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Enzyme linked immunosorbent assays (ELISA) for the qualitative detection of IgA anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings

Enzyme linked immunosorbent assays (ELISA) for the qualitative detection of IgG anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings

This test is performed as a solid phase immunoassay. Microwells are coated with antigen. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the gliadin antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgA or IgG conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 mm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.

Here's a breakdown of the acceptance criteria and study findings for the Immulisa Enhanced Gliadin IgA Antibody ELISA and Immulisa Enhanced Gliadin IgG Antibody ELISA, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document describes several non-clinical and clinical tests. However, explicit "acceptance criteria" in the form of pre-defined thresholds for performance metrics (like minimum sensitivity/specificity) are not explicitly stated within the provided text for the new Immulisa Enhanced Gliadin assays. Instead, the study presents the performance of the new devices in comparison to existing predicate devices and against a set of characterized clinical samples. The "acceptance" is implied by demonstrating substantial equivalence and satisfactory performance in these various tests.

I've organized the reported performance for the new devices based on the test sections:

Table 1: Device Performance Summary

Study Details

Here's the detailed information regarding the studies:

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

   • Method Comparison (Vs Predicate):
     • IgA test set: 400 samples (109 Positive, 291 Negative by predicate).
     • IgG test set: 459 samples (205 Positive, 254 Negative by predicate).
     • These samples appear to be clinical samples ("well-characterized CD and DH subjects and disease controls").
     • Data Provenance: Not explicitly stated, but based on the overall document (Immco Diagnostics, Buffalo, NY), it's likely from the US or procured for use in the US. The terms "well-characterized" suggest retrospective collection.
   • Cross-Reactivity Study:
     • Test set: 456 sera from individuals with other potentially cross-reactive autoimmune and infectious disorders.
     • Data Provenance: Not explicitly stated, but likely retrospective clinical samples.
   • Clinical Study:
     • Test set: 250 celiac disease samples, 45 dermatitis herpetiformis samples, and 456 autoimmune and infectious disease controls. IgA deficient CD patients were excluded from these calculations.
     • Data Provenance: Not explicitly stated, but likely retrospective clinical samples.

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

   • The document implies ground truth was established by "well-characterized CD and DH subjects and disease controls" and "clinical samples." It also directly compares the new device to existing predicate devices.
   • However, the specific number and qualifications of experts (e.g., "radiologist with 10 years of experience") used to establish the ultimate ground truth for the patient classifications (celiac, DH, healthy, specific autoimmune diseases) are not mentioned in the provided text. It's typical for such characterization to involve clinical diagnosis based on a combination of endoscopy, biopsy, serology, and clinical presentation, but the specific expert involvement is not detailed.

3. Adjudication method for the test set:

   • Not applicable / Not specified. The document describes laboratory studies comparing results to predicate devices and clinical diagnoses, rather than human reader interpretation that would require adjudication.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) assay, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, this type of study is not relevant.

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

   • Yes, this is a standalone performance study. The device itself is an automated ELISA system. The performance metrics (sensitivity, specificity, agreement, precision, etc.) represent the performance of the assay (the "algorithm"/test process) without human interpretive intervention beyond running the test and reading the output. The interpretation of the ELISA results (positive/negative/borderline) is inherent to the device's design.

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

   • For the "Method Comparison" studies against the predicate devices, the predicate device's result itself acts as a form of "ground truth" for comparison purposes.
   • For the "Clinical Study" and "Cross-Reactivity" studies, the ground truth for celiac disease, dermatitis herpetiformis, and the various autoimmune/infectious diseases was based on the "well-characterized" nature of the samples. This typically implies a clinical diagnosis (likely involving expert consensus from physicians, pathology results from biopsies, and other diagnostic tests). The document does not provide the specific modalities (e.g., gold standard biopsy results for all celiac cases) used for this characterization for each individual sample, but generally, for celiac disease, this would involve small intestinal biopsy as a definitive diagnostic tool.

7. The sample size for the training set:

   • Not applicable / Not specified. This document describes the performance of an ELISA assay, which is a biochemical test, not a machine learning or AI algorithm that undergoes "training." The results presented are from validation and clinical evaluation studies of the developed assay.

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

   • Not applicable. As this is not an AI/ML algorithm requiring a training set, the concept of establishing ground truth for such a set is irrelevant in this context.

