Search Results

Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.

Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.

The provided document is a 510(k) clearance letter from the FDA for the Cerner FetaLink™ device. It primarily focuses on the regulatory approval of the device based on substantial equivalence to predicate devices and outlines the device's indications for use.

Crucially, this document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

The FDA clearance letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a legally marketed device or has different technological characteristics but does not raise different questions of safety and effectiveness. This determination is primarily based on a comparison to predicate devices, not typically on a new, comprehensive clinical study with specific performance metrics and acceptance criteria that would be detailed in the submission.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not present.
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: Not present. The Cerner FetaLink™ is described as a software application that displays data and alerts clinicians, implying it's a monitoring and information-display system, not necessarily an AI-powered diagnostic tool that would typically undergo MRMC studies for improved human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. Given its description as displaying data and alerting clinicians, it's inherently a human-in-the-loop system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

To obtain this information, you would need to consult the original 510(k) submission document (if publicly available in a more detailed form than the clearance letter), or technical documentation provided by Cerner Corporation for FetaLink™.

Ask a specific question about this device