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Elecsys CalCheck CK-MB is intended for use in the quantitative verification of the calibration curve established by the Elecsys CK-MB reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

The Elecsys CalCheck CK-MB is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.

Here's an analysis of the provided text regarding the Elecsys® CalCheck™ CK-MB, focusing on acceptance criteria and study details.

Based only on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria related to diagnostic accuracy, clinical outcomes, or human reader performance.

The document is a 510(k) Summary for a calibration verification material, not a diagnostic device that analyzes patient samples or involves human interpretation of results in the traditional sense. Its purpose is to verify the calibration curve of an automated immunoassay analyzer.

Therefore, most of the questions posed in the prompt are not applicable to this type of device and the information provided.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The provided text does NOT include a table of acceptance criteria or reported device performance in terms of diagnostic metrics (e.g., sensitivity, specificity, accuracy).

• Implied Performance: The "performance" of this device is its ability to verify the calibration curve. This is achieved by assaying the material and comparing the results to "target values." The acceptance criteria would likely be related to the deviation of the measured values from these target values, but these criteria are not specified in the provided text.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. The "test set" for this device would be the Elecsys® CalCheck™ CK-MB samples themselves (three levels). Their performance is assessed by being run on the Elecsys 1010 or 2010 immunoassay analyzers. There's no mention of patient data, retrospective/prospective studies, or country of origin for such data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. The "ground truth" for a calibration verification material is its assigned target value, which is established through rigorous internal validation and sometimes by reference to national or international reference materials/methods. It doesn't involve expert medical interpretation in the way a diagnostic imaging device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. Adjudication methods are relevant for subjective interpretations, which are not involved here.

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

Not applicable/Not provided. This device is not an AI-assisted diagnostic tool for human readers.

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

Not applicable/Not provided in the context of "algorithm only." The device itself is a material that is run by an automated analyzer. Its "standalone performance" would be its chemical stability and its consistent concentration of the analyte, independent of the analyzer it's run on.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the Elecsys® CalCheck™ CK-MB is its assigned target values for each of the three levels of lyophilized material after reconstitution. These values are established during the manufacturing and characterization process, likely through highly precise reference methods, internal validation studies, and possibly comparisons to certified reference materials or industry standards. The document doesn't specify how these target values were established.

8. The sample size for the training set

Not applicable/Not provided. This is not a machine learning or AI device that requires a training set of data.

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

Not applicable/Not provided. As above, this is not a device requiring a training set in that context. The "ground truth" (target values) for the product itself would be established by the manufacturer's analytical testing, as described in point 7.

Summary based on the provided text:

The document describes a calibration verification material called Elecsys® CalCheck™ CK-MB. Its purpose is to quantify and verify the calibration curve of Elecsys CK-MB reagents and calibrators on specific Elecsys immunoassay analyzers. The performance of this device is intrinsically linked to its "target values" against which measurements are compared. However, the specific acceptance criteria for this comparison (e.g., acceptable percentage deviation from target values) and any detailed study demonstrating adherence to these criteria are not included in this 510(k) summary. The comparison focuses on substantial equivalence to a predicate device based on intended use rather than detailed performance metrics.

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