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The FIDIS™ CELIAC kits are quantitative homogeneous fluorescent-based microparticles immunoassays using flow cytometry readings. They are designed for the simultaneous detection of human isotype IgA and/or IgG autoantibodies directed against Gliadin and tissue Transglutaminase Enzyme.

The presence of tissue Transglutaminase and Gliadin autoantibodies can be used to aid in the diagnosis of Celiac disease.

The FIDIS™ CELLAC kit is a semi-quantitative homogencous fluorescent-hased microparticles immunoassay using flow cytometry readings. It is designed for the simultancous detection of human isotype IgA or IgG antibodies directed against Gliadin and tissue Transglutaminase Enzyme.

Clinical utility:

The presence of these antibodies can be used in conjunction with clinical findings to aid in diagnosis of Celiac disease. The FIDIS™ CELIAC kit is to be used in serum only

The FIDISTM CELIAC Kits are to be used on FIDISTM Analyzer, software and washer.

The assay kits consist of:

• a mixture of color-coded microspheres respectively sensitized by Gliadin (Glia) or tissue transglutaminase (tTG),

• a ready to use phycoerythrin conjugated anti-human IgA or phycoerythrin conjugated anti-human IgG.

• a ready to use calibrator IgA or calibrator IgG,

• a positive control IgA or positive control IgG to be diluted,

• a negative control to be diluted.

• a 10X concentrated PBS-Tween.

Rk: Calibrators, positive and negative controls are diluted human sera.

The FIDIS™ System is a fully integrated and automated system for immunodiagnostic testing.

FIDIS™ System comprised of FIDIS flow cytometer, XYP platform for automatic sampling into the analyser, the analyzer itself, a SD pump, some assay products and a software MLX-BOOSTER.

The FIDIS™ CELIAC kits resemble traditional EIA, but allow simultaneous detection and identification of several antibodies in a single well.

The serum sample is combined with a mix of microspheres individually coated with gliadin or tTG and form an antigen / antibody complex.

After washing, this complex is incubated with phycoerythrin labeled anti-human IgG or IgA. If autoantibodies are present in the sample, the final sandwich complex antigen / human antibody / anti-human antibody will form.

Reactions are directly analysed by the cvtometer and calculated in biological units using specific data software (MLX-BOOSTER).

The FIDIS™ Instrument is able to distinct the specific color-coded of each microsphere types and it could associated the microsphere type with the individual tested antigen.

The FIDIS™ Instrument could quantify the fluorescence of the antibody captured by each microsphere. Measurement of the fluorescent signal from the final reaction complex allows the quantification of the presence or absence of autoantibodies.

It's a simple (just two steps), quick (2 x 30 minutes for the two incubations) and multiple parameter test.

This document is a 510(k) Premarket Notification Summary for the FIDIS™ CELIAC kits. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving device performance in the way you've outlined for diagnostic AI/medical device studies.

Specifically, the document does not provide:

• A table of acceptance criteria with specific thresholds for performance metrics (e.g., sensitivity, specificity, accuracy).
• Reported device performance metrics against those specific acceptance criteria.
• Sample sizes used for a "test set" in the context of an independent validation, nor data provenance details like country of origin or whether data was retrospective/prospective for such a validation.
• Information about the number or qualifications of experts used to establish ground truth for a test set.
• Adjudication methods.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study, nor effect sizes of human readers with/without AI assistance.
• Standalone algorithm performance data.
• Details about the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for a specific test set.
• Sample size for a "training set" (as this is a diagnostic assay, not an AI algorithm) or how ground truth was established for it.

Instead, the document focuses on:

• Identification of the device: FIDIS™ CELIAC kits (IgA and IgG assays for gliadin and tTG).
• Intended Use: Aid in the diagnosis of Celiac disease by detecting IgA and/or IgG autoantibodies.
• Description of the device: A quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry.
• Predicate Devices: Lists several INOVA Diagnostics and Sweden Diagnostics kits.
• Summary of technological characteristics: Compares the FIDIS™ System to traditional EIAs, highlighting its ability for simultaneous multi-antibody detection and automated analysis.
• Testing: Mentions "a data set including: results obtained within a comparison study analysing positive, equivocal and negative sera; results obtained for samples from apparently healthy subject (normal population); results obtained for samples from samples with potential biological cross reactivity." This is a high-level description and lacks the specific quantitative performance data you're requesting.
• Conclusion: States that the new devices are "substantially equivalent to the predicate devices."

