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The Corometrics TCpO2/CO2 Module is used for non-invasive continuous monitoring of oxygen and/or carbon dioxide when used with the Marquette Medical System's Solar Monitor Series and TRAM-RAC 4A. It is indicated for use as a monitor of oxygen and/or carbon dioxide in neonates not under anesthesia.

The Corometrics TcpO2/CO2 Module provided continuous monitoring of transcutaneous pO2 and pCO2 when used in conjunction with the Marquette Medical Systems' solar Monitor Series and the Tram-Rac 4A interface. The Solar monitor provides the display and control function for the TC Module.

The provided text does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria beyond a general statement that the "Corometrics TCpO2/CO2 Module has been extensively tested to meet its requirements and design." Therefore, the requested information cannot be fully extracted.

Here's what can be inferred from the text:

1. A table of acceptance criteria and the reported device performance
Not provided in the document.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not provided in the document.

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 provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not provided in the document.

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 device is a medical monitor, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a monitor, implying a standalone performance capability to provide readings. However, specific standalone performance study details are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided in the document. For a transcutaneous monitoring device, ground truth would typically come from comparative measurements using blood gas analysis or other established methods.

8. The sample size for the training set
Not provided in the document.

9. How the ground truth for the training set was established
Not provided in the document.

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