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The TCM4 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.

The TCM40 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures as well as of oxygen saturation of arterial hemoglobin and pulse rate. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.

The TCM4/40 Monitoring Systems essentially consist in a monitor unit, a combined oxygen/carbon dioxide interface module along with the combined electrodes assembly and (for the TCM40 only) an oxygen saturation/pulse module with a selection of three sensors.

The provided 510(k) Premarket Notification for the Radiometer Copenhagen TCM4/40 Monitoring Systems does not contain a typical study with acceptance criteria and reported device performance in the way a clinical trial or algorithm performance study would.

Instead, the submission relies on compliance with established consensus standards for medical devices and existing predicate devices to demonstrate safety and effectiveness. Therefore, many of the requested data points (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth for training) are not applicable or explicitly stated in this type of submission.

Here's an attempt to answer your questions based only on the provided text, indicating when information is not present:

Acceptance Criteria and Study Details for Radiometer TCM4/40 Monitoring Systems

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are framed in terms of compliance with regulatory standards for medical devices. The "reported device performance" is implicitly that it meets the requirements of these standards.

2. Sample size used for the test set and the data provenance

Not applicable. No specific "test set" in the context of a clinical performance study with patient data is mentioned. The evaluation relies on compliance with standards. The document explicitly states: "Based upon the extensive use of consensus standards covering all aspects of safety and performance, no clinical evaluation was deemed necessary to assess the product performance levels."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth establishment for a test set is described, as no clinical performance study was deemed necessary.

4. Adjudication method for the test set

Not applicable. No test set requiring expert adjudication is described.

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 monitoring system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.

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

This refers to the performance of the device's monitoring capabilities. The "standalone" performance is established through its compliance with the listed consensus standards for transcutaneous oxygen/carbon dioxide monitoring and pulse oximetry. The exact performance metrics (e.g., accuracy, precision) as measured against these standards are not detailed in this summary, but the conclusion is that the device "performs up to the requirements of the relevant international consensus standards."

7. The type of ground truth used

For the purpose of this 510(k) submission, the "ground truth" for demonstrating the device's safety and effectiveness is the requirements specified within the cited international consensus standards. The device's design and testing were assessed against these established engineering and performance criteria.

8. The sample size for the training set

Not applicable. The device's technological characteristics are adaptations of existing, previously cleared devices (TCM400, TCM3, OxiMAX N-550). There's no mention of a "training set" in the context of machine learning or AI.

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

Not applicable. No training set is described. The device's development appears to be based on established engineering principles and components from predicate devices, validated against consensus standards.

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