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The PREMIER Platinum HpSA PLUS 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 and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

The PREMIER Platinum HpSA® PLUS test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool. The test utilizes a plurality (mixture) of monoclonal antibodies adsorbed to microwells. Diluted patient samples and an enzyme conjugate reagent are added to the microwells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for 10 minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically. No calculations are required and the visual color change makes the interpretation of results objective and simple.

In addition, the HpSA test permits assessment of established or novel anti-H. pylori treatment during and posttherapy to monitor for treatment effectiveness, relapse or eradication.

PREMIER Platinum HpSA PLUS (K053335), as the predicate device for this submission, was a modification of PREMIER Platinum HpSA (K983255, K980076) that provided increased signal strengths with positive test results and better discrimination between low positive and negative tests. This submission is for modifications to the antibodies used in the microwells and conjugate reagent.

The PREMIER Platinum HpSA PLUS assay is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool, intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy.

Here's the breakdown of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The modification being assessed is to the antibodies used in the microwells and conjugate reagent of the PREMIER Platinum HpSA® PLUS. The relevant performance characteristics for comparison are based on the predicate device.

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

• Sample Size for Clinical Study: 159 archived, unpreserved stool samples.
• Data Provenance: The samples were from symptomatic patients but no country of origin is specified. The samples were "archived," indicating a retrospective study.

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

The documentation does not provide details on the number or qualifications of experts used to establish the ground truth for this specific clinical study comparing the modified device to the predicate. The "ground truth" for this comparison was the result obtained from the predicate device itself.

4. Adjudication Method for the Test Set

Not applicable. The study involved a direct comparison of the modified device's results against the predicate device's results. There was no independent adjudication of individual cases against an external ground truth in the traditional sense, as the predicate served as the reference.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic (EIA) test for detecting antigens, not an imaging or diagnostic aid that involves human readers interpreting results in a variable manner. The interpretation of results is visual or spectrophotometric, implying a more objective, less reader-dependent outcome.

6. Standalone Performance Study

Yes, a standalone performance of the modified device was effectively demonstrated by comparing its results against the predicate device on the same set of samples. The performance metrics (sensitivity, specificity, reproducibility, analytical sensitivity, cross-reactivity, interfering substances) are all measures of the algorithm's (or device's) standalone performance under specified conditions.

7. Type of Ground Truth Used

For the clinical study, the ground truth was established by the predicate device (PREMIER Platinum HpSA® PLUS K053335). The study aimed to demonstrate substantial equivalence by showing agreement between the modified device and the predicate. For analytical studies, the ground truth was based on controlled experimental conditions (e.g., known concentrations of H. pylori protein for LoD, known presence/absence of microorganisms for cross-reactivity, known interfering substances).

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. The PREMIER Platinum HpSA PLUS is an enzyme immunoassay, implying a deterministic chemical reaction, not a machine learning algorithm that requires a separate training phase. The development of the device would involve optimization and internal testing, which might be analogous to model training, but these details are not provided in terms of sample size or methodology.

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

As noted above, there's no mention of a traditional "training set" in the context of an EIA device. The "ground truth" during initial development and optimization would have been established through controlled experiments using known concentrations of H. pylori antigens and various other substances (cross-reactants, interferents) to characterize the assay's performance and specificity. This would involve laboratory standards and analytical methods to confirm the composition of samples.

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The Premier Platinum HpSA PLUS 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 and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

Premier Platinum HpSA PLUS is an in vitro diagnostic, microwell-based, enzymelinked immunoassay for the detection of Helicobacter pylori antigen in human stool. The assay is intended for use in clinical laboratories to test for bacterial colonization to aid diagnosis, or monitor a patient's response during therapy to eradicate infection. The assay consists of Microwells coated with specific antibodies (solid phase/capture antibodies), Enzyme Conjugate (detector antibodies), Sample Diluent, Premier 20X Wash Buffer I, Premier Substrate Solution I, Premier Stop Solution I and Positive Control. Sample Diluent also functions as the Negative Control reagent.

No calibrators are needed to use this device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Premier Platinum HpSA PLUS device:

Device Acceptance Criteria and Performance Study Analysis

The submission describes the Premier Platinum HpSA PLUS, an in vitro diagnostic enzyme immunoassay (EIA) for detecting H. pylori antigen in human stool. The primary goal of the submission is to demonstrate substantial equivalence to a predicate device, Premier Platinum HpSA.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as a separate section with predefined targets. Instead, the study aims to demonstrate that the new device performs "similarly" to the predicate, and that certain analytical performance characteristics are met. Based on the provided text, I've inferred the acceptance criteria from the reported performance and the comparisons made to the predicate or industry standards like EP12-A.

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

• Test Set (Clinical Comparison): 291 samples from symptomatic patients.
  • Data Provenance: Not explicitly stated, but collected from "symptomatic patients" suggesting a clinical setting. It is retrospective as 33 of these samples were originally evaluated in an earlier trial for the predicate device.
• Test Set (Reproducibility): 2 high positive, 2 low negative, 1 low positive, and 1 high negative specimen in a reference panel, with 9 replicates each of the low positive and high negative samples, bringing the total cohort to 22 reference specimens.
  • Data Provenance: Prepared from "archival specimens" and tested in "three different laboratories." This indicates a controlled, retrospective, and multi-site analytical study.
• Test Set (Interference Testing): 5 known H. pylori-positive and 5 known negative samples for drug interference; an unspecified number of samples for microbial/viral interference.
  • Data Provenance: Laboratory-controlled spike-in experiments, prospective in nature for the study itself, using known positive/negative samples.

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

There were no experts used to establish ground truth in the traditional sense for the clinical comparison. Instead, "other conventional tests such as CLO, Histology, or UBT" were used to arbitrate discordant results between the new device and the predicate. The qualifications of those performing these conventional tests are not specified.

4. Adjudication Method for the Test Set

For the clinical comparison, when results between Premier Platinum HpSA PLUS and the predicate were discordant, they were adjudicated against "test data from other conventional tests such as CLO, Histology, or UBT to determine the trueness of the results." This implies a form of external reference standard adjudication, rather than a consensus among human readers of the device output. It's not a 2+1 or 3+1 method directly related to human interpretation of the device results, but rather a comparison to established diagnostic methods.

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 study was done, nor is this an AI/human-in-the-loop device. It is a laboratory-based enzyme immunoassay. The comparison is between two similar lab tests.

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

Yes, this is a standalone device. Its performance characteristics are reported as the output of the assay itself, interpreted quantitatively (OD readings) against a predefined cutoff. There is no human interpretation component in the sense of a radiologist reading an image or a pathologist reviewing a slide that would then be assisted by AI.

7. The Type of Ground Truth Used

• Clinical Comparison (for discordant results): A combination of other conventional diagnostic tests for H. pylori infection (CLO, Histology, UBT). These serve as the de facto "ground truth" to determine if the device's results are true positives/negatives.
• Analytical Sensitivity (Limit of Detection): Purified antigens and bacterial strains, where known concentrations were spiked, serving as a controlled, known standard.
• Interference Testing: Known H. pylori-positive and negative samples spiked with various substances/microbes, representing a known state (positive/negative for H. pylori, plus presence of interferent).
• Reproducibility: A reference panel with defined states (high positive, low positive, high negative, low negative), serving as a known standard.

8. The Sample Size for the Training Set

No specific training set is mentioned as this device is not an AI/machine learning algorithm that requires a training phase. It is a traditional immunoassay.

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

Not applicable, as there is no training set for this type of device.

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