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Clinical Blood Gas Mixtures are intended for use as calibration gases for research and Blood Gas Analyzers.

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I am sorry, but the provided text from the FDA 510(k) K993789 letter and associated documents does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

This document is a notification from the FDA to General Air Service & Supply regarding their "Clinical Blood Gas Mixture." It primarily states that the device is substantially equivalent to a legally marketed predicate device and can proceed to market, subject to general controls.

Specifically, the document does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample size for a test set, data provenance, or ground truth establishment.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Stand-alone algorithm performance or training set details.

The letter focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific metrics and methodologies.

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