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EliA SmDP-S is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and EDTA-plasma as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP-S uses the EliA IgG method.

The EliA SmD -S is a semi-quantitative solid-phase fluoroimmunoassay, for the determination of autoantibodies against Sm. The EliA SmDP-S test System is fully integrated and automated system which comprises of assay-specific reagents, EliA method-specific reagents, and general reagents.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EliA SmDP-S device are not explicitly stated as distinct criteria with numerical targets in the provided document. Instead, the document presents performance characteristics that implicitly serve as acceptance criteria by demonstrating that the device is substantially equivalent to a predicate device. Below is a summary of the reported device performance for key analytical and clinical characteristics.

2. Sample Sizes and Data Provenance

• Test Set (Method Comparison):
  • Sample Size: A total of 628 patient samples were initially tested in the method comparison study with the predicate device. For statistical analyses, 460 samples were used after excluding 168 values outside the measuring range.
  • Data Provenance: Not explicitly stated, but typically such studies involve samples collected from various clinical sites. It is implied to be clinical patient samples, likely retrospective given they were previously collected for comparison.
• Test Set (Clinical Sensitivity and Specificity):
  • Sample Size: 328 clinically defined samples: 104 with Systemic Lupus Erythematosus (SLE) and 224 disease controls (Mixed connective tissue disease, Sjögren's syndrome, Scleroderma, Polymyositis/Dermatomyositis, Rheumatoid arthritis, Graves' disease, Hashimoto's disease, Bacterial infections, Viral infections).
  • Data Provenance: Not explicitly stated, but implied to be from clinical settings for diagnosed patients and controls. Likely retrospective.
• Reference Range/Expected Values:
  • Sample Size: 632 apparently healthy subjects.
  • Data Provenance: Sera obtained from a blood bank, equally distributed by age and gender, from Caucasian, African American, Hispanic and Asian populations.

3. Number of Experts and their Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: The ground truth for clinical sensitivity and specificity was based on "clinically defined samples with a diagnosis". This implies that the diagnosis was established by medical professionals (e.g., rheumatologists, infectious disease specialists) based on a comprehensive clinical assessment, which would include other laboratory and clinical findings. The document does not provide details on the number or specific qualifications (e.g., years of experience) of these clinicians or specialists.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing the ground truth of the test set samples. The samples were "clinically defined with a diagnosis" or "apparent healthy subjects," implying that their disease status or health status was established through standard clinical practice/diagnostic criteria rather than a specific expert adjudication process for the purpose of this study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is an in vitro diagnostic (IVD) immunoassay, which typically does not involve human readers interpreting results in the same way imaging devices do. The performance evaluation focuses on the analytical and clinical accuracy of the assay itself compared to a predicate device and clinical diagnoses, not on human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The entire document describes the performance of the EliA SmDP-S device as an in vitro diagnostic assay, which functions independently (algorithm only) to measure IgG antibodies. There is no human-in-the-loop component described for its operation or result generation. The device produces a semi-quantitative measurement (EliA U/mL) that is then interpreted based on defined cut-offs.

7. Type of Ground Truth Used

• For Method Comparison: The ground truth was the result obtained from the predicate device (EliA SmDP assay) for common patient samples.
• For Clinical Sensitivity and Specificity: The ground truth was based on "clinically defined diagnoses" of patients with Systemic Lupus Erythematosus (SLE) and various disease controls. This implies a diagnosis established through standard clinical criteria, which would include medical history, physical examination, other laboratory tests, and imaging findings (i.e., clinical diagnosis/outcomes data).
• For Reference Range: The ground truth was a group of "apparently healthy subjects."

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or algorithm training. For IVD devices like this, the development process usually involves internal validation and optimization batches, but not typically a formally labeled "training set" in the sense of machine learning. The studies described are primarily for validation and verification of the final device performance.

9. How Ground Truth for Training Set was Established

As no explicit "training set" is mentioned, the method for establishing its ground truth is also not detailed. However, for the development and optimization of such assays, ground truth for sample panels would typically be established using confirmed clinical diagnoses, reference methods, or well-characterized reference materials, similar to how the validation samples' ground truth was established using clinical diagnoses and predicate device comparisons.

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