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Establishment of reference curves for the determination of IgG, IgG1-4, IgA, IgE, C3c, C4, Transferrin, Albumin, α1-antitrypsin, α2-macroglobulin, Haptoglobin, α3-acid glycoprotein, Prealbumin, Hemopexin, Ceruloplasmin, RbP, Ig/L-chain Iambda & kappa, soluble Transferrin Receptor (sTfR), Ferritin, ß2-microglobulin, and Total protein by immunonephelometry with BN™ Systems.

N Protein Standard SL is a liquid standard prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the quantitative determination of human serum proteins by immunonephelometry with BN™ Systems (particle-enhanced nephelometry).

This document describes various aspects of the N Protein Standard SL device. However, it does not contain information typically required to describe acceptance criteria and a study that proves a device meets them for a AI/ML-based medical device.

The provided text is a 510(k) summary for a calibrator, multi-analyte, which is a laboratory reagent used to establish reference curves for measuring human serum proteins. It is not an AI/ML-based device.

Therefore, I cannot provide the requested information in the format of a table detailing acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC) or address aspects like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. These criteria are relevant for evaluating AI/ML models, not for a chemical calibrator.

The only "performance characteristic" mentioned is stability:

Device Performance Characteristics:

• Stability: Stability was evaluated according to Dade Behring protocols and the standard was found stable as originally packaged and for at least 14 days at +2° to +8° C, once opened.

This describes a stability test, which is a common quality control measure for chemical reagents, but it doesn't involve the kind of rigorous clinical or radiological study described in your prompt for AI/ML devices. Therefore, a table of acceptance criteria and reported performance, as requested, cannot be generated from this document because the device type and the nature of its evaluation are fundamentally different.

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