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AESKULISA DGP-Check is an in-vitro diagnostic device. This solid phase enzyme immunassay employs synthetic, deemicated gliadin-derived pertides for the combined seniqualitative detation of 194 and 195 and 195 and 195 and its deamical desirical d Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diac disease (gluter-sensitive enteropatiy) and should be used in conjunction with ather serological tests and clinical findings.

AESKULISA DGP-G is an in-vitro diagnostic device This salid phase enzyme immuncessay employs synthetic, deamicated gliadin-derived peptides for the semiquantitative and qualitative detection of IgG antibodies against deamidded Gliadin-specific peptides (DGP) in human serum. The assy is an aid in the diegnosis of celies disease (gluter-sensitive enteropedly) and should be used in conjunction with other serological tests and clinical findings.

AESKULISA DGP-A is an in-vitro diagnostic device. This solid phase enzyme immunossay employs synthetic, deamidated gliadin-derived peptides for the semiqualitative and qualitative detection of 1gA antibodies against deaminded Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of cellac disease (gluter-sensitive enteropathy) and should be used in corjunction with other serological tests and clinical findings.

Not Found

I am sorry, but the provided document does not contain the detailed study information required to fill out the table and answer your questions. The text includes an FDA 510(k) clearance letter for the AESKULISA DGP-A, AESKULISA DGP-G, and AESKULISA DGP-Check devices, which are in-vitro diagnostic devices for celiac disease.

While it states the indications for use and classification, it does not provide:

• Details of any specific study (e.g., design, methodology, results) that proves the device meets acceptance criteria.
• Acceptance criteria themselves, or reported device performance metrics like sensitivity, specificity, accuracy, etc.
• Information on sample sizes for test or training sets, data provenance, ground truth establishment, expert involvement, or any multi-reader multi-case studies.

Therefore, I cannot fulfill your request based on the given information.

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The a-Gliatest® IgA is intended for the semi-quantitative determination of IgA antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

The a-Gliatest® IgG is intended for the semi-quantitative determination of IgG antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

The a-GliaPep® IgA is intended for the semi-quantitative determination of IgA antibodies directed against deamidated gliadin peptide in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

The a-GliaPep® IgG is intended for the semi-quantitative determination of IgG antibodies directed against deamidated gliadin peptide in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

Each test kit for a-Gliatest® IgA, a-Gliatest® IgG, a-GliaPep® IgA, and a-GliaPep® IgG consists of one (1) microtiter plate (12 strips of 8 microwells coated with purified a-gliadin antigen or deamidated gliadin peptide antigen), assay controls (positive and negative), a ready-to-use set of five (5) calibrators, Horseradish Peroxidase (HRP) goat anti-human IgA or IgG conjugate, serum diluent, Tetramethylbenzidine (TMB) enzyme substrate, stop solution, and washing solution required for the assay.

The provided document describes the Grifols USA, Inc. a-Gliatest® IgA, a-Gliatest® IgG, a-GliaPep® IgA, and a-GliaPep® IgG devices, which are intended for the semi-quantitative determination of IgA/IgG antibodies directed against gliadin or deamidated gliadin peptide in human serum as an aid in the diagnosis of celiac disease.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied through comparison with a predicate device (Aeskulisa® Glia A/G (K052439)) and through performance metrics like precision, linearity, and detection limits. The method comparison and clinical studies aim to demonstrate substantial equivalence and adequate diagnostic performance.

Below is a summary of the reported performance for each device, with implied acceptance criteria based on the context of 'substantial equivalence' to the predicate and satisfactory clinical utility. The document does not explicitly state pre-defined acceptance criteria for the clinical or method comparison studies in terms of specific percentages, but rather presents the results. For analytical performance, the studies demonstrate what is considered acceptable.

