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IntelliVue MP40, MP50, MP60, MP70, MP80, MP90 and MX800 and IntelliBridge EC10 and EC5 IC Module: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

IntelliVue TcG10 Measurement Module:

Indicated for use by health care professionals whenever there is a need to support the continuous and noninvasive monitoring of transcutaneous partial pressures of blood gas carbon dioxide and oxygen of patients not under gas anesthesia.

The modified Philips MP40, MP50, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors are a flexible and modular monitoring solution optimized for the surgical, cardiac, general medical and neonatal care environments. The monitors can be connected to the Philips Multi-Measurement Module (MMS) family with its extensions and to the IntelliVue family plug-in measurement modules. The monitors can also be connected to the IntelliVue anesthetic gas modules and to the new Intellivue TcG10 Measurement Module.

The modified Philips IntelliBridge EC10 and EC5 ID modules build an external medical device solution to collect data from external devices at the bedside providing the data to patient monitors, and patient monitoring networks. The modified EC10 and EC5 ID modules support the interface of the IntelliVue patient monitors with the new IntellVue TcG10 Measurement Module.

The new IntellVue TcG10 Measurement Module is a device for the continuous and noninvasive measurement of the transcutaneous partial pressures of blood gas carbon dioxide (pCO2) and oxygen (p02) of patients from all pediatric subgroups and of adult patients not under gas anesthesia in hospital environment. The transcutaneous measurement of pCO2 and pO2 makes use of the fact that carbon dioxide and oxygen gases are able to diffuse through body tissue and skin and can be detected by a sensor placed at the skin surface. By warming up this sensor, a local hyperemia is induced, which increases the supply of arterial blood to the dermal capillary bed below the sensor. The transcutaneous blood gas values (tcpCO2 and tcpO2) have to be interpreted primarily as the blood gas partial pressures prevailing at the level of the arterialized skin tissue. In general, this value correlates well with the corresponding arterial blood gas partial pressure.

The provided 510(k) summary (K110474) describes the Philips IntelliVue TcG10 Measurement Module and related system components. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical bench testing. It explicitly states that clinical data are not required for this type of device according to specific guidance documents.

Therefore, the information requested regarding a study proving acceptance criteria for AI performance is largely not applicable to this submission, as it concerns a medical device that measures transcutaneous blood gas pressures, not an AI-powered diagnostic or assistive tool.

However, I can extract the information that is present about performance and testing from the document.

Acceptance Criteria and Device Performance (Based on "within specifications" and "substantially equivalent"):

Study Details:

1. Sample size used for the test set and the data provenance: Not specified for a "test set" in the context of an AI study, as this refers to a medical device's performance testing. The document states "bench performance testing."

   • Data provenance: Not applicable.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is not relevant to this device's non-clinical performance testing.

3. Adjudication method for the test set: Not applicable.

4. 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 device is a measurement module, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI algorithm. This device is a standalone measurement module. Its performance was tested as a system comprising the measurement module and modified patient monitors/interface modules.

6. The type of ground truth used:

   • For the non-clinical performance tests: The ground truth was based on the specifications cleared for the predicate devices. This implies that measurements from the new device were compared to established engineering and performance standards expected for such devices, likely using calibrated instruments or reference methods in a laboratory setting.
   • "Pass/Fail criteria were based on the specifications cleared for the predicate devices."

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

Additional Notes from the Document:

• Clinical Performance Tests: "Clinical data are not required in accordance to the special controls guidance document... A clinical evaluation was conducted including literature review and clinical acceptance studies with experienced nursing and physician staff." This "clinical evaluation" appears to be an assessment of user experience and acceptance rather than a clinical trial to establish diagnostic accuracy against a ground truth.
• Basis of Equivalence: The primary basis for substantial equivalence is the use of "identical functional measurement and calibration module as the predicate device" and "identical Radiometer tc Sensor 84 and the identical medical accessories." The changes are primarily software modifications for interfacing and an internal power supply.

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