Search Results

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.

Ask a specific question about this device