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The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SS-A (60kDa and TRIM 21 (SS-A 52kDa)), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere (CENP-B).

(*Antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl-70, Jo-1, ribosomes and CENP-B can be reported using this assay).

Clinical utility:
The results of the FIDIS™ CONNECTIVE 10 are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis and CREST syndrome).

FIDIS™ CONNECTIVE 10 kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER™ Software.

FIDIS™ CONNECTIVE 10 kit may be used with the CARIS™ system (diluting and dispensing device).

This kit is for In vitro diagnostic use.

FIDIS™ CONNECTIVE 10 kit is a multiplex flow immunoassay, which allows simultaneous identification and detection of several antibodies.

FIDIS™ CONNECTIVE 10 is based on the use of distinct uniform size color-coded microsphere sets and a benchtop flow cytometer interfaced to digital signal processing hardware and software. A red diode laser beam in the flow cytometer recognizes each set of microspheres on the basis of its unique fluorescence intensity (red and infrared) thus identifying which parameter is being tested. At the same time, a green laser beam illuminates the external second molecule fluorescence to quantify the reaction related to the specific antigen.

Ten different fluorescently "colored" sets of microspheres are coated with antigens associated with various connective diseases (dsDNA, SS-A (60kDA and TRIM 21 (SS-A 52kDa}}, SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere). An additional microsphere (Internal Bead standard) set is coated with anti-IgG to ensure that false negative results due to operational error are detected.

The eleven different sets of microspheres are mixed together. The mixture is lyophilized and constitutes the final microspheres reagent.

The test is performed using a 96 wells microplate with a filtering membrane at the bottom of the wells.

In the first step, the sample is distributed in each well containing the reconstituted microspheres mixture, allowing any anti-dsDNA; anti-SS-A (60kDa and TRIM 21 (SS-A 52kDa)), anti-SS-B, anti-Sm, anti-Sm/RNP, anti-Scl-70, anti-Io-1, anti-ribosomes and anti-centromere antibodies present to bind to the immobilized antigens on the microspheres, as well as free IgG to bind to the anti-IgG microsphere.

After incubation, a wash step using a filtration process removes the unbound antibodies.

A phycoerythrin anti-human IgG conjugate is then added that binds to the previously bound antibodies.

A final wash step stops the reaction and eliminates the unbound conjugate.

The reaction is then measured directly by the flow cytometer, which distinguishes each set of microspheres by its fluorescence color while simultaneously measuring the average fluorescence emitted by the conjugate.

A calibration system allows the determination of the titer (AU/mL) of each sample by interpolation for each antigenic specificity.

Here's a breakdown of the acceptance criteria and the study details for the FIDIS™ CONNECTIVE 10 Assay kit:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified FIDIS™ CONNECTIVE 10 assay were based on demonstrating substantial equivalence to the predicate device (K071210). This was primarily assessed through agreement studies, ensuring high Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Overall Agreement.

The document reports two main studies:

• Comparison Study with Predicate - Using Manual Pipetting: This compares the modified device against the predicate device.
• Performance Data for Modified FIDIS™ CONNECTIVE 10 with CARIS™ (diluting/dispensing Device): This compares the modified device using automated (CARIS™) versus manual assay preparation steps.

Below is a summary of the reported performance for each antigenic specificity from the "Comparison study with predicate - Using Manual Pipetting" (equivocal results considered negative, as presented in the first set of measures, which typically represents a more conservative approach). Similar performance was observed when equivocal results were considered positive, and across the CARIS™ system comparisons.

Note: The document implicitly defines "high agreement" as meeting the criteria for substantial equivalence to the predicate device. Specific numerical thresholds for agreement were not explicitly stated as acceptance criteria in the document, but the consistent high percentages demonstrate that the device met the expectation for equivalence.

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

• Sample Size for Test Set: 80 samples for each comparison study (77 positive for one or more parameters, 3 negative samples).
• Data Provenance: The document does not explicitly state the country of origin for the samples used in the comparison studies. It also does not specify if the data was retrospective or prospective, though it appears to be retrospective as the samples were "characterized with the predicate test."

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

The document does not mention the use of experts to establish ground truth for the test set. The comparison studies used the results from the predicate device (FIDIS™ CONNECTIVE 10 K071210) as the comparator (reference standard) for calculating agreement.

4. Adjudication Method for the Test Set

There was no human adjudication for the test set. Equivocal results were handled by being considered either negative or positive for calculation purposes, and both scenarios were presented.

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

Not applicable. This is an in vitro diagnostic (IVD) assay kit for autoantibody detection, not an AI-assisted diagnostic imaging device that involves human readers.

