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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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical tests (biocompatibility, software, electronic hardware, mechanical, functional, electrical safety, EMC, and environmental performance). It does not mention a "test set" in the context of patient data or clinical performance evaluation that would require a sample size or data provenance like country of origin, retrospective, or prospective. The "testing conducted" section describes verification and validation activities against engineering specifications and regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document as the study described is not a clinical performance study involving expert ground truth for patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided as the study described is not a clinical performance study involving expert adjudication.

5. 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

There is no mention of an MRMC comparative effectiveness study or AI assistance in this submission. The device is a fetal monitor, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.

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

This concept is not applicable to the device described. The Sonicaid Team3 is a fetal monitor designed to directly measure physiological parameters, not an algorithm providing interpretations or diagnoses in isolation. Its performance is evaluated through its accuracy and reliability in measuring those parameters. The "Functional Performance Testing" section covers the interaction of hardware and software for its various functions, which could be considered a form of standalone performance evaluation for the device's measurement capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests described, the "ground truth" would be established by:

• Engineering specifications and design requirements: For software, electronic hardware, and mechanical performance.
• Recognized consensus standards: For biocompatibility (ISO 10993-1), electrical safety (AAMI/ANSI ES60601-1), and EMC.
• Reference measurement instruments or established methods: For verifying the accuracy of physiological parameter measurements during functional testing (e.g., a calibrated pressure sensor for NIBP, a known heart rate generator for FHR). Specific details on the reference methods used for functional performance testing are not provided but implied by "verification of the hardware software interaction."

8. The sample size for the training set

This information is not applicable/provided. The document describes a traditional medical device submission (510(k)) that focuses on engineering and performance validation rather than machine learning or AI model development, which would typically involve training sets.

9. How the ground truth for the training set was established

This information is not applicable, as there is no mention of a training set for an AI/ML algorithm.

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