(124 days)
The Premier Platinum HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection in adult symptomatic patients.
The Premier Platinum HpSA test utilizes polyclonal anti-H. pylori capture antibody adsorbed to microwells. Diluted patient samples and a peroxidase conjugated polyclonal antibody are added to the wells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for ten minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.
Here's a breakdown of the acceptance criteria and study details for the Premier Platinum HpSA device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the overall performance evaluation. They aim to demonstrate that the Premier Platinum HpSA test is "substantially equivalent" to existing methods for detecting H. pylori.
| Performance Metric | Acceptance Criteria (Implied/Predicate) | Reported Premier Platinum HpSA Performance (Compiled Data) |
|---|---|---|
| Sensitivity | ~95.4% (89.6-98.5%) (from predicate CLOtest) or demonstrating high clinical agreement | 96.1% (90.4-98.9%) |
| Specificity | ~100.0% (96.4-100.0%) (from predicate CLOtest) or demonstrating high clinical agreement | 95.7% (89.5-98.8%) |
| Correlation | ~97.6% (94.5-99.2%) (from predicate CLOtest) or demonstrating high clinical agreement (95.9% desired) | 95.9% (92.2-98.2%) |
Note: The document explicitly states, "The differences in technology does not raise additional concerns regarding safety and effectiveness. Safety and effectiveness are demonstrated to be substantially equivalent." This indicates that the reported performance metrics for the Premier Platinum HpSA were considered sufficient to meet the acceptance criteria by demonstrating equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 200 symptomatic adults were evaluated in the clinical study. Nine patients were considered unevaluable, meaning the effective sample size for performance calculations was 191 (99 infected, 90 not infected, plus 2 'Equ' and 1 'Equ' at site 3, 2 'Equ' at site 4, which were excluded from the main table's infected/not infected counts but are implicitly part of the overall 200 evaluated).
- Data Provenance: The data was collected prospectively from four sites:
- One midwestern United States location
- One site in Canada
- Two sites in Italy
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications directly. However, it states that the diagnosis of H. pylori infection (ground truth) was "judged by objective reference methods." These reference methods are:
- Culture
- Rapid Urease Test (RUT)
- Histology
- Urea Breath Test (UBT)
It's implied that these objective reference methods were interpreted by qualified personnel (e.g., microbiologists for culture, pathologists for histology, and trained technicians for RUT and UBT), but no specific number or detailed qualifications are provided.
4. Adjudication Method for the Test Set
Patients were considered H. pylori positive if:
- Culture was positive, OR
- Two or more of the other three tests (Rapid Urease, Histology, UBT) were positive.
Patients were considered unevaluable if:
- They had negative or no culture results, AND
- Only one other test (RUT, Histology, UBT) was positive.
This acts as a consensus-based adjudication method for establishing the ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study compares the Premier Platinum HpSA test (an in vitro diagnostic device) against established diagnostic reference methods for H. pylori infection (the ground truth), not against human readers with and without AI assistance. The device in question is a laboratory assay, not an AI-powered image analysis tool for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The Premier Platinum HpSA test is a standalone in vitro diagnostic device. Its performance metrics (Sensitivity, Specificity, Correlation) are reported for the device itself, functioning independently, with results interpreted visually or spectrophotometrically. There is no "human-in-the-loop" component in the direct processing of the sample by the device; rather, it's a lab test where technicians perform the procedure and interpret the final result based on established cutoffs.
7. The Type of Ground Truth Used
The ground truth used was a composite reference standard based on objective laboratory and pathological evidence. Specifically, it relied on a combination of:
- Culture
- Rapid Urease Test (RUT)
- Histology
- Urea Breath Test (UBT)
A patient was considered positive if culture was positive, or if two or more of the other three tests were positive. This is referred to as expert consensus (albeit on objective data) or composite clinical diagnosis.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This device is an immunoassay, not a machine learning model that typically requires a distinct training phase. Therefore, the concept of a "training set" in the context of AI models does not apply here. The performance evaluation is based on a clinical test set.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no mention of a "training set" for this immunoassay device. The ground truth for the test set was established using a composite reference standard (Culture, Rapid Urease, Histology, UBT) as detailed in point 7.
§ 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).