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The Cardiac Troponin-I (TROP) Calibrator is intended to be used to calibrate the Cardiac Troponin-I Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Dimension® Cardiac Troponin-I (TROP) Calibrator is a five level frozen product with target concentrations of 0, 2, 9, 25, and 55 ng/mL containing native human troponin complex in a buffered bovine protein matrix. The kit consists of five vials; two at each level.

The provided text describes a 510(k) submission for a medical device: Dimension® RxL Cardiac Troponin-I (TROP) Calibrator.

Based on the document, this is a calibrator (a lab reagent used to set the scale of an instrument), not a diagnostic device that directly measures a patient's condition or relies on expert interpretation of images or other data. Therefore, many of the typical questions related to diagnostic device studies (like expert consensus, adjudication, MRMC studies, or standalone performance for an algorithm) do not apply to this type of product.

The study described is a comparison to a predicate device to establish substantial equivalence.

Here's the information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not specify formal "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) because it is a calibrator, not a diagnostic test with an output about a patient's condition. Instead, the "acceptance" for this submission is demonstrating substantial equivalence to a previously cleared predicate device based on its intended use, analyte, matrix, form, volume, values, and levels.

   Characteristic	Predicate Device: Dimension® RxL TROP Calibrator	Modified Device: Dimension® RxL TROP Calibrator
   Intended Use	Calibrator	Calibrator
   Analyte	Cardiac troponin-I	Native human troponin-I complex
   Matrix	Buffered bovine protein	Buffered bovine protein
   Form	Frozen	Frozen
   Volume	2.0 mL per vial	3.0 mL per vial
   Values	Assigned	Assigned
   Levels	5 levels	5 levels

   Reported Device Performance: The conclusion states: "The modified Dimension® RxL Cardiac Troponin I Calibrator is substantially equivalent to the Dimension® RxL Cardiac Troponin-I Calibrator currently marketed by Dade Behring based on the comparison summarized above."

2. Sample size used for the test set and the data provenance:

   Not applicable in the typical sense for a diagnostic device. The "test" here is a comparison of product specifications (physical characteristics and intended use) between the new and predicate calibrator. There is no mention of patient samples or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   Not applicable. This is a calibrator, not a diagnostic device relying on expert interpretation of images or clinical data.

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

   Not applicable.

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 is a calibrator, not an AI-assisted diagnostic device.

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

   Not applicable. This is a calibrator, not an algorithm or an AI device.

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

   Not applicable for a device that is a calibrator. The "ground truth" for showing substantial equivalence relies on comparing the characteristics and functional aspects of the new calibrator against those of an already cleared predicate calibrator. The "truth" is whether the characteristics (analyte, matrix, form, values, levels) are sufficiently similar or justified in their differences (like volume or specific analyte source) to achieve the same intended use.

8. The sample size for the training set:

   Not applicable. This device does not use machine learning or require a "training set."

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

   Not applicable.

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