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

This is an in vitro diagnostic immunoassay Kit. The performance described is for the device operating in a standalone manner, providing semi-quantitative results for autoantibodies in serum. There isn't a "human-in-the-loop" component in the interpretation of the assay's direct numerical output, but clinical interpretation of the results in conjunction with other findings is intended. The comparison studies effectively represent standalone performance against a predicate device.

7. The Type of Ground Truth Used

The ground truth for the comparison studies was based on the results obtained from the legally marketed predicate device: FIDIS™ CONNECTIVE 10 (K071210). This implicitly means the predicate device's results were considered the "truth" for the purpose of demonstrating substantial equivalence.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of an algorithm or AI. For the precision studies, various samples were used to calculate within-run and between-run variability. For the comparison studies, 80 samples were used as the test set to compare the modified device against the predicate. This is a traditional IVD device, not an AI/ML device with distinct training and test sets in the software sense.

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

Not applicable, as there is no explicitly defined "training set" with a separate ground truth establishment process in the context of this IVD device submission. The performance assessment relies on comparison to a cleared predicate device and internal precision studies.

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The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticle immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of anti-neutrophil cytoplasmic antibodies (ANCA) directed against Myeloperoxidase (MPO), Serine Proteinase 3 (PR3) and antibodies directed against glomerular basement membrane (GBM) in human serum samples.

The results of the FIDIS™ VASCULITIS* test are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of various primary systemic small blood vessel vasculitides and glomerular basement membrane disease.

Clinical utility:
The detection of ANCA is associated with primary systemic small blood vessel vasculitides: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopathic crescentic glomerulonephritis; and the detection of anti-GBM antibodies is associated with Goodpasture's syndrome.

FIDIS™ VASCULITIS* kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER Software.

FIDIS™ VASCULITIS* kit may be used with the CARIS™ system (diluting and dispensing device).

This kit is for In vitro diagnostic use.

• Detection of the serologic markers for primary systemic small blood vessel vasculitides (ANCA) and for Goodpasture syndrome (GBM).

FIDIS™ VASCULITIS* kit is a multiplex flow immunoassay, which allows simultaneous identification and detection of several antibodies.

FIDIS™ VASCULITIS* is based on the use of distinct uniform size color-coded microsphere sets and a benchtop flow cytometer interfaced to digital signal processing hardware and software. A red diode laser beam in the flow cytometer recognizes each set of microspheres on the basis of its unique fluorescence intensity (red and infrared) thus identifying which parameter is being tested. At the same time, a green laser beam illuminates the external second molecule fluorescence to quantify the reaction related to the specific antigen.

Three different fluorescently "colored" sets of microspheres are coated with antigens associated with various primary systemic small blood vessel vasculitides and glomerular basement membrane disease (MPO, PR3 and GBM). An additional microsphere (Internal Bead standard) set is coated with anti-IgG to ensure that false negative results due to operational error are detected.

The four different sets of microspheres are mixed together. The mixture is lyophilized and constitutes the final microspheres reagent.

The test is performed using a 96 wells microplate with a filtering membrane at the bottom of the wells.

In the first step, the sample is distributed in each well containing the reconstituted microspheres mixture, allowing any anti-MPO, anti-PR3 or anti-GBM antibodies present to bind to the immobilized antigens on the microspheres, as well as free IgG to bind to the anti-IgG microsphere.

After incubation, a wash step using a filtration process removes the unbound antibodies.

A phycoerythrin anti-human IgG conjugate is then added that binds to the previously bound antibodies.

A final wash step stops the reaction and eliminates the unbound conjugate.

The reaction is then measured directly by the flow cytometer, which distinguishes each set of microspheres by its fluorescence color while simultaneously measuring the average fluorescence emitted by the conjugate.

A calibration system allows the determination of the titer (AU/mL) of each sample by interpolation for each antigenic specificity.

Here's a breakdown of the acceptance criteria and the study details for the FIDIS™ VASCULITIS Assay kit, based on the provided document:

Acceptance Criteria and Device Performance:

The acceptance criteria for the FIDIS™ VASCULITIS Assay kit are derived from demonstrating substantial equivalence to a predicate device (K070458 FIDIS™ VASCULITIS system) and demonstrating comparable performance between manual and automated assay preparation. The performance metrics are Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Overall Agreement (OA) for three specificities: MPO, PR3, and GBM. Precision (within-run and between-run %CV) was also assessed.

Table of Acceptance Criteria and Reported Device Performance:

Study Proving Acceptance Criteria:

The document describes two primary studies to demonstrate that the device meets acceptance criteria:

1. Comparison study with predicate - Using Manual Pipetting: This study aimed to show substantial equivalence of the modified FIDIS™ VASCULITIS kit to the legally marketed predicate device (K070458).
2. Comparison studies (manual versus automated assay preparation steps) with CARIS™: This study aimed to demonstrate that the use of the CARIS™ system for automated sample preparation provided comparable results to manual preparation with the modified FIDIS™ VASCULITIS kit.

