(96 days)
The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting.
The MFM-CNS is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record.
The MFM-CNS has display fields for the following obstetric data:
- patient demographics
- provider notes
- fetal heart rate (FHR)
- uterine activity (via tocodynamometry or IUP)
- fetal movement
- maternal heart rate
- SpO2
- non-invasive blood pressure (NIBP)
- respiratory rate
- temperature
- pulse
The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application. Its function is to manage clinical data of fetal heart and maternal vital signs (CTG - Cardiotocography), which is automatically acquired from bedside monitors, for the purpose of collecting, processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. It provides electronic medical records and operates with off-the-shelf software and hardware.
The MFM-CNS is intended to be used in hospital clinical areas such as monitor units, delivery room, etc. It is intended to be operated by or under guidance of qualified healthcare professionals, not intended for home healthcare environment. During monitoring, the user should check the results on the bedside monitor in person, even though they could observe the results on the MFM-CNS system interface. The user cannot only depend on the MFM-CNS system to obtain monitoring data, because whether the data provided by the system is accurate depends on the stability of the operating system, the performance of PC station and the network. Although the software has its independent alarm system, the alarm information provided by the system is just for reference.
The provided document is a 510(k) premarket notification for the Edan Instruments Inc. "Central Monitoring System" (MFM-CNS). It outlines the device's description, indications for use, comparison to predicate devices, and non-clinical testing for safety and effectiveness.
However, the document explicitly states:
- "Clinical test: Clinical testing is not required." (Page 8)
- The non-clinical tests relate to software validation, risk analysis, usability analysis, and software life cycle management, not direct performance criteria against a ground truth.
Therefore,Based on the provided document, the following information regarding acceptance criteria and a study proving the device meets them cannot be provided:
- A table of acceptance criteria and the reported device performance: The document states no clinical testing was required, and the non-clinical tests focused on software quality assurance (validation, risk, usability, lifecycle management) rather than performance metrics against specific acceptance criteria.
- Sample size used for the test set and the data provenance: No clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set.
- Adjudication method for the test set: Not applicable.
- 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 applicable. This device is described as a "clinical data managing software application" for viewing perinatal monitoring data, not an AI-assisted diagnostic tool that would enhance human reader performance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no indication of an algorithm performing diagnoses or analyses independently that would require standalone performance testing against a ground truth.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth was established or used for performance evaluation since no clinical testing was deemed necessary.
- The sample size for the training set: Not applicable, as there's no mention of Machine Learning/AI training in the document.
- How the ground truth for the training set was established: Not applicable.
Summary from the document:
The device, MFM-CNS, is a "clinical data managing software application." Its purpose is to facilitate the management, viewing, and electronic record-keeping of perinatal monitoring data (FHR, uterine activity, maternal vital signs, etc.) acquired from bedside monitors or manual input. The substantial equivalence determination was based on non-clinical software quality assurance measures and a comparison to predicate devices, noting that the differences do not affect safety and effectiveness.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).