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IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer and designed for the quantitative measurement of Creactive protein (CRP) in serum or plasma. It is intended strictly for in vitro use as an aid in the evaluation of the amount of injury to body tissues.

IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer

The provided document is a 510(k) summary for the IMMULITE® C-Reactive Protein device. It describes the device, its intended use, and states that the data presented led to substantial equivalence. However, it does not include details about specific acceptance criteria, study methodologies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown based on the available information:

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

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

• Sample size for the test set: Not provided in the document.
• Data provenance: Not provided in the 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)

• This device is an In Vitro Diagnostic (IVD) for quantitative measurement of C-reactive protein. "Experts" in the sense of radiologists interpreting images are not relevant here. Ground truth would typically be established by reference methods or validated assays. The document does not specify how C-reactive protein levels were confirmed for study samples.

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

• Not applicable/Not provided. Adjudication methods are typically used in image interpretation studies where multiple readers' opinions need to be reconciled. For a quantitative IVD, the "ground truth" is a measured value rather than an 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

• No. This is an In Vitro Diagnostic device for measuring C-reactive protein. It is not an AI-assisted diagnostic tool that humans would "read" or interpret in the same way as an imaging device. Therefore, an MRMC study and human reader improvement with AI assistance are not relevant.

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

• Yes, implicitly. As an automated immunoassay system, the IMMULITE® C-Reactive Protein system operates as a standalone device to produce quantitative results. The stated "performance" (though not detailed in this summary) would be the algorithm/device's performance without human intervention in the CRP measurement process itself. Human involvement would be in sample collection and result interpretation.

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

• Not explicitly stated, but for a quantitative IVD, ground truth would typically be established by:
  • Reference methods: A highly accurate and precise method for measuring CRP, often a gold standard.
  • Validated comparative methods: Comparison against another legally marketed and accepted CRP assay.
    The document mentions substantial equivalence to another IMMULITE® C-Reactive Protein device (K984132), implying comparison to a known standard.

8. The sample size for the training set

• Not provided in the document.

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

• Not provided in the document. (Similar to point 7, it would likely involve reference or validated comparative methods).

**Summary of what is available: **

• Device Name: IMMULITE® C-Reactive Protein
• Intended Use: Quantitative measurement of C-reactive protein (CRP) in serum or plasma, as an aid in evaluating tissue injury.
• Predicate Device: IMMULITE® C-Reactive Protein (K984132)
• Conclusion: The FDA granted substantial equivalence based on the data presented (though the data itself is not detailed in this summary).

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