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PreciControl Troponia T is used for quality control of the Elecsys Troponin T (CARDIAC T) immunoassay of the Elecsys immunoassay systems.

The Elecsys PreciControl Troponin T is a lyophilized manufactured using recombinant human Troponia T in human serum matrix. The analyte is spiked into the matrix to the correct concentration levels.

The provided text does not contain detailed information about the acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a medical device called "Elecsys® PreciControl Troponin T," which is a calibration verification material used for quality control of the Elecsys Troponin T immunoassay.

The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to detail comprehensive performance studies with specific acceptance criteria and outcome metrics for standalone device performance or human-in-the-loop studies.

Here's an analysis based on the lack of the requested information in the provided text:

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

• Information not provided. The document states the intended use of the device and compares it to a predicate device, noting they are for the same purpose (quality control of immunoassays). It does not present specific quantitative acceptance criteria or performance metrics for the Elecsys® PreciControl Troponin T itself.

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

• Information not provided. There is no mention of a test set, sample size, or data provenance for any performance study.

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/Information not provided. Since this is a quality control material and not a diagnostic device interpreting patient data, the concept of "experts establishing ground truth for a test set" in the context of clinical images or patient outcomes doesn't directly apply. The ground truth for a quality control material would typically be its manufacturing-determined analyte concentration values, which are then used to verify the performance of the immunoassay. No details on this process are given.

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

• Not applicable/Information not provided. No test set or related adjudication process is described.

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. This device is a quality control material, not an AI or imaging device involving human readers. Therefore, an MRMC study or AI assistance is irrelevant to its function.

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

• Not applicable. This device is a physical material (lyophilized recombinant human Troponia T in human serum matrix) used for quality control, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The performance of the quality control material itself would be assessed through its stability, accuracy of target values, and precision, but these details are not provided.

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

• Information not provided explicitly. For a quality control material, the "ground truth" usually refers to the assigned values or target concentrations of the analytes within the control material, established during its manufacturing and characterization. These values are then used to verify the accuracy of diagnostic assays. The document doesn't detail how these "true" or "assigned" values for the Elecsys® PreciControl Troponin T were established.

8. The sample size for the training set

• Not applicable/Information not provided. As this is not an AI or machine learning device, there is no "training set."

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

• Not applicable/Information not provided. As there is no training set, this question is not relevant.

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