Therefore, based on the provided document, I cannot fulfill your request for a detailed table of acceptance criteria, reported performance against those criteria, or the specific study details (sample sizes, expert qualifications, ground truth methods, MRMC studies, standalone performance) typically associated with modern device validation studies, especially those involving AI or detailed clinical outcomes.

The document is a regulatory submission demonstrating substantial equivalence to existing diagnostic devices, not a detailed performance study with explicit acceptance criteria and corresponding results as might be found in a peer-reviewed publication or a more comprehensive technical report.

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The FIDIS™ Celiac kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings.

Celian IgA is designed for the simultaneous detection of human IgA isotype antibodies directed against Gliadin and Tissue Transglutaminase Enzyme.

Celiac IgG is designed for the detection of human IgG isotype antibodies directed against Gliadin.

The presence of these antibodies can be used in conjunction with clinical findings to aid in the diagnosis of Celiac disease.

The FIDIS™ Celiac kit is to be used on serum only.

FIDIS™ Celiac kits are to be used on FIDIS™ Analyser, software and washer.

For in vitro diagnostic use.

FIDISTM Celiac is based on Luminex 100TM Technology.

The Luminex technology (LabMAP™, Laboratory Multi-Analyte Profiling) is a unique system I ho handler tooning of microspheres, flow cytometer, high speed digital signal processor and an X-Y platform for reading 96-well microtiter plates facilitating automated sample acquisition. This combination allows the diagnostic of multiple biological analytes simultaneously.

This multiplexed microsphere-based flow cytometric assay involves fluorescent polystyrene microspheres. The antigen-coated microspheres are mixed and incubated with sample containing the analytes to be detected. A fluorochrome-conjugated detection molecule is subsequently incubated for analyte quantification.

The flow cytometer is equipped with a powerful digital signal processor and two lasers. A red "classification" laser, excites fluorescent molecules intrinsic embedded to the microspheres and a green "reporter" laser, excites the extrinsic fluochrome (Phycoerythrin or Alexa-532nm) bound to the microsphere surface.

During the sample reading, the flow cytometer analyzes individual microsphere, first, by size, and, second, by fluorescence emissions. Digital signal processors and computers algorithms provide simultaneous real-time acquisition of classification and reporter fluorescence signals output from the microspheres. Upon excitation, the emitted fluorescent signal from the microspheres travels through the optics paths to the individual detectors. According to the fluorescence ratio detected by the red laser, each microsphere is classified into on the basis of its unique fluorescence intensity which allows identifying which analyte is being tested. At the same time, the green "reporter" laser beam excites the external second molecule fluorescence to quantify the specific reaction related to each analyte.

Each antigen required for the assay is covalently coupled to an individual set of microspheres through its surface functional groups. The different antigen coupled microspheres are mixed together to constitute the final microspheres reagent. Celiac IgA allows the detection of antigliadin and anti-tissue transglutaminase IgA isotype antibodies. Celiac IgG allows the detection of anti-gliadin IgG isotype antibodies.

The test is performed in a 96 wells blank microplate including a filtering membrane at the bottom of the wells. In the first step, the sample is distributed in duplicate for the 2 isotypes (IgA and IgG) selected in each well containing respectively the Celiac A microspheres mixture, for the IgA isotype and the Celiac G microspheres mixture for the IgG isotype. After incubation, a wash step through a filtration process will eliminate the unbound antibodies. A specific conjugate consisting of either anti-human IgA or IgG antibodies coupled to phycoerythrin, is added to the mixture. It will bind to the previously captured antibodies.

The reaction is then directly measured by the flow cytometer, which categorizes each microspheres set according to its fluorescence colour the microspheres while simultaneously measuring the average fluorescence emitted by the conjugate. A calibration system allows expressing by interpolation the titer of the sample for each antibody specificity using a specific software developed by bmd.

The mixed and antigen-coated microspheres are first incubated with the sample to be analyzed. After the washing step, a phycoerythrin (PE)-labelled secondary anti-human IgA conjugate is added for antibodies quantifications at the surface of each microsphere set.

