(58 days)
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
| Acceptance Criteria (Inferred) | Reported Device Performance (Trinity Biotech H. pylori IgG ELISA) |
|---|---|
| Sensitivity relative to biopsy: Comparable to predicate (98.5%) | 96.4% (95% CI: 94.1% - 98.8%) |
| Specificity relative to biopsy: Comparable to predicate (98.1%) | 96.1% (95% CI: 92.3% - 99.9%) |
| Agreement relative to biopsy: Comparable to predicate (98.4%) | 96.4% (95% CI: 94.4% - 98.3%) |
| % Agreement positive relative to predicate: High agreement expected | 99.2% (95% CI: 98.1% - 100%) |
| % Agreement negative relative to predicate: High agreement expected | 97.0% (95% CI: 93.6% - 100%) |
| Overall % Agreement relative to predicate: High agreement expected | 98.6% (95% CI: 97.3% - 99.8%) |
| Precision (Coefficient of Variation - CV): Low variability expected across intra- and inter-assays, generally below a certain threshold. | Ranges from 4.75% to 67.0% (intra-assay) and 6.06% to 38.8% (inter-assay) |
| Cross-Reactivity: No significant cross-reactivity with closely related organisms (C. jejuni, C. fetus, Borrelia burgdorferi). | No rise in antibody for C. jejuni paired sera, negative responses for C. fetus and Borrelia burgdorferi. |
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
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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.
- Pylori Stat (Predicate Device) Evaluation: 386 serum samples.
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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.
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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.
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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.
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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.
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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."
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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.
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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.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).