(132 days)
The FM-9000 Plus Fetal and Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartumn examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartumn examination rooms, labor and delivery rooms. The FM-9000 Plus Fetal and Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.
The Fetal & Maternal Monitor provides the following primary features that can be available for the multiple configurations:
- Basic parameters: FHR, TOCO, Event Mark, AFM .
- Dual FHR monitoring .
- Internal parameters: UIP, DECG .
- FHR limit alarm .
Following facilities are also provided in addition to the above: - Maternal ECG monitoring ●
- Maternal SP02 monitoring ●
- Maternal NIBP .
- Maternal temperature monitoring ●
{
"1. A table of acceptance criteria and the reported device performance": "The provided text does not contain a table of acceptance criteria or reported device performance for clinical endpoints. It primarily discusses the device's technical aspects and regulatory classification.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document explicitly states: "Clinical testing is not required." Therefore, no test set sample size or data provenance is available for clinical performance.",
"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)": "As clinical testing was not required, there is no mention of experts or ground truth establishment for a clinical test set.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Clinical testing was not required, so no adjudication method for a test set is discussed.",
"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": "No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device is a Fetal and Maternal Monitor, not an AI-assisted diagnostic tool for human readers.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The document states "Clinical testing is not required." Therefore, no standalone performance study was conducted or reported.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Since clinical testing was not required, no specific type of ground truth was used for clinical performance evaluation.",
"8. The sample size for the training set": "The document does not mention a training set or its sample size. The device is a medical monitoring instrument, and the regulatory submission indicates that clinical testing was not required for its approval.",
"9. How the ground truth for the training set was established": "As no training set is mentioned and clinical testing was not required, there is no information on how ground truth for a training set was established."
}
§ 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).