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EliA PR3s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA, formerly called Wegener's Granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3s uses the EliA IgG method on the instrument Phadia 2500/5000.

EliA MPOs is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of microscopic polyangiitis (MPA) in conjunction with other laboratory and clinical findings. EliA IgG method on the instrument Phadia 2500/5000.

EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies to a3 chain of collagen IV in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K140225, but are filled in containers specific for the Phadia® 2500/5000 instrument. Each device consists of:

• Test Wells: -
  EliA PR3S Wells are coated with human PR3 protein – 4 carriers (12 wells each), ready to use:

EliA MPOS Wells are coated with human MPO protein – 4 carriers (12 wells each), ready to use;

EliA GBM Wells are coated with human recombinant α3 chain of collagen IV – 2 carriers (12 wells each), ready to use;

• 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 IgG Conjugate 50 or 200: ß-Galactosidase labeled anti-IgG (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 IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 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 IgG Curve Control Strips: Human IgG (20 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 IgG Calibrator Well: Coated with mouse monoclonal antibodies 4 carriers (12 wells each), ready to use.
• -EliA ANCA/GBM Positive Control 2500/5000: Human serum containing IgG antibodies to PR3, MPO and GBM in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 6 single use vials, 0.3 mL each, ready to use;
• -EliA IgG/IqM/IgA Negative Control 2500/5000: Human sera from healthy donors in PBS containing BSA, detergent and 0.095% (w/v) sodium azide -6 single-use vials, 0.3 mL 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 ANCA/GBM Positive Control 2500/5000 and the EliA IgG/ IgM/IgA Negative Control 2500/5000, all packages listed above are required to carry out an EliA PR3°, EliA MPOS and EliA GBM tests.

The provided text describes the acceptance criteria and study results for the EliA PR3s, EliA MPOs, and EliA GBM immunoassays when used on the Phadia 2500/5000 instrument. This submission is to add these previously cleared assays to a new instrument platform, so the focus is on method comparison rather than clinical studies.

Here's the breakdown of the requested information:

1. Table of acceptance criteria and reported device performance for Instrument Comparison (Method Comparison):

The acceptance criteria for method comparison (comparing Phadia 2500/5000 to the predicate Phadia 250) were:

• Slope for the regression lines should be between 0.9 and 1.1 for single replicate to single replicate.
• Intercept close to 0.

The performance is reported for each immunoassay (EliA PR3s, EliA MPO®, EliA GBM) and for each of the three Phadia 2500/5000 instruments (A, B, C) tested against the Phadia 250.

EliA PR3s on Phadia 2500/5000 (vs. Phadia 250):

EliA MPO® on Phadia 2500/5000 (vs. Phadia 250):

EliA GBM on Phadia 2500/5000 (vs. Phadia 250):

2. Sample size used for the test set and the data provenance:

• Sample Size: More than 100 samples for each EliA test (PR3s, MPO®, GBM). The submission also specifies "≥20% of the samples within ±25% of the medical decision point."
• Data Provenance: Not explicitly stated as "country of origin," but implies clinical samples used for method comparison. The samples are referred to as "patient serum samples." It is a prospective study as the comparison aims to show equivalence of the new instrument platform with the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the given text. The study is a method comparison between two instruments (Phadia 250 and Phadia 2500/5000) using the same assays, not a clinical study to establish diagnostic accuracy against a clinical gold standard determined by experts. The "ground truth" for the method comparison is the measurement value obtained from the predicate Phadia 250 instrument.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the study is a method comparison of quantitative measurements, not a diagnostic study requiring expert adjudication of cases. The comparison is based on numerical results from two instruments.

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 is not applicable. The device described is an immunoassay system for semi-quantitative measurement of antibodies, not an AI-assisted diagnostic imaging device used by human readers.

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

The device (EliA immunoassays on Phadia 2500/5000) operates as a standalone automated system for measuring antibody levels. The results are semi-quantitative measurements that are an aid in clinical diagnosis, meaning a human clinician interprets the results in conjunction with other findings. However, the performance data presented (precision, linearity, detection limits, method comparison) is reflective of the standalone performance of the algorithm/instrument system. Therefore, the analytical performance studies (precision, linearity, detection limit) and method comparison effectively represent standalone algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the method comparison study, the "ground truth" for evaluating the performance of the EliA assays on the Phadia 2500/5000 instrument was the results obtained from the predicate device, Phadia 250 instrument.

8. The sample size for the training set:

This information is not applicable as the devices are immunoassays, not machine learning algorithms that require a specific training set in the typical sense. The underlying EliA IgG method and its associated reagents were previously reviewed (K140225), implying that analytical performance of the assay itself was established in prior submissions. This current submission focuses on instrument equivalence.

9. How the ground truth for the training set was established:

This is not applicable for the same reasons as point 8. The assays do not involve machine learning with a distinct training set. The "ground truth" for establishing the analytical parameters and clinical performance of the immunoassays themselves would have been established through extensive analytical validation (e.g., against reference methods, known positive/negative samples, clinical samples with confirmed diagnoses) in their original clearance (K140225).

