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Reference Material for Amphetamine/Methamphetamine in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte and imetabolite in human urine.

Reference Material for Amphetamine/Methamphetamine in Human Urine

The provided text is a 510(k) clearance letter from the FDA for a diagnostic reference material, not an AI device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving an AI device meets these criteria.

The document discusses:

• The FDA's determination of substantial equivalence for a "Reference Material for Amphetamine/Methamphetamine in Human Urine."
• Regulatory classifications and general controls for medical devices.
• Requirements under CLIA-88 (Clinical Laboratory Improvement Amendments of 1988).
• Contact information for various FDA departments.

Therefore, I cannot extract the following information from the provided text:

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
6. If a standalone (algorithm only) 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

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