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The Elecsys DHEA-S CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys DHEA-S reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys DHEA-S CalCheck 5 is a lyophilized product consisting of DHEA-S in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

This submission describes Elecsys DHEA-S CalCheck 5, a lyophilized product containing DHEA-S in a human serum matrix, intended for calibration verification and assay range verification of the Elecsys DHEA-S reagent.

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

The provided text does not explicitly state quantitative acceptance criteria for the Elecsys DHEA-S CalCheck 5. However, it indicates that the device was evaluated for "value assignment and stability." The comparison table with the predicate device, Elecsys C-Peptide CalCheck 5, highlights similarities in intended use, levels (five), format (lyophilized), handling, and stability (unopened and reconstituted). The primary difference is the analyte (DHEA-S vs. C-Peptide) and the matrix (human serum vs. equine serum).

Without specific numerical performance metrics, concrete acceptance criteria cannot be listed. However, based on the context of a 510(k) submission, the implicit acceptance criteria would be that the device performs equivalently to the predicate device for its intended use, particularly regarding its ability to accurately verify calibration and assay ranges.

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

The document does not provide details on the sample size used for the test set, the country of origin of the data, or whether the study was retrospective or prospective. It only states that the device was "evaluated for value assignment and stability."

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)

This information is not provided in the document. For a product like a calibration verification control, ground truth would typically relate to the assigned target values for the analytes, which are established through rigorous analytical methods and reference materials, not typically through expert consensus in the conventional sense of clinical interpretation.

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

This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., imaging studies) where multiple experts assess the same cases and discrepancies need to be resolved. For an in vitro diagnostic control, the "ground truth" for value assignment and stability is determined through analytical measurements.

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

An MRMC study is not applicable to this device. The Elecsys DHEA-S CalCheck 5 is an in vitro diagnostic control material, not an AI-assisted diagnostic tool that involves human reader interpretation. Therefore, no MRMC study was performed, and there is no discussion of human reader improvement with or without AI assistance.

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

This concept is not directly applicable to this device. The Elecsys DHEA-S CalCheck 5 is a biological control material for an immunoassay system, not an algorithm. Its "standalone performance" would relate to its inherent stability and accurate value assignment, as assessed by analytical methods, rather than an algorithm's performance. The document states it was "evaluated for value assignment and stability."

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

The ground truth for a calibration verification control like Elecsys DHEA-S CalCheck 5 would be the assigned target values and acceptable ranges (analytical ground truth) for DHEA-S concentrations at each of the five levels. These values are established through very precise analytical measurements, often using reference methods and materials, and are critical for ensuring the accuracy and reliability of the immunoassay system.

8. The sample size for the training set

The concept of a "training set" is not applicable in the context of this device. A training set is used for machine learning algorithms. The Elecsys DHEA-S CalCheck 5 is a physical control material, not an algorithm that requires training data.

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

As there is no training set for this device, this question is not applicable.

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