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

• α-Gliatest® IgA:
  • Method Comparison Test Set: 178 clinical samples. Provenance: Includes clinically-diagnosed celiac positive (clinical history and/or biopsy) and negative samples (healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective.
  • Clinical Study Test Set: 262 clinical samples (114 celiac positive, 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings and/or confirmed with biopsy. Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 196 healthy blood donor samples. Retrospective.
• α-Gliatest® IgG:
  • Method Comparison Test Set: 198 clinical samples (51 celiac positive, including 10 IgA-deficient celiac patients; negative samples from healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective.
  • Clinical Study Test Set: 285 clinical samples (127 celiac positive, 10 IgA-deficient celiac patients; 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings and confirmed with biopsy. Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 196 healthy blood donor samples. Retrospective.
• α-GliaPep® IgA:
  • Method Comparison Test Set: 179 clinical samples. Provenance: Clinically-diagnosed celiac positive (clinical history and/or biopsy) and negative samples (healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective. The samples were within the linearity range of the assay.
  • Clinical Study Test Set: 241 clinical samples (93 celiac positive, 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings and confirmed with biopsy. Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 145 healthy blood donor samples. Retrospective.
• α-GliaPep® IgG:
  • Method Comparison Test Set: 201 clinical samples (57 celiac positive, including 10 IgA-deficient celiac patients; 146 negative samples recruited similarly to other assays). Provenance: Clinically-diagnosed celiac positive (clinical history and/or biopsy) and negative samples (healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective. The samples were within the linearity range of the assay.
  • Clinical Study Test Set: 253 clinical samples (95 celiac positive, including 10 IgA-deficient celiac patients; 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings (31.6%) and confirmed with biopsy (68.4%). Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 145 healthy blood donor samples. Retrospective.

For all studies, data provenance is global/not specified, and the data is retrospective.

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish the ground truth for the test sets. It mentions that celiac positive samples were "clinically-diagnosed celiac positive (clinical history and/or biopsy)" and "diagnosed with clinical findings and confirmed with biopsy." This implies that the ground truth was established by medical professionals, likely gastroenterologists or pathologists, based on established diagnostic criteria for celiac disease, including clinical presentation and histological findings from biopsy. However, the specific number and formal qualifications of these experts are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in ground truth determination or in the interpretation of clinical findings and biopsies for the test set. The ground truth seems to be implicitly accepted based on the "clinical findings and/or biopsy" diagnosis.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These devices are in vitro diagnostic (IVD) assays, not imaging interpretation algorithms where human readers would typically be involved in interpreting results. The studies compare the performance of the device itself to a predicate device or to clinical ground truth, not to human reader performance with or without AI assistance.

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

Yes, the studies conducted are standalone performance evaluations of the assay devices. The "method comparison studies" and "clinical studies" evaluate the performance of each assay (α-Gliatest® IgA, α-Gliatest® IgG, α-GliaPep® IgA, α-GliaPep® IgG) in isolation, comparing its output to a predicate device's output or to the clinical ground truth. There is no human-in-the-loop component described for the operation or interpretation of these assays beyond standard laboratory procedures.

7. The Type of Ground Truth Used

The ground truth for celiac positive samples was established based on:

• Clinical findings: Clinical history and presentation consistent with celiac disease.
• Biopsy: Histological confirmation from intestinal biopsy, which is a gold standard for celiac disease diagnosis.

For negative samples, the ground truth was based on:

• Healthy blood donors.
• Patients with other relevant conditions (IBD, IBS, autoimmune disorders, infectious diseases, Type 1 diabetes) who would not be expected to have celiac disease.

This can be categorized as a combination of expert consensus (clinical findings) and pathology (biopsy).

8. The Sample Size for the Training Set

The document primarily describes validation studies (test sets) and does not explicitly mention a separate "training set" for the development of these IVD assays. IVD products are typically developed through iterative processes of antigen/antibody selection and optimization, with assay parameters being refined, but these development phases are not usually referred to as "training sets" in the same way machine learning models are. The calibrators and controls are formulated from pooled sera, and new lots are calibrated against original calibrators, which involves testing (effectively a form of internal "training" or standardization) against:

• Original calibrators
• Normal human sera
• Clinical samples
• Internal standards

However, a specific "training set" size for algorithm development (as would be typical for AI/ML devices) is not applicable or stated for this type of immunoassay.

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

As noted above, a distinct "training set" for an algorithm in the AI/ML sense is not applicable to these IVD assays. Instead, the assay's operational parameters (like calibrator values) are established using:

• Pooled sera with known anti-gliadin antibody levels from celiac patients.
• Normal human sera.
• Clinical samples.
• Internal standards.

The ground truth for these calibrators and controls would stem from the clinical diagnoses (clinical findings and/or biopsy) of the patient populations from which the sera were obtained. The document states, "Calibrators are dilutions of pooled sera with anti-gliadin antibody from patients with celiac disease." This implies that the ground truth for these pooled sera was established through the diagnosis of celiac disease in the donor patients.

