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CLINIQA LiniCAL™ Protein 2 Calibration Verifiers are intended for use in the clinical Iaboratory to verify calibration and/or assess linearity of the Olympus® AU Analyzers. Five assayed levels of Anti Streptolysin O, C-Reactive Protein, Complement C3, Complement C4, Ferritin, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Prealbumin and Transferrin are provided to allow monitoring of the reportable range.

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The provided document is a 510(k) premarket notification letter from the FDA for a device named "LiniCAL™ Protein 2 Calibration Verifiers Levels A – E for Olympus® AU Analyzers." This device is a quality control material and is therefore not subject to the same kind of performance studies as a diagnostic medical device that would involve human subjects, image analysis, or expert interpretations.

The information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically associated with evaluating the performance of diagnostic algorithms or imaging devices. Since the LiniCAL™ device is a calibration verifier (a type of quality control material), its "performance" is assessed differently, primarily through its ability to accurately verify the calibration and assess the linearity of clinical analyzers.

Therefore, the available document does not contain the specific information requested regarding acceptance criteria in the context of human-in-the-loop performance, expert consensus, or clinical outcome studies. The FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning its intended use and performance characteristics are comparable to existing, approved devices of the same type.

To provide a hypothetical response based on what might be expected for a device of this nature, if it were a diagnostic assay or an AI-powered diagnostic tool, I would need more context. However, based solely on the provided document, the requested details are not present.

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