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The Trinity Biotech Captia™ H. pylori IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to Helicobacter pylori, as an aid in the diagnosis of H. pylori infection in adult patients with clinical signs and symptoms of gastrointestinal disease, and is not intended for use in asymptomatic patients.

The H. pylori IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to antigen. The Trinity Pylori IgG ELISA assay may be used as an aid in the diagnosis of Helicobacter pylori infection in persons with gastrointestinal symptoms. For In Vitro Diagnostic Use Only.

The H. pylori IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Helicobacter pylori. Purified Helicobacter pylori antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

The provided document is a 510(k) premarket notification for the Trinity Biotech H. pylori IgG ELISA test kit. It describes the device, its predicate device, and performance characteristics, but does not explicitly state formal acceptance criteria. However, we can infer the performance targets based on the comparison to the predicate device and the presented results.

Here is an analysis based on the provided information:

Acceptance Criteria and Reported Device Performance

Note on Inferred Acceptance Criteria: The document primarily demonstrates substantial equivalence to "biopsy" (culture or stain) and to a predicate device (Pylori Stat). Therefore, the "acceptance criteria" are implicitly met if the performance characteristics are deemed substantially equivalent to these established methods. The exact numerical thresholds for acceptance are not explicitly listed, but the device's performance falling within the confidence intervals and showing high agreement suggests it met the unstated bar for equivalence.

Study Details

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

   • Pylori Stat (Predicate Device) Evaluation: 386 serum samples.
     • Data Provenance: From five geographically different areas.
     • Retrospective/Prospective: Not explicitly stated, but samples were "having biopsy with stain or culture results," suggesting a retrospective collection of samples with known outcomes.
   • Trinity Biotech H. pylori IgG ELISA Evaluation: 371 serum samples.
     • Data Provenance: From five geographically different areas.
     • Retrospective/Prospective: Not explicitly stated, but samples were "having biopsy with stain or culture results," suggesting a retrospective collection of samples with known outcomes.
   • Precision Test: Six different serum samples, each tested ten times over three days (total of 180 individual tests for CV calculation).
   • Cross-Reactivity Test: Paired sera from 5 C. jejuni infections, 4 single sera from C. fetus infections, and 10 sera positive for Borrelia burgdorferi.

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

   • The ground truth for the test set was established by "biopsy with stain or culture results for H. pylori."
   • The document does not specify the number of experts, their qualifications (e.g., pathologist, microbiologist), or the process involved in interpreting these biopsy/culture results.

3. Adjudication method for the test set:

   • The document explicitly states that "Equivocals were not included in the above calculations" for sensitivity, specificity, and agreement calculations. This implies that any samples yielding "equivocal" results from the ELISA tests were excluded from the primary performance metrics. There is no mention of an adjudication process to re-classify these equivocal results or conflicting ground truth interpretations.

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 report describes the performance of an in vitro diagnostic (IVD) ELISA kit, which is a laboratory test, not an AI-assisted diagnostic tool for human readers. Therefore, there is no "human readers improve with AI vs without AI assistance" component.

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

   • Yes, a standalone performance study was done. The entire evaluation of the Trinity Biotech H. pylori IgG ELISA against biopsy and against the predicate device is a standalone performance assessment of the diagnostic kit itself, without human interpretation influencing the test result once the serum is processed by the ELISA method. The "interpretation" of the ELISA results (positive, negative, equivocal) is inherent to the kit's design and predetermined cut-offs.

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

   • The primary ground truth used was pathology in the form of "biopsy with stain or culture results for H. pylori."
   • For cross-reactivity, ground truth for C. jejuni and C. fetus was established by "culture" (fecal culture on Campylobacter-specific media for C. jejuni, blood culture for C. fetus). For Borrelia burgdorferi, it was "positive for antibodies by ELISA and Western Blot."

7. The sample size for the training set:

   • The document does not mention a training set in the context of an algorithm or machine learning model. This is an ELISA kit, which is a biochemical assay with established protocols and reagents. Its "training" is more akin to assay development and optimization, rather than a data-driven machine learning training phase. The described studies are performance validation studies.

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

   • As there is no explicit training set in the context of an algorithm, this question is not applicable. The development and optimization of such a kit would rely on known positive and negative samples, but these are part of the assay development, not a "training set" with ground truth in the current sense of diagnostic AI.

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The Wampole Pylori IgG ELISA assay may be used as an aid in the diagnosis of Helicobacter pylori infection in persons with gastrointestinal symptoms. For In Vitro Diagnostic Use Only.

The Pylori IgG ELISA kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative determination of IgG antibodies in human serum to Helicobacter pylori antigen. The Pylori IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Helicobacter pylori. Purified Helicobacter pylori antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled antihuman IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds. Instead, it presents the performance characteristics of the Pylori IgG ELISA and the previously evaluated Pylori Stat, with the underlying implication that the Pylori IgG ELISA's performance is deemed acceptable relative to the Pylori Stat and biopsy.

Based on the provided data, we can infer the achieved performance:

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

• Pylori IgG ELISA Test Set Sample Size: 371 serum samples
• Pylori Stat (predicate device) Test Set Sample Size: 386 serum samples
• Data Provenance (Both devices):
  • Country of Origin: Not explicitly stated, but mentioned as "five geographically different areas."
  • Retrospective or Prospective: Not explicitly stated. However, the use of "serum from patients" and existing biopsy results suggests a retrospective analysis of collected samples.

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

This information is not provided in the document. The ground truth was established by "biopsy with stain or culture results for H. pylori." The number of pathologists/microbiologists interpreting these biopsies and their qualifications are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided in the document. It only states that equivocal results were not included in the sensitivity and specificity calculations.

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

This is not applicable. The device is an immunoassay (ELISA kit) for detecting antibodies, not an AI-powered diagnostic tool that assists human readers. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

Yes, a standalone performance evaluation of the Pylori IgG ELISA was done. The device directly produces results (qualitative determination of IgG antibodies), and its performance metrics (sensitivity, specificity, agreement) were calculated independently against the biopsy ground truth. This is the inherent nature of an ELISA test.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation was: Biopsy with stain or culture results for H. pylori. This combines histological and microbiological evidence.

8. The Sample Size for the Training Set

This information is not provided. The document describes the evaluation of the Pylori IgG ELISA and its predicate, Pylori Stat, which implies they are already developed products. There is no mention of a "training set" in the context of developing the ELISA assay, as it's a biochemical test, not a machine learning algorithm.

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

This information is not applicable/provided for the reasons stated in point 8.

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