(18 days)
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.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.