(217 days)
The Trinity Biotech Uni-Gold™ H. pylori assay is intended for the rapid in vitro qualitative detection of IgG antibodies to Helicobacter pylori (H. pylori) in adult human serum, plasma, or whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease.
As the sample flows laterally through the membrane, the specific antibody bindingprotein dye conjugate binds to the human immunoglobulins in the sample. If the sample contains IgG antibodies to H. pylori, the complex binds to the antigens on the solid phase of the device's test region producing a red/pink (red) line. In the absence of H. pylori antibodies, no line appears in the test region of the device. A procedural-functional control is built in to each device. As the sample migrates across the control region, the appearance of a red line at the control region indicates correct procedure and a functional device.
This document describes the Uni-Gold™ H. pylori test kit, a rapid in-vitro qualitative immunoassay for detecting IgG antibodies to Helicobacter pylori in adult human serum, plasma, or whole blood.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
While explicit acceptance criteria are not stated as numerical thresholds (e.g., "sensitivity must be >X%"), the study's goal was to demonstrate "substantial equivalence" and "accuracy." Given the results, it can be inferred that performance around these reported accuracy metrics was deemed acceptable by the FDA for substantial equivalence to the predicate device.
| Performance Metric | Implied Acceptance Criteria (Inferred from Study Results) | Reported Device Performance (Uni-Gold™ H. pylori test kit) |
|---|---|---|
| Clinical Sensitivity | (Not explicitly stated, but around 83%) | 83% (136/164 positive samples correctly identified) |
| Clinical Specificity | (Not explicitly stated, but around 83%) | 83% (152/184 negative samples correctly identified) |
| Overall Accuracy | (Not explicitly stated, but around 83%) | 83% |
| Cross-Reactivity | No cross-reactivity with tested organisms and substances | No cross-reactivity observed |
| Sample Stability | Accurate results within specified storage conditions | Accurate for serum/plasma at 2-8℃ for 3 days; -20°C longer |
| Hematocrit Effects | Accurate results within physiological range | Accurate with hematocrits 39% to 53% |
| Matrix Equivalence | Equivalent results across matrices | Equivalent results in whole blood, serum, and plasma |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 348 clinical samples (164 positive and 184 negative based on biopsy results).
- Data Provenance: The clinical trials were performed at three independent sites in the USA, Canada, and Sweden. This indicates a prospective and multi-site collection with a mixed population (race, sex, age) of patients presenting with gastrointestinal symptoms.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish the ground truth for the test set, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the ground truth was established by "gastric biopsy for culture and histology for the detection of H. pylori infection." This implies medical professionals (pathologists, microbiologists) involved in the analysis of these biopsy samples.
4. Adjudication Method for the Test Set
The adjudication method for the biopsy results (ground truth) was defined as follows:
- Biopsy "positive": Culture and histology positive OR culture positive.
- Biopsy "negative": Negative for both culture and histology OR negative for culture.
This is a specific rule-based adjudication method rather than an expert consensus voting method (like 2+1 or 3+1). It establishes a clear hierarchy and condition for positivity and negativity based on multiple diagnostic tests.
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 MRMC comparative effectiveness study was mentioned. This device is a rapid diagnostic test kit, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting images. Therefore, the concept of human readers improving with or without AI assistance does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The Uni-Gold™ H. pylori test kit is a physical diagnostic device, and its performance (sensitivity, specificity, accuracy) was evaluated independently against the biopsy gold standard. There is no "human-in-the-loop" once the sample is applied and the test runs; the interpretation is visual (presence/absence of a red line) and inherent to the device's design.
7. The Type of Ground Truth Used
The primary ground truth used was biopsy results, specifically defined as:
- Biopsy positive: Culture and histology positive OR culture positive.
- Biopsy negative: Negative for both culture and histology OR negative for culture.
Additionally, an ELISA assay was used to evaluate 60 discrepant results between the Uni-Gold™ test and the biopsy, indicating a secondary, corroborative ground truth in ambiguous cases, although the primary ground truth remained the biopsy.
8. The Sample Size for the Training Set
The document does not provide information on a separate training set. For rapid diagnostic test kits like this, the development process typically involves internal optimization and validation with various panels of known positive and negative samples, rather than a distinct "training set" in the machine learning sense. The 348 clinical samples tested are referred to as the "clinical data" used to determine the device's accuracy, essentially serving as a validation or test set.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set is identified, the method for establishing its ground truth is not described. However, it can be inferred that any samples used during the development and optimization phases would have had their H. pylori status confirmed by established laboratory methods, likely similar to or including culture, histology, or reference serological tests.
§ 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).