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EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K102673, but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells: EliA RF IqM Wells are coated with aggregated rabbit IgG 4 carriers (12 wells each), ready to use; EliA Sample Diluent: EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use; EliA IgM Method Reagents: EliA IgM Conjugate 50 or 200: ß-Galactosidase labeled anti-IgM (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide - 6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use - -EliA IgM Calibrator Strips: Human IgM (0, 10, 35, 80, 500, 1000 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use; - EliA IgM Curve Control Strips: Human IgM (80 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide – 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use; - EliA IgM 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. All packages are required to carry out an EliA RF IgM test.

Here's a breakdown of the acceptance criteria and study information for the EliA RF IgM Immunoassay on the Phadia 2500/5000 instruments, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The core of this submission is to demonstrate that the EliA RF IgM Immunoassay, previously cleared on the Phadia 250 instrument (K102673), performs substantially equivalently when used on the new Phadia 2500/5000 instrument platform. Therefore, the acceptance criteria are primarily focused on method comparison and analytical performance to show this equivalence. No explicit "acceptance criteria" are provided as a single table within this document for each performance characteristic, but they are implied by the statistical analyses and cut-offs used.

Here's an organized table presenting the relevant acceptance criteria (implied or stated) and the reported device performance:

2. Sample Sizes and Data Provenance

• Precision Test Set Sample Size: Five samples (at various concentrations: 1.6, 3.9, 7.0, 73.7, 169.6 IU/mL). Each sample tested in four replicates/run, over 21 runs (3 instruments x 7 runs), totaling 84 replicates per sample.
• Linearity Test Set Sample Size: Four patient serum samples.
• Detection Limit (LoD/LoB) Test Set Sample Size: One blank sample (measured in 33 replicates in each of two runs) and three low-level samples (measured in 11 replicates in each of two runs). Total 66 blank determinations and 66 low-level determinations for LoD. 66 determinations for LoQ.
• Method Comparison Test Set Sample Size: More than 100 samples (with ≥20% of the samples within ±25% of the medical decision point).
• Expected Values/Reference Range Test Set Sample Size: n = 400 apparently healthy subjects.
• Data Provenance: Not explicitly stated for specific sample origins (e.g., country of origin, retrospective/prospective). The reference range study mentions "sera from a Caucasian population obtained from a blood bank," which implies a prospective collection for that specific study, but the overall patient samples used in other analytical studies are not detailed.

3. Number of Experts and Qualifications (Ground Truth Establishment for Test Set)

• Not Applicable: This submission is for an immunoassay, which detects specific antibodies in patient samples. The "ground truth" for such devices is established by the assay's ability to accurately measure the analyte (IgM class rheumatoid factor antibodies) and correlate with clinical diagnosis of rheumatoid arthritis, as per established medical criteria for the disease itself, not by expert consensus on image interpretation or similar qualitative assessments. For method comparison studies, the "ground truth" is essentially the result obtained by the predicate device (EliA RF IgM on Phadia 250).

4. Adjudication Method (for Test Set)

• Not Applicable: Adjudication methods (like 2+1 or 3+1) are typically used for qualitative assessments, such as image interpretation, where multiple experts provide independent reads that may then be reconciled. This device is a quantitative immunoassay.

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

• No: An MRMC study is not relevant for this type of in vitro diagnostic device (immunoassay). MRMC studies are used to assess the comparative effectiveness of different diagnostic methods (e.g., AI-assisted vs. unassisted human readers) using multiple readers and multiple cases, typically for image-based diagnostics.

6. Standalone Performance Study (Algorithm Only)

• Yes, implicitly: The entire submission describes the standalone performance of the device (EliA RF IgM Immunoassay on the Phadia 2500/5000 instrument) in terms of its analytical characteristics (precision, linearity, detection limits, method comparison to the predicate). There is no "human-in-the-loop" for this automated immunoassay; the result is generated by the instrument and its associated software based on the specimen's reaction.

7. Type of Ground Truth Used

• For Analytical Performance:
  • Predicate Device Results: For method comparison, the results obtained from the predicate device (EliA RF IgM on Phadia 250) served as the comparative "ground truth" against which the new instrument's results were evaluated for substantial equivalence.
  • Expected Values/Spiked Samples/Known Standards: For studies like linearity and precision, the "ground truth" is based on samples with known or expected concentrations, or samples created through controlled dilutions.
• For Clinical Relevance: While the direct analytical studies here used the predicate as a reference, the original clinical performance values for the EliA RF IgM immunoassay were "reviewed in K102673," which would have established its "aid in diagnosis" claim against clinical findings of rheumatoid arthritis.

8. Sample Size for the Training Set

• Not Applicable in the traditional sense: This device is an immunoassay, not an AI/ML algorithm that undergoes a distinct "training phase" on a dataset in the way an imaging algorithm would. The development of an immunoassay involves optimization of reagents and protocols, which is a different process than "training" an algorithm. The 510(k) process focuses on demonstrating analytical and clinical performance for regulatory clearance.

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

• Not Applicable: As explained above, there is no traditional "training set" or "ground truth for a training set" as it would apply to an AI/ML device. The "ground truth" related to the assay's development (optimization, reagent formulation, etc.) would stem from biochemical principles, manufacturing specifications, and initial performance evaluations to ensure the assay functions as intended before formal validation studies.

