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F6/F9 Fetal & Maternal Monitor is intended for non-invasive monitoring of fetus 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.

F6/F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

F6 Express/F9 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.

F6 Express/F9 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.

F3/F2 Fetal Monitor is intended for non-invasive monitoring of fetus 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.

The monitor provides non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

The subject devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. The submission seeks clearance for several devices and their accessories, which were modified since their last 510(k) clearance.

The subject devices of the present submission include the F2/F3 and F6/F9 fetal monitors as well as the F6/F9 Express, which provide both fetal and maternal monitoring capabilities.

The fetal and maternal physiological parameters that are supported by the EDAN bedside monitors are as follows:

• Fetal heart rate (FHR)
• Tocodynamometry (TOCO) for external monitoring of uterine contractions .
• Fetal Movement (FM) ●
• Automated Fetal Movement (AFM) ●
• Direct ECG (DECG) for internal monitoring of fetal heart rate
• . Intrauterine pressure catheter (IUP) for internal monitoring of uterine contractions
• . Maternal ECG (MECG)
• . Noninvasive blood pressure (NIBP) was added to F6/F9 Express in this submission
• Maternal Sp02 (MSp02) for monitoring pulse rate (PR) .
• . Temperature (TEMP) for monitoring maternal temperature

This document describes the regulatory submission for Fetal & Maternal Monitors (Models F6, F6 Express, F9, F9 Express) and Fetal Monitors (Models F2, F3) by Edan Instruments, Inc. It is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to previously marketed predicate devices.

The document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technical specifications and regulatory safety/performance testing. The performance data provided are related to general device functionality, electrical safety, electromagnetic compatibility, and sensor evaluations, rather than demonstrating performance against an AI algorithm's specific performance targets (like sensitivity, specificity, or accuracy) on a clinical test set.

Therefore, many of the requested elements pertaining to an AI/algorithm study (such as ground truth establishment, sample sizes for training/test sets in an AI context, expert qualifications, or MRMC studies) are not present in this document.

However, I can extract information related to the device's technical specifications and the types of performance data submitted for its clearance, which could be interpreted as acceptance criteria for a traditional medical device, rather than an AI.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a formal "acceptance criteria table" with specific numerical targets and results in the way an AI performance study would. However, it lists technical specifications for the new devices and compares them to predicate devices, indicating that "Same" values or minor acceptable "Different" values (with justification) serve as the "acceptance criteria" for substantial equivalence for these non-AI features.

Here's an attempt to structure relevant technical specifications from the comparison tables (pages 7 and 12-15), which imply the "acceptance criteria" through their "Comparison" column:

Note: Differences are highlighted. The document states that "The differences in technological characteristics do not raise different questions for safety or effectiveness."

For Fetal Monitors F2 & F3 vs. Predicate F3:

Note: Differences are highlighted. The document states that "The differences in technological characteristics do not raise different questions for safety or effectiveness."

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

• Test Set Sample Size: Not specified for any AI/algorithm performance testing as none was conducted in this context. The performance data listed (software validation, electrical safety, EMC, NIBP sensor evaluation, ultrasound transducer evaluation) are typical for medical device regulatory clearance, which usually involves a defined set of tests on the device itself, rather than a clinical dataset for AI performance.
• Data Provenance: Not applicable for an AI test set. The nature of these tests is laboratory or bench testing on the device prototypes. No mention of country of origin of data or retrospective/prospective studies in the context of clinical data for performance evaluation.

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

• Not applicable. No AI/algorithm performance study requiring expert adjudication was conducted or reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No AI/algorithm performance study requiring adjudication was conducted or reported.

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 study was done or reported. This device is a monitoring system and not an AI-assisted diagnostic tool for which such a study would be relevant.

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

• Not applicable. This is a monitoring device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. The performance data provided relate to device function and safety parameters (e.g., electrical safety, NIBP accuracy against reference measurements, etc.). "Ground truth" in this context would be defined by standard test methodologies and calibrated reference equipment.

8. The sample size for the training set:

• Not applicable. This document is not describing an AI/machine learning device.

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

• Not applicable. This document is not describing an AI/machine learning device.

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