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For in vitro diagnostic use in the quantitative determination of creatine kinase-MB in recommended when Acute Myocardial Infarction is suspected.

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The provided text is a 510(k) premarket notification letter from the FDA for a Creatine Kinase-MB Reagent Set. This document is a regulatory clearance for an in vitro diagnostic device and does not contain the detailed study information typically found in clinical trials for AI/ML-based medical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and device performance based on the input document. The document primarily focuses on regulatory approval, substantial equivalence to a predicate device, and general regulatory requirements for marketing the device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Details about experts for ground truth establishment or adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample sizes for training sets or how their ground truth was established.

This is a clearance letter for a chemical reagent set, not an AI/ML-driven device, so the type of performance data requested is not applicable to this document.

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