Detailed Study Information:

1. Sample sized used for the test set and the data provenance:

• Comparison with predicate Study:
  • Test set sample size: 280 samples.
  • Data provenance: Not explicitly stated, but given that both the original and modified device are from "Biomedical Diagnostics S.A." in France, it is highly likely the data is from French or European sources. The study is retrospective as it compares the modified device against previously characterized samples with the predicate test.
• CARIS™ Comparison Study:
  • Test set sample size: 106 samples.
  • Data provenance: Not explicitly stated, but also likely from French or European sources. The study seems to be prospective or concurrent comparison of two methods on the same set of samples.

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

The document does not mention the use of experts or their qualifications for establishing ground truth. The "ground truth" for these studies is not clinical diagnosis by experts, but rather the results obtained from the predicate device (K070458 FIDIS™ VASCULITIS system) for the first study, and the modified FIDIS™ VASCULITIS with manual assay preparation for the second study. These methods are considered the reference for comparison.

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

Not applicable. There was no explicit adjudication described as the "ground truth" was established by the reference assays (predicate device or modified device with manual preparation). The document mentions how equivocal results were handled for calculation purposes (included with negative or positive results), but this is not an adjudication method for ground truth.

4. 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:

Not applicable. This device is an in vitro diagnostic (IVD) assay kit, not an AI-assisted diagnostic tool that involves human readers. The performance is based on agreement between two assay methods.

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

The device itself (FIDIS™ VASCULITIS Assay kit) is essentially a standalone algorithm/test in the context of generating a quantitative result (AU/mL). The "standalone" performance is assessed by its agreement with the predicate device and the manual method. There is no human-in-the-loop directly interpreting raw data beyond what is typical for laboratory technicians running an assay and interpreting its results. The comparison studies effectively represent "standalone" performance against a defined reference.

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

The "ground truth" in these studies is the results of a reference in-vitro diagnostic method.

• For the predicate comparison study, the ground truth was the results obtained from the predicate device (K070458 FIDIS™ VASCULITIS).
• For the CARIS™ comparison study, the ground truth was the results obtained from the modified FIDIS™ VASCULITIS with manual assay preparation.

7. The sample size for the training set:

Not applicable. This is an IVD assay kit, not an AI/machine learning model that typically requires a distinct training set. The performance is established through analytical validation studies (precision, method comparison).

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

Not applicable, as there is no training set in the AI/ML sense.

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The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticle immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of anti-neutrophil cytoplasmic antibodies (ANCA) directed against Myeloperoxidase (MPO), Serine Proteinase 3 (PR3) and antibodies directed against glomerular basement membrane (GBM) in human serum samples.

The results of the FIDIS™ VASCULITIS* test are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of various primary systemic small blood vessel vasculitides and glomerular basement membrane disease.

Clinical utility:

The detection of ANCA is associated with primary systemic small blood vessel vasculitides: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopathic crescentic glomerulonephritis; and the detection of anti-GBM antibodies is associated with Goodpasture's syndrome.

FIDIS™ VASCULITIS* kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER Software.

FIDIS™ VASCULITIS* kit may be used with the CARIS™ system (diluting and dispensing device).

This test is for In vitro diagnostic use.

• Detection of the serologic markers for primary systemic small blood vessel vasculitides (ANCA) and for Goodpasture syndrome (GBM).

The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticle immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of anti-neutrophil cytoplasmic antibodies (ANCA) directed against Myeloperoxidase (MPO), Serine Proteinase 3 (PR3) and antibodies directed against glomerular basement membrane (GBM) in human serum samples. The kit includes a 96 wells microplate, vials of color-coded microsphere beads coupled with MPO, PR3, and GBM, plus internal standard beads, sample dilution buffer, calibrator, positive control, negative control, anti-human IgG coupled to phycoerythrin, washing buffer, package insert, microplate assay configuration worksheet, and microplate sealing films. The test is run on the FIDIS™ Instrument and MLX-BOOSTER Software and may be used with the CARIS™ system (diluting and dispensing device).

Here's a summary of the acceptance criteria and study details for the FIDIS™ VASCULITIS assay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K053012 FIDIS™ VASCULITIS) and the equivalence of manual vs. automated assay preparation with the CARIS™ system. The "acceptance criteria" are therefore implicit in the comparison studies (e.g., high percentage agreement with the predicate device) and explicit in the precision studies.

Analytical Performance (Precision)

Comparison Study with Predicate Device (K053012 FIDIS™ VASCULITIS)

The acceptance criteria for these sections are implied to be high agreement percentages indicating substantial equivalence.

