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

EliA Rib-P is a semi-quantitative solid-phase fluoroenzymeimmunoassay, for the determination of autoantibodies against Rib-P. The EliA Rib-P test System is fully integrated and automated system which comprises of assay-specific reagents, EliA method-specific reagents, and general reagents.

Assav-Specific Reagents include:

• EliA Rib-P Wells: coated with human recombinant ribosomal P-proteins P0, P1 . and P2 - 2 carriers (12 wells each), ready to use;
• . EliA ANA 3 Positive Control 250 or 2500/5000: Human monoclonal antibodies in Tris buffer containing IgG antibodies to Ro52, Rib-P and RNA Pol III – 6 single use vials, 0.3 mL each, ready to use;
• . EliA IgG/IgM/IgA Negative Control 250 or 2500/5000: Human blood preparation 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 Method-Specific Reagents include:

• 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;
• I EliA IqG Conjuqate 50 or 200: ß-Galactosidase labeled anti-lgG (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 IgG Calibrator Strips: Human IqG (0, 4, 10, 20, 100, 600 uq/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 ug/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;

General Reagents include:

• Development Solution: 0.01% 4-Methylumbelliferyl-β-D-galactoside, 110, 6x >170, or 6x >1165 determinations;
• I Stop Solution: 4% Sodium Carbonate - 6 bottles (65 mL, 119 mL, or 2800 mL each), sufficient for 6x >292, 6x >560, or 6x >13100 determinations;
• 트 Washing Solution Additive: detergent, preservative

The provided document is a 510(k) Summary for the EliA Rib-P device, an in vitro semi-quantitative immunoassay for detecting IgG antibodies directed to Rib-P as an aid in diagnosing Systemic Lupus Erythematosus (SLE). This document does not describe a study involving an AI-enabled device or human-in-the-loop performance. Instead, it focuses on the analytical and clinical performance of a standalone laboratory diagnostic device and its substantial equivalence to a predicate device.

However, I can extract and structure the information related to acceptance criteria and the performance study of this specific diagnostic device in the format requested, even without AI-specific parameters.

Acceptance Criteria and Device Performance Study for EliA Rib-P

The EliA Rib-P device is an automated semi-quantitative solid phase fluoroenzymeimmunoassay for the measurement of IgG antibodies directed to Rib-P in human serum. This summary outlines the performance characteristics tested to demonstrate its substantial equivalence to a legally marketed predicate device, the Quanta Lite Ribosome P ELISA.

1. Table of Acceptance Criteria and the Reported Device Performance

• Range of Total Imprecision %CV across 5 samples: 4.0% - 13.3%
• Within-lab Imprecision %CV across 4 samples: 3.5% - 13.8%
  Phadia 2500/5000:
• Range of Total Imprecision %CV across 5 samples: 5.7% - 18.4% (one sample had high CV, 18.4%) |
  | Linearity/Reportable Range| Coefficient of determination (R²) close to 1.00, and slopes close to 1.00, across the measuring range. CLSI EP6-A guidelines followed. | Phadia 250:
• R² values: 1.00 for all three dilution ranges.
• Slopes: 0.95, 1.00, 1.00.
  Phadia 2500E:
• R² values: 0.99, 1.00, 0.99 for the three dilution ranges.
• Slopes: 1.03, 1.00, 1.02.
  "Linearity was shown for the entire measuring range." |
  | Detection Limit | LoB, LoD, and LoQ to be established according to CLSI EP17-A2 guidelines (false positives and false negatives 10 EliA U/mL |
  | Comparison Studies | | |
  | Method Comparison (vs. Predicate Device) | High Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Total Agreement with the predicate device. CLSI EP09c-ED3 followed. | EliA Rib-P (equivocal considered negative):
• PPA: 94.7% (95% CI: 82.3% - 99.4%)
• NPA: 98.6% (95% CI: 96.4% - 99.6%)
• Total Agreement: 98.1% (95% CI: 96.0% - 99.3%)
  EliA Rib-P (equivocal considered positive):
• PPA: 100% (95% CI: 90.7% - 100%)
• NPA: 88.1% (95% CI: 83.7% - 91.6%)
• Total Agreement: 89.5% (95% CI: 85.6% - 92.6%) |
  | Instrument Comparison | Strong correlation and agreement between different Phadia instrument series. | Regression analysis showed a slope of 0.94 (95% CI: 0.93 - 0.98) and an intercept of -0.76 (95% CI: -1.20 - -0.48) between Phadia 250 and Phadia 2500E. |
  | Clinical Studies | | |
  | Clinical Sensitivity and Specificity | Acceptable sensitivity for SLE and high specificity against other autoimmune and infectious diseases. | EliA Rib-P (equivocal considered positive):
• Sensitivity (for SLE): 34.9% (95% CI: 27.2% - 43.3%)
• Specificity (against disease controls): 99.3% (95% CI: 97.9% - 99.9%)
  EliA Rib-P (equivocal considered negative):
• Sensitivity (for SLE): 28.1% (95% CI: 21.0% - 36.1%)
• Specificity (against disease controls): 99.8% (95% CI: 98.7% - 100%) |

