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The Stat-Site® M Hgb System is for in-vitro diagnostic use only. The Stat-Site® M Hgb Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® M Hgb meter.

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The provided text is a 510(k) cleared document for the Stat-Site® M *** System Whole Blood Hemoglobin Assay. It does not contain the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.

The document is a clearance letter and an "Indications for Use Statement". It confirms that the device is substantially equivalent to a legally marketed predicate device and outlines its intended use. It does not include the technical study results or performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test set and data provenance.
3. Number and qualifications of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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