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The QUANTA Flash™ DGP IgA is a chemiluminescent immunoassay for the semi-quantitative determination of of IgA antibodies to synthetic, deamidated gliadin peptides in human serum. The measurement of IgA deamidated gliadin peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease and dermatitis herpetiformis.

The QUANTA Flash™ DGP IgG is a chemiluminescent immunoassay for the semi-quantitative detection of IgG antibodies to synthetic, deamidated gliadin peptides in human serum. The measurement of IgG deamidated gliadin peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease in IgA deficient and IgA deficient patients, as well as dermatitis herpetiformis.

The QUANTA Flash DGP IgA Calibrators are intended for use with the QUANTA Flash DGP IgA chemiluminescent immunoassay (CIA). Each calibrator establishes a point of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgA anti-DGP antibodies in serum.

The QUANTA Flash DGP IgA Calibrators are intended for use with the QUANTA Flash DGP IgA chemiluminescent immunoassay (CIA). Each calibrator establishes a point of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgA anti-DGP antibodies in serum.

The QUANTA Flash DGP IgA Controls are intended for quality control purposes of the QUANTA Flash DGP lgA chemiluminescent immunoassay (CIA) kit run on the BIO FLASH® instrument that is used for the measurement of IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum.

The QUANTA Flash DGP IgG Controls are intended for quality control purposes of the QUANTA Flash DGP IgG chemiluminescent immunoassay (CIA) kit run on the BIO FLASH® instrument that is used for the measurement of IgG anti-deamidated gliadin peptide (DGP) antibodies in human serum.

Synthetic deamidated gliadin peptide is coated onto the surface of paramagnetic beads (microparticles), which are stored in the reagent cartridge under conditions that preserve the antigen in its reactive state. The reagent cartridge is then loaded onto and used by the BIO-FLASH instrument.

Serum samples are prediluted by the instrument with system rinse buffer, and added to disposable plastic cuvettes. Small amounts of the diluted patient serum, the DGP beads, and assay buffer are all combined into a second cuvette, and mixed. This cuvette is incubated at 37℃. The beads are then magnetized and washed several times. Isoluminol conjugated anti-human IgA (or IgG) antibody is then added to the cuvette, and incubated at 37°C. Again, the beads are magnetized and washed repeatedly. The isoluminol conjugate produces a luminescent reaction when reagents ("Triggers") are added to the cuvette. The light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of bound isoluminol conjugate, which in turn is proportional to the amount of anti-DGP antibodies bound to the DGP on the beads.

For quantitation, the QUANTA Flash DGP IgA and IgG assays utilize a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use with the QUANTA Flash DGP IgA and IgG Calibrators. Based on the results obtained with the two Calibrators included in the Calibrator set, an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU) from the RLU obtained for each patient.

The QUANTA Flash DGP IgA reagent cartridge contains the following reagents:

• DGP coated paramagnetic beads in buffer, containing protein stabilizers and a. preservative.
• Assay buffer colored pink, containing Tris-buffered saline, Tween 20, protein b. stabilizers and preservatives.
• Tracer IgA Isoluminol labeled anti-human IgA antibodies in buffer, containing protein ن stabilizers and preservative.

The QUANTA Flash DGP IgG reagent cartridge contains the following reagents:

• DGP coated paramagnetic beads in buffer, containing protein stabilizers and a. preservative.
• Assay buffer colored pink, containing Tris-buffered saline, Tween 20, protein ﻗ stabilizers and preservatives.
• Tracer IgG Isoluminol labeled anti-human IgA antibodies in buffer, containing protein ﻥ stabilizers and preservative.

The QUANTA Flash™ DGP IgA Calibrators and the QUANTA Flash™ DGP IgG Calibrators kits each contain 2 vials of Calibrators:

QUANTA Flash™ DGP IgA Calibrators:

• QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.
• QUANTA Flash DGP IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL . prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.

QUANTA Flash™ DGP IgG Calibrators:

• QUANTA Flash DGP IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL . prediluted, ready to use reagent. Calibrators contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.
• QUANTA Flash DGP IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.

The QUANTA Flash™ DGP IgA Controls kit and the QUANTA Flash™ DGP IgG Controls kits each contain 2 vials of Negative Control and two vials of Positive Control:

QUANTA Flash™ DGP IgA Controls:
QUANTA Flash™ DGP IgA Negative Control: Two (2) barcode labeled tubes containing 0.5 ml, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.

