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The Elecsys TSH 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 TSH reagent on the indicated Elecsys cobas e immunoassay analyzers.

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

The provided 510(k) summary for the device, "Elecsys TSH CalCheck 5," is for an in-vitro diagnostic control material. As such, it does not involve clinical studies with human patients, image analysis, or expert-based ground truth establishment in the same way a diagnostic imaging device would. Instead, its "performance" is assessed based on its chemical and physical characteristics and how accurately it can verify instrument calibration and assay ranges.

Therefore, many of the requested categories in the prompt are not applicable to this type of device submission.

Here is an analysis based on the information provided in the K093836 document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative, pass/fail table as would be expected for a diagnostic device. Instead, it states that the device was evaluated for "value assignment and stability." The implication is that the performance characteristics (e.g., how well the assigned values match expectations, and the stability over time) were deemed acceptable for substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Test set: Not applicable in the traditional sense of patient data. The "test set" would be samples of the manufactured control material itself, used for evaluation. The document does not specify the number of batches or individual vials tested.
• Data Provenance: The exact location or nature of the testing is not specified, but it would have been conducted by Roche Diagnostics as part of their product development and validation process. This would be considered prospective manufacturing and testing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. For an in-vitro diagnostic control, the "ground truth" is established through highly controlled analytical methods and established reference materials/methods, not through expert human interpretation. The concentrations of TSH in the control material are assigned through a rigorous internal process, not "established by experts."

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication is involved for this type of chemical control material. The "adjudication" is metrological, relating to the accuracy and precision of the analytical measurements used to assign values and assess stability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical images or data. This device is a quality control material for an automated immunoassay analyzer.

6. If a Standalone (Algorithm only without human-in-the-loop performance) was done

• Not Applicable / Inherent. This device itself is not an algorithm or a diagnostic tool; it's a calibrator/control. Its performance is entirely "standalone" in the sense that it is a physical product with defined chemical characteristics. Its interaction is with the immunoassay analyzer, not a human interpreter directly.

7. The Type of Ground Truth Used

• Assigned Values based on Analytical Methods and Reference Materials: The "ground truth" for the Elecsys TSH CalCheck 5 is the assigned TSH concentration values for each of its five levels. These values are determined by the manufacturer (Roche Diagnostics) using highly precise and accurate analytical methods, typically traceable to international reference standards and/or internal established reference methods. This ensures that the control material has known concentrations to verify the performance of the Elecsys TSH reagent and analyzer.

8. The Sample Size for the Training Set

• Not Applicable. This device is a chemical control product, not a machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. See point 8.

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