Search Results

The F9 Express and F6 Express fetal & maternal monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

F9 Express and F6 Express fetal & 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: IUP, DECG .
• FHR limit alarm

Following facilities are also provided in addition to the above:

• Maternal ECG monitoring .
• Maternal SpO2 monitoring .
• Maternal NIBP .
• Maternal temperature monitoring .

This document describes the Edan Instruments Fetal & Maternal Monitor (Models F9 Express and F6 Express), which is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor, and delivery. It is to be used by trained personnel in antepartum examination rooms, labor, and delivery rooms. The device monitors Fetal Heart Rate (FHR), TOCO, Event Mark, AFM, and can also offer dual FHR, internal parameters (IUP, DECG), FHR limit alarm, maternal ECG, SpO2, NIBP, and temperature monitoring.

Here is the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics. However, it indicates equivalence to predicate devices, which implies meeting the performance standards of those devices.

The summary states that "Verification and validation testing was done on the Fetal & Maternal Monitor" and that "This premarket notification submission demonstrates that Fetal & Maternal Monitor is substantially equivalent to the predicate device." This is the primary "acceptance criterion" mentioned – demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance:

The document does not provide details on the sample size used for clinical testing (if any beyond in-house validation), the nature of the test set, or the data provenance (e.g., country of origin, retrospective or prospective). The testing primarily involved "Software testing, Hardware testing, Safety testing, Environment test, Risk analysis, Final validation." These appear to be in-house engineering and regulatory compliance tests rather than clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The testing described focuses on technical and safety aspects, not clinical performance requiring expert ground truth for interpretation (e.g., image analysis, diagnosis).

4. Adjudication method for the test set:

This information is not provided, as the nature of the testing described does not involve an adjudication process typical of clinical performance studies.

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 MRMC comparative effectiveness study was mentioned. This device is a monitoring system, not an AI-assisted diagnostic tool for interpretation by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device described is a medical monitor, not an algorithm, and it always involves a human operator ("trained and qualified personnel"). Therefore, a standalone algorithm-only performance study is not applicable and was not performed.

7. The type of ground truth used:

The document doesn't specify the type of ground truth used in the context of clinical performance data. The "final validation" likely refers to verifying the device's functionality against its specifications and safety standards, rather than clinical parameters requiring a specific ground truth. For example, for FHR monitoring, the ground truth would be the actual fetal heart rate, but the methodology for establishing this is not detailed.

8. The sample size for the training set:

Not applicable. This device is a hardware monitoring system, not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As noted above, this, a hardware monitoring system, does not have a training set.

Ask a specific question about this device