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EliA PR3s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (heparin, EDTA, citrate) to aid in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA; formerly known as Wegener's granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3s uses the EliA IgG method on the instrument Phadia 100.

EliA PR3s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (heparin, EDTA, citrate) to aid in the clinical diagnosis of Granulomatosis with Polyangitis (GPA; formerly known as Wegener's granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3s uses the EliA IgG method on the instrument Phadia 250.

EliA MPOs is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of microscopic polyangitis (MPA) in conjunction with other laboratory and clinical findings. EliA IgG method on the instrument Phadia 100.

EliA MPOs is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of microscopic polyangitis (MPA) in conjunction with other laboratory and clinical findings. EliA IgG method on the instrument Phadia 250.

EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to alpha3 chain of collagen IV in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instrument Phadia 100.

EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to alpha3 chain of collagen IV in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instrument Phadia 250.

EliA ANCA/GBM Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 100 using the EliA IgG method.

EliA ANCA/GBM Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 250 using the EliA IgG method.

The new devices belong 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 Phadia 100 and Phadia 250.

The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ß-D-Galactoside as substrate.

The total IgG calibration is based on a set of six WHO-standardized 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 Phadia US, Inc. EliA™ PR3s, EliA™ MPOs, and EliA™ GBM immunoassays are intended for the semi-quantitative measurement of IgG antibodies to PR3, MPO, and alpha3 chain of collagen IV, respectively. These tests aid in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA), microscopic polyangitis (MPA), and Goodpasture syndrome when used in conjunction with other laboratory and clinical findings. The EliA ANCA/GBM Positive Controls are for monitoring the performance of these immunoassays.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) for the new devices (EliA PR3s, EliA MPOs, EliA GBM). Instead, it focuses on demonstrating "laboratory equivalence" to predicate devices.

The study indicates:

• Results obtained within a comparison study between new and predicate device.
• Results obtained for clinically defined sera.
• Results obtained for samples from apparently healthy subjects (normal population).

The overarching conclusion is: "In summary, all available data support that the new devices are substantially equivalent to the predicate devices."

Without explicit quantitative criteria, a table like the one requested cannot be fully populated. However, if we infer "equivalence" as the acceptance criterion, the reported performance is that this equivalence was supported by the comparison studies.

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

The document mentions "a data set including results obtained within a comparison study between new and predicate device, results obtained for clinically defined sera, and results obtained for samples from apparently healthy subjects (normal population)."

• Test Set Sample Size: The document does not specify the exact sample sizes used for the comparison study, clinically defined sera, or healthy subjects.
• Data Provenance: The document does not specify the country of origin for the data. It also does not explicitly state if the data was retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic, it is highly probable that the "clinically defined sera" and "samples from apparently healthy subjects" would be retrospective collections, but this is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document describes the devices as "intended for the in vitro semi-quantitative measurement of IgG antibodies... to aid in the clinical diagnosis... in conjunction with other laboratory and clinical findings." The "clinically defined sera" implies that the cases likely had their diagnosis confirmed by clinical experts.

• Number of Experts: The document does not specify the number of experts used to establish the ground truth for the clinically defined sera.
• Qualifications of Experts: The document does not specify the qualifications of these experts. However, for "clinically defined" cases, it would typically involve physicians specializing in the relevant diseases (e.g., rheumatologists, nephrologists) who use a combination of clinical symptoms, imaging, and other laboratory tests for diagnosis.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth for the test set.

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

• Was an MRMC study done? No, the devices are immunoassays, which are laboratory tests that produce a quantitative or semi-quantitative result. They are not image-based AI tools interpreted by human readers, so an MRMC comparative effectiveness study involving human readers is not applicable to this type of device.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Yes, the described "comparison study between new and predicate device," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects" represent the standalone performance of the immunoassay system. The device itself (the immunoassay) produces the semi-quantitative measurement of antibodies. There is no human-in-the-loop component for interpreting the direct output of these specific diagnostic tests, although a clinician then uses these results in conjunction with other findings for diagnosis.

7. Type of Ground Truth Used

The ground truth for the clinical cases appears to be "clinically defined diagnoses." The document specifically mentions "clinically defined sera," implying that patients were diagnosed with GPA, MPA, or Goodpasture syndrome based on established clinical criteria, which would likely include a combination of clinical symptoms, other laboratory tests, and potentially biopsy results (e.g., pathology for kidney biopsies in Goodpasture syndrome). For the "healthy subjects," the ground truth is the absence of these diseases.

8. Sample Size for the Training Set

The document does not provide information on a specific "training set" sample size. For an immunoassay, the "training" analogous to machine learning often involves assay development, optimization, and establishment of referent ranges and cut-offs. The sample sets described ("comparison study," "clinically defined sera," "healthy subjects") are typically used for validation or verification of performance, not explicitly for "training" in the AI sense.

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

As no explicit "training set" is described in the context of machine learning, the establishment of its ground truth is not applicable. For the performance studies, as mentioned in point 7, the ground truth was based on clinically defined diagnoses.

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