Performance Data for Modified FIDIS™ VASCULITIS with CARIS™ (Precision)

Comparison Studies (Manual vs. Automated Assay Preparation Steps with CARIS™)

The acceptance criteria for these sections are implied to be high agreement percentages indicating substantial equivalence.

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

• Comparison Study with Predicate Device:
  • Sample Size: 219 samples.
  • Data Provenance: Not explicitly stated, but samples were "characterized with the predicate test." The origin (e.g., country, retrospective/prospective) is not provided.
• Interfering Substances Study:
  • Sample Size: 27 samples.
  • Data Provenance: "obtained from a routine laboratory," suggesting retrospective clinical samples. Origin not specified.
• Threshold values study:
  • Sample Size: 37 samples from blood donors and 28 samples selected for potential biological interferences (total = 65 samples).
  • Data Provenance: Not explicitly stated, likely clinical samples. Origin not specified.
• CARIS™ Comparison Studies (Manual vs. Automated):
  • Sample Size: 117 samples.
  • Data Provenance: Not explicitly stated. The samples were "characterized with the modified FIDISTM VASCULITIS with manual assay preparation step." Origin not specified.

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

The document does not describe the use of human experts to establish ground truth for the test sets. For the comparison studies, the "ground truth" for the modified device was the results obtained from the predicate device (K053012 FIDIS™ VASCULITIS) or the manual preparation method for the CARIS™ comparison. The predicate device itself would have undergone its own validation studies to establish its accuracy. Similarly, for precision, the "ground truth" is the assay's own measurement, with reproducibility being the focus.

4. Adjudication Method for the Test Set

No adjudication method involving experts is described. In the comparison studies, equivocal results were consistently treated as negative for the purpose of calculating agreement percentages.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable as the device is an in vitro diagnostic (IVD) assay for detecting autoantibodies, not an AI-assisted diagnostic imaging or interpretation tool designed to improve human reader performance. The device provides quantitative results, and the studies assess the analytical performance and agreement with a predicate device or different preparation methods.

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

The device itself (FIDIS™ VASCULITIS kit and FIDIS™ Analyzer/MLX-BOOSTER software) is a standalone system in the sense that it performs the measurement and provides results without human interpretive input beyond following the assay protocol. The studies presented are essentially standalone performance studies demonstrating the analytical performance (precision, linearity, interference, stability) of the assay system itself, and its agreement with a previously cleared device. The CARIS™ system is an optional automated sample preparation component, and its impact on the assay's performance is also assessed in a standalone manner (automated vs. manual).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" used in these studies is primarily:

• Predicate Device Results: For the comparison study of the modified FIDIS™ VASCULITIS against its predicate (K053012), the results obtained from the predicate device served as the reference or "ground truth" for determining agreement.
• Manual Assay Preparation Results: For the comparison study involving the CARIS™ system, the results obtained using manual assay preparation steps served as the reference for determining the agreement of the automated method.
• Internal Assay Measurements: For analytical performance studies like precision, linearity, interfering substances, and stability, the "ground truth" is typically established by the inherent physical/chemical properties of the samples and the expected performance characteristics of the assay itself, often with reference to spiked samples or known concentrations.

There is no mention of expert consensus, pathology, or outcomes data being used directly to establish ground truth for these performance evaluations.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of machine learning or AI models. This device is an IVD assay, not an AI algorithm that undergoes a training phase. The samples used for establishing analytical performance parameters (precision, linearity, interference, stability) and for comparison against the predicate are test samples used for validation, not for training a model.

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

As noted above, the concept of a "training set" and its associated ground truth establishment is not applicable to this in vitro diagnostic assay. The studies focus on validating the performance of a wet-lab assay and associated instrumentation.

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The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescentbased microparticles immunoasay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDa and 52 kDa), SSB, Sm, Sm/RNP, Scl70, Jo1, ribosome and centromere. (*Antibodies to dsDNA, Sm, Sm/RNP, SSA, SSB, Scl-70, Jo-1, ribosome and centromere can be reported using this assay).

Clinical utility: The results of the FIDIS™ CONNECTIVE 10* are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis and CREST syndrome).

FIDIS™ CONNECTIVE 10* kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER™ Software.

FIDIS™ CONNECTIVE 10* kit may be used with the CARIS™ system (diluting and dispensing device).

This test is for in vitro diagnostic use.

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescentbased microparticles immunoasay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDa and 52 kDa), SSB, Sm, Sm/RNP, Scl70, Jo1, ribosome and centromere. The kit includes a 96 wells microplate, vials of color-coded microsphere beads coupled with antigens and internal standard beads, sample dilution buffer, calibrator, positive control, negative control, anti-human IgG coupled to phycoerythrin, washing buffer, reconstitution buffer, package insert, microplate assay configuration worksheet, and microplate sealing films. The test is run on the FIDIS™ Instrument and MLX-BOOSTER™ Software, and may be used with the CARIS™ system (diluting and dispensing device).

