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ImmunoCard STAT!® Flu A&B is a rapid, qualitative, lateral-flow immunoassay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasopharyngeal swab samples. It is designed to test samples from symptomatic patients. It is recommended that all negative test results be confirmed by cell culture.

ImmunoCard STAT! Flu A & B is distributed as a test kit that includes the following reagents: ImmunoCard STAT! Flu A & B Test Device: A chromatography strip housed in a plastic frame and enclosed in a foil pouch with a desiccant. The strip contains immobilized monoclonal antibody at the CONTROL line. The strip also contains colloidal gold conjugated anti-mouse antibody at the CONTROL line. The strip also contains colloidal gold conjugated anti-influenza A and anti-influenza B as the detection antibodies. A buffered protein solution containing sodium azide (0.095%) as a preservative. Positive Control: Inactivated influenza A and influenza B virus in a buffered solution containing sodium azide (0.095%) as a preservative.

Here's a breakdown of the acceptance criteria and study information for the ImmunoCard STAT! Flu A & B device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of sensitivity and specificity targets. Instead, it presents the performance of the ImmunoCard STAT! Flu A & B device and compares it to a predicate device (Binax NOW Flu A + B) and the gold standard (cell culture). The efficacy is demonstrated by the clinical trial results showing its ability to detect Influenza A and B.

Given the context of a 510(k) summary for a diagnostic device, the implied acceptance criteria would be that the device performs similarly to legally marketed predicate devices and demonstrates reasonable accuracy against a "gold standard" (cell culture).

Here's a summary of the reported performance, derived from Table 6-2 (Overall Performance)

Performance of ImmunoCard STAT! Flu A & B vs. Tissue Culture (Gold Standard)

(Note: Sensitivity and Specificity are calculated based on the provided counts).

The document concludes that the ImmunoCard STAT! Flu A & B "Performs similarly to the predicate devices Binax NOW Flu A and NOW Flu B." This statement serves as the primary evidence that it meets the implicit acceptance criteria of demonstrating comparable effectiveness.

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

• Test Set Sample Sizes (Clinical Trials):

  • Wash/Aspirate Samples: 215 total (across Flu A and Flu B evaluations)
  • Swab Samples: 428 total (across Flu A and Flu B evaluations)
  • Total Clinical Samples: 643

• Data Provenance:

  • "archival frozen (retrospective) or fresh (prospective) samples"
  • "collected from symptomatic patients."
  • The study was performed by "Three independent laboratories and Meridian's Development Laboratory." The country of origin is not explicitly stated, but Meridian Bioscience, Inc. is located in Cincinnati, OH, USA.

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

• The ground truth for the clinical trials was established by cell culture. There is no mention of human experts being used to establish the ground truth for the clinical samples themselves. The interpretation of the cell culture results would have been performed by laboratory professionals, but these are not explicitly termed "experts" with specific qualifications in the context of ground truth establishment for the test set.

4. Adjudication Method for the Test Set

• The document implies that cell culture was the definitive gold standard. For "discordant results" between ImmunoCard STAT! Flu A & B and cell culture, PCR testing was used as an additional confirmatory method (Table 6-4). This acts as a form of adjudication for discordant results by introducing a third, more sensitive method to resolve discrepancies between the index test and the primary gold standard.

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was NOT done. This device is a rapid, qualitative lateral-flow immunoassay, which does not involve "human readers" in the sense of interpreting complex images or data that AI would assist with. The results are typically read visually as the presence or absence of a line. The document does mention "reproducibility" testing where clinical sites graded reactions, but this is to assess inter-site and inter-day variability, not human performance with/without AI.

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

• This device is a manual, non-instrumented test. Its "standalone" performance is its performance, as it does not rely on an algorithm or a human-in-the-loop for interpretation beyond visual reading of the lines presented on the test strip. The clinical trial data presented reflects the standalone performance of the device when used by laboratory professionals.

7. The Type of Ground Truth Used

• The primary ground truth used for the clinical trials was cell culture isolation, which is explicitly referred to as the "gold standard for the detection of influenza."
• For discordant results, PCR results were also used for further characterization.

8. The Sample Size for the Training Set

• The document does not explicitly describe a separate training set or its sample size. This is common for traditional immunoassay development, where often a "development" or "optimization" phase occurs, but not necessarily a distinct, formalized "training set" in the same way as machine learning models. The LOD (Limit of Detection) study used laboratory-prepared antigen preparations (ATCC strains), which could be considered part of the development/training process.

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

• As there's no explicitly defined "training set" in the context of the clinical evaluation, the method for establishing its ground truth is not detailed. For the LOD study, the "ground truth" was the known concentration of virions/mL in the prepared antigen samples.

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