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The C3 assay is used for the quantitation of C3 in human serum or plasma. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of C3 in the sample.

Here's a breakdown of the acceptance criteria and the study details for the C3 assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size used for the comparative performance studies or precision studies. It mentions "two levels of control material" for precision, but not the number of individual runs or samples within each control level. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).

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

Since this is an in vitro diagnostic assay focusing on quantitative measurement and comparison to a predicate device, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists for imaging) is not directly applicable. The ground truth for the comparison was the results obtained from the K-ASSAY® C3 on the Hitachi® 717 Analyzer, which is itself an established and legally marketed device. The "expertise" lies in the established performance and accuracy of this predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative assay comparison, not a diagnostic interpretation with potential inter-observer variability requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

Not applicable. This document describes an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the study describes the standalone performance of the C3 assay (the algorithm/device itself) in comparison to a predicate device and through precision studies. There is no human-in-the-loop component mentioned.

7. The Type of Ground Truth Used

The primary "ground truth" used for the comparative effectiveness study was the results obtained from the legally marketed predicate device, K-ASSAY® C3 on the Hitachi® 717 Analyzer. For precision, the "ground truth" was established by the known concentrations of the control materials.

8. The Sample Size for the Training Set

Not applicable. This document describes the performance of a chemical assay, not a machine learning or AI model that typically requires a separate training set. The assay's parameters would have been developed and optimized through standard analytical chemistry methods, not a "training set" in the AI sense.

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

Not applicable, as there's no "training set" in the AI sense for this type of device. The development of the assay would have involved rigorous analytical procedures to establish its performance characteristics against known standards and reference materials.

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