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EliA Symphony Immunoassay is intended for the in vitro qualitative measurement of antinuclear IgG antibodies in human serum and plasma (heparin, EDTA and citrate). EliA Symphony Immunoassay is based on human recombinant U1RNP (RNP 70, A, C). SS-A/Ro (60 kDa. 52 kDa), SS-B/La, Centromere B, Sc1-70, Jo-1 proteins and native purified Sm proteins as antigen and is useful as an aid in the clinical diagnosis of patients with systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, scleroderma and polymyositis/dermatomyositis, in conjunction with other laboratory and clinical findings. EliA Symphony Immunoassay uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.

EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodics (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbellifery|-8D-Galactoside as substrate. The total IgG calibration is based on a set of six WHOstandardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.

The provided text describes the EliA™ Symphony Immunoassay and EliA™ ANA Control, but it does not contain a detailed study proving the device meets specific acceptance criteria with reported performance metrics, sample sizes, ground truth establishment, or expert qualifications.

The document is a 510(k) summary for premarket notification, indicating substantial equivalence to predicate devices, rather than a detailed clinical study report. It mentions "laboratory equivalence" being supported by "a data set including results obtained within a comparison study between new and predicate devices," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)," but it lacks specific details about these studies.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can be inferred or is explicitly stated, alongside what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be provided definitively from the given text.

The document states: "In summary, all available data support the conclusion that the new device is substantially equivalent to the predicate devices." This implies that the acceptance criterion was likely demonstrating substantial equivalence through comparable performance to the predicate devices (QUANTA Lite™ ENA 6 and NOVA Lite™ HEp-2). However, specific performance metrics (e.g., sensitivity, specificity, accuracy with numerical thresholds) for the new device or the study results are not reported in this summary.

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

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: The document mentions "results obtained for clinically defined sera" and "results obtained for samples from apparently healthy subjects (normal population)." This suggests that real patient samples were used, but the country of origin is not specified, and it implies a retrospective or mixed collection of known samples.

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

Not explicitly stated. The document is for an immunoassay, where ground truth is typically established by clinical diagnosis and/or other laboratory results, not necessarily by interpretation of images by a panel of human experts in the same way as an imaging device.

4. Adjudication Method for the Test Set

Not explicitly stated. Given the nature of an immunoassay, traditional adjudication methods like "2+1" or "3+1" are not applicable. Ground truth would have been established through clinical diagnosis (e.g., of SLE, MCTD, Sjögren's syndrome, scleroderma, polymyositis/dermatomyositis) or by comparison to the predicate device results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation of results (e.g., imaging devices) to assess how the device assists human readers. The EliA Symphony Immunoassay is an automated immunoassay.

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

Yes, the device operates in a standalone manner. The EliA Symphony Immunoassay is described as a "fully integrated and automated system for immunodiagnostic testing" that uses instruments ImmunoCAP 100/250 and software for evaluation. Its performance is measured intrinsically, not in conjunction with human interpretation in the loop in the sense of an assist device for cognitive tasks.

7. The Type of Ground Truth Used

The ground truth for evaluating the device would be based on:

• Clinical Diagnosis: Diagnosis of systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, scleroderma, and polymyositis/dermatomyositis. The device is intended as an "aid in the clinical diagnosis" using "other laboratory and clinical findings."
• Predicate Device Results: Comparison studies were performed against the QUANTA Lite™ ENA 6 and NOVA Lite™ HEp-2 assays. This implies the predicate device results served as a reference point for substantial equivalence.

8. The Sample Size for the Training Set

Not explicitly stated. The document is a 510(k) summary and focuses on demonstrating equivalence rather than detailing the development and training of a machine learning model, which is what "training set" typically refers to. For an immunoassay, the concept of a "training set" for an algorithm in the AI/ML sense is not directly applicable. Method development and optimization would likely have involved numerous samples, but these are not quantified here.

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

Not applicable in the context of an AI/ML training set. The "training" of an immunoassay involves method development and optimization to achieve desired performance characteristics. This would rely on well-characterized samples (e.g., clinically diagnosed patient samples, controls) to establish the assay's sensitivity, specificity, and accurate measurement of analytes. The process is one of analytical validation and optimization rather than machine learning model training.

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