The Biomedical Diagnostics S.A. (bmd) FIDIS™ CONNECTIVE 10* assay is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay that uses flow cytometry to detect 10 autoantibody specificities. The device's performance was established through analytical performance studies and comparison studies against a predicate device (K053653 FIDIS™ CONNECTIVE 10* system) and manual assay preparation steps.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria mainly for precision and outlines performance through agreement studies.

Precision Acceptance Criteria and Reported Performance

Comparison Study with Predicate Device (K053653 FIDIS™ CONNECTIVE 10)*

The acceptance criteria for the comparison study are implicitly that the agreement (Positive Percent Agreement, Negative Percent Agreement, and Overall Agreement) should demonstrate substantial equivalence to the predicate device. While specific percentage targets are not explicitly stated as "acceptance criteria" in the table format, the observed agreement percentages with 95% LCLs are reported and deemed sufficient for substantial equivalence.

Comparison Study: Manual vs. Automated (CARIS™) Assay Preparation

Similar to the predicate comparison, the acceptance criteria here are also implicit that agreement between manual and automated methods shows substantial equivalence.

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

• Precision Study Test Set:

  • Within-run: 6 samples (5 for Jo1) tested 10 times in the same run.
  • Between-run: 6 samples (5 for Jo1) tested 3 times per run, across 6 runs.
  • The document does not specify the country of origin or whether the data was retrospective or prospective for the precision study samples.

• Comparison Study with Predicate Device Test Set:

  • Sample Size: 264 samples.
  • Composition: 194 samples positive for one or more parameters, and 70 negative samples (including some with potential biological interferences).
  • Data Provenance: The document states "obtained from routine laboratory" for interfering substances study (part of analytical performance) and implies a similar source for the comparison study, but the specific country of origin or retrospective/prospective nature isn't explicitly stated. However, given the manufacturer is based in France, it's plausible the samples originated from Europe.

• Comparison Study with Automated (CARIS™) system Test Set:

  • Sample Size: 264 samples.
  • Composition: 194 samples positive for one or more parameters, and 70 negative samples (including some with potential biological interferences).
  • Data Provenance: Same as above.

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

The document does not mention the use of human experts to establish ground truth for the test sets. Instead, the "ground truth" for the comparison studies is defined by the results obtained from the predicate device (K053653 FIDIS™ CONNECTIVE 10 system)* or the manual assay preparation steps of the modified device. For the analytical performance (e.g., precision, interfering substances), the "truth" is based on the inherent characteristics of the spiked or characterized samples.

4. Adjudication Method for the Test Set

This type of in-vitro diagnostic device study typically doesn't involve human adjudication in the traditional sense (e.g., for imaging studies). For the comparison studies, discrepancies were handled as follows:

• "All equivocal samples with predicate and modified CONNECTIVE 10* assays are considered negative for the comparison and the evaluation studies."
• For individual specificities, the number of equivocal results is noted (e.g., "There were 3 equivocal results with the assay. For purposes of calculation, these results were considered as negative."). This method effectively converts equivocal results into negative results for agreement calculations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test system, not an AI-assisted diagnostic tool that human readers would interact with in the context of interpretation. The comparison is between different versions or methods of the assay itself, or against a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a standalone in-vitro diagnostic test system. The performance studies evaluate the device's analytical characteristics and its agreement with a predicate device or different operational modes (manual vs. automated sample preparation). There isn't an "algorithm" in the sense of a standalone AI intended to perform diagnostic interpretation; rather, it's a test system that provides semi-quantitative results. The system operates without human interpretive intervention beyond running the assay and reading the numerical output.

7. The Type of Ground Truth Used

The ground truth for the comparison studies was:

• The results generated by the predicate device (K053653 FIDIS™ CONNECTIVE 10 system)* when comparing the modified device to the predicate.
• The results generated by the manual assay preparation steps when comparing the automated (CARIS™) assay preparation to manual preparation.

For the analytical precision and interfering substances studies, the ground truth was based on the known characteristics of the samples (e.g., characterized positive/negative samples, spiked samples, or samples with known interferences). There is no mention of pathology, expert consensus, or outcomes data being directly used as ground truth for these performance evaluations.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of machine learning or algorithm development. The studies performed are for performance evaluation and comparison studies for a medical device. Therefore, no training set size is reported in the provided text.

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

As no training set is indicated, this question is not applicable. The device's operational characteristics and comparisons are the focus of performance evaluation, not machine learning model training.

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The FIDIS™ THYRO kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against thyroperoxydase (TPO) and thyroglobuline (TG).