QUANTA Flash™ DGP IgA Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.

QUANTA Flash™ DGP IgG Controls:
QUANTA Flash™ DGP IgG Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.

QUANTA Flash™ DGP IgG Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.

The provided text describes the performance characteristics of the QUANTA Flash™ DGP IgA and QUANTA Flash™ DGP IgG assays, including various studies conducted to demonstrate their analytical and clinical performance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for many of the studies are implicitly stated or are standard for diagnostic assays (e.g., %CV for precision, recovery percentages for interference).

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

• Precision Studies: 8 samples containing various concentrations were used for both IgA and IgG assays.
  • Provenance: Not explicitly stated, but likely in-house (INOVA) and potentially external labs (Akron City Hospital, Mitogen Advanced Diagnostics Laboratory).
• Between-Sites Reproducibility: 3 samples (negative, low positive, medium positive) tested at each of three sites (INOVA, Mitogen Advanced Diagnostics Laboratory in Calgary, Canada, and Akron City Hospital in Akron, Ohio, USA).
  • Provenance: Multi-national (USA and Canada), prospective (samples run for the study).
• Limit of Detection (LoD): 140 determinations (60 blank and 80 low-level samples) for each assay.
  • Provenance: Not explicitly stated, but typical for analytical validations to be in-house.
• Linearity: Six serum samples with various concentrations were used for each assay.
  • Provenance: Not explicitly stated, likely in-house.
• Auto-rerun Function: Two high positive specimens for each assay.
  • Provenance: Not explicitly stated.
• High Concentration Hook Effect: Not explicitly stated, but high positive specimens were used.
  • Provenance: Not explicitly stated.
• Interference:
  • DGP IgA: Three specimens tested.
  • DGP IgG: Five specimens tested (one excluded).
  • Provenance: Not explicitly stated.
• Cross-reactivity:
  • DGP IgA: 201 patient samples (infectious diseases and connective tissue diseases).
  • DGP IgG: 185 patient samples (infectious diseases and connective tissue diseases).
  • Provenance: Not explicitly stated, but implies patient samples, presumably retrospective from collections.
• Method Comparison:
  • DGP IgA: N=96 samples (clinical validation studies: CD, non-CD, DH patients). N=21 DH samples.
  • DGP IgG: N=235 samples (clinical validation studies: CD, non-CD, DH patients). N=21 DH samples. N=13 IgA deficient samples.
  • Provenance: Clinical validation studies (library samples, patients on gluten-free diet, unconfirmed CD, controls, DH patients). The source "library" often implies retrospective.
• Clinical Sensitivity/Specificity:
  • DGP IgA:
    • Initial validation: 54 CD samples (library), 39 samples (CD on GFD/unconfirmed CD), 103 non-celiac controls, 21 DH samples.
    • External study: 93 CD samples, 98 disease controls. 151 samples (58 adults, 93 pediatric) suspected CD.
    • Control Population for cut-off: 355 subjects (healthy blood bank donors, inflammatory bowel disease, H. pylori, autoimmune thyroid, infectious diseases, rheumatoid arthritis, ANA patients, tTG workshop study controls from Children's Hospital and University of Colorado).
  • DGP IgG:
    • Initial validation: 62 CD samples (INOVA library, 7 IgA deficient), 87 non-celiac controls, 39 samples (CD on GFD/unconfirmed CD), 23 DH samples.
    • External study: 102 CD samples (9 IgA deficient), 151 samples (suspected CD, 58 adults, 93 pediatric), 98 disease controls.
    • Control Population for cut-off: 392 subjects (healthy blood bank donors, inflammatory bowel disease, H. pylori, autoimmune thyroid, tTG workshop study controls from Children's Hospital and University of Colorado).
  • Provenance: Mixed. "Library" samples indicate retrospective data. "External study" samples could be prospective or retrospective depending on how they were collected for that specific study. Multiple sources are mentioned, including patients from a tTG workshop study, individuals seeking medical attention. Specific geographical provenance (e.g., Colorado, USA for some controls) is mentioned for some control groups.

