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The Diamedix Is anti-Gliadin IgA Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgA antibodies to gliadin in human serum as an aid in the diagnosis of celiac disease. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor

The Is anti-Gliadin IgA Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgA antibodies to gliadin in human serum

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific threshold percentages for sensitivity, specificity, or agreement. Instead, it presents the calculated performance metrics and implies their acceptance through the 510(k) clearance.

Here's a table summarizing the reported performance, with implied "acceptance criteria" being the demonstrated values:

2. Sample Sizes and Data Provenance

• Relative Sensitivity and Specificity Study (Comparison to predicate device):
  • Sample Size: 190 frozen retrospective sera.
  • Data Provenance: Not explicitly stated by country, but mentions "samples submitted to a large reference laboratory for celiac disease evaluation." This suggests a clinical laboratory setting, likely within the US given the submission to the FDA. The data is retrospective.
• Clinical Sensitivity and Specificity Study:
  • Sample Size: 484 frozen retrospective, clinically characterized sera.
  • Data Provenance: Not explicitly stated by country, but sourced from "214 normal sera, 72 sera from patients with possible celiac disease... 61 sera from patient with diagnosed celiac disease, 54 sera from patients with other gastrointestinal diseases, etc." This suggests a clinical setting, likely within the US. The data is retrospective.
• Correlation of Manual and MAGO Plus results:
  • Sample Size: 177 serum samples.
  • Data Provenance: Not specified, but implied to be from the same development/testing location.
• Precision Study:
  • Sample Size: 6 serum samples tested in triplicate in three separate runs (total of 9 measurements per sample for inter-assay determination).
  • Data Provenance: Not specified.
• Expected Values (Normal Population):
  • Sample Size: 148 S. Florida blood donors.
  • Data Provenance: South Florida, USA; prospective (testing for prevalence in a specific healthy population).
• Expected Values (Clinical Population):
  • Sample Size: 61 sera from patients with celiac disease.
  • Data Provenance: Not explicitly stated, likely related to the clinical sensitivity study samples.

3. Number of Experts and Qualifications (for Ground Truth)

• Relative Sensitivity and Specificity Study:
  • Ground truth was based on a "commercially available ELISA kit for detecting gliadin IgA antibodies" (the predicate device) and "a referee EIA method" for discordant samples. No human experts are explicitly mentioned for establishing ground truth in this section, as it's a comparison to other assays.
• Clinical Sensitivity and Specificity Study:
  • The sera were "clinically characterized," and for "Diagnosed Celiac Disease," it implies a prior clinical diagnosis. For "Normals," it's understood they are healthy individuals based on clinical assessment.
  • The document does not specify the number or qualifications of experts involved in establishing the clinical characterization or diagnosis for the retrospective samples.

4. Adjudication Method for the Test Set

The adjudication methods for establishing ground truth for the test sets are as follows:

• Relative Sensitivity and Specificity Study: Discordant samples between the investigational device and the predicate device were adjudicated using "a referee EIA method." This implies an independent, tertiary test for conflict resolution rather than human expert consensus.
• Clinical Sensitivity and Specificity Study: The "clinically characterized sera" implies that patients were categorized based on established clinical diagnostic criteria for celiac disease or other conditions, potentially involving biopsies, clinical symptoms, and other serological markers, but a specific "adjudication method" (e.g., 2+1 physician review) is not detailed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The device is a diagnostic assay (ELISA), not an imaging or interpretive AI system that typically involves human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire performance evaluation (Relative Sensitivity/Specificity, Clinical Sensitivity/Specificity, Precision, Correlation with automation) assesses the algorithm's performance (in this case, the assay's performance) as a standalone diagnostic tool without human-in-the-loop assistance in the interpretation of the primary result. The output is a semi-quantitative measurement of IgA antibodies.

7. Type of Ground Truth Used

The types of ground truth used are:

• Relative Sensitivity and Specificity Study: Comparison against a predicate commercial ELISA kit for anti-gliadin IgA antibodies and a "referee EIA method" for discordant samples. This is a form of comparative ground truth against established assays.
• Clinical Sensitivity and Specificity Study: Clinical characterization/diagnosis of patients (e.g., "Diagnosed Celiac Disease," "Normals," "Other Gastrointestinal Diseases"). This relies on a combination of clinical outcomes, other diagnostic tests, and physician diagnosis, which can be considered a form of clinical ground truth or patient outcomes ground truth.

8. Sample Size for the Training Set

The document does not mention or specify a separate training set for the device. This device is an in-vitro diagnostic (IVD) ELISA assay, not a machine learning or AI algorithm that typically requires a distinct training phase on a large dataset. The performance studies evaluate its diagnostic capabilities on test sets.

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

Since a distinct "training set" is not described for this type of device, the method for establishing its ground truth is not applicable. The development and optimization of such assays typically involve internal R&D validation using characterized samples, but this is not explicitly outlined as a "training set" in the context of this 510(k) submission.

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