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The RAPIRUN H. pylori Antibody Detection Kit is a rapid immunochromatographic assay intended for the qualitative detection of antibodies against Helicobacter pylori (H. pylori) in urine to aid in the diagnosis of H. pylori infection. The RAPIRUN Kit is suitable for use in both point-of-care and clinical laboratory settings.

The RAPIRUN H. pylori Antibody Detection Kit is an immunochromatographic method for the qualitative detection of anti-H. pylori antibodies in urine using a nitrocellulose membrane immobilized with proteins extracted from H. pylori as an antigen. The test device includes a sample window in which the test specimen is placed in a dropwise manner and an evaluation window in which a test line and a control line are visible. Colloidal gold-conjugated anti-human IgG (Fc) polyclonal antibody (goat) is present between the sample window and the evaluation window. The test line and the control line in the evaluation window are immobilized with H. pylori-extracted protein and with anti-human IgG polyclonal antibodies (goat), respectively.

When a urine specimen diluted with the sample diluent is added dropwise to the sample window, the IgG in the diluted sample reacts with the conjugated antibodies. Immunocomplexes are formed and flow into the nitrocellulose membrane. If anti-H. pylori IgG antibody complexes are present in these immunocomplexes, they react with the H. pylori antigen immobilizing on the test line and are captured producing a red band. On the other hand, immunocomplexes without anti-H. pylori IgG antibodies pass the test line and are captured by the anti-human IgG polyclonal antibodies (goat) immobilizing on the control line producing a red band. A test specimen is judged to be positive for anti-H. pylori antibodies if red colored bands appear in both the test zone and the control zone, or is judged to be negative for anti-H. pylori antibodies if a red colored band only appears in the control zone.

Here's a breakdown of the acceptance criteria and study details for the RAPIRUN H. pylori Antibody Detection Kit, based on the provided text:

Acceptance Criteria and Device Performance

• Note: The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds that were required for clearance. Instead, it presents the results of the clinical study, which are then used to demonstrate substantial equivalence to predicate devices. The implicit acceptance criteria would be for the device's performance to be comparable to, or "substantially equivalent" to, the predicate devices.

Study Information

1. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: 188 evaluable subjects.
* Data Provenance: Prospective, multi-center study conducted at four Physician Office Laboratory (POL)/Point-of-Care (POC) settings. The country of origin is not explicitly stated, but the sponsor is Japanese and the contact information includes a US contact, suggesting the study was likely conducted in the US (given the FDA submission context).

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
* The study did not use human experts to establish "ground truth" for the test set in the traditional sense of diagnostic interpretation. Instead, it used predicate medical devices (HM-CAP™ H. pylori Enzyme Immunoassay Test and UBiT-IR300 Infrared Spectrophotometer) as the reference standards for comparison. Therefore, no information is provided about the number or qualifications of experts for ground truth establishment.

3. Adjudication Method for the Test Set:
* Not applicable. The "ground truth" was established by the results of predicate devices, not through expert consensus requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
* No, an MRMC comparative effectiveness study was not done. This was a direct comparison of the new device to existing predicate devices, not a study evaluating human reader performance with and without AI assistance.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
* Yes, this was a standalone performance study. The RAPIRUN H. pylori Antibody Detection Kit is a rapid immunochromatographic assay with visual interpretation of test and control lines. Its performance was evaluated purely based on its own output compared to the predicate devices, without human-in-the-loop assistance in the sense of an algorithm supporting a human reader.

6. The Type of Ground Truth Used:
* The "ground truth" for evaluating the RAPIRUN Kit was established by predicate medical devices:
* HM-CAP™ H. pylori Enzyme Immunoassay Test (serum)
* UBiT-IR300 Infrared Spectrophotometer method (breath)
* These predicate devices themselves are considered established methods for diagnosing H. pylori infection.

7. Sample Size for the Training Set:
* The document does not mention a "training set" or "training data" for the device itself. Immunochromatographic assays like the RAPIRUN Kit are typically developed and optimized through laboratory studies and then directly validated in clinical performance studies. They are not machine learning algorithms that require a distinct training phase with annotated data in the same way.

