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EliA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and EDTA-plasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease in conjunction with other laboratory and clinical findings. EliA Celikey IgG uses the EliA IgG method on the instrument Phadia 2500/5000.

EliA GliadinDP IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgA uses the EliA IgA method on the instrument Phadia 2500/5000.

EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgG uses the EliA IgG method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K062583 (EliA Celikey IgG) and K093459 (EliA Gliadin® IgA and EliA Gliadin® IgG), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells (EliA Celikey IgG Wells, EliA GliadinDP IgA Wells, EliA GliadinDP IgG Wells), EliA Sample Diluent, EliA IgG reagents (EliA IgG Conjugate, EliA IgG Calibrator Strips, EliA IgG Curve Control Strips, EliA IgG Calibrator Well), and EliA IgA reagents (EliA IgA Conjugate, EliA IgA Calibrator Strips, EliA IgA Curve Control Strips, EliA IgA Calibrator Well). 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 Celikey IgG and EliA GliadinDP IgA and EliA GliadinDP IgG tests.

The provided document is a 510(k) Premarket Notification from the FDA, detailing the substantial equivalence determination for the Phadia AB EliA Immunoassays (Celikey IgG, GliadinDP IgA, GliadinDP IgG) for use on the Phadia 2500/5000 instrument. The document primarily focuses on demonstrating that the performance of these assays on the new instrument platform is substantially equivalent to their performance on a previously cleared instrument (Phadia 250).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a single table outlining "acceptance criteria" alongside "reported device performance" for the overall substantial equivalence determination. Instead, it details performance characteristics for various analytical aspects, and the acceptance criteria are implied by the ranges and thresholds specified for these studies. The primary "acceptance criteria" for the overall submission appear to be demonstrating equivalence to the predicate device and meeting specific statistical thresholds for precision and linearity.

However, based on the sections "M. Performance Characteristics (if/when applicable)" and "2. Comparison studies: - Instrument comparison C.", we can construct a table for the analytical performance and comparative study results:

Table: Acceptance Criteria (Implied) and Reported Device Performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Test Set: The study used "a total of 21 runs (3 instruments x 7 runs)". Each sample was tested in "four replicates/run giving in total 84 replicates per sample." The number of distinct samples for precision is not explicitly stated, but multiple samples covering various concentrations are typically used (e.g., 5 samples in the EliA Celikey IgG table).
• Linearity Test Set: "Four patient serum samples (five for Celikey IgG)" were diluted and tested.
• Detection Limit Test Set: "One blank sample and three low level samples were measured in thirty-three and eleven replicates, respectively, in each of two runs." For Celikey IgG LoD, "6 low level samples and a total of 132 determinations" were used. For LoQ, "66 determinations of 3 low level samples."
• Method Comparison Test Set: "More than 100 samples (≥20% of the samples within ±25% of the medical decision point)" were run for each of the three EliA tests.
• Expected Values/Reference Range: 400 "apparently healthy subjects ... from a Caucasian population obtained from a blood bank."

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It is a 510(k) submission for a device, and the focus is on analytical performance and comparison to a predicate device, not primary clinical trial data of patient outcomes. The "Expected Values/Reference Range" suggests the use of existing blood bank samples, which typically implies retrospective use of collected samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device and study. The EliA Immunoassays measure specific antibodies (tTG IgG, Gliadin IgA, Gliadin IgG) in patient samples. The "ground truth" for the analytical studies (precision, linearity, detection limits, method comparison) is based on the quantitative concentration of these analytes as measured by the predicate device or a reference method, rather than subjective expert interpretation (like in imaging studies). For the reference range, the "ground truth" is simply the measured values in a defined healthy population.

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

This information is not applicable. Adjudication methods (like 2+1 or 3+1 for resolving discrepancies) are typically used in clinical studies where expert readers independently interpret data (e.g., medical images) and their interpretations need to be reconciled to establish a "ground truth" or reference standard. This document describes analytical and comparative studies for an in vitro diagnostic immunoassay, where quantitative measurements are the primary data.

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 information is not applicable. MRMC studies are primarily relevant for AI-powered diagnostic devices, particularly in medical imaging, where multiple human readers interpret cases, and the AI's impact on their diagnostic performance is assessed. This document pertains to an in vitro diagnostic immunoassay, not an AI-assisted diagnostic tool that aids human "readers."

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

Yes, this can be considered a standalone performance evaluation in the context of an immunoassay. The device (EliA Immunoassays on Phadia 2500/5000) operates as an automated system to semi-quantitatively measure antibody levels. The analytical performance studies (precision, linearity, LoD/LoQ) and the instrument comparison are essentially the "standalone" performance of the assay on the new platform. It's not an "algorithm only" in the sense of a software-only device, but the analytical steps are automated, and the reported values are direct outputs of the system. Human intervention relates to sample loading and equipment maintenance, not interpretation of raw data for diagnosis.

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

The "ground truth" for the performance studies described is primarily:

• Quantitative Analytical Values: For precision, linearity, LoD/LoQ, the ground truth is derived from the inherent nature of the samples at known or measured concentrations, often established by reference methods or highly characterized materials.
• Predicate Device Measurements: For the "Instrument Comparison," the results obtained from the previously cleared Phadia 250 instrument serve as the reference or "ground truth" against which the new Phadia 2500/5000 is compared to demonstrate substantial equivalence.
• Clinically Defined Healthy Population: For "Expected Values/Reference Range," the ground truth is simply the distribution of the analyte in a healthy population.

It's important to note that this 510(k) is for "adding previously cleared assays on a new instrument platform." This means the clinical utility and diagnostic performance (e.g., clinical sensitivity/specificity for celiac disease) of the assays themselves were already established and reviewed in the original 510(k) clearances (K062583 and K093459). The current submission leverages that prior clinical validation by demonstrating that the new instrument maintains equivalent analytical performance. Thus, the "clinical ground truth" for celiac disease diagnosis (e.g., biopsy confirmation, clinical outcomes) was established in those prior studies, not detailed here. The current submission's focus is on bridging the analytical performance to the new instrument.

8. The sample size for the training set

This document describes a 510(k) submission for an IVD immunoassay, not a machine learning or AI model. Therefore, there is no "training set" in the context of artificial intelligence/machine learning. The assays are based on established biochemical principles (antigen-antibody reactions, fluorescence detection), not on training data to learn patterns or parameters.

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

As there is no "training set" for an AI/ML model, this question is not applicable. The methods for establishing the performance characteristics are described in point 7 above.

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