Clinical utility:

The test system is used on serum samples as an aid in the diagnostic of auto-immune thyroid pathologies (Graves' disease and Hashimoto thryroiditis), in conjunction with clinical findings and other laboratory tests.

The FIDIS™ THYRO kit is to be used on FIDIS™ Analyser, software and washer.

The assay kits consist of:

• a vial of color-coded microsphercs coupled with thyroperoxydase (TPO) or thyroglobulin (TG)

• a ready to use anti-human IgG coupled to phycocrythrin,

• a ready to use calibrator titered for the specificity,

• a 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 FIDIS™ kits and a software MLX-BOOSTER.

The FIDIS™ THYRO kit resembles traditional EIA and allows the detection and identification of antibodies against thyroperoxydase (TPO) and thyroglobuline (TG).

• 1. Diluted patient sera and microsphere suspension are thoroughly mixed in the 96 well microtiter plate. TPO or TG specific antibodies in the patient sera, if present, bind to the immobilised antigen on the beads. Any unbound material is removed by performing a wash step.
• 2. Phycoerythrin-conjugated goat anti-human IgG is added to the plate and a further incubation performed. The conjugated anti-human IgG binds to the TPO or TG specific antibodies immobilised on the microsphere surface to form an antigen/antibody complex.
• 3. The bead suspension is then analysed by the FIDIS™ Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER).
     The FIDIS™ Instrument is able to distinguish the specific color-coded of the microsphere 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.

The provided document is a 510(k) Premarket Notification for the FIDIS™ THYRO device. It details the device's intended use, technological characteristics, and comparison to predicate devices, focusing on establishing substantial equivalence. However, it does not contain the specific acceptance criteria or the detailed results of a study designed to prove the device meets those criteria, nor does it provide information on sample sizes, ground truth establishment, or expert involvement in the manner requested.

The document states:

• "The comparability of predicate devices and new devices is supported by 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"
• "In conclusion, all available data support that the new devices, FIDIS™ THYRO kit is substantially equivalent to the predicate devices."

This indicates that studies were performed, but the specifics of those studies (e.g., acceptance criteria, detailed performance metrics, sample sizes, ground truth methodology) are not included in this summary.

Therefore, I cannot populate the requested table or provide the detailed study information based solely on the provided text. The document serves as a high-level summary for regulatory submission rather than a detailed study report.

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The FIDIS™ dsDNA kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against double stranded DNA (dsDNA).

Clincal unlity:

The test system is used on serum samples as an aid in the diagnostic of systemic lupus erythematosus (SLE), in conjunction with clinical findings and other laboratory tests.

The FIDIS™ dsDNA kit is to be used on FIDIS™ Analyser, software and washer.

The assay kits consist of

• a vial of color-coded microspheres coupled with dsDNA
• a ready to use anti-human IgG coupled to phycoerythrin.
• a ready to use calibrator littered for the specificity.
• a positive control lgG 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 invmunodiagnostic lesting

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

The IIIDIS™ dsDNA kit resembles traditional EIA and allows the detection and identification of antibodies against dsDNA

• i . Diluted patient sera and microsphere suspension are thoroughly mixed in the 96 well microtiter plate. dsDNA specific antibodies in the patient sera, if present, bind to the immobilised untigen on the beads. Any unbound material is removed by performing a wash step.

• 2. Phycoerythrin-conjugated goal anti-human IgG is added to the plate and a further antibedies, immentiliand antibodies immobilised on the microsphere surface to form an antigen/antibody complex
• 3. The bead suspension is then analysed by the FIDISTM Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER)
     The FIDIS™ Instrument is able to distinct the specific code-colored of the microsphere and it could associated the microsphere type with the individual tested antigen. The FIDIS™ Instrument could quantify the finorescente of the antibody captured by
     each microsphere. Measurent of the finorescence of the antibody captured by
     allows the overl allows the quantification of the presence or absence of autoantibudies m

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

The provided document is a 510(k) summary for the FIDIS™ dsDNA kit, a semi-quantitative immunoassay for detecting antibodies directed against double-stranded DNA, used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). This summary focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for a novel device. Therefore, much of the requested information, particularly regarding specific numerical acceptance criteria, detailed study results against those criteria, and information about expert consensus, is not explicitly present in the document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a traditional sense. Instead, it relies on demonstrating substantial equivalence to a predicate device (Varelisa dsDNA antibodies by Sweden Diagnostics, GMH). The "performance" is reported in terms of comparability with this predicate device.

