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Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM30:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM40:

Avalon Fetal/Maternal Monitor FM50:

Device Description

The legally marketed Philips Avalon fetal/maternal monitors FM20. FM30. FM40. and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal electrocardiography (ECG) wave, maternal noninvasive blood pressure (NIBP), oxygen saturation (SpO2) with pulse rate and temperature, during antepartum testing and labor and delivery.

The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters:

Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
Fetal Movement Profile -
Uterine activity via external Toco -
-Maternal nulse rate
-Maternal Heart Rate via maternal ECG
Noninvasive blood pressure (NBP) -
Maternal temperature -
Pulse oximetry (maternal SpO2) -

The Avalon Fetal/Maternal Monitor FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters:

One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
-Uterine activity via intrauterine pressure (IUP)
-Maternal ECG (MECG) wave

*) Note: maximum three fetal heart rates can be monitored.

The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters:

Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
Fetal Movement Profile -
Uterine activity via external Toco -
-Maternal Pulse Rate
Maternal Heart Rate via maternal ECG -
-Noninvasive blood pressure (NBP)
-Maternal temperature
-Pulse oximetry (maternal SpO2)

The Avalon Fetal/Maternal Monitor FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters:

One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
Uterine activity via intrauterine pressure (IUP) -
-Maternal ECG (MECG) wave

*) Note: maximum three fetal heart rates can be monitored.

AI/ML Overview

This document describes the Philips Avalon Fetal/Maternal Monitors (FM20, FM30, FM40, and FM50) with software revision J.30.

The document does not explicitly list acceptance criteria in a table format with reported device performance alongside it. Instead, it states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices" and that "The test results are passed and showed substantial equivalence."

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

Based on the provided text, a specific table of acceptance criteria and reported device performance is not explicitly given. The document generally states that the device "passed" tests based on the specifications of predicate devices.

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

The document mentions "Bench testing included the use of previously recorded patient raw signals and traces." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

The document does not provide information regarding the number of experts, their qualifications, or how they established ground truth for any test set.

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

The document does not describe any adjudication method used for a test set.

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:

This document describes a medical device for monitoring physiological parameters, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

The document describes performance verification and validation. While software testing was performed ("Software verification and validation testing were conducted"), it primarily focuses on the device's functionality and safety in relation to its predicate devices, rather than a standalone algorithm performance in a diagnostic context. The device is a "monitor" and its modifications are related to interfaces and measuring capabilities. There is no explicit mention of a standalone algorithm-only performance study.

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

The document mentions "previously recorded patient raw signals and traces" were used for bench testing. The quality and origin of these 'raw signals' as ground truth are not further specified beyond being "previously recorded."

8. The sample size for the training set:

The document does not mention a training set as this is not an AI/machine learning device in the typical sense that would require a distinct training set.

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

As no training set is discussed, information on how ground truth was established for it is not applicable and not provided.

Summary of Acceptance Criteria and Study:

The primary "acceptance criteria" appear to be meeting the specifications cleared for the predicate devices, and the "study" involved a series of non-clinical verification and validation activities.

Verification and Validation Activities Included:

Biocompatibility testing (Cytotoxicity, Irritation, Delayed Type Hypersensitivity, Chemical characterization)
Testing of new or impacted hazards from risk management analysis
Software performance and regression verification and validation
Performance and regression verification testing of wireless functionality
Verification according to applicable EMC, safety, and performance standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-37, ISO 80601-2-56, ISO 80601-2-61, IEC 62304, AAMI ANSI ISO 10993-1)
Bench testing using previously recorded patient raw signals and traces.

The conclusion states that these non-clinical tests demonstrated that the modified devices are "as safe, as effective, and perform as well or better as the predicate devices" and "do not introduce new questions concerning the safety or effectiveness." No clinical studies were deemed necessary.

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