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used to measure creatinines concentrations in serum, plasma, or urine on the SYNCHRON CX 3 System

Creatinine Reagent Set, Procedure Number C7058, is formulated based on a modification of the Jaffe reagents described by Heinegard and Tiderstrom.

This document describes a diagnostic reagent set, not a device that involves artificial intelligence, image analysis, or complex algorithms that would require the specified criteria like expert ground truth, MRMC studies, or multi-reader scenarios. The "device" in this context is primarily a chemical reagent.

Therefore, many of the requested categories are not applicable to the information provided. However, I can extract the relevant performance data and address the applicable points.

Here's the information based on the provided text for the Sigma Diagnostics CX®3 Creatinine Reagent Set:

Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are largely implied based on typical performance expectations for medical devices of this type when demonstrating substantial equivalence, with specific precision and linearity values explicitly stated as met.

Additional Study Information:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The text mentions "serum samples" and "urine samples" in the context of comparison studies and precision, but does not provide the specific number of samples for each.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective comparison studies conducted as part of the reagent's validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a chemical assay, not a device requiring expert interpretation of images or complex data. The "ground truth" would be established by the reference method (Beckman Creatinine Reagent Kit) for comparison studies.

3. Adjudication method for the test set: Not applicable. This concept applies to cases where human interpretation is involved.

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 is a chemical assay, not an AI-powered diagnostic device involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The performance described is standalone algorithm (reagent) performance. There is no human-in-the-loop component for the direct measurement process of the reagent. The device (SYNCHRON CX 3 System) provides the automated measurement.

6. The type of ground truth used: For the comparison studies, the "ground truth" was established by the predicate device, the Beckman Creatinine Reagent Kit (Part No. 443340), run on the SYNCHRON CX 3 System. In essence, the performance of the new reagent was compared against an already established and cleared method.

7. The sample size for the training set: Not applicable. This is a chemical reagent, not a machine learning algorithm that requires a "training set."

8. How the ground truth for the training set was established: Not applicable. There is no training set for this type of medical product.

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