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The Premier HpSA Flex enzyme immunoasay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The test is intended for use with unpreserved stool specimens or preserved stool specimens in transport media. 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.

Meridian Bioscience has modified its FDA-cleared PREMIER Platinum HpSA® PLUS assay (K182559), a qualitative, in vitro diagnostic test for the detection of Helicobacter pylori antigens present in unpreserved human stool specimens. This modification, to be marketed under new device trade name Premier HpSA® Flex upon FDA clearance, is the addition of a new specimen type claim to the intended use of the previously cleared device (K182559) whereby specimens may be preserved in Cary-Blair or Culture and Sensitivity (C&S) transport media.

The Premier HpSA Flex test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool specimens, either unpreserved in transport media. The test uilizes a plurality (mixture) of monoclonal anti-H. pylori capture 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.

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text.

Acceptance Criteria and Device Performance

The core of this submission is about adding a new specimen type claim (preserved stool in Cary-Blair or C&S transport media) to an already FDA-cleared device. Therefore, the "acceptance criteria" revolve around demonstrating that the device performs equivalently with these new specimen types as it did with the original unpreserved stool and that the performance remains robust.

Here's a summary of the performance characteristics presented as implicit acceptance criteria and the reported device performance:

Study Details

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

   • Analytical Sensitivity (LoD): Not explicitly stated how many samples per lot were used in the LoD study, but it mentions "Three lots" and "positive results >= 95% of the time."
   • Precision/Reproducibility: 360 samples (10 panels x 12 blinded samples x 3 laboratories). The samples were "contrived stool samples" with H. pylori antigen spiked in. Data provenance is implied to be domestic (USA) due to the submission context, and it's a prospective study looking at controlled, contrived samples.
   • Preserved Specimen Storage Stability: Not explicitly stated how many samples were used, but the study was designed to validate stability claims.
   • Freeze/Thaw Stability: Not explicitly stated how many samples were used.
   • Analytical Specificity/Interference: Not explicitly stated how many samples were used, but testing was performed in the presence of various substances.
   • Analytical Specificity/Cross-reactivity: Not explicitly stated how many samples were used, but each organism was tested with a true negative and a contrived low positive sample at specified concentrations.
   • Method Comparison (Clinical Performance): 200 archived stool specimens were enrolled, of which 182 were evaluable and used for the comparison. Data provenance is of archived specimens from patients, suggesting retrospective data. The specific country of origin is not mentioned.

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

   • This device is an in-vitro diagnostic (IVD) for detecting antigens, not an imaging device requiring expert interpretation for ground truth.
   • For the Precision/Reproducibility study, "expected assay result" was used as ground truth for contrived samples. This implies the ground truth was based on the known concentration of spiked antigen.
   • For the Method Comparison study, the comparison was against an "FDA-cleared comparator device" and "Standard of Care (SoC) testing using an FDA-cleared commercial assay." The "ground truth" for clinical performance appears to be established by the results of these existing FDA-cleared methods. No human expert consensus was used to define the ground truth for individual samples.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • No human adjudication method was mentioned or implied, as the device is an IVD detecting antigens, and ground truth was established either by known concentrations in contrived samples or by results from existing FDA-cleared assays.

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 MRMC comparative effectiveness study was conducted. This type of study is typically performed for AI-assisted diagnostic imaging devices where human interpretation directly impacts results. This device is an immunoassay (IVD).

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

   • Yes, the performance data provided (LoD, Reproducibility, Interference, Cross-reactivity, Method Comparison) represent the standalone performance of the Premier HpSA Flex assay. It's an automated or semi-automated EIA, not an algorithm requiring human interaction for its direct output.

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

   • For analytical performance studies (LoD, Precision, Interference, Cross-Reactivity), the ground truth was known concentrations of H. pylori antigen in contrived samples or known presence/absence of interfering/cross-reacting substances/organisms.
   • For the method comparison (clinical performance), the ground truth was established by results from an FDA-cleared comparator device and Standard of Care (SoC) testing using an FDA-cleared commercial assay.

7. The sample size for the training set:

   • This is a traditional in-vitro diagnostic device (immunoassay), not a machine learning/AI algorithm that requires a "training set" in the conventional sense. The device's components and parameters are developed through standard chemistry and assay development processes, not through iterative training on a dataset.

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

   • As stated above, there is no "training set" for an immunoassay in the context of AI/ML. The "ground truth" for the development of the assay itself would align with standard analytical validation methods, ensuring the assay accurately detects the target analyte (H. pylori antigens) at various concentrations and in the presence of relevant interferents, against known standards.

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