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" in the traditional sense (e.g., radiologists interpreting images) for establishing ground truth. The ground truth for the clinical studies appears to be based on:

• Clinical Diagnosis: Celiac Disease (CD) and Dermatitis Herpetiformis (DH) status.
• Biopsy Results: Mention of Marsh III and Marsh II biopsies for some CD patients. While a pathologist is involved in biopsy interpretation, the document doesn't specify how many pathologists or their specific qualifications, or if a consensus process was used.
• Other Laboratory Tests: The intended use states the device should be used "in conjunction with clinical findings and other laboratory tests to aid in the diagnosis." This implies other methods were used to confirm CD/DH status for the clinical validation.
• Pre-existing sample cohorts: "54 CD samples from library", "62 CD samples from INOVA's serum library". This suggests the diagnosis was established clinically through a standard diagnostic pathway prior to the samples being included in the library.

There is no mention of "experts" specifically establishing ground truth for the test set in the traditional sense of independent review.

4. Adjudication Method for the Test Set

No explicit adjudication method (like "2+1" or "3+1") is described for establishing the ground truth for the test set. The diagnoses (CD, DH) appear to be pre-determined based on clinical and pathological findings before the samples were included in the studies.

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 diagnostic immunoassay that measures antibody levels in serum, not an imaging device that requires human readers/interpreters. Therefore, an MRMC study is not applicable.

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

Yes, the studies presented (Precision, LoD, Linearity, Interference, Cross-reactivity, Clinical Sensitivity/Specificity, Method Comparison) represent standalone performance of the assay. The device generates a quantitative (CU) result, and the performance characteristics evaluate the accuracy and reliability of this direct measurement.

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

The ground truth for the clinical validation studies appears to be:

• Clinical Diagnosis: Established diagnoses of Celiac Disease (CD) and Dermatitis Herpetiformis (DH).
• Pathology: Biopsy results (e.g., Marsh III classification for CD) are mentioned for some patients, indicating histological confirmation contributed to the ground truth for CD cases.
• Other Diagnostic Tests/Criteria: The statement emphasizes the device aids diagnosis "in conjunction with clinical findings and other laboratory tests," suggesting a multi-faceted diagnostic approach established the true disease status of the patients whose samples were tested.

For control populations, healthy blood bank donors and patients with other diseases (e.g., autoimmune liver disease, viral hepatitis, inflammatory bowel disease) were used. Their ground truth is their confirmed disease status or health status.

8. The Sample Size for the Training Set

The document does not explicitly delineate separate "training sets" and "test sets" in the context of machine learning. The studies described are performance validation studies for an immunoassay.

However, for establishing the assay's internal parameters:

• Master Curve: A predefined lot-specific Master Curve is uploaded onto the instrument, which would have been established using a set of samples during manufacturing/development. The size and nature of this "training" data are not specified.
• Cut-off establishment:
  • DGP IgA: Control population of 355 subjects, supplemented by 37 CD specimens for sensitivity/specificity optimization.
  • DGP IgG: Control population of 392 subjects, supplemented by 37 CD specimens for sensitivity/specificity optimization.
    These populations were used to define the CU cut-offs (20 CU for IgA, 20 CU for IgG).

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

Given the context, the "training set" would refer to the data used to establish the assay's intrinsic parameters like the Master Curve and cut-off values.

• Master Curve: This is likely established by the manufacturer using a comprehensive set of characterized samples (controls, various concentrations) during the development and manufacturing process of each reagent lot. The details of how these samples were characterized are not provided in this summary.
• Cut-off values:
  • Control Population: For both IgA and IgG, control populations (355 for IgA, 392 for IgG) consisted of healthy blood bank donors and patients with various other conditions. The "ground truth" for these samples was their established health status or specific disease diagnosis (not CD/DH).
  • DGP IgA/IgG Positive Samples for Optimization: 37 CD specimens were used to optimize the cut-off. The ground truth for these samples would have been their confirmed Celiac Disease diagnosis, obtained through clinical findings and other laboratory tests, including biopsy in some cases.
  • Method: The cut-off was established in accordance with CLSI C28-A3c ("Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory") using the non-parametric percentile method (99th percentile for IgA, 99th/98th percentile for IgG RLU values). The software "Analyse-it for Excel" was used for calculations. The final cut-off was selected to provide the "combination of the highest sensitivity and specificity" based on the results from the CD patient specimens and control population.

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The QUANTA Flash™ DGP Screen is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG and IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH® instrument. It is an aid in the diagnosis of celiac disease and dermatitis herpetiformis in conjunction with clinical findings and other laboratory tests.

The QUANTA Flash™ DGP Screen Calibrators are intended for use with the QUANTA Flash™ DGP Screen chemiluminescent immunoassay (CIA) kit run on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgG and IgA anti-DGP antibodies in serum.

