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The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization of instruments and methods for the determination of Ethyl alcohol in whole blood or serum. The Standard Solutions may also be used for validation of the standardization of instruments and/or control materials.

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The provided text is a 510(k) clearance letter from the FDA for an "Ethyl Alcohol Calibrator" product. It states that the device is substantially equivalent to a predicate device and can be marketed.

However, the document does not contain specific information about:

• Acceptance criteria for device performance.
• The study that proves the device meets acceptance criteria (e.g., performance metrics, statistical analyses).
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used or how it was established.

The document is a regulatory approval letter, not a performance study report. Therefore, I cannot extract the requested information from the given text.

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The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization caruments and methods for the determination of ethyl alcohol in whole blood or serum. The Standard tions may also be used for validation of the laboratory's routine standards and/or control materials.

Not Found

This document is a 510(k) clearance letter from the FDA for "Ethyl Alcohol Clinical Standard Solutions." It does not contain information about acceptance criteria or a study proving device performance in the way described in the request. The letter confirms substantial equivalence to a legally marketed predicate device, but it doesn't detail performance metrics or studies.

Therefore, I cannot extract the requested information from the provided text. The document is regulatory approval, not a performance study report.

Ask a specific question about this device