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MAS® Tox · Ammonia Control is intended for use in the clinical laboratory as quantitative controls for monitoring test procedures used to assay human serum and/or plasma specimens for alcohol, ammonia, acetaminophen and salicylate. Include Tox · Ammonia Control with patient serum or plasma specimens when assaying for any of the listed constituents. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

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This document is a 510(k) clearance letter from the FDA for a device called "MAS® Tox - Ammonia Control Liquid Assayed Toxicology Control." This type of device is a control material used in clinical laboratories to monitor the performance of diagnostic tests.

The information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically found in the 510(k) submission itself or a summary of its contents, not in the FDA's clearance letter. The clearance letter only states that the FDA has reviewed the submission and found the device to be "substantially equivalent" to a legally marketed predicate device. This means the FDA believes the new device is as safe and effective as a similar device already on the market.

Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications. The letter primarily focuses on regulatory approval.

Here's what I can extract from the provided text, and why the other information is missing:

• Device Name: MAS® Tox - Ammonia Control Liquid Assayed Toxicology Control
• Predicate Device Mentioned: Bayer ToxAmmonia Control (in the Indications for Use form)
• Regulation Number: 21 CFR 862.3280 (Clinical toxicology control material)
• Regulatory Class: Class I
• Product Code: DKC
• Indications for Use: "MAS® Tox · Ammonia Control is intended for use in the clinical laboratory as quantitative controls for monitoring test procedures used to assay human serum and/or plasma specimens for alcohol, ammonia, acetaminophen and salicylate. Include Tox · Ammonia Control with patient serum or plasma specimens when assaying for any of the listed constituents. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument."
• Predicate Device Indications for Use (from the form): "For in vitro diagnostic use to monitor the precision and the accuracy of chemistry systems, including the ADVIA IMS®"

Why the specific questions cannot be answered from this document:

1. Table of acceptance criteria and reported device performance: This letter does not contain performance data or acceptance criteria for the new device. It only refers to a "substantial equivalence" determination based on information provided in the 510(k) submission.
2. Sample sizes, data provenance: The document doesn't detail any specific study data or sample sizes used to demonstrate performance.
3. Number of experts, qualifications: Not applicable for this type of regulatory letter; this relates to the specific studies performed, not the FDA's decision letter.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as this is a control material, not typically an AI-assisted diagnostic device. Its performance is about its stability and accurate concentration, not reader interpretation.
6. Standalone performance: While the device has "standalone performance" in the sense that it performs as a control, the document does not describe a study proving this performance.
7. Type of ground truth used: Not applicable in the context you're asking (e.g., expert consensus for images). For a control material, the "ground truth" would be the assayed values of the analytes within the control, which are established through analytical methods by the manufacturer.
8. Sample size for training set: Not applicable, as this is a control material, not an algorithm trained on data.
9. How ground truth for training set was established: Not applicable.

To obtain the detailed information you are seeking regarding a device's performance, acceptance criteria, and study methodology, you would need to access the actual 510(k) submission summary (often available on the FDA's website) or the manufacturer's technical documentation for the device.

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