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EliA SymphonyS is intended for the in vitro, qualitative measurement of antibodies in human serum and plasma (Li-heparin, EDTA). EliA SymphonyS is based on human recombinant U1RNP (RNP 70, A, C), SS-A/Ro (60 kDa, 52 kDa), SSB/La, Centromere B, Scl-70, Jo-1 proteins and a synthetic SmD3 peptide 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, scleroderna and polymyositis, in conjunction with other laboratory and clinical findings. EliA SymphonyS uses the EliA IgG method on the instrument Phadia 250.

EliA SymphonyS is intended for the in vitro, qualitative measurement of antibodies in human serum and plasma (Li-heparin, EDTA). EliA SymphonyS is based on human recombinant U1RNP (RNP 70, A, C), SS-A/Ro (60 kDa, 52 kDa), SSB/La, Centromere B, Scl-70, Jo-1 proteins and a synthetic SmD3 peptide 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, in conjunction with other laboratory and clinical findings. EliA SymphonyS uses the EliA IgG method on the instrument Phadia 2500/5000.

The method specific reagents on Phadia® 250 and Phadia® 2500/5000 are identical; they are only filled in different containers. Each device consists of:

• EliA Symphony® Wells are coated with human recombinant U1RNP (RNP70, A. -C). SS-A/Ro (60 kDa. 52 kDa). SS-B/La. Centromere B. Scl-70. Jo-1 proteins and synthetic SmD3 peptide - 4 carriers (16 wells each), ready to use;
• EliA Sample Diluent: PBS containing BSA, detergent and 0.095% sodium azide --6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use;
• EliA IgG Conjugate 50 or 200: ß-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% sodium azide -6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use
• EliA ANA Positive Control 250 or 2500/5000: Human serum containing lgG antibodies to dsDNA, RNP, Sm, Ro. La. Scl-70. CENP and Jo-1 in PBS containing BSA, detergent and 0.095% sodium azide - 6 single use vials, 0.3 mL each, ready to use;
• -EliA Negative Control 250 or 2500/5000: Human sera from healthy donors in PBS containing BSA, detergent and 0.095% sodium azide - 6 single-use vials, 0.3 mL each, ready to use;
• EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
• -EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
• EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies 4 carriers (12 wells each), ready to use.

The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. Apart from the EliA ANA Positive Control 250 or 2500/5000 and the EliA IqG/IqM/IgA Neqative Control 250 or 2500/5000, all packages listed above are required to carry out an EliA SymphonyS Test.

Here's a breakdown of the acceptance criteria and study information for the EliA SymphonyS Immunoassay, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

2. Sample Size and Data Provenance (Test Set)

• Precision Study (Phadia 250): 5 samples, 252 replicates per sample (totaling 1260 determinations). Data provenance not explicitly stated, but clinical samples are generally used for such studies.
• Precision Study (Phadia 2500/5000): 7 samples, 84 replicates per sample (totaling 588 determinations). Data provenance not explicitly stated.
• Interference Study: 3 serum samples (negative, cut-off, high positive), analyzed in triplicates, repeated twice. Spiked with specific interfering substances. Data provenance not explicitly stated.
• Cut-off Study: 70 apparently healthy blood donor samples from Caucasian individuals (equally distributed by sex and age). 30 ANA positive samples with known reactivities. Data provenance not explicitly stated.
• Method Comparison Study: 633 serum samples from patients with various diagnoses (Mixed Connective Tissue Disease, Poly-/Dermatomyositis, Systemic Sclerosis, SLE, Sjögren's Syndrome, Bacterial Infection, HIV Infection, HCV Infection, HBV Infection, Rheumatoid Arthritis, Cancer). Data provenance not explicitly stated (likely retrospective clinical samples from diverse sources).
• Matrix Comparison Study: 62 patients, serum, lithium heparin plasma, and EDTA plasma collected from the same patients. Data provenance not explicitly stated.
• Instrument Comparison Study: 110 samples (81 positive, 10 equivocal, 19 negative). Data provenance not explicitly stated.
• Clinical Sensitivity and Specificity Study: 444 clinically defined samples with a diagnosis from patients with various autoimmune diseases and control conditions (Mixed Connective Tissue Disease, Poly-/Dermatomyositis, Systemic Sclerosis, SLE, SLE/Lupus nephritis, Sjögren's Syndrome, Bacterial Infection, Viral Infection, Rheumatoid Arthritis, Celiac Disease, Crohn's Disease, Ulcerative Colitis, Graves' Disease, Hashimoto's Disease, primary Antiphospholipid Syndrome, PBC, Autoimmune hepatitis, Granulomatosis with Polyangiitis). Data provenance not explicitly stated (likely retrospective clinical samples from diverse sources).
• Expected Values/Reference Range Study: 558 apparently healthy subjects (Caucasian, African American, Hispanic and Asian population) obtained from a blood bank. This suggests diverse geographic and demographic provenance for the "normal" population.