8. How the Ground Truth for the Training Set Was Established:
* Not applicable, as there is no mention of a distinct "training set" or "ground truth for the training set" in the context of this device's development as described.

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The BreathTek™ - UBT for H. pylori collection kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy.

For these purposes, the test utilizes the UBiT IR spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2content in breath gas.

For administration by health care professionals. To be administered under a physician's supervision.

The scientific basis underlying the BreathTek™ UBT and the BreathTek™ -UBiT® UBT kit is identical. Both kits contain a pouch of Pranactin-Citric drug product, a reconstitution cup, sample collection containers, sample identification labels and a package insert. The parts lists of the two kits differ for types of sample collection containers, the configuration of the barcode labels and the quantity of straws provided. The UBiT version of the kit directly collects breath samples into two 300cc breath bags each fitted with a mouthpiece containing a check valve and the original kit collects breath samples via a straw into glass test tubes. The glass test tubes must be quickly sealed with screw-on caps to contain the breath; the check valve incorporated in the breath bags eliminates this concern. The original kit contains a back-up set of sample collection tubes to compensate for the fragility of the tubes' glass structure. Use of barcode labels will be mandatory for the original kit and optional for the UBiT version.

The two kits will coexist on the market and share the same package insert. The package insert will be modified to include the UBiT version's component list and step-by-step procedure for collecting samples. The package insert will instruct the health care provider to analyze the tube samples using a GIRMS spectrometer and the bag samples using an UBiT IR spectrophotometer.

The provided text describes a 510(k) premarket notification for a medical device called "BreathTek™ - UBiT® UBT for H. pylori." This submission focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way a clinical trial typically would for a new device's efficacy.

However, based on the information provided, we can infer some aspects and address the questions to the best of our ability within the context of a 510(k) submission for equivalence.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" or "reported device performance" in terms of specific sensitivity, specificity, or other diagnostic metrics for the BreathTek™ - UBiT® UBT for H. pylori. Instead, the submission is focused on demonstrating substantial equivalence to an already marketed device (BreathTek™ UBT for H. pylori).

The core "acceptance criteria" in this context is likely that the modified device (with breath bags) performs equivalently to the predicate device (with glass tubes) such that the diagnostic results regarding H. pylori detection are comparable.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated. The document mentions "Human breath samples" and "simulated breath samples," but does not quantify the number of each.
• Data Provenance: Not explicitly stated. The context of a US-based company submitting to the FDA suggests the testing would adhere to US regulatory standards, but the specific country of origin for the samples is not provided. The testing appears to be prospective as freshly collected "human breath samples" were used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document describes a technical equivalence study focusing on sample collection methods and stability, not a diagnostic accuracy study requiring expert-established ground truth for a test set. The predicate device's diagnostic performance, based on its existing FDA approval (NDA # 20-586/S-004), is referenced.

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

Not applicable. This was not a diagnostic accuracy study involving adjudication of clinical cases.

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

Not applicable. This device is a breath test for H. pylori detection, not an AI-assisted diagnostic imaging or interpretation system. Therefore, an MRMC study with AI assistance is irrelevant to this submission.

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

Not applicable. This device is a diagnostic test kit that still requires human interaction for sample collection and analysis by a spectrometer, not a standalone algorithmic diagnostic tool.

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

For the stability study, the "ground truth" would be the known initial composition of the breath samples (both human and simulated) for the stability measurements. For the diagnostic accuracy of H. pylori, the ground truth would be established through methods typically used for validating such tests, likely via biopsy and histological examination or other established H. pylori detection methods, but this is related to the predicate device's original approval, not explicitly detailed here for the equivalence study.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would require a training set in the conventional sense. The "training" here refers to the development and validation of the collection methods and stability.

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

Not applicable, as there is no "training set" in the context of an AI/ML device. For the H. pylori diagnostic capability of the overall system (predicate and proposed), the ground truth for diagnostic accuracy would have been established during the original NDA approval for the Pranactin-Citric drug product and the associated breath test.

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