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

• Precision/Reproducibility:
  • Phadia 250: 5 samples, tested in 252 replicates each across 3 lots and 3 instruments over 7 days.
  • Within-Lab Imprecision: 4 samples, tested in 80 replicates each on 1 instrument over 20 days.
  • Phadia 2500/5000 (E-module): 5 samples, tested in 84 replicates each on 3 instruments over 7 days.
  • Provenance: Not explicitly stated, typically laboratory-prepared controls or banked human serum samples.
• Linearity/Assay Reportable Range: 3 serum samples (diluted). Provenance not explicitly stated.
• Detection Limit: 4 blank and 4 low-level samples (depleted IgG sera and prepared low-level samples) tested in 5-fold determination across 3 runs on Phadia 250 and Phadia 2500E.
• Analytical Specificity (Interference): 3 serum samples (one negative, one equivocal, one high positive) spiked with interfering substances. Provenance not explicitly stated.
• Assay Cut-Off: A cohort of 70 apparently healthy blood donors and 30 samples from SLE patients. Provenance not explicitly stated.
• Method Comparison with Predicate Device: 323 patient samples. Provenance not explicitly stated, but implies diverse clinical samples covering the measuring range.
• Instrument Comparison: 47 positive, 10 equivocal, and 28 negative samples. Provenance not explicitly stated.
• Clinical Sensitivity and Specificity: 560 clinically defined serum samples from various diagnostic groups (146 SLE, 414 disease controls). Provenance not explicitly stated, but these are patient samples with confirmed diagnoses.
• Expected Values/Reference Range: 638 apparently healthy subjects, equally distributed by age and gender from Caucasian, African American, Hispanic, and Asian populations obtained from a blood bank.

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

The document does not mention the use of experts to establish ground truth for the analytical performance characteristics. For clinical studies, the "ground truth" for patient samples was based on "clinically defined serum samples with a diagnosis" (e.g., systemic lupus erythematosus, Celiac disease, etc.). This typically implies diagnosis by medical professionals (e.g., rheumatologists, gastroenterologists, etc.) based on established diagnostic criteria, but the number and specific qualifications of these experts are not explicitly stated in this summary.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

No explicit adjudication method is mentioned. The ground truth for clinical samples appears to be based on pre-existing clinical diagnoses.

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 section is not applicable as the device is a standalone in vitro diagnostic immunoassay, not an AI-enabled device or an assist device for human readers. No MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This device is a standalone algorithm/device in the sense that it performs automated semi-quantitative measurement of antibodies without real-time human interpretation impacting the measurement result. The assay directly measures the amount of antibody via fluorescence. The interpretation of results (negative, equivocal, positive) is based on predefined cut-offs.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

• Analytical ground truth: Based on reference materials, spiked samples, and dilution series with known concentrations or characteristics.
• Clinical ground truth: "Clinically defined serum samples with a diagnosis" (e.g., SLE patients, various disease controls). This implies established clinical diagnoses, likely based on standard diagnostic criteria, which could involve expert clinical assessment, pathology, and other laboratory findings.

8. The Sample Size for the Training Set

This document does not specify a separate "training set" in the context of machine learning or AI. For a traditional immunoassay, method development and optimization would involve various experiments and sample sets, but these are not explicitly termed "training sets" here. The "Assay Cut-Off" study used 70 healthy blood donors and 30 SLE patients to define the cut-off, which could be considered a form of "training" for the interpretive criteria.

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

As noted above, a formal "training set" in the AI sense is not described. For the cut-off determination, the ground truth was established by using "apparently healthy blood donors" and "samples from SLE patients," indicating that these samples had known clinical statuses (healthy or diagnosed with SLE).

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