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

• Test Set Sample Size: The document mentions "results obtained within a comparison study analysing positive, equivocal and negative sera," and "results obtained for samples from apparently healthy subject (normal population)," and "samples with potential hiological cross reactivity." However, the exact number of samples used in these studies is not specified.
• Data Provenance: Not explicitly stated. The document indicates the device manufacturer (Biomedical Diagnostics S.A.) is located in France, suggesting the studies could have been conducted there or in other European countries. It is not specified if the data is retrospective or 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 document. The method for establishing "ground truth" (e.g., expert diagnosis, clinical outcomes) is also not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A MRMC comparative effectiveness study is not mentioned in the document. The focus is on the device's performance as an immunoassay, not on human reader improvement with or without AI assistance.

6. Standalone Performance Study

The FIDIS™ dsDNA kit itself is the "algorithm" in this context (an immunoassay performed by an automated system). The comparability study described is essentially a standalone performance assessment against a predicate.

• "results obtained within a comparison study analysing positive, equivocal and negative scra ."
• "results obtained for samples from apparently healthy subject (normal population)"
• "results obtained for samples from samples with potential hiological cross reactivity"
  While not using the term "standalone study," the various testing methods described are designed to evaluate the device's performance characteristics on its own.

7. Type of Ground Truth Used

The document describes the device as a "detection test of autoantibodies directed against double stranded DNA (dsDNA)" that "can be used to aid in the diagnosis of SLE." This implies that the 'ground truth' for evaluating the test performance would likely be based on:

• Clinical diagnosis of SLE: Established by clinical findings and other laboratory tests, against which the presence/absence of dsDNA antibodies would be evaluated.
• Predicate device results: As the primary comparison is with the "Varelisa dsDNA antibodies" predicate, the results from this established test would serve as a comparative standard.
  The exact methodology for establishing the ground truth is not explicitly detailed (e.g., whether it relied on specific clinical criteria for SLE diagnosis, or primarily on concordance with the predicate).

8. Sample Size for the Training Set

This information is not provided. As a diagnostic kit, the concept of a "training set" in the context of machine learning algorithms may not directly apply. If assay parameters were optimized, the details of that process (including sample sizes) are not given.

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

This information is not provided.

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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™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent based microparticles immunoassay using flow cytometry readings. It is designed for the simultaneous detection of autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDA and 52 kDA), SSB, Sm. Sm/RNP, Scl-70, Jo-1 ribosome and centromere in human serum. (* Antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere can be reported using this assay).

The test system is used to screen serum samples and detect the presence of antinuclear antibodies associated with connective diseases systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, and CREST syndrome, in conjunction with clinical findings and other laboratory tests.

The assay kits consist of:

• a mixture of color-coded microspheres sensitized respectively by dsDNA, SSA 60kDa, SSA 52kDa, SSB, Sm, Sm/RNP, Scl70, Jo-1, Ribosomes and Centromeres.
• a ready to use anti-human IgG coupled to phycoerythrin,
• a ready to use calibrator titered for each specificity,
• a 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 MLX-BOOSTER software.

The FIDIS™ CONNECTIVE 10 kit resembles traditional EIA, but allows simultaneous detection and identification of several antibodies in a single well.

• 1. Diluted patient sera and multiplexed bead suspension are thoroughly mixed in the 96 well microtiter plate. Antigen specific antibodies in the patient sera, if present, bind to the immobilised antigen on one or more of the bead sets. Any unbound material is removed by performing a wash step.
• 2. Phycoerythrin-conjugated goat anti-human IgG is added to the plate and a further incubation performed. The conjugated anti-human igG binds to the antigen specific antibodies immobilised on the microsphere surface to form an antigen/antibody complex.
• 3. The bead suspension is then analysed by the FIDIS™ Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER).

The FIDIS™ Instrument is able to distinguish the specific color-code of each microsphere types and it could associate the microsphere type with the individual tested antigen.
The FIDIS™ Instrument can 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.

Here's a summary of the acceptance criteria and the study details for the FIDIS™ CONNECTIVE 10 device, based on the provided text:

Premarket Notification 510(k) Summary for FIDIS™ CONNECTIVE 10 (K053653)

The document primarily focuses on establishing substantial equivalence to predicate devices, rather than defining specific numerical acceptance criteria for performance metrics like sensitivity and specificity. The acceptance criteria appear to be implicit in demonstrating comparability to the predicate devices across various sample types.

