Search Results

Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. 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.

The ELECSYS® CK-MB STAT and Elecsys® CK-MB Assays are a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection.

Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.

The Elecsys® CK-MB application is identical to the Elecsys® CK-MB STAT assay, the only difference being the length of incubation (18 minutes vs. 9 minutes).

The provided 510(k) summary (K022654) describes the Elecsys® CK-MB STAT and Elecsys® CK-MB Assays, which are in vitro quantitative immunoassays for the MB isoenzyme of creatine kinase. This document focuses on demonstrating substantial equivalence to a predicate device, not on establishing specific acceptance criteria and proving the device meets them through a formal clinical study with ground truth and expert adjudication.

However, based on the information provided, we can extract details about the performance characteristics of the modified devices and how they compare to the original device (which serves as a benchmark for what might be considered "acceptance" for the predicate).

Here’s a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) is implicitly derived from the performance of the legally marketed predicate device (the "original device") and the demonstration that the modified devices ("CK-MB STAT (modified device)" and "CK-MB (modified device)") maintain comparable or improved performance characteristics. Since this is an immunoassay and not a diagnostic imaging AI, many of the typical AI-specific criteria (like specificity, sensitivity, ROC AUC) are not directly discussed in the provided text. Instead, the focus is on analytical characteristics.

Note: The "acceptance criteria" here are inferred from the need to demonstrate substantial equivalence. The modified devices either retain the same characteristics as the predicate or show improvements (e.g., standardization method, more detailed expected values).

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size for any test set or the data provenance (country of origin, retrospective/prospective). The data presented for "Expected values" (median, 97.5th, and 99th percentiles) would have been derived from a study on healthy individuals, but the details of this study are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This 510(k) pertains to an in vitro diagnostic immunoassay, not a device relying on human interpretation (like radiology images) or clinical expert consensus for its "ground truth" establishment in the way an AI diagnostic tool would. Therefore, this information is not applicable and not provided in the summary. The "ground truth" for an immunoassay largely relies on biochemical reference methods or validated standards.

4. Adjudication method for the test set

As above, this information is not applicable and not provided for this type of in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretations or clinical diagnoses, which is not the nature of this submission.

5. 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic imaging or interpretation tools, not for an automated quantitative immunoassay like the Elecsys® CK-MB. There is no human-in-the-loop component for interpretation in the conventional sense that would necessitate such a study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, in a sense, the performance described here is standalone performance of the assay itself. The Elecsys® CK-MB assays are automated quantitative immunoassays performed on specific analyzers (Roche Elecsys® 1010 / 2010 and Modular Analytics E170). The results are generated by the algorithm/system, and there is no subsequent human interpretation step that would modify the numerical output of the assay. The measured concentrations are the direct output.

7. The type of ground truth used

The ground truth implicitly used for the standardization of the modified devices is the AACC CK-MB reference material (human recombinant CK-MB). This indicates reliance on a well-defined and recognized reference standard for calibration, which serves as the "ground truth" for accurate measurement.

8. The sample size for the training set

The document does not provide information on the sample size for any "training set." This is because the device as described is an immunoassay, not a machine learning or AI model in the modern sense that requires a "training set." The assay relies on established biochemical reactions, calibrated against reference materials, and characterized through analytical validation.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/ML model for this immunoassay. The calibration and standardization are established using the AACC CK-MB reference material, which serves as the reference standard for analytical accuracy.

Ask a specific question about this device