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The K-ASSAY C4 Assay is intended to be used for the quantitative determination of C4 in human serum. Complement is a group of serum proteins which destroy cells by immunologically mediated lysis. Quantitative determination of these proteins aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.

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This is a 510(k) clearance letter for the K-ASSAY C4 device, dated November 30, 1999. It states that the device is substantially equivalent to legally marketed predicate devices. This type of document, particularly one from 1999, typically does not contain the detailed study information you are requesting. The focus of a 510(k) is to demonstrate substantial equivalence, not to provide comprehensive performance study results in the same way a PMA or a more recent device submission might.

Therefore, many of the requested data points (acceptance criteria, specific performance metrics, sample sizes, ground truth details, expert qualifications, MRMC studies, etc.) are not available in this document.

However, I can extract the following limited information:

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

This document does not contain a table of acceptance criteria or reported device performance metrics. The FDA letter grants clearance based on substantial equivalence to a predicate device, meaning detailed performance data against specific acceptance criteria is not typically outlined in the clearance letter itself. Such data would be found in the 510(k) submission itself, which is not provided here.

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

Not available in this document.

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):

Not applicable/Not available in this document. For an in-vitro diagnostic device like K-ASSAY C4, "ground truth" would typically be established by reference methods or clinical diagnosis, not by experts adjudicating image data. However, the details of how any reference range or accuracy was established are not present here.

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

Not applicable/Not available in this document.

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. The K-ASSAY C4 is an in-vitro diagnostic assay for quantitative determination of C4, not an AI-assisted diagnostic imaging device that would involve human readers.

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

Not applicable. As an in-vitro diagnostic assay, its performance is inherently "standalone" in its measurement, but the specific validation study details are not provided.

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

For an in-vitro diagnostic assay like K-ASSAY C4 (which quantifies C4 in human serum or plasma), "ground truth" for validation would typically be established through reference methods, comparison to established predicate devices, and potentially clinical correlation with disease states known to affect C4 levels. However, the specifics of how this was established for this particular submission are not described in this document.

8. The sample size for the training set:

Not applicable/Not available in this document. This is a clearance letter for a 1999 device, likely not an AI/ML device that would refer to "training sets."

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

Not applicable/Not available in this document. (See above, not an AI/ML device in the context of "training set").

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