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The intended use of the MX40 is to:

The device is intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals.

Indications for Use

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 and pediatrics in hospital environments and during transport inside hospitals.

Rx only.

The MX40 is a multi-parameter, battery operated patient monitor that is small enough to be worn by the patient. Its multi-radio design enables device operation within existing Philips telemetry networks while providing compatibility to the IntelliVue Information Center solutions. Along with infrastructure radios, the MX40 integrates a short-range radio (SRR), enabling wireless connectivity to the litelliVue family of monitors. Acquired physiological data, along with physiological alarms and technical alert information are provided to multiple monitoring systems (local, bedsides and /or information systems).

Previously cleared compatible Accessories are still in use, compatibility to additional Massimo accessories are documented in this filing. The MX40 is compatible with the legally marketed Philips CL SpO2 Pod and CL NBP Pod (K101600, K111905). The CL SpO2/NBP Pods are small battery powered devices that measure oxygen saturation, pulse rate and blood pressure, pulse rate, respectively. A list of all accessories is available in the Instructions for Use.

The provided text is a 510(k) summary for the Philips MX40 Release C.01, a physiological patient monitor. It describes the device, its intended use, and a comparison with a predicate device (Philips IntelliVue MX40 Release B.07).

However, this document does not contain the specific information required to answer your request regarding acceptance criteria and the study proving the device meets them.

The document states:

• "No performance standards have been issued under the authority of Section 514."
• "The MX40 Release C.01 was tested in accordance with Philips verification and validation processes."
• "Clinical Performance testing for MX40 Release C.01 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence."
• "Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. Testing involved system level tests, performance 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."

This indicates that the submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing (system level tests, performance tests, and safety testing based on hazard analysis) and adherence to Philips' internal verification and validation processes, rather than conducting a new clinical study with specific acceptance criteria as one might expect for a novel device or a device with new clinical applications.

Therefore, I cannot provide the requested information from this document for the following reasons:

1. A table of acceptance criteria and reported device performance: This document explicitly states that "No performance standards have been issued." While it mentions "Pass/Fail criteria were based on the specifications cleared for the predicate device," these specific criteria and the detailed performance results are not provided in this summary.
2. Sample size used for the test set and data provenance: The document mentions "non-clinical performance testing" and "system level tests, performance tests, and safety testing," but does not specify sample sizes or data provenance (e.g., number of patients, records, or the nature of the test data).
3. Number of experts used to establish ground truth and qualifications: This information would typically be relevant for clinical studies or studies establishing ground truth, which were not performed for this 510(k) as per the document.
4. Adjudication method for the test set: Not applicable as a clinical study for establishing ground truth was not performed.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document clearly states, "Clinical Production testing for MX40 Release C.01 was not performed." Therefore, no MRMC study was conducted.
6. Standalone (algorithm only without human-in-the-loop performance) study: This would typically refer to AI/ML device performance. The MX40 is a physiological monitor, not an AI/ML algorithm in the context typically discussed for standalone performance. Its functions are monitoring and alarm generation for vital parameters. The document focuses on hardware, software, and accessory changes.
7. Type of ground truth used: Not explicitly stated, as clinical performance testing was not performed. The "ground truth" for the non-clinical testing would be the established specifications and expected performance of the predicate device.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) pertains to a modification of an existing physiological monitor, and its acceptance criteria and proof of performance are based on demonstrating substantial equivalence through non-clinical verification and validation against the predicate device's established specifications, rather than a new clinical study with the type of data points you are requesting.

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