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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. Alternally 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.

F series Fetal & Maternal Monitor, including F6, F6 Express, F9, F9 Express which 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
• Software for data transmission to PC, which means the subject device can be connected to Central Nursing System provided by EDAN, which has been cleared by K100358.
• Quick printing for stored waveform
• Lithium battery for continuous working
• Maternal ECG monitoring
• Maternal SpO2 monitoring
• Maternal NIBP
• Maternal temperature monitoring
• Used with FTS-3 Fetal Telemetry System (hereinafter called FTS-3)

This document is a 510(k) Pre-market Notification for the Edan Instruments Fetal & Maternal Monitor (models F6, F6 Express, F9, F9 Express), seeking to demonstrate substantial equivalence to previously cleared predicate devices. The submission focuses on non-clinical performance data.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a dedicated "acceptance criteria" table in the format of pass/fail metrics. Instead, it provides a "Predicate Device Comparison" table that lists performance specifications for the subject devices and the predicate device. The implied acceptance criterion for each parameter is that the subject device's performance is "Same" or "Different" but without raising new questions of safety or effectiveness.

Below is a summarized table consolidating various performance parameters and their comparison to the predicate device, indicating the reported performance:

2. Sample Size for the Test Set and Data Provenance

The submission primarily relies on non-clinical testing to demonstrate substantial equivalence. No specific "test set" in the context of clinical data (e.g., patient cases for a diagnostic AI) is mentioned, as clinical data was deemed "Not applicable."

For the non-clinical tests:

• Biocompatibility testing: The "worst case of the whole system is considered tissue contacting for a duration of less than 24 hours." This doesn't specify a sample size for the tests themselves (e.g., number of test specimens), but rather the basis for the test choice.
• Electrical safety and electromagnetic compatibility (EMC): Performed on "the F series Fetal & Maternal Monitor device, consisting of all the modules and accessories in the system." This likely refers to a single device or a small number of units for engineering testing.
• Bench Testing: Performed on "the F series Fetal & Maternal Monitor device, consisting of all the modules and accessories in the system." Similar to EMC, this implies engineering testing on a limited number of devices.
• Software Verification and Validation Testing: Documented according to FDA guidance. No specific "sample size" of software test cases is provided, but it would involve comprehensive testing scenarios.
• Acoustic testing: Conducted using standard measurement procedures (NEMA Standard Publications UD-2 and IEC 62359).

Data Provenance: All data appears to be from retrospective internal testing conducted by the manufacturer, Edan Instruments, Inc., likely at their facilities in P.R. China or through contracted testing laboratories. There is no mention of data from specific countries of origin related to patient studies, as no clinical data was submitted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the submission relies on non-clinical testing and states "Clinical data: Not applicable." For non-clinical tests (e.g., electrical safety, performance measurements), the "ground truth" is established by calibrated reference instruments, defined test procedures, and adherence to international standards. Experts involved would be engineers and technicians qualified in performing such tests, not clinical experts establishing diagnostic ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set requiring expert adjudication of ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Clinical data: Not applicable" and focuses on demonstrating substantial equivalence through non-clinical performance data and comparison of specifications with predicate devices. Therefore, there is no effect size of human readers improving with or without AI assistance.

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

This concept is not directly applicable to this device in the context of AI/algorithm performance. The Fetal & Maternal Monitor is a hardware device with embedded software for monitoring physiological parameters (FHR, TOCO, ECG, SpO2, NIBP, TEMP). Its performance is evaluated as a whole system, not as a standalone AI algorithm. The software verification and validation are part of the overall system performance.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" is based on:

• International Standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, ISO 80601-2-61, etc.
• Reference Measurements: Use of calibrated equipment and defined test methodologies to measure parameters (e.g., FHR accuracy, SpO2 accuracy, NIBP accuracy) against expected or known values.
• Biocompatibility Standards: Results of standard biological tests (Cytotoxicity, Skin Sensitization, Irritation) against defined pass/fail criteria from ISO 10993-1.

There is no mention of expert consensus, pathology, or outcomes data as these are typically associated with clinical studies for diagnostic accuracy, which were not performed.

8. The Sample Size for the Training Set

This information is not applicable as the device is not described as an AI/ML device that requires a "training set" in the conventional sense for algorithm development. It's a monitoring device with specified performance characteristics.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8; no training set in the AI/ML context is mentioned or implied. If the device uses any internal algorithms (e.g., for signal processing or heart rate detection), their "truth" would be established by engineering validation against known input signals or simulated physiological data, but this is handled under the general "Software Verification and Validation Testing" section.

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