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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments
The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments The MP5 is also intended for use during patient transport outside of a hospital environment The monitors are not intended for home use They are intended for use by health care professionals

The Philips MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors. The modification is a change of the labelling with regard to M1021A and the introduction of software revision G.06 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips IntelliVue Patient Monitors, structured according to your request:

Based on the provided 510(k) summary, the device in question is the Philips MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, with a modification involving a software revision G.06. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than a de novo submission with specific acceptance criteria for a novel algorithm.

Therefore, the requested information elements related to algorithmic performance and ground truth establishment are largely not applicable or not explicitly detailed in this type of 510(k) submission which focuses on a software update for an existing, cleared device family.

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

Given that this 510(k) pertains to a software update for an existing patient monitor, the "acceptance criteria" are intrinsically tied to the performance specifications of the predicate devices. The document states:

"Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence."

This implies that the acceptance criteria are to meet or exceed the performance of the previously cleared versions of the IntelliVue Patient Monitors. Specific quantitative metrics for individual physiological parameters (e.g., accuracy of heart rate, blood pressure, etc.) are not provided in this summary. Instead, a general statement of meeting prior specifications is used.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate Testing involved system level and regression tests, safety and performance tests, EMC and environmental tests, such as testing from the hazard analysis."

• Sample Size for Test Set: Not explicitly stated. The document refers to "system level and regression tests, safety and performance tests, EMC and environmental tests," but does not provide details on the number of test cases, durations, or subjects.
• Data Provenance: Not explicitly stated. Given the nature of patient monitors, testing would typically involve a combination of simulated data, bench testing, and potentially clinical data, but the specifics (country, retrospective/prospective) are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not stated. As this is for a patient monitor and a software update, the "ground truth" would generally refer to the accuracy of physiological measurements against established standards or reference devices (e.g., a calibrated ECG simulator for arrhythmia detection, a reference blood pressure cuff for NIBP, etc.). It does not involve expert adjudication in the way AI imaging algorithms do.

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

Not applicable/Not stated. This type of adjudication method is relevant for expert review of complex data, such as medical images. For patient monitors, performance is typically assessed against quantifiable metrics using reference equipment, not through expert consensus on interpretation.

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

Not applicable. This specific 510(k) relates to a software update for a patient monitor, not an AI-powered diagnostic application that would involve human readers interpreting images or data with and without AI assistance. The device's primary function is to monitor and display physiological parameters and generate alarms, not to provide diagnostic insights in the same manner as an AI imaging tool.

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

The document describes "system level and regression tests, safety and performance tests," which implies standalone testing of the device's functionality. The patient monitor itself operates largely as a "standalone" system in terms of its parameter acquisition and display, though human healthcare professionals interpret the output. The performance tests would have evaluated the device's ability to accurately measure, process, and display physiological parameters independently.

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

Not explicitly stated in detail. For patient monitors measuring physiological parameters, the "ground truth" would typically involve:

• Reference Standards/Calibrated Equipment: For accuracy of measurements (e.g., using a known voltage input for ECG, a pressure generator for NIBP, a known gas mixture for gas analysis).
• Simulated Data: For testing specific physiological conditions or arrhythmias.
• Clinical Data (potentially): Comparison of device measurements against invasively acquired or laboratory-confirmed values, if applicable for certain parameters, or against a predicate device in a clinical setting.

The summary refers generally to "specifications cleared for the predicate devices," implying that the ground truth for performance metrics aligns with those previously established and validated for the predicate monitors.

8. The sample size for the training set

Not applicable/Not stated. This 510(k) is for an update to an existing patient monitor system, not the clearance of a novel algorithm that would typically undergo a separate training phase with a specific training set size. While the initial development of signal processing algorithms within the monitor might have involved training, this information is not part of this specific software update filing.

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

Not applicable/Not stated. (As per point 8).

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