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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of of multiple physiological parameters of adults, pediatrics and neonates healthcare facilities. The MP20, MP30, MP40 and MP50 are in additionally intended for use in transport situations within healthcare facilities.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCC2) is restricted to neonatal patients only.

The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release D.03 software for the IntelliVue patient monitor devices, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90.

The Philips IntelliVue Patient Monitor, Release D.03, is a patient monitoring device that received 510(k) clearance (K060541) in 2006. The device is intended for monitoring, recording, and alarming multiple physiological parameters of adult, pediatric, and neonatal patients in healthcare facilities, with some models also suitable for in-hospital transport.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The provided summary does not specify the sample size used for the test set or the data provenance. It generally refers to "system level tests, performance tests, and safety testing," but does not detail the specific number of patients, data records, or cases used in these tests. The nature of this device (patient monitor) suggests testing would likely involve simulated physiological data, bench testing, and potentially clinical data, but specifics are not given.

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

The provided summary does not mention the involvement of experts for establishing ground truth for a test set. Given that this is a patient monitoring device and the evaluation primarily focuses on substantial equivalence to predicate devices and meeting their specifications, the "ground truth" would likely be defined by the known physiological parameters and expected device responses based on engineering and medical standards, rather than expert interpretation of complex medical imagery or conditions.

4. Adjudication Method for the Test Set

The provided summary does not describe any adjudication method. As mentioned above, the evaluation seems to rely on established specifications and objective measures of device performance rather than subjective expert interpretations that would require adjudication.

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 or mentioned in the provided summary. This type of study is typically performed for diagnostic imaging devices where human interpretation plays a significant role and the AI's impact on human performance is being assessed. For a patient monitor, the primary evaluation is about the accuracy and reliability of its physiological measurements and alarms.

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

The evaluation of the Philips IntelliVue Patient Monitor is fundamentally about its standalone performance in measuring and alarming physiological parameters. While it's a device that assists human caregivers, the "testing activities" described (system level, performance, safety) intrinsically refer to the device's inherent functional capabilities without necessarily evaluating a human-in-the-loop scenario impacting the device's measurements. The device itself acts in a standalone capacity by continuously monitoring and providing data and alarms.

7. The Type of Ground Truth Used

The ground truth for evaluating this device appears to be based on:

• Established Specifications: "Pass/Fail criteria were based on the specifications cleared for the predicate device." This implies adherence to predetermined acceptable ranges and accuracy for physiological measurements (e.g., heart rate, blood pressure, oxygen saturation, gas concentrations).
• Engineering and Medical Standards: The "performance, functionality, and reliability characteristics" are assessed against what are considered acceptable and safe parameters for patient monitoring in a clinical setting.
• Predicate Device Performance: The core of the 510(k) submission is to demonstrate "substantial equivalence" to legally marketed predicate devices, meaning its performance matches or is equivalent to established, already-cleared devices.

8. The Sample Size for the Training Set

The provided summary does not mention a training set or its sample size. Patient monitoring devices like the IntelliVue are typically developed and validated against known physiological signals and simulated data, rather than "training" in the machine learning sense from a specific dataset of patient cases. While the internal algorithms (e.g., for arrhythmia detection) might have been developed using data, the document does not elaborate on this.

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

Since a "training set" is not explicitly mentioned, the method for establishing its ground truth is also not described. For a traditional patient monitor, the underlying algorithms for parameter calculation and alarm generation are based on established physiological principles and signal processing, validated through rigorous engineering and clinical testing rather than a separate "training set" with explicit ground truth labels as seen in AI/ML applications.

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