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The BD Directigen™ EZ Flu A+B assay is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal washes/aspirates, nasopharyngeal swabs and throat swabs of symptomatic patients. The Directigen™ EZ Flu A+B assay is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. All negative test results should be confirmed by cell culture because negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The Directigen EZ Flu A+B test is a chromatographic assay to qualitatively detect influenza A and B viral antigens in samples processed from respiratory specimens. When specimens are processed and added to the test device, influenza A or B viral antigens bind to anti-influenza antibodies conjugated to visualizing particles in the corresponding A and B test strips. The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by the line of antibody on the membrane. A positive result for influenza A is visualized as a reddish purple line at the Test "T" position and the Control "C" position in the Directigen EZ Flu A read window. A positive result for influenza B is visualized as a reddish purple line at the Test "T" position and the Control "C" position in the Directigen EZ Flu B read window.

The provided text describes a modification to an existing medical device, the BD Directigen™ EZ Flu A+B assay. The modification is a change from liquid controls to dry swab controls. The submission is a Special 510(k), which typically focuses on design changes to a previously cleared device that do not significantly alter its fundamental scientific technology or intended use. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the validation studies conducted to ensure the modified aspects perform comparably to the original device.

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

Study and Acceptance Criteria Summary

The study described here is focused on validating the change from liquid controls to dry swab controls for the BD Directigen™ EZ Flu A+B assay. The acceptance criteria primarily revolve around the stability and performance comparability of these new dry swab controls against the existing liquid controls. This is not a study assessing the overall sensitivity and specificity of the diagnostic device against clinical samples, but rather a validation of a component change within the device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for the test set. It mentions "Data to date" and "studies" but no explicit numbers of samples or tests performed.

The data provenance is not explicitly stated in terms of country of origin. The studies are internal validation studies conducted by Becton, Dickinson and Company. They are likely prospective studies designed specifically to evaluate the new dry swab controls.

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

This type of information is not applicable to this specific validation study. The study focuses on comparing the performance of two types of controls (liquid vs. dry swab) within a diagnostic assay, rather than evaluating the diagnostic assay's performance against a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This is not applicable as the study design does not involve expert adjudication for establishing a clinical ground truth. The evaluation is focused on the consistency and performance of the controls themselves within the assay.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance with and without AI assistance (or a new diagnostic tool) compares. The current filing is for a change in a control component of an in-vitro diagnostic device, not for a new AI-powered diagnostic or a study on human reader performance.

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

The device is an in vitro diagnostic immunoassay, not an algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable in the traditional sense of AI or software-as-a-medical-device. The device itself performs the detection, but a human interprets the visual lines. The validation focuses on the performance of the control (a physical component) within this system.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established performance and stability characteristics of the original liquid controls. The new dry swab controls are being evaluated against these established characteristics to demonstrate comparability.

8. The Sample Size for the Training Set

The provided text does not mention a training set. This type of submission (Special 510(k) for a control component change) typically involves validation testing against pre-defined specifications rather than machine learning and training/test set splits.

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

As no training set is mentioned or applicable in this context, the method for establishing its ground truth is not applicable.

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