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PyloriProbe™ is an ELISA test intended for the qualitative detection of serum IgG antibodies to H. pylori as an aid in the diagnosis of H. pylori infection in adult patients with gastrointestinal symptoms. The test is not to be used with asymptomatic patients. The tests are carried out in clinical laboratories by laboratory technologists / technicians and the test results are measured in a microtiter plate reader instrument.

PyloriProbe™ is an ELISA test intended for the qualitative detection of serum IgG antibodies to H. pylori.

This FDA letter for K981396, "PyloriProbeTM," does not contain the detailed information necessary to answer the questions about acceptance criteria and the study proving device performance as typically expected for medical device submissions. This letter is a 510(k) clearance, which confirms substantial equivalence to a predicate device, rather than a full review of a new clinical study.

Therefore, many of the requested details are not available in the provided document.

However, based on the information present, here's what can be extracted and noted regarding the lack of other information:

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

• Not Available. The document is a 510(k) clearance letter and does not include performance data or specific acceptance criteria. It only states that the device is "substantially equivalent" to legally marketed predicate devices.

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

• Not Available. The document does not provide details about a test set sample size or its provenance.

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 Available. The document does not describe the establishment of a ground truth for a test set or the involvement of experts in that process.

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

• Not Available. The document does not mention any adjudication methods for a test set.

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 / Not Available. The PyloriProbeTM is an ELISA test for the detection of H. pylori antibodies, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study with AI assistance is not relevant to this device type. The document does not mention any comparative effectiveness studies.

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

• Not Applicable / Not Available. This device is an in vitro diagnostic (IVD) ELISA test that is performed and interpreted by laboratory technologists/technicians. It is not an algorithm-only device. The document does not detail performance studies for the device.

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

• Not Available. The document does not specify the type of ground truth used for any performance evaluation. For an IVD like this, ground truth would typically be established through other definitive diagnostic methods for H. pylori infection (e.g., biopsy, culture, urea breath test) against which the ELISA results are compared.

8. The sample size for the training set

• Not Available. The document does not provide information about a training set since this is a 510(k) clearance for an IVD test, not a submission for an AI/machine learning model.

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

• Not Available. As above, no training set is discussed or implied by the document's content.

In summary, the provided FDA 510(k) clearance letter focuses on the regulatory determination of substantial equivalence rather than on detailed performance study results that would contain the requested information. To find such details, one would typically need to review the full 510(k) submission summary or detailed results from the manufacturer (AMDL, Inc.).

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