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Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.

The modified device Philips IntelliVue MP5 Patient Monitor with Microstream Side Stream CO2 Measurement Module. The modification consists of the integration of the Microstream CO2 Measurement Module, which is substantial equivalent to the legally marketed Philips M3015A Measurement Server Extension (K993383) and to the Oridion Capnostream2o with A2 Adaptive Averaging Software and Extended CO2 Measurement Range (K072295).

The provided text describes the Philips IntelliVue MP5 Patient Monitor with an integrated Microstream Side Stream CO2 Measurement Module. The document focuses on showing substantial equivalence to predicate devices rather than providing a detailed acceptance criteria table with specific performance metrics and their verification.

Here's a breakdown of the information that can be extracted, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit acceptance criteria (e.g., minimum accuracy rates, sensitivity, specificity) for specific physiological parameters. Instead, it states that the device was validated according to ISO 21647 for accuracy and that "Pass/Fail criteria were based on the specifications cleared for the predicate device." It also claims that "test results showed substantial equivalence" and that the device "meets all reliability requirements and performance claims."

Therefore, based on the provided text, a detailed table cannot be constructed. The implicit acceptance criteria are that the device performs equivalently to the predicate devices and meets relevant ISO standards.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It generically mentions "system level tests, performance tests, and safety testing from hazard analysis."

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided in the document.

4. Adjudication Method

This information is not provided in the document.

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

No MRMC study is mentioned in the document. The study described is not focused on human reader performance with or without AI assistance, but rather on the technical performance and equivalence of the device itself.

6. Standalone Performance

The description of "system level tests, performance tests, and safety testing" implies that standalone (algorithm only without human-in-the-loop) performance testing was conducted to demonstrate the device's functional integrity and equivalence to predicate devices. However, specific metrics of this standalone performance are not provided beyond the general statement of meeting "all reliability requirements and performance claims."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. Given the context of monitoring physiological parameters (like CO2 measurement accuracy), the ground truth would likely be established through highly accurate reference measurement devices or laboratory-grade instruments. The validation against ISO 21647 suggests adherence to established standards for verifying accuracy against a known truth.

8. Sample Size for the Training Set

No information about a "training set" or its sample size is provided. This is expected as the device in question is a patient monitor with an integrated CO2 module, not typically an AI/machine learning algorithm requiring a distinct training set in the modern sense. The "training" for such devices involves calibration and validation against known standards.

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

Since no training set is mentioned, this information is not available.

Summary of Study Information:

• Study Type: Verification, validation, and testing activities focused on demonstrating substantial equivalence to predicate devices.
• Key Validation Standard: Accuracy was validated according to ISO 21647.
• Comparison: The modified device (Philips IntelliVue MP5 Patient Monitor with Microstream CO2) was compared to its legally marketed predicate device (IntelliVue MP5 Patient Monitor (K063725, K081793)) and the Microstream CO2 module was compared to the Philips M3015A Measurement Server Extension (K993383) and the Oridion Capnostream2o (K072295).
• Conclusion: "Test results showed substantial equivalence" and "The results demonstrate that the Philips IntelliVue MP5 Patient Monitor meets all reliability requirements and performance claims."

In conclusion, while the document confirms that a study was conducted to demonstrate the device's performance and substantial equivalence according to ISO 21647 and predicate device specifications, it lacks the detailed quantitative acceptance criteria and specific study metrics (like sample sizes, expert details, or ground truth establishment methods) that would typically be associated with modern AI/ML device studies.

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