1. Table of Acceptance Criteria and Reported Device Performance

• Results from a comparison study analyzing positive, equivocal, and negative sera.
• Results from samples of apparently healthy subjects (normal population).
• Results from samples with potential biological cross-reactivity. |
  | Accuracy | Not explicitly stated as a separate numerical criterion | Implied through substantial equivalence to predicate device results, which are presumed to be accurate. The device allows for the detection of 10 autoantibody specificities (dsDNA, SSA 60kDa, SSA 52kDa, SSB, Sm, Sm/RNP, Scl70, Jo-1, Ribosomes, and Centromeres) and its measurements are directly calculated in biological units using specific data software. |
  | Precision/Reproducibility | Not explicitly stated as a separate numerical criterion | Not explicitly detailed in the provided summary. |
  | Clinical Utility | Ability to screen serum samples and detect the presence of anti-nuclear antibodies associated with connective diseases (SLE, Sjogren's syndrome, MCTD, Scleroderma, Dermatomyositis, CREST syndrome) | The device is designed for this intended use and is presented as being able to screen serum samples and detect these autoantibodies. Its use is in conjunction with clinical findings and other laboratory tests. |

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

The exact sample sizes for the test set (comparison study, healthy subjects, cross-reactivity samples) are not specified in this summary document.
The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) test for autoantibody detection, not an imaging device requiring human reader interpretation in the same way.

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

The device is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is an automated system for immunodiagnostic testing. The "standalone" performance is inherent to its function as an IVD device, where the instrument performs the detection and quantification. The summary describes the assay steps culminating in analysis by the FIDIS™ Instrument which calculates results using specific software. Therefore, the reported performance is a standalone (algorithm/instrument only) performance.

7. The Type of Ground Truth Used

The ground truth for the comparison studies is implicitly based on the results obtained from legally marketed predicate devices. The summary states the comparison included "positive, equivocal and negative sera" and "samples from apparently healthy subject (normal population)" and "samples with potential biological cross reactivity." This suggests that the ground truth for these samples was likely established through existing clinical diagnoses and reference methods (including the predicate devices themselves) based on a combination of clinical findings, other laboratory tests, and potentially expert consensus on patient status.

8. The Sample Size for the Training Set

The document does not provide information on a separate "training set" or its sample size. For IVD devices, the characterization of reagents and assay parameters during development might be analogous to "training," but the summary does not detail this.

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

Since no separate training set is explicitly mentioned, there is no information on how its ground truth was established.

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The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. The test system is used to detect in patient serum samples the presence of anti-neutrophil cytoplasm antibodies (ANCA) directed against Myeloperoxidase (MPO) and Serine Proteinase 3 (PR3) ; and anti-glomerular basement membrane (GBM) antibodies.

The results of the FIDIS™ VASCULITIS* test are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of various primary systemic small vessel vasculitis.

Clinical utility:

The presence of anti-MPO and anti-PR3 antibodies associated primary systemic small vessel vasculitis: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopatic crescentic glomerulonephritis; and the presence of anti-GBM antibodies is associated with Goodpasture's syndrome.

FIDIS™ VASCULITIS* kit is used on the FIDIS Analyser, MLX-BOOSTER Software and Washer.

FIDIS™ VASCULITIS* kit could be used with CARIS™ system (diluting and dispensing device).

This test is for in vitro diagnostic use.

• Detection of the serologic markers for primary systemic small vessel vasculitis (ANCA) and for Goodpasture syndrome (GBM)

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

The provided document is a 510(k) clearance letter for the FIDIS™ VASCULITIS* device and its "Indications For Use" statement. It does not contain information about acceptance criteria, detailed study results, sample sizes for training or test sets, expert qualifications, or adjudication methods for ground truth establishment.

Based on the nature of the document as an FDA 510(k) clearance, it primarily focuses on the device's substantial equivalence to a legally marketed predicate device rather than comprehensive performance study details. The information required in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically found in the 510(k) summary or the full 510(k) submission, not in the clearance letter itself.

Therefore, I cannot provide the requested information from the given text.

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The FIDISTN CONNECTIVE 8* kit is a semi-quantitative homogencous fluorescentbased microparticles immunoassay using flow cytometery readings. It is designed for the simultaneous detection of 8 autoantibody specificities: double stranded DNA (dsDNA), SSA 60 kDa, SSA 52 kDa, SSB, Sm, Sm/RNP, Sc170 and Jo-1 (*antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl-70 and Jo-1 can be reported using this assay).

Clinical utility:

The test system is used to screen serum samples and detect the presence of anti-nuclear antibodies associated with connective diseases, systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, polymyositis in conjunction with clinical findings and other laboratory tests.

The FIDISTN CONNECTIVE 8* kit is a semi-quantitative homogencous fluorescentbased microparticles immunoassay using flow cytometery readings.

The provided text is a 510(k) summary for the FIDIS™ Connective 8 device, which is an immunoassay for the detection of autoantibodies associated with connective tissue diseases. It does not contain a study detailing the device's performance against acceptance criteria in the way an AI/ML device submission would. This document is a regulatory clearance letter and the "Indications For Use" statement.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document. The document describes the device, its intended use, and the FDA's determination of substantial equivalence to predicate devices, but not a detailed study report of its performance metrics.

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