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The Varelisa ReCombi ANA Screen EIA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma (citrate/EDTA) to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/ dermatomyositis. The Varelisa ReCombi ANA Screen detects antibodies against dsDNA, UIRNP (RNP70, A, C), Sm, SS-A/Ro (52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B and Jo-1 in a single microwell.

The Varelisa ReCombi ANA Screen is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of antinuclear antibodies in serum and plasma (citrate/EDTA). Designed as a screening assay, it detects eight antinuclear antibodies in a single microwell. The determination of antinuclear antibodies (ANA) is of central importance for the clinical diagnosis of rheumatic diseases. The presence of ANA suggests the possibility of rheumatic autoimmune diseases, These diseases include Systemic Lupus Erythemtosus (SLE), Polymyositis/ Dematomyositis, Scleroderma, Sjögren's Syndrome and Mixed Conective Tissue Diseases.

The provided text does not contain a specific study designed to establish acceptance criteria for the Varelisa ReCombi ANA Screen device. Instead, it focuses on the device's substantial equivalence to a predicate device (K993108) and describes laboratory data supporting this equivalence. The FDA letter confirms the substantial equivalence determination but does not detail a separate study proving the device meets explicit acceptance criteria in the format requested.

Therefore, many of the requested fields cannot be directly populated from the provided documents.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity, specificity, or agreement thresholds) that the new device needed to meet. Instead, it relies on demonstrating comparable performance to the predicate device.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: "150 disease controls and 103 CTD samples."
• Data Provenance: The document does not specify the country of origin. It indicates that the data includes "clinically defined sera and for international reference sera" and "samples from apparently healthy subjects (normal population)," suggesting a mix of sources. It's a retrospective analysis, comparing the new device's results to the predicate device and established serum characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The "ground truth" seems to be established by the clinical definition of the sera (e.g., "clinically defined sera," "disease controls," "CTD samples") and international reference sera.

4. Adjudication method for the test set:

This information is not provided in the 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:

This is not applicable. The device is an in vitro diagnostic (IVD) assay for qualitative determination of antibodies, not an AI-assisted diagnostic tool that humans would "read." It produces a quantitative result (OD at 450 nm and 620 nm) that is interpreted qualitatively.

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

This is implicitly a standalone device. As an IVD assay, the device itself provides the result based on the biochemical reaction and optical density measurement. There isn't a "human-in-the-loop" component in the sense of a human interpreting complex images or data that the device first processes. The interpretation is of the assay's output.

7. The type of ground truth used:

The ground truth appears to be based on:

• Clinical Diagnosis: For "clinically defined sera," "disease controls," and "CTD samples," the ground truth is their established clinical diagnosis.
• International Reference Sera: These typically have well-characterized antibody profiles that serve as a ground truth for comparison.
• Healthy Controls: Samples from "apparently healthy subjects" serve as a negative ground truth.

8. The sample size for the training set:

This information is not provided. The document describes a comparison study for validation of the new device's performance against the predicate, rather than a separate "training set" in the context of machine learning. The "development" of the new device (e.g., choice of recombinant antigens, synthetic peptides) would have occurred prior, potentially using other samples, but details are not given.

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

This information is not provided as a separate "training set" is not explicitly mentioned in the context of the performance validation study.

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