by meeting safety and performance standards and showing that technological differences do not raise new questions of safety or effectiveness.

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