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The Elecsys Rubella IgG CalCheck is an assayed calibrator control intended for use in the verification of the calibration established by the Elecsys Rubella IgG reagent on the Elecsys 2010, the MODULAR ANALYTICS E170, and cobas e immunoassay analyzers.

The Elecsys Rubella IgG CalCheck is a lyophilized product consisting of human anti-Rubella IgG antibodies in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

Here's an analysis of the provided 510(k) summary for the Elecsys Rubella IgG CalCheck, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a calibrator control, not a diagnostic device. As such, the typical "performance criteria" for diagnostic devices (sensitivity, specificity, accuracy) and associated studies (MRMC, standalone) are not applicable or detailed in the same way. This summary focuses on verifying calibration and stability, which are the relevant performance characteristics for a calibrator.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Elecsys Rubella IgG CalCheck revolve around its ability to perform as an assayed calibrator control for the Elecsys Rubella IgG reagent. The key performance characteristics evaluated are value assignment and stability. While specific numerical acceptance criteria (e.g., ±X% deviation from target value) are not explicitly stated in this summary, they would have been defined internally by Roche Diagnostics and submitted as part of the full 510(k) application.

Study That Proves the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is implied by the statement: "The Elecsys Rubella IgG CalCheck was evaluated for value assignment and stability." This indicates internal testing performed by Roche Diagnostics.

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

   • Sample Size: Not specified in this summary. For a calibrator, the sample size typically refers to the number of lots or batches tested and the number of replicates for each test.
   • Data Provenance: Not specified in this summary. Given it's a calibrator manufactured by Roche Diagnostics, the testing would likely be performed in their R&D and manufacturing facilities, presumably in the US or Europe. The study would be prospective, as it involves testing newly manufactured calibrators.

2. 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 in the context of a calibrator control. "Ground truth" for a calibrator is established by precise manufacturing, characterization, and assignment of target values based on established reference methods and robust statistical analysis within a quality control framework, not by expert consensus on clinical findings.

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

   • Not applicable. Adjudication methods are used for interpreting clinical data, often in cases of diagnostic disagreement. For a calibrator, the 'truth' is defined by the manufacturing process and metrological traceability.

4. 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 calibrator control, not an AI-powered diagnostic device, nor does it involve human readers interpreting images or data for diagnostic purposes.

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

   • Not applicable. This is not an algorithm or AI device. The "performance" of a calibrator is its ability to consistently provide expected values when measured on the intended immunoassay analyzers.

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

   • For a calibrator, the "ground truth" for value assignment is the assigned target concentration/value of the analyte (Rubella IgG antibodies) within the calibrator material. This is established through a rigorous process of:
     • Traceability: Often traceability to international reference standards or highly characterized internal reference materials.
     • Multi-site/Multi-instrument testing: Measuring the calibrator on multiple instruments and sites using the Elecsys Rubella IgG reagent to ensure consistency and assign robust mean values.
     • Statistical analysis: Using statistical methods to determine the mean and acceptable ranges for the assigned values.

7. The sample size for the training set:

   • Not applicable. This device is a calibrator, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for a calibrator control.

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