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The Elecsys Myoglobin 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 Myoglobin reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys Myoglobin CalCheck 5 is a liquid product consisting of human myoglobin in a buffer/protein (bovine serum) matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided text describes the Elecsys Myoglobin CalCheck 5, a liquid control product used for calibration verification and assay range verification on Elecsys and cobas e immunoassay analyzers. However, the text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the device, focusing on its description, intended use, and comparison to a predicate device (Elecsys Digoxin CalCheck 5). It also includes the FDA's letter granting substantial equivalence.

Therefore, I cannot populate the table or answer most of the questions based on the provided input.

Here's what can be stated based on the given information:

1. Table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not provided in the text.
   • Reported Device Performance: The "Performance Characteristics" section only states: "The Elecsys Myoglobin CalCheck 5 was evaluated for value assignment and stability." No specific performance data or criteria are given.

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

   • No information provided.

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 as no test set evaluation is described.

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

   • Not applicable as no test set adjudication 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-assisted diagnostic tool.

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

   • Not applicable. This device is a quality control material, not an algorithm.

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

   • Not applicable. For a quality control material, "ground truth" would typically refer to the accurately assigned values of the analyte within the control. The text mentions "value assignment" but does not detail the method or source of "ground truth" for these values.

8. The sample size for the training set

   • Not applicable. This device is a quality control material, not a machine learning model.

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

   • Not applicable.

Summary of what is known:

The document describes the Elecsys Myoglobin CalCheck 5 as a liquid product containing human myoglobin in a buffer/protein matrix, "spiked into the matrix at the desired concentration levels" during manufacture, for use in calibration verification and assay range verification. It also mentions an evaluation for "value assignment and stability" was performed. However, details of these evaluations, including specific acceptance criteria, performance results, or how the "ground truth" (i.e., the assigned values) was established, are not provided in this excerpt.

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