The QUANTA Flash™ DGP Screen Controls are intended for quality control purposes of the QUANTA Flash™ DGP Screen chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument.

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The provided document is a 510(k) premarket notification letter from the FDA for a diagnostic device, not a study report that details acceptance criteria and performance data in the structured format requested. Therefore, I cannot extract most of the requested information directly from this document.

However, I can provide the following based on the information available:

1. Device Name: QUANTA Flash™ DGP Screen, QUANTA Flash™ DGP Screen Calibrators, QUANTA Flash™ DGP Screen Controls
2. Indications For Use: The QUANTA Flash™ DGP Screen is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG and IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH® instrument. It is an aid in the diagnosis of celiac disease and dermatitis herpetiformis in conjunction with clinical findings and other laboratory tests.

The document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth.
• Qualifications of experts.
• Adjudication method.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of human reader improvement with AI assistance.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

This document is primarily for regulatory clearance and states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail the specific studies and performance metrics used to make that determination. Such details would typically be found in the actual 510(k) submission summary or a separate clinical study report, neither of which is included in this extract.

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EliA™ Gliadinºº IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA™ Gliadin47 IgG uses the EliA IgG method on the instruments Phadia® 100 and Phadia® 250.

EliA™ Gliadinºº IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA™ Gliadinºº IgA uses the EliA IgA method on the instruments Phadia® 100 and Phadia® 250.

The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250.

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

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

The total IgG and IgA calibration is based on a set of six WHO-standardized IgG and IgA Calibrators, respectively, derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.

Acceptance Criteria and Device Performance Study for EliA™ Gliadin IgG/IgA Immunoassays

This document summarizes the acceptance criteria and the supporting study for the EliA™ Gliadin IgG and EliA™ Gliadin IgA immunoassays, as presented in the 510(k) summary. These devices are intended for the in vitro semi-quantitative measurement of IgG and IgA antibodies directed to gliadin, respectively, to aid in the diagnosis of celiac disease.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state numerical acceptance criteria for a "study" in the traditional sense of a comparative effectiveness study with defined performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices through various comparability studies. The "reported device performance" is thus presented as evidence of this equivalence.

The primary method for demonstrating equivalence was through a "comparison study between new and predicate device," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)." These studies are summarized below as demonstrating laboratory equivalence.

• Comparison study between new and predicate device
• Results obtained for clinically defined sera
• Results obtained for samples from apparently healthy subjects (normal population) |

Note: The 510(k) summary does not provide specific numerical performance metrics (e.g., correlation coefficients, concordance rates, sensitivity, specificity, etc.) from these equivalence studies, nor does it define explicit numerical acceptance thresholds for these metrics. The conclusion of substantial equivalence is a qualitative statement based on the totality of the collected data.

2. Sample Size and Data Provenance for the Test Set

The document states that comparability was supported by a "data set" that included results from:

• A comparison study between the new devices and predicate devices.
• Clinically defined sera.
• Samples from apparently healthy subjects.

However, the exact sample sizes for these "test sets" (i.e., the number of patient samples used in the comparison studies) are not specified in the provided 510(k) summary.

Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the manufacturer is Phadia AB from Uppsala, Sweden, and the US contact is in Michigan, USA, and the predicate devices are INOVA products, it's plausible the data could have originated from various locations, but this is not confirmed.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of "experts" in the context of establishing ground truth for a test set. The ground truth for the "clinically defined sera" would implicitly refer to the clinical diagnosis of celiac disease, which would have been established by medical professionals. However, the exact number or qualifications of these professionals are not specified.

4. Adjudication Method

No adjudication method is mentioned in the provided text.

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

No MRMC comparative effectiveness study is mentioned. The studies described focus on the analytical performance and clinical comparability of the device itself, rather than assessing improvements in human reader performance with or without AI assistance. The device is an immunoassay, not an AI-assisted diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance Study

The EliA™ Gliadin IgG and IgA immunoassays are standalone diagnostic devices. Their performance is evaluated directly through the semi-quantitative measurement of antibodies. The "comparison study between new and predicate device" and evaluation with "clinically defined sera" effectively represent standalone performance evaluations to demonstrate analytical and clinical performance in comparison to existing methods.