Most of the studies likely used retrospective clinical samples, given the disease-specific grouping. No specific country of origin is mentioned for individual studies, but the applicant is Phadia AB from Sweden, and the 510(k) contact is in the USA, implying potential multi-site studies or data collection.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set.

• For the "clinically defined samples" in the clinical sensitivity/specificity study, the "diagnosis from patients" would be considered the ground truth, presumably established by treating physicians based on clinical findings and other laboratory tests, but not by a specific panel of experts for the purpose of this device's validation.
• Reference sera (CDC and AMLI) have "target" values, which are established by their respective institutions (Centers for Disease Control and Prevention, and Association of Medical Laboratory Immunologists) and represent a consensus or assigned value, but not necessarily a specific "number of experts" for this study.

4. Adjudication Method for the Test Set

The document does not mention any explicit adjudication method (e.g., 2+1, 3+1) for establishing the ground truth for the test set. Clinical diagnoses are typically made by single treating physicians, and reference materials have predefined target values.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic immunoassay, which does not involve human readers interpreting results in the same way an imaging AI might. Its performance is measured directly through analytical and clinical studies against predicate devices or known clinical statuses.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the device performance described is standalone (algorithm only). The EliA SymphonyS Immunoassay is an automated system that measures antibody levels and provides a qualitative result (negative, equivocal, positive) based on predefined cut-offs, without direct human-in-the-loop interpretation during the measurement process. The "aid in clinical diagnosis" part implies that clinicians interpret the results in conjunction with other findings, but the device itself operates in a standalone manner.

7. Type of Ground Truth Used

The types of ground truth used include:

• Clinical Diagnoses: For the clinical sensitivity/specificity study, the "diagnosis from patients with" various diseases (e.g., SLE, MCTD, Sjögren's syndrome) served as the ground truth. This is based on established clinical criteria for each disease.
• Reference Material Targets: For the evaluation of CDC and AMLI sera, the "Target" reactivity/results defined by these external institutions were used as ground truth.
• Expected Behavior: For precision, interference, carry-over, and cut-off studies, the ground truth is often the expected behavior of the assay (e.g., negative sample should be negative, spiked sample should show no interference, etc.) or statistically derived values from healthy populations.
• Predicate Device Results: For the method comparison study, the results from the legally marketed predicate device (EliA Symphony) served as a comparative ground truth to demonstrate substantial equivalence.

8. Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of machine learning. This is an immunoassay, which typically relies on established biochemical reactions, calibration curves, and empirically determined cut-offs rather than a machine learning model that requires a discrete training phase with labeled data. The calibration curve is established using calibrator strips (human IgG at known concentrations).

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

As noted above, there isn't a "training set" in the machine learning sense for this immunoassay.

• The calibration curve is established using EliA IgG Calibrator Strips, which contain human IgG at known concentrations (0, 4, 10, 20, 100, 600 µg/L). The "ground truth" for these calibrators is their precisely defined IgG concentrations, which are traceable to the International Reference Preparation (IRP) 67/86 of Human Serum Immunoglobulins A, G and M from WHO.
• The cut-off values (0.7 Ratio and 1.0 Ratio) were established by evaluating 70 apparently healthy blood donor samples and taking into account the 95th percentile, along with testing 30 ANA positive samples with known reactivities. This is a form of empirical ground truth setting based on biological distribution and known positive/negative samples.

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