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EliA Scl-70s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA Scl-70s uses the EliA IgG method on the instrument Phadia 100.

EliA Scl-70s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA Scl-70s uses the EliA IgG method on the instrument Phadia 250.

The Phadia EliA immunodiagnostic system is automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages except the positive and negative controls are required to carry out an EliA Scl-70° test.

The acceptance criteria and study detailed in the provided document pertain to the EliA™ Scl-70S Immunoassay, an in vitro semi-quantitative test for IgG antibodies directed to Scl-70.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the clinical performance (sensitivity and specificity). However, it reports the performance of the EliA Scl-70S based on its clinical study. For analytical performance, the acceptance criteria are implied by the reported results meeting generally accepted ranges for such assays.

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

• Sample Size for Analytical Performance Tests:
  • Precision/Reproducibility: 3 samples for Phadia 250, 1 batch for Phadia 100.
    • Phadia 100: 84 replicate determinations per sample (21 runs: 3 instruments x 7 runs each, over 7 days).
    • Phadia 250: 252 replicate determinations per sample (21 runs: 3 instruments x 7 runs each, over 7 days).
  • Linearity: 4 patient serum samples.
  • Hook Effect: One high positive serum sample.
  • Detection Limit (LoB/LoD): 6 blood donors. Each measured in 12 replicates in each of 6 runs on 6 different days (432 replicates per sample).
  • Endogenous Interference: 5 serum samples (2 negative, 2 around cut-off, 1 positive).
• Sample Size for Comparison Studies:
  • Method Comparison with Predicate Device: 390 serum samples.
    • Collected from patients with Scleroderma (SSc, n = 101), CREST (n = 33), MCTD (n = 37), SLE (n = 34), Sjögren's syndrome (SS, n = 26), Poly/Dermatomyositis (PM/DM, n = 5), Rheumatoid arthritis (RA, n = 30), various cancers (n = 20), various bacterial infections (n = 24), various viral infections (n = 26), and technical samples positive or equivocal for EliA Scl-70° (n = 54).
  • Matrix Comparison: 50 patients (serum, lithium heparin plasma, EDTA plasma collected from each).
  • Instrument Comparison: 24 positive, 8 equivocal, and 4 negative samples (total 36).
• Sample Size for Clinical Studies:
  • Clinical Sensitivity and Specificity: 336 clinically defined sera.
    • Diagnostic groups: Scleroderma (SSc, n=101) and Controls (n=235) which include other connective tissue diseases, bacterial/viral infections, cancer, and rheumatoid arthritis.
  • Assay Cut-off / Expected values: 400 apparently healthy blood donor samples from Caucasian individuals (equally distributed by sex and age).
• Data Provenance: The document does not explicitly state the country of origin for the patient or blood donor samples. It is implied to be retrospective as samples were "collected from patients with diagnosis of..." for the comparison and clinical studies. For the assay cut-off, "400 apparently healthy blood donor samples from Caucasian individuals" were used.

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

The document does not specify the number of experts used or their qualifications to establish the ground truth for the clinical diagnosis of scleroderma (SSc) or other conditions in the test set. It states "clinically defined sera from patients with scleroderma or other connective tissue diseases, bacterial or viral infections, cancer or rheumatoid arthritis," implying that the diagnosis was based on standard clinical practice rather than a dedicated expert panel for this study.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth diagnoses for the clinical test set. Clinical findings are referenced as the basis for diagnosis ("clinically defined sera"), but no specific multi-reader adjudication process is mentioned for the study itself.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The device is a laboratory immunoassay, and its performance is evaluated against a predicate device and clinical diagnoses, not as an aid to human readers in interpreting images or other data.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, the study is inherently a standalone performance evaluation of the immunoassay itself. The reported performance characteristics (precision, linearity, detection limits, clinical sensitivity, specificity) reflect the algorithm's (immunoassay's) ability to detect the target antibodies in patient samples without direct human-in-the-loop interpretation once the sample is loaded into the automated Phadia instruments. The results are quantitative (EliA U/mL) leading to a categorical output (negative, equivocal, positive) based on predefined cut-offs.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was clinical diagnosis. The document states "336 clinically defined sera from patients with scleroderma or other connective tissue diseases, bacterial or viral infections, cancer or rheumatoid arthritis." This implies that the ground truth was established by medical professionals through standard diagnostic procedures (e.g., patient history, physical examination, other laboratory tests, imaging, etc.) to arrive at a clinical diagnosis.

For the method comparison, the ground truth was essentially the results from the predicate device (INOVA QuantaLite™ Scl-70 ELISA), against which the new device's technical agreement was measured.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate training set for the device's development or a study related to training a machine learning model. This immunoassay device is a chemical/biological test system with predefined reagents and a specific detection methodology, not a machine learning algorithm that typically requires a distinct training phase with a labelled dataset. Its calibration employs calibrators and controls.

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

As there is no explicit training set discussed in the context of machine learning or algorithm training, this question is not directly applicable. For the immunoassay, the "ground truth" for calibration and controls would be established by the manufacturer through rigorous characterization and standardization of the calibrator and control materials, often traceable to international reference preparations (e.g., WHO standards for IgG). The document mentions that "New batches of IgG calibrators are compared to a secondary standard (standardized with the IRP) or the IRP directly and adjusted accordingly to meet the correct concentration."

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