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For in vitro diagnostic use only. These calibrators are intended for use with instruments for the measurement of HbA1c and are designed to allow calibration to either the American NGSP system or the International IFCC system.

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This document is a 510(k) clearance letter from the FDA for a Glycated Haemoglobin Two Level Calibrator Kit. It does not contain detailed information about acceptance criteria or specific study results showing device performance.

Therefore, I cannot fulfill your request for:

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

This document primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information. To find the information you're looking for, you would typically need to consult the full 510(k) submission or the device's labeling/user manual, which would include performance studies and validation data.

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