The microspheres are classified on the basis of their unique fluorescence intensity ratio that allows the identity of analyte being tested. Each dot in a white plot corresponds to an individual microsphere.

This document describes the FIDIS™ Celiac kit, a semi-quantitative fluorescent-based immunoassay for the detection of IgA and IgG antibodies related to Celiac disease. The information provided is for regulatory clearance (510(k) K041002) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for performance in discrete clinical endpoints.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of specific performance targets (e.g., "sensitivity must be >X%"). Instead, the study's goal was to demonstrate "substantial equivalence" to existing predicate ELISA devices. This means the performance of the FIDIS™ Celiac kit should be comparable to or better than the predicate devices. The "reported device performance" in this context is the agreement with these predicate devices.

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

• Sample Size for Comparative Study: 182 samples.
  • 66 samples related to Celiac Disease
  • 55 samples from blood donors
  • 61 samples with potential biological interferences (cryoglobulinemia, hypergammaglobulinemia, IgG and IgM monoclonal immunoglobulins, complement, rheumatoid factor, hemolyzed sera, plasma, and lipemic serum).
• Data Provenance: The document does not explicitly state the country of origin for the samples directly. It is implied that the studies were conducted by Biomedical Diagnostics S.A. in France. It is a retrospective study since it uses "samples previously tested" for the comparative study. The context of a 510(k) submission generally involves retrospective analysis of collected samples.

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

• This information is not provided in the document. For a diagnostic kit like this, the "ground truth" for the test set is established by the results of the predicate devices, which are already accepted diagnostic methods for Celiac disease. There isn't an "expert" panel assessing each case independently outside of the predicate device's established performance.

4. Adjudication Method for the Test Set

• This information is not applicable in the traditional sense of human reader adjudication for image analysis. The comparison is made against the results of the predicate ELISA tests. For borderline results from the FIDIS™ Celiac assay, the document states: "For purposes of calculation, these results were considered as negative." This is a specific rule applied for calculating agreement percentages.

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. This is a standalone diagnostic kit for in vitro detection of antibodies, not an AI-assisted diagnostic tool that would involve human readers or interpretation of complex medical images. Therefore, an MRMC comparative effectiveness study involving human readers is not relevant in this context.

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

• Yes, this is a standalone device. The FIDIS™ Celiac kit operates essentially as an "algorithm only" (though it's a biochemical assay, not a software algorithm in the AI sense) because its output is a quantitative measure (U/mL) for each antibody, which is then categorized as negative, borderline, or positive based on predefined cut-offs. The performance data presented (precision, linearity, comparison with predicate) are for the device operating independently. There is no "human-in-the-loop" interaction for interpreting the direct assay results; human involvement is in performing the test and interpreting the final diagnosis in conjunction with clinical findings.

7. The Type of Ground Truth Used

• The ground truth for the comparison study was the results obtained from the predicate devices:
  • BINDAZYME™ ELISA Human Anti Gliadin IgG Kit
  • BINDAZYME™ ELISA Human Anti Gliadin IgA Kit
  • BINDAZYME™ ELISA Human Anti Tissue Transglutaminase IgA Kit

8. The Sample Size for the Training Set

• The document does not explicitly describe a separate "training set" for the FIDIS™ Celiac device in the context of machine learning or AI. For in vitro diagnostic assays, the development and optimization of the assay (e.g., determining optimal reagent concentrations, incubation times, and cut-off values) typically involve a development phase using various characterized samples. The document mentions "The FIDIS™ Celiac assay has been optimised to express the average binding capacity at the current dilution (1/200)" and "Threshold values and normal range values were estimated from the 2 populations previously used for the comparative study: 55 samples from blood donors and 61 samples selected from their potential biological interferences." These 116 samples (blood donors and interference samples) were used to establish the negative threshold for the device. However, this is distinct from a "training set" in an ML context.

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

• Since a "training set" in the machine learning sense is not explicitly described, the method for establishing its ground truth is also not detailed.
• For the establishment of cut-off values, which is somewhat analogous to calibration or defining decision boundaries, the ground truth was implied by the classification of the 116 samples (55 blood donors and 61 interference samples) as predominantly negative, allowing for the determination of percentile-based thresholds. For example, the negative threshold (

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