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The TCM CombiM Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO₂), oxygen (tcpO₂) partial pressure in neonates, pediatrics and adults not under gas anesthesia.

The TCM TOSCA Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO2), oxygen saturation of arterial haemoglobin (SpO2) and pulse rate in pediatrics and adults.

The TCM TOSCA monitoring system and the TCM CombiM monitoring system are based on the TCM 4/40 Monitoring System (K043003) which consist of a basic unit that has touch screen and two modules. One module for the combined tcpO2/tcpCO2 monitoring and one for SpO2. Both new modules have an integrated callbration unit. Both Sensors can be used with either earclip- or a conventional fixation ring application system. In addition the CombiM also comes with a double adhesive ring. The software of the TCM 4/40 basic unit has been updated (to version 3.01) and two new modules have been developed to enable the use of the sensor technology from the TOSCA500 Monitoring System (K063434) and from the MicroGas 7650 rapid (K003943). Thereby the SpO2 and tcpCO2 can be measured using the new TCM TOSCA module and the combined SpO2/tcpCO2 sensor of the TOSCA500 system. The tcpO2 and tcpCO2 can be monitored using the new TCM CombiM module and the combined tcpOz/tcpCO2 sensor of the MicroGas 7650 rapid system. A new single tcpCO2 sensor can also be used with this module.

This document is a 510(k) Premarket Notification Submission for the TCM TOSCA/CombiM Monitoring System. It describes the device's intended use and claims substantial equivalence to predicate devices, but does not contain any information about clinical studies or acceptance criteria with reported device performance.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This type of submission often focuses on demonstrating equivalence through comparison of technical characteristics and intended use, rather than presenting new clinical study data to establish performance against acceptance criteria for a novel device.

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