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The Elecsys® Anti-Tg CalCheck is intended for use in the verification of the calibration established by the Elecsys® Anti-Tg reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

The Elecsys® Anti-Tg CalCheck is a lyophilized product manufactured using a human serum base, human Anti-Tg, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration.

The provided document is a 510(k) summary for the Elecsys® Anti-Tg CalCheck, a calibration verification material. This type of device is a control material used to verify the calibration of an immunoassay analyzer and does not typically involve traditional "device performance" in terms of diagnostic accuracy metrics like sensitivity or specificity. Instead, the performance characteristics relevant to this device are related to its value assignment and stability. Therefore, some of the requested information (e.g., MRMC studies, number of experts for ground truth, adjudication methods) is not applicable to this type of medical device's evaluation.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Elecsys® Anti-Tg CalCheck was evaluated for "value assignment and stability." While specific numerical acceptance criteria (e.g., ±X% deviation from target value) and detailed reported performance metrics are not explicitly provided in this 510(k) summary, the FDA's clearance indicates that these criteria were met during the submission's review.

Note: For this type of device, the "performance" is about whether the control material provides the correct, stable values needed to verify the calibration of the primary diagnostic assay. The 510(k) summary confirms these evaluations were performed and found acceptable for clearance.

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

This information is not provided in the 510(k) summary. Given that it's a calibration verification material, the "test set" would likely refer to the number of lots or samples of the CalCheck material manufactured and tested. Data provenance (country of origin, retrospective/prospective) is also not detailed for this type of product.

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

This information is not applicable/not provided. For a calibration verification material, the "ground truth" would be established by reference methods or highly accurate analytical techniques to determine the true concentration of the analyte (Anti-Tg) in the control material. This is a characteristic determined by laboratory measurements, not human expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting images or clinical data to establish a ground truth, which is not relevant for the performance evaluation of a calibration verification material.

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

This information is not applicable. This device is a calibration verification material, not an AI-powered diagnostic tool for human interpretation. Therefore, MRMC studies and AI-assisted performance improvements are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The Elecsys® Anti-Tg CalCheck is a physical control material, not an algorithm. Its "performance" is inherent to its physical and chemical properties and how accurately it can verify the calibration of an immunoassay system.

7. The Type of Ground Truth Used

For a calibration verification material, the "ground truth" is typically established by:

• Reference methods: Highly accurate and precise analytical methods used to determine the true concentration of the analyte (Anti-Tg) within the control material.
• Traceability to an international standard: Ensuring the assigned values are directly comparable to recognized international reference materials.

The 510(k) summary describes the device as a "lyophilized product manufactured using a human serum base, human Anti-Tg, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration," implying that the concentrations are scientifically determined and assigned during manufacturing.

8. The Sample Size for the Training Set

This information is not applicable/not provided. Calibration verification materials do not involve "training sets" in the context of machine learning or AI.

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

This information is not applicable/not provided. (See points 7 and 8.)

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