Search Results

The Philips Multi-Measurement Module (MMX) is for use with Philips IntelliVue Patient Monitors.

The Multi-Measurement Module, with its host patient monitor, is intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare facilities.

It sends processed measurement data (for example, measurement waves and numerics) to the monitor screen, generates alerts, and supports the transfer of patient data between monitors.

The Multi-Measurement Module is intended for use by trained healthcare professionals in a hospital environment. The Multi-Measurement Module is additionally intended for use in transport situations within hospital environments together with its host patient monitor.

The Multi-Measurement Module is only for use on one patient at a time. It is not intended for home use. It is not a therapeutic device. The Multi-Measurement Module is for prescription use only.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The newly introduced IntelliVue Multi-Measurement Module MMX acquires multiple physiological patient signals, sends processed measurement data (for example, measurement waves and numerics) to the host monitor screen, generates alerts, and supports the transfer of patient data between monitors.

The device, together with its compatible host monitor, offers a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. It can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals.

The measurement sensors are applied at diverse body locations, depending on the physiological parameters monitored.

The new device has the same range of functions as the legally marketed predicate devices; it provides the same measurement parameters as the predicates.

The Multi-Measurement Module MMX provides multiple non-invasive and invasive measurements: ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2.

The Philips IntelliVue Multi-Measurement Module MMX is a device intended for monitoring, recording, and alarming multiple physiological parameters in adults, pediatrics, and neonates within healthcare facilities. The following details describe its acceptance criteria and the study that proves the device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a validation and verification (V&V) study, but it does not present a single consolidated table of acceptance criteria with corresponding performance statistics. Instead, it refers to fulfilling requirements of various standards and guidance documents. Based on the "Summary of V&V Activities" section, the acceptance criteria are generally defined as meeting all applicable requirements of recognized consensus standards and FDA guidance documents, and that "All specified pass/fail criteria have been met."

Since specific numerical acceptance criteria and reported device performance values are not explicitly listed in a table, here's a conceptual representation of what such a table would contain, based on the types of testing mentioned:

2. Sample Size and Data Provenance for the Test Set

The document does not explicitly state the sample size for any specific test set beyond "a minimum of three devices" for non-invasive blood pressure intra-device variability testing.
The origin of the data (country, retrospective/prospective) is not specified. The testing appears to be conducted by the manufacturer, Philips Medizin Systeme Boeblingen GmbH, based in Germany. The nature of the V&V activities suggests prospective testing against established standards and internal specifications.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set. The validation relies on meeting criteria defined by recognized consensus standards and FDA guidance rather than expert consensus on individual cases. For parameters like SpO2 and NBP, ground truth would typically be established by validated reference methods (e.g., co-oximetry for SpO2, invasive arterial pressure for NBP).

4. Adjudication Method

No adjudication method is mentioned, as the validation strategy is based on direct measurement against technical standards and reference methods, not subjective expert review of cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not conducted. This device is a physiological monitoring module, and its performance is evaluated against technical standards and reference measurements, not by human reader interpretation of outputs requiring AI assistance.

6. Standalone (Algorithm Only) Performance

A standalone performance evaluation was done. The entire "Summary of V&V Activities" section describes the testing of the device itself (the IntelliVue Multi-Measurement Module MMX) against various technical standards without human-in-the-loop intervention for the core physiological measurements. The measurements (ECG, respiration, SpO2, NBP, invasive pressure, temperature, CO2) are automatically processed and displayed by the device.

7. Type of Ground Truth Used

The ground truth used for testing is primarily based on:

• Reference Standards: Performance specifications defined by international standards (e.g., IEC, ISO, AAMI/ANSI) for physiological measurement devices.
• Reference Methods: For parameters like SpO2 and NBP, the ground truth would typically involve comparison against highly accurate and validated reference measurement techniques (e.g., co-oximetry for SpO2, intra-arterial catheter for NBP).
• Internal Specifications: Philips' own defined specifications for the device's behavior and performance.

The document does not mention pathology, outcomes data, or expert consensus on patient cases as ground truth for the device's technical validation.

8. Sample Size for the Training Set

The document does not mention a training set. This document describes the validation of a medical device with established algorithms for physiological parameter measurement, not a machine learning or AI-based system that typically requires a distinct training phase with a large dataset. The underlying algorithms for most physiological monitors are well-established and are typically validated through engineering and clinical testing rather than "training" in the machine learning sense.

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

As no training set is described or implied for this type of medical device's validation, no information is provided on how its ground truth would have been established.

Ask a specific question about this device