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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, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and healthcare environments.

The modification creates the Masimo SET SpO₂ pulse oximetry module for use in Philips host patient monitors.

The provided text is a 510(k) summary for the Philips Medical Systems Masimo SET SpO2 module. This document focuses on establishing substantial equivalence of a new device to a legally marketed predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics for the new device's specific clinical efficacy or accuracy.

Therefore, much of the requested information cannot be directly extracted from the provided text. The summary explicitly states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the pulse oximetry module functionality meets all reliability requirements and performance claims."

This indicates that the testing performed largely confirmed the new device's ability to operate similarly to the predicate under various conditions, rather than a clinical study establishing new performance benchmarks.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." It does not provide specific acceptance criteria or reported device performance metrics in a table format for the new device. The focus is on equivalence, not on new performance claims.

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

This information is not provided in the 510(k) summary. The summary refers to "system level tests, integration tests, environmental tests, and safety testing," which are typically laboratory or engineering tests, not clinical studies with a "test set" in the context of patient data.

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)

This information is not provided. As noted above, the "test set" likely refers to engineering testing, not a clinical dataset requiring expert ground truth.

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

This information is not provided.

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

This information is not provided. The device is an SpO2 module, which provides a physiological measurement, not an AI-powered diagnostic tool requiring human reader studies to improve interpretation. An MRMC study would not be relevant in this context.

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

The device is a pulse oximetry module, which inherently provides a standalone measurement (SpO2, pulse rate). The summary confirms its "functionality" and "performance claims," implying its ability to provide these measurements independently. However, the exact details of standalone performance metrics are not explicitly stated beyond meeting predicate specifications.

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

For a pulse oximeter, "ground truth" for accuracy is typically established through controlled desaturation studies compared against arterial blood gas measurements. The provided text does not detail the type of ground truth used for specific accuracy validation, but implies it was sufficient to demonstrate equivalence to the predicate.

8. The sample size for the training set

This information is not provided. Pulse oximeters do not typically employ a "training set" in the machine learning sense. Their algorithms are based on established physiological principles and signal processing, often calibrated and validated against clinical data, but not "trained" as an AI model would be.

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

As there is no "training set" in the AI sense for this device, how its ground truth was established is not applicable and therefore not provided.

In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not a detailed clinical study report on the new device's performance metrics against specific acceptance criteria.

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