Search Results

The PYLORI DETECT IgG is a qualitative Enzyme Immunoassay( EIA) Kit for the detection of IgG antibodies against H. pylori in human serum. The test is intended as an aid in the diagnosis of infection by H. pylori in patients with gastrointestinal symptoms. FOR IN VITRO DIAGNOSTIC USE ONLY.

The Micro Detect, Inc. H. pylori reagent ( PYLORI DETECT IgG) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution. The Micro plate ELISA formats is a commonly used format for the detection of many entities of clinical interest, including infectious diseases.

Here's a breakdown of the acceptance criteria and study information for the Pylori Detect IgG device, based on the provided documents:

Acceptance Criteria and Device Performance

Note: The document states "The patient results obtained using the PYLORI DETECT IgG are substantially equivalent to those obtained by endoscopic evaluations." This implies that the metrics listed (Sensitivity, Specificity, PPV, NPV, Accuracy) were based on comparison to endoscopic evaluations as the gold standard, and the reported values met what was considered "substantially equivalent." However, specific numerical acceptance criteria are not explicitly defined in the provided text. The "Accuracy" metric in the provided text is garbled.

Study Details

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

   • Test Set Sample Size: Not explicitly stated.
   • Data Provenance: Not explicitly stated. The document refers to "patient results" but does not specify the country of origin or whether the data was retrospective or prospective.

2. 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):

   • Number of Experts: Not explicitly stated.
   • Qualifications of Experts: Not explicitly stated. The ground truth method is "endoscopic evaluations," which would typically be performed and interpreted by medical professionals (e.g., gastroenterologists), but the number or specific qualifications are not detailed.

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

   • Not applicable as the ground truth appears to be based on a singular diagnostic method ("endoscopic evaluations") rather than an expert consensus process requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (ELISA kit) for detecting antibodies, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, a standalone study was performed. The reported performance metrics (Sensitivity, Specificity, etc.) represent the performance of the PYLORI DETECT IgG assay system itself, as a "manual procedure" without human interpretative intervention beyond performing the assay according to instructions. The device directly produces results for IgG antibodies.

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

   • Endoscopic evaluations. The document states: "The patient results obtained using the PYLORI DETECT IgG are substantially equivalent to those obtained by endoscopic evaluations". This implies endoscopy was the reference standard for diagnosing H. pylori infection.

7. The sample size for the training set:

   • Not explicitly stated. The document describes a "510(k) Safety and Effectiveness Information" summary, which focuses on validation data rather than the development of the assay.

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

   • Not explicitly stated, as details regarding a training set are absent from the provided "Safety and Effectiveness Information."

Ask a specific question about this device