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EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgA uses the EliA IgA method on the instrument Phadia 2500/5000.

EliA Cardiolipin IgA is intended for the in vitro sem-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K112414 (EliA B2-Glycoprotein I IqA) and K131821 (EliA Cardiolipin IqA), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of:
-Test Wells: EliA ß2-Glycoprotein I IqA Wells are coated with human ß2-Glycoprotein I antigen - 2 carriers (12 wells each), ready to use;

• EliA Cardiolipin IgA Wells are coated with bovine cardiolipin antigen and boyine ß2-glycoprotein I as co-factor - 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 IqA Conjuqate 50 or 200: ß-Galactosidase labeled anti-IgA (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 IgA Calibrator Strips: Human IgA (0, 0.3, 1.5, 5, 15, 80 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 IgA Curve Control Strips: Human IgA (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 IgA 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 EliA ß2-Glycoprotein I IgA and EliA Cardiolipin IgA tests.

Here's a breakdown of the acceptance criteria and study particulars for the EliA Beta2-Glycoprotein I IgA and EliA Cardiolipin IgA Immunoassays on the Phadia 2500/5000 instrument, based on the provided FDA 510(k) summary (K181329):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are primarily for method comparison (regression analysis against the predicate device/instrument) and for the performance metrics of Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Total Percent Agreement (TPA) when comparing the new instrument platforms (Phadia 2500/5000) to the predicate Phadia 250.

EliA ß2-Glycoprotein I IgA on Phadia 2500/5000

EliA Cardiolipin IgA on Phadia 2500/5000

Note: The document primarily outlines how the studies were performed and what the results were, rather than explicit pre-defined quantitative acceptance criteria for all metrics. For method comparison, it states: "The acceptance criteria for the method comparison (the slope for the regression lines should be 0.9 - 1.1 for single replicate to single replicate and intercept close to 0) were met." For LoQ, it mentions "a target uncertainty goal of 20%." For PPA/NPA/TPA, the high reported values and FDA clearance imply acceptance.

2. Sample Size and Data Provenance for Test Set

• Method Comparison (Instrument Comparison):

  • Sample Size: More than 100 serum samples (for each immunoassay).
  • Data Provenance: Not explicitly stated, but serum samples were used. It is implied to be from patient populations relevant to the intended use. The samples included "≥20% of the samples within ±25% of the medical decision point," suggesting a distribution covering diagnostically relevant ranges.
  • Retrospective/Prospective: Not specified, but typically such comparison studies use retrospectively collected samples for method validation.

• Precision/Reproducibility:

  • Sample Size: 5 serum samples. Each sample tested in 21 runs (3 instruments x 7 runs) with 4 replicates per run, totaling 84 replicates per serum sample.
  • Data Provenance: Serum samples. Country of origin not specified.
  • Retrospective/Prospective: Retrospective, as these are pre-collected serum samples.

• Linearity/Assay Reportable Range:

  • Sample Size: 4 patient serum samples.
  • Data Provenance: Patient serum samples. Country of origin not specified.
  • Retrospective/Prospective: Retrospective.

• Detection Limit (LoB, LoD, LoQ):

  • Sample Size:
    • LoB: One blank sample measured in 33 replicates in each of two runs.
    • LoD & LoQ: Three low-level serum samples measured in 11 replicates in each of two runs.
  • Data Provenance: Blank samples and low-level serum samples. Country of origin not specified.
  • Retrospective/Prospective: Retrospective.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

• This device is an in-vitro diagnostic (IVD) immunoassay, not an AI or imaging device requiring human expert adjudication for ground truth. The "ground truth" for these studies refers to the reference method's result (e.g., predicate device Phadia 250 for method comparison) or the known characteristics of the samples (e.g., spiking for linearity, known concentration for precision controls).
• Therefore, the concept of "number of experts" or their "qualifications" for establishing ground truth in the context of an IVD assay's analytical performance studies is not applicable here.

4. Adjudication Method for the Test Set

• Not applicable as this is an IVD immunoassay, not an AI or imaging device requiring human subjective interpretation and adjudication. The "adjudication" is based on instrumental readings and comparison to defined calibrators and predicate device results.

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

• No, an MRMC comparative effectiveness study was not done. This is an IVD immunoassay, not a device that involves human "readers" interpreting cases in the context of medical imaging or clinical decision-making with or without AI assistance.
• The study involved comparing instrumental results of the new Phadia 2500/5000 platform to the predicate Phadia 250 platform.

6. Standalone Performance Study

• Yes, standalone performance studies were done. The precision, linearity, and detection limit studies are examples of standalone performance evaluations of the EliA immunoassays on the Phadia 2500/5000 instrument.
• The primary scope of this 510(k) submission was to introduce these previously cleared assays onto a new instrument platform (Phadia 2500/5000), meaning the "algorithm" (assay chemistry and measurement principle) itself was already established as effective and safe. The studies here demonstrate that this established assay performs equivalently on the new instrument.

7. Type of Ground Truth Used

• Method Comparison: The predicate device's results (EliA ß2-Glycoprotein I IgA on Phadia 250 instrument, K112414; EliA Cardiolipin IgA on Phadia 250 instrument, K131821) served as the "ground truth" or reference for assessing equivalence of the new instrument platform.
• Precision and Linearity: The values obtained from the predicate device or a well-characterized reference are used to establish control ranges and expected values. For linearity, known dilutions are used against expected concentrations.
• Detection Limit: Controlled blank samples and low-level spiked/characterized samples are used.
• Clinical Studies (reference): For clinical utility and cut-off determination mentioned as reviewed in K112414 and K131821, the ground truth would have been clinical diagnosis (e.g., confirmed APS or SLE) and outcomes data. This summary itself does not include new clinical ground truth studies for K181329.