7. Type of Ground Truth Used

The ground truth used for the evaluation involved:

• Clinical Diagnoses: The document refers to "clinically defined sera," implying that patient samples with confirmed celiac disease diagnoses (or confirmed healthy status) were used. These diagnoses are typically established through a combination of clinical findings, serology, and biopsy results (pathology). The specific method for clinical diagnosis is not detailed.
• Comparison to Predicate Devices: Performance was also assessed by comparing results directly to cleared predicate devices, which serve as a de-facto standard.

8. Sample Size for the Training Set

The document does not describe a separate "training set" in the context of machine learning. These are immunoassay devices, not AI/ML algorithms that typically require large training datasets. The "calibration" of the immunoassay system relies on WHO-standardized calibrators and control materials, which are distinct from a machine learning training set of patient samples.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the AI/ML sense, this question is not applicable. The device's calibration curves are established using WHO-standardized IgG and IgA calibrators, derived from human serum.

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Enzyme linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of IgA or IgG antibodies to qliadin in human serum to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings.

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This is a 510(k) premarket notification for an immunoassay device (ImmuLisa Celiac G+ (Gliadin) IgA and IgG Antibody ELISA) and not an AI/ML device. Therefore, the provided document does not contain the specific information required to answer the prompt regarding AI/ML device acceptance criteria and study details.

The document discusses the substantial equivalence determination for a laboratory diagnostic test. It outlines the regulatory classification, product codes, and general controls for such devices, but it does not detail performance studies in the context of AI/ML algorithms.

Therefore, I cannot extract the requested information from this document.

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The Anti-Gliadin (GAF-3X) ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.

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The provided text is an FDA 510(k) clearance letter and an "Indications for Use" statement for the EUROIMMUN US INC. Anti-Gliadin (GAF-3X) ELISA (IgG) device. It does NOT contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for a study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text.

The document indicates that the device has received 510(k) clearance based on its substantial equivalence to a legally marketed predicate device. This type of clearance does not typically involve the detailed performance study and acceptance criteria reporting that you are asking for in the same way a PMA (Pre-Market Approval) submission would, or as you might see for a diagnostic AI/ML device where performance metrics against a defined ground truth are central.

To answer your questions, one would need to access the actual 510(k) submission document (K083053), which would contain the performance data and the comparison to the predicate device that led to the substantial equivalence finding.

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The Anti-Gliadin (GAF-3X) ELISA (IgA) test kit is intended for the qualitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.

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This is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically an ELISA test. These types of clearances typically do not involve the kind of AI/ML performance acceptance criteria and study designs described in the prompt. The information requested, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance for AI, are not applicable to the clearance of this type of device.

Instead, for IVD devices like the Anti-Gliadin (GAF-3X) ELISA (IgA), the acceptance criteria and supporting studies usually focus on analytical performance (e.g., sensitivity, specificity, accuracy against a predicate device or clinical diagnosis), precision, linearity, and interference studies.

Therefore, I cannot provide the requested information in the format of the prompt because it describes criteria and studies relevant to AI/ML medical devices, not to an ELISA test cleared via a 510(k) pathway as described in the provided document.

The document indicates:

• Device Name: Anti-Gliadin (GAF-3X) ELISA (IgA)
• Intended Use: Qualitative determination of IgA class antibodies against gliadin in human serum as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.
• Regulatory Class: II
• Product Code: MST
• Predicate Device: Not explicitly detailed in the provided excerpt, but it is implied that the device demonstrates substantial equivalence to a legally marketed predicate.

To provide information analogous to the prompt's request for an IVD ELISA test, one would look for data on diagnostic sensitivity, specificity, and agreement with a reference method or predicate device, typically found in the 510(k) summary if available, or the full submission. However, this level of detail is not present in the provided FDA clearance letter itself.

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These assays are designed for the in-vitro measurement of specific IgG or IgA antibodies against a modified gliadin peptide (MGP) in human serum, as an aid in the diagnosis of coeliac disease in conjunction with other clinical and laboratory findings.

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I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is an FDA 510(k) clearance letter for the BINDAZYME™ Human Anti-Gliadin (MGP) IgG/IgA EIA Kits, which indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the letter does not include:

• A table of acceptance criteria and reported device performance.
• Information about specific studies conducted to prove the device meets acceptance criteria.
• Details on sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for either test or training sets.

This type of information is typically found in the 510(k) submission itself, which is a much more comprehensive document than the clearance letter provided. The clearance letter is merely the FDA's decision based on its review of that submission.

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