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The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Alere H. pylori tests are lateral flow immunochromatographic assays for the qualitative detection of Immunoglobulin G (IgG) antibodies to Helicobacter pylori (H. pylori) in whole blood, serum and plasma. The test devices consist of a membrane strip coated with immobilized human IgG antibodies and H. pylori antigen encased in a plastic housing. In the test procedure, anti-human IgG is immobilized in the test line region of the cassette. The sample reacts with H. pylori antigen-coated particles that have been applied to the label pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-human IgG. If the sample contains H. pylori IgG antibodies, a colored line will appear in the test line region indicating a positive result. If the sample does not contain H. pylori IgG antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of sample has been added and membrane wicking has occurred.

The provided text describes a 510(k) premarket notification for Alere Signify® H. pylori and Alere Clearview® H. pylori tests, which are rapid chromatographic immunoassays for the qualitative detection of IgG antibodies to Helicobacter pylori.

Here's an analysis of the acceptance criteria and study information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with specific thresholds (e.g., Sensitivity > X%, Specificity > Y%). Instead, it describes a performance study related to interfering substances and concludes substantial equivalence based on the device's expected performance and lack of interference.

• Implied Acceptance Criterion: The tests should produce expected (correct) positive or negative results in the presence of various interfering substances.
• Reported Device Performance: All negative and positive H. pylori samples tested as expected, with no false results, even in the presence of high levels of triglycerides.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • For the interfering substance study related to triglycerides:
    • H. pylori standards: low positive (presumably 1 sample) and high positive (presumably 1 sample).
    • H. pylori negative plasma sample: 1 sample.
    • Each of these 3 samples was spiked with two concentrations of triglyceride reference material.
    • Each spiked sample was tested in replicates of three.
    • Three unspiked replicates of each H. pylori standard and negative sample were also tested.
    • Calculation: (2 positive standards + 1 negative sample) * (2 triglyceride concentrations * 3 replicates + 3 unspiked replicates) = 3 * (6 + 3) = 3 * 9 = 27 tests in total for the triglyceride study. This is a very small sample size focused specifically on interference, not diagnostic accuracy.
  • For other interfering substances (hemoglobin, bilirubin, human serum albumin, hematocrit), the document mentions "samples containing high levels" but does not specify the exact number of distinct samples or replicates tested.
• Data Provenance: Not explicitly stated (e.g., country of origin). However, given the context of a medical device submission to the FDA, it is typically expected to be from a controlled laboratory setting. It is a retrospective analysis of prepared samples designed to evaluate interference.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The document describes an interfering substance study, not a clinical study requiring expert diagnosis of H. pylori. The "ground truth" for the test set in this context refers to whether the samples were genuinely positive or negative for H. pylori, as well as the known concentration of the interfering substances.
• The ground truth (e.g., low positive, high positive, negative H. pylori samples, and known concentrations of spiked triglycerides) would have been established by laboratory methods or reference materials.
• No human experts (like radiologists) were involved in establishing the ground truth for this specific type of performance study presented.

4. Adjudication Method for the Test Set

• None directly applicable as this was not an expert review or clinical trial for diagnostic accuracy. The results were assessed against expected outcomes (positive should remain positive, negative should remain negative).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document describes a laboratory-based interfering substance study, not a clinical study comparing human reader performance with and without AI assistance. The device itself is a rapid immunoassay, not an AI-powered diagnostic system requiring human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• While the device itself is a standalone diagnostic (a rapid immunoassay, not an algorithm in the traditional AI sense), the performance data presented is for the device's reaction to spiked samples under controlled lab conditions, not its standalone diagnostic accuracy in a clinical population. The device provides a visual result (colored lines) that is interpreted.

7. The Type of Ground Truth Used

• The ground truth used for the interfering substance study was based on known H. pylori positive/negative status of the samples (presumably established by reference methods or manufacturing standards for the "standards" used) and known spiked concentrations of interfering substances. This is a form of laboratory-controlled ground truth.

8. The Sample Size for the Training Set

• The document does not mention a training set in the context of machine learning or AI. This device is a lateral flow immunoassay, which does not typically involve "training data" in the AI sense for its core function. Its design and performance are based on biochemical interactions.

9. How the Ground Truth for the Training Set Was Established

• Not applicable as there is no mention of a training set for an algorithm.

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