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The ACON® H. pylori Rapid Test Strip and ACON® H. pylori Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of antibodies specific to H. pylori in human whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. They are intended for healthcare professionals and professionals at point of care sites only.

The ACON® H. pylori rapid Test Strip and ACON® H. pylori rapid Test Device are lateral flow immunochromatographic assays for the qualitative detection of IgG antibodies specific to Helicobacter pylori in whole blood, serum or plasma. They utilize H. pylori antigen coated particles and immobilized anti-human IgG to selectively detect elevated levels of IgG antibodies to H. pylori. These tests can be performed without the use of an instrument.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to predicate devices and the clinical performance data provided. The device aims to demonstrate "substantial equivalence" to the predicate devices. The performance is reported as agreements (positive, negative, and overall) with predicate devices, and sensitivity, specificity, and accuracy against "Culture/Histology" and "Histology/Rapid Urease Test" as the ground truth.

ACON® H. pylori Rapid Test Strip:

ACON® H. pylori Rapid Test Device:

The study concludes that the ACON H. pylori Rapid Test Strip and Test Device are "substantially equivalent" to the predicate devices and "suitable for professional and point-of-care use", indicating that the reported performance met the acceptance criteria for regulatory clearance. Specific numerical thresholds for acceptance criteria are not explicitly stated beyond achieving substantial equivalence.

2. Sample size used for the test set and the data provenance

A total of 484 clinical specimens were used for the clinical evaluation of accuracy.

The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth (Culture/Histology or Histology/Rapid Urease Test).

4. Adjudication method for the test set

The document does not specify the adjudication method used for the test set results. The comparison is made against existing diagnostic methods (predicate devices and ground truth methods), implying that the results from these methods were considered definitive.

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

This is not applicable. The device is an immunochromatographic rapid test for the detection of antibodies to H. pylori. It is a standalone diagnostic test, not an AI-assisted tool for human readers. Therefore, an MRMC study related to human reading improvement with AI assistance was not performed.

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

Yes, a standalone performance study was done. The ACON® H. pylori Rapid Test Strip and Device are described as "immunoassays" that "can be performed without the use of an instrument" and provide "Colored Lines" as the endpoint. This indicates that the reported performance reflects the device's inherent ability to detect H. pylori antibodies qualitatively, independent of subjective human interpretation beyond visual confirmation of colored lines. The accuracy studies compare the device's results directly against established diagnostic methods.

7. The type of ground truth used

The ground truth used for performance validation was a combination of:

• Culture/Histology
• Histology/Rapid Urease Test

Additionally, the devices' performance was compared against two predicate devices:

• Quidel QuickVue One-Step H. pylori gII Test
• Beckman Coulter FlexSure HP

8. The sample size for the training set

The document does not specify the sample size for a training set. As this is a rapid immunochromatographic test, rather than a machine learning algorithm, the concept of a "training set" in the context of AI models is not directly applicable. The device's formulation and design are developed through analytical studies, but this process is distinct from the algorithmic training of AI. The provided data focuses on clinical validation.

9. How the ground truth for the training set was established

This is not applicable as there is no explicitly defined "training set" in the context of an AI algorithm described for this device. The ground truth for the clinical evaluation (test set) was established through Culture/Histology and Histology/Rapid Urease Test.

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