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The M1026B Anesthesia Gas Module is intended to measure and monitor anesthesia gas and to provide this data to health care contents in the volunation varially varialy via the Component Monitoring System, for the support of clinical decision making.

The device is indicated for use in health care facilities by health care professionals whenever The device is intriculour of assiric and neonate patient anesthesia gas monitoring.

The name of this device is the PhilipsM1026B Anesthetic Gas Monitor for use with the Philips IntelliVue Family of Patient Monitors MP40/50/60/70/90, the Anesthesia Component Monitoring System M1176A and the Philips Viridia 24 System. The common name is the Philips Anesthesia Gas Monitor.

This document is a 510(k) summary for the Philips M1026B Anesthetic Gas Monitor. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary identifies the device as being substantially equivalent to the Philips M1026A, which was cleared under K951127, K982619, and K994188. This means the manufacturer is asserting that the new device performs as safely and effectively as the predicate devices. The FDA's letter (APR 29 2004) confirms this determination of substantial equivalence.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
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 study 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 detailed performance data is typically found in the full 510(k) submission, not in the summary document. The summary focuses on substantiating equivalence, not on detailing a new performance study against specific acceptance criteria.

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