Search Results

The intended use of ACS CKMB II is for the quantitative determination of CK-MB (CK-2) in serum or plasma using the Ciba Corning Automated Chemiluminescence Systems.

The Ciba Corning ACS CKMB II assay is a two-site chemilumometric (sandwhich) assay. which uses constant amounts of two antibodies. The first antibody or Lite Reagent is a monoclonal mouse anti-CK-MB antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-CK-BB antibody covalently coupled to paramagnetic particles. A direct relationship exists between the CK-MB in a sample and the relative light units (RLUs) detected by the ACS:180 systems. The assay is unaffected by increased levels of other CK isoenzymes.

The provided text describes a medical device, the "ACS CKMB II Immunoassay," and its performance but does not include information relevant to AI/ML device studies as outlined in your request.

Specifically, the document focuses on an immunoassay for detecting CK-MB, which is a laboratory test. The "performance data" section details traditional analytical performance characteristics of such an assay (Sensitivity, Accuracy using a correlation with a reference method, and Precision).

Therefore, I cannot extract the following information because it is not present in the provided text:

• A table of acceptance criteria and the reported device performance (in the context of AI/ML performance metrics like sensitivity, specificity, AUC, etc.): The document lists traditional analytical performance metrics.
• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): While a sample size of 1744 is mentioned for the accuracy study, details on data provenance are absent.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an immunoassay.
• Adjudication method: Not applicable for an immunoassay.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is an immunoassay, not an imaging AI device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is an immunoassay, not an AI algorithm.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for this immunoassay is likely the result from the "FEIA reference method."
• The sample size for the training set: Not applicable for an immunoassay, which does not typically involve machine learning training sets in this context.
• How the ground truth for the training set was established: Not applicable for an immunoassay.

In summary, the provided document describes a traditional in-vitro diagnostic device (an immunoassay) and its analytical performance, not an AI/ML powered device. Therefore, none of the requested AI/ML specific criteria can be extracted from this text.

Ask a specific question about this device