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Architect B12 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the B12 assay on the Abbott Architect i System.

Architect B12 MasterCheck Level 0 contains borate buffer with protein (bovine) stabilizers.

Architect B12 MasterCheck Levels 1, 2, 3 and 4 contain cyanocobalamin prepared in borate buffer with protein (bovine) stabilizers.

Preservative: Antimicrobial Agent.

The provided text is a 510(k) Summary for the Bio-Rad Architect B12 MasterCheck device. This type of submission is for in vitro diagnostic devices (IVDs), specifically controls used to verify the performance of an assay. The information requested (acceptance criteria, study details, sample sizes, ground truth, etc.) is typically found in performance studies for diagnostic assays or prognostic devices that classify or predict outcomes in patients.

For the Bio-Rad Architect B12 MasterCheck, which is a calibration verification and linearity control, the "acceptance criteria" and "device performance" are established in a different context. These devices are designed to have known concentrations of analytes, and their performance is typically evaluated by demonstrating that they produce expected results within a specified range when tested on the target analytical system (in this case, the Abbott Architect i System for B12 assay).

Therefore, many of the requested points are not directly applicable to this specific type of device or cannot be extracted from the provided 510(k) summary. I will answer the applicable questions based on the information available:

1. A table of acceptance criteria and the reported device performance

The 510(k) summary does not explicitly state specific numerical acceptance criteria or performance data for the Architect B12 MasterCheck. For a control device, performance is typically demonstrated by showing that the manufactured lots consistently yield the expected B12 concentrations when run on the Abbott Architect i System, verifying the system's sensitivity, calibration linearity, and reportable range.

The "performance" of such a device is inherently tied to its ability to control the assay it's designed for, rather than producing diagnostic results itself. The summary implies that "performance" is a comparison of its technological characteristics to a predicate device.

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

The summary does not describe a "test set" in the context of patient samples or a diagnostic study. This device is a control product. Performance verification would involve running multiple replicates of the control material on the Abbott Architect i System. The specific number of replicates or runs for a performance verification study is not provided. Data provenance is not available.

3. 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)

This is not applicable. The "ground truth" for a control material like Architect B12 MasterCheck is its manufactured, assigned concentration of B12. This concentration is established by the manufacturer (Bio-Rad Laboratories) through rigorous analytical methods and reference to recognized standards. It does not involve expert consensus in the diagnostic sense.

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

Not applicable, as there is no "test set" requiring adjudication in the context of diagnostic interpretation.

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 device is a laboratory control, not an AI-assisted diagnostic tool, and involves no human readers or diagnostic interpretation.

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

Not applicable. This device is an IVD control, not an algorithm or AI system.

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

The "ground truth" for the Architect B12 MasterCheck is the assigned B12 concentration within each level of the control material. This is established through the manufacturer's gravimetric preparation and analytical value assignment processes, traceable to reference standards.

8. The sample size for the training set

Not applicable. This device is a control, not a machine learning algorithm that requires a training set.

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

Not applicable for the same reason as point 8.

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