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The Philips Avalon FM20, FM30, FM40 and FM50 Fetal/Maternal Monitors are intended for non-invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. All monitors are intended for monitoring fetal heart rates, fetal movement profiles, maternal heart rates, uterine activity, maternal noninvasive blood pressure, and additionally for the FM30, FM40 and FM50 maternal oxygen saturation (Sp02). The FM30 and FM50 are additionally intended for maternal ECG and for invasive monitoring of fetal Direct ECG and intrauterine pressure. All monitors are intended for generating alarms from fetal and maternal parameters, for displaying, storing and recording patient data and related waves, transmitting patient data to a patient information and surveillance system on a network, and for postpartum monitoring of the mother. All monitors are intended for use by trained health care professionals. They are intended for use in labor and delivery rooms, antepartum testing areas and during postpartum recovery in the hospital environment. They are not intended for use in intensive care units or operating rooms. The FM20 and FM30 are additionally intended for use in healthcare and for example in doctors' offices, and in private households.

The subject devices Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 are a modification of the legally marketed Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 and offer monitoring of fetal heart rates, fetal movement profiles, fetal Direct ECG, maternal uterine activity, maternal heart rates, maternal pulse rates, maternal ECG, maternal non-invasive blood pressure (NIBP) and maternal oxygen saturation (Sp02) during antepartum testing and labor and delivery. The modification of the Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 only permits specific Sp02 sensors, which are already cleared for the Philips picoSATIIplus SpO2 pulse oximetry module, the Philips Intellivue X2 (M3002A) multi measurement module and the Philips M1020B Sp02 plug-in module, to be also used with the Philips Avalon Fetal monitors FM30, FM40 and FM50.

The Philips Avalon Fetal Monitors (FM20, FM30, FM40, and FM50) are a modification of previously cleared devices, primarily to permit the use of specific SpO2 sensors already cleared for other Philips modules. The submission focuses on demonstrating substantial equivalence to these predicate devices.

Acceptance Criteria and Device Performance:

The document explicitly states that "hazard criteria were based on the Pass/Fail analysis. specifications cleared for the predicate devices and test results showed substantial equivalence." This implies that the acceptance criteria for the modified devices were the same performance specifications as those established for the predicate devices. The study concludes that the "results demonstrate that the Philips Avalon Fetal Monitors meet all reliability requirements and performance claims."

Study Details:

1. Sample Size and Data Provenance (Test Set):

   • The document does not specify the sample size used for the test set.
   • The data provenance (country of origin, retrospective/prospective) is not mentioned.

2. Number of Experts and Qualifications (Ground Truth for Test Set):

   • The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.

3. Adjudication Method (Test Set):

   • The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned. The submission focuses on device performance and substantial equivalence, not human reader improvement with AI assistance.

5. Standalone Performance Study:

   • A standalone performance study was implicitly done, as "Verification and Validation testing activities" were conducted to "establish the performance, functionality, and reliability characteristics of the modified devices." This testing was against predefined specifications, indicating an algorithm-only (device-only) performance assessment.

6. Type of Ground Truth Used:

   • The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The ground truth for the verification and validation appears to be the "specifications cleared for the predicate devices."

7. Sample Size for Training Set:

   • The document does not mention a training set, as the evaluation method described is primarily focused on verification and validation against pre-established specifications for the modified device, rather than training a new algorithm from data.

8. How Ground Truth for Training Set was Established:

   • Not applicable, as no training set is mentioned in the context of this submission. The device is a modification of an existing, cleared device, implying its core algorithms were already established and validated. The current submission focuses on verifying continued performance after a component modification.

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