8. Sample Size for the Training Set

• This type of submission (510(k) for a new instrument platform for existing assays) generally does not involve a "training set" in the context of machine learning or AI.
• For IVD assays, optimization and method development would involve numerous samples, but these are part of product development rather than a formal "training set" that would be distinct from a "test set" in the way AI/ML studies define them. The stability and calibration curves are established using a series of known calibrators and controls.

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

• Not applicable in the AI/ML sense. For standard IVD assay development, ground truth for calibrators and controls is established through rigorous characterization, often against international reference materials or highly purified substances, and validated using established analytical methods and statistical approaches. The clinical cut-offs were derived from "clinical studies (s. K112414 and K131821)", meaning the previous submissions involved clinical data and patient diagnoses to define the clinically relevant ranges.

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EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA ß2-Glycoprotein 1 IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.

The new device belongs 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 IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.

The total IgA calibration is based on a set of six WHO-standardized IgA 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-specific, method-specific and general reagents that are packaged as separate units.

Here's a breakdown of the acceptance criteria and study information for the EliA™ ß2-Glycoprotein I IgA Immunoassay, based on the provided 510(k) summary:

The provided 510(k) summary primarily focuses on establishing "substantial equivalence" to a predicate device for this in vitro diagnostic (IVD) immunoassay, rather than presenting a performance study with detailed acceptance criteria in the manner one might see for an AI/software device or a medical imaging device. The "performance" here relates to how well the new device compares to the predicate and its ability to detect the target antibodies.

1. Table of Acceptance Criteria and the Reported Device Performance

• Comparison study between new and predicate device
• Results from clinically defined sera
• Results from samples of apparently healthy subjects (normal population)
  Overall Finding: All available data support the new device is substantially equivalent to the predicate device. |
  | Intended Use | Semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I to aid in diagnosis of antiphospholipid syndrome (APS) and thrombotic disorders related to systemic lupus erythematosus (SLE). | The device's performance supports its intended use as described. |
  | Method | Uses EliA IgA method on Phadia 100 and Phadia 250 instruments. | The device is designed to operate with these instruments and methods. |
  | Calibration | IgA calibration based on six WHO-standardized IgA Calibrators; initial calibration curve valid for up to 28 days; includes calibrator (curve) controls with defined recovery ranges. | The system incorporates this calibration method to ensure validity and accuracy. |

Explanation of "Acceptance Criteria" for IVDs in a 510(k) context: For an in vitro diagnostic device seeking 510(k) clearance, acceptance criteria often revolve around demonstrating analytical and clinical performance comparable to a legally marketed predicate device. This typically involves studies on precision, accuracy (comparison to a reference method or predicate), linearity, detection limits, interference, and agreement studies for clinical samples. The provided summary is very high-level and only states that data supports equivalence, rather than detailing specific numerical criteria used in those studies (e.g., "agreement rate >90%").

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

The summary does not provide specific sample sizes for the "test set" or explicit data provenance (e.g., country of origin). It generally refers to:

• "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)"

This indicates the data was collected retrospectively from various sample sources to facilitate comparison. Without more detail, it's not possible to determine if the samples were prospective.

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

This information is not provided in the summary. For an IVD, "ground truth" (or clinical truth) for samples used in method comparison or clinical concordance studies would typically be established by combining patient clinical diagnoses (e.g., diagnosed with APS or SLE by a rheumatologist/hematologist) with results from established, often predicate, diagnostic tests. The summary implies "clinically defined sera" were used, meaning these samples had a known clinical status, but the process of establishing that status (e.g., number and qualifications of clinicians) is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the summary. For IVDs, adjudication isn't typically used in the same way as for imaging devices where multiple readers interpret images. Instead, the "ground truth" for clinical samples is based on a patient's overall clinical presentation and diagnosis, typically accepted as definitive for the study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging AI devices where human readers interpret images. The EliA™ ß2-Glycoprotein I IgA Immunoassay is an in vitro diagnostic (IVD) serological test, not an imaging device, and does not involve human "readers" interpreting results in a way that an MRMC study would be applicable.

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

This refers to the performance of the immunoassay system itself. The device is described as a "fully integrated and automated system for immunodiagnostic testing" and requires operation on the "Phadia 100/Phadia 250" instruments which include "software for evaluation of test results." Therefore, its performance is inherently "standalone" in the sense that the instrument-software system processes the sample and yields a result without direct human interpretation of a raw signal. The comparison studies described are essentially evaluating this standalone performance against the predicate.

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

The summary implies two types of "ground truth" for the performance studies:

• Predicate Device Results: For the "comparison study between new and predicate device," the predicate device's results (Varelisa ß2-Glycoprotein I IgA Antibodies, K040450) would serve as a comparative ground truth.
• Clinical Diagnoses: For "clinically defined sera," the ground truth would be the clinical diagnosis of the patient (e.g., presence or absence of APS or SLE-related thrombotic disorders), presumably based on a combination of clinical symptoms, other laboratory findings, and expert physician assessment. The "samples from apparently healthy subjects" provide a "negative" ground truth based on their healthy status.

8. The Sample Size for the Training Set

The summary does not mention a training set in the context of machine learning or AI. This device is an immunoassay, not an AI or machine learning device that requires a separate training phase. The "calibration" of the device is based on a set of WHO-standardized IgA Calibrators, which is distinct from a machine learning training set.

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

As no training set (in the machine learning sense) is discussed, this question is not applicable. The "ground truth" for the calibration is established by using "WHO-standardized IgA Calibrators derived from human serum," implying these calibrators have a known and certified IgA concentration.

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