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The Team3 fetal monitors are indicated for use by trained healthcare professionals in noninvasive and 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 with singleton or twin pregnancies from the 28th week of gestation, through to term and delivery.

In cases of triplet, the Team3 fetal monitors are intended for use from 30th week of gestation through 35 weeks gestation.
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:

• Single, twin or triplet fetal heart rates by means of ultrasound
• Uterine activity - externally sensed
• Manual fetal movement detection - maternally identified using the event marker
• Automatic fetal movement detection (defaults to OFF / Not for use in twin or triplet pregnancies)
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure
• The DAWES REDMAN Cardiotocography (CTG) analysis output - advises whether a number of defined criteria indicative of a normal cardiotocograph record has been met for singleton pregnancies but not for triplet pregnancies. It provides nonspecific analysis in twin pregnancies due to nonspecific fetal movement input

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

• Single, twin or triplet fetal heart rates by means of ultrasound and/or FECG
• Manual fetal movement detection - maternally identified using the event marker
• Maternal heart rate via ECG electrodes
• Uterine activity - externally or internally sensed
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure

The Sonicaid Team3 is a fetal monitoring device designed for perinatal monitoring. The subject device provides non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses, including singleton, twin, and triplet fetal heart rate monitoring, during antepartum and intrapartum periods. The subject device includes systems and accessories intended to perform perinatal monitoring as aligned with product code HGM.

The subject device is a modification to the Sonicaid Team3 (K241368) to allow for triplet fetal heart rate monitoring. This modification affects the hardware of the device only. An additional port has been made available on the front of the monitor to allow for a third ultrasound transducer to be connected, so three fetal heart rates can be monitored at once.

All other parameters, materials, software and technology remain identical to the predicate device.

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The Team3 fetal monitors are indicated for use by trained healthcare professionals in non-invasive and 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:

• Single or twin fetal heart rates by means of ultrasound
• Uterine activity externally sensed
• Fetal movement maternally sensed and externally via ultrasound
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure
• CTG analysis advises whether a number of defined criteria indicative of a normal cardiograph record has been met

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

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

The Sonicaid Team3, subject device, is a fetal monitoring device designed for perinatal monitoring and includes a software function, the Dawes-Redman CTG Analysis, previously cleared under K992607. The subject device provides non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses during antepartum and intrapartum periods. The subject device includes systems and accessories intended to perform perinatal monitoring as aligned with product code HGM.

Features included in the subject device are the Dawes Redman analysis, used to assess clinically indicated antepartum cardiotocographs (CTGs) in pregnancies from 26 weeks gestation onwards, assisting physicians in identifying normal and nonreassuring traces. The Dawes-Redman software is embedded in the subject device, ensuring integration with the existing hardware. The device is not intended for use in latent or established labor due to the influence of additional factors such as labor contractions and pharmacological agents.

The provided text indicates that the Sonicaid Team3 fetal monitor has incorporated the Dawes-Redman CTG Analysis software, which was previously cleared under K992607, into its hardware. The submission for K241368 aims to demonstrate substantial equivalence by addressing this integration.

However, the provided document does not contain the specific acceptance criteria or performance study details for the Dawes-Redman CTG Analysis software as requested in the prompt. The "Performance Data" section (page 10), under "Software Performance Testing," generically states: "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content for the Premarket Submissions for Software Contained in Medical Devices'. The software for this device was considered as a 'major' level of concern."

This statement confirms that software testing was performed and documentation provided, and that the software was considered "major" in terms of concern, but it does not include the acceptance criteria, reported performance, sample size, ground truth establishment, expert qualifications, or MRMC study details.

Therefore, I cannot fulfill all parts of your request based on the provided text. I can only infer what was stated:

Here's what can be extracted/inferred from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:
* Cannot be provided. The document states software V&V was performed, but does not specify the acceptance criteria for the Dawes-Redman CTG Analysis or the performance metrics achieved against those criteria.

2. Sample size used for the test set and the data provenance:
* Cannot be provided. The document does not specify the sample size for the test set or the provenance of the data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Cannot be provided. The document does not mention the number or qualifications of experts used for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Cannot be provided. The document does not describe any adjudication method.

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:
* Cannot be provided. The document specifically mentions the Dawes-Redman CTG Analysis assists physicians in "identifying normal and nonreassuring traces," which implies a human-in-the-loop scenario. However, it does not state whether an MRMC study was performed or any effect size related to human reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Cannot be explicitly confirmed or denied. While the indication for use states it "assists physicians," the document does not detail individual study types (standalone vs. human-in-the-loop).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Cannot be provided. The document does not specify the type of ground truth used to evaluate the Dawes-Redman CTG Analysis.

8. The sample size for the training set:
* Cannot be provided. The document does not mention any details about a training set for the software.

9. How the ground truth for the training set was established:
* Cannot be provided. Since no training set details are given, how its ground truth was established is also not available.

In summary, the provided FDA premarket notification document for K241368 focuses on demonstrating substantial equivalence by integrating a previously cleared software (Dawes-Redman CTG Analysis) into new hardware. It confirms that general software verification and validation were conducted according to FDA guidance for "major" level of concern software and cybersecurity testing was performed. However, it does not include the detailed performance study results, acceptance criteria, sample sizes, ground truth methodologies, or expert qualifications for the Dawes-Redman CTG analysis itself. Such specific performance data would typically be found in more detailed test reports, which are not part of this summary document.

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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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