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The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasopharyngeal wash, aspirate and swab in transport media samples from symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B 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. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Outside the U.S. a negative test is presumptive and it is recommended that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country of use. FDA has not cleared this device outside the U.S. Negative test results do not prectude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens.

The BD Veritor™ Fly A+B test is an immunochromatographic assay for the qualitative detection of influenza A and B viral antigens in respiratory specimens. The patient specimen is added to a reaction tube prefilled with RV Reagent C. gently mixed, and then added to the test device. RV Reagent C contains mucolytic agents that function to break down mucus in a patient specimen thereby exposing viral antigens and enhancing detection on the assay device. Processed specimens are expressed through a filter tip into a single sample well on the BD Veritor™ Flu A+B test device.

After addition to the test device, any influenza B viral antigens present in the specimen bind to anti-influenza antibodies conjugated to detector particles on the Veritor ™ Flu A+B test strip. The antigen-conjugate complexes migrate across the test strip to the reaction area and are captured by a line of antibody striped on the membrane. The Veritor™ Flu A+B test devices are designed with five spatially-distinct zones including positive and negative control line positions, separate test line positions for the target analytes, and a background zone. The test lines for the target analytes are labeled on the test device as 'A' for Flu A position, and 'B' for Flu B position. The onboard positive control ensures the sample has flowed correctly and is indicated on the test device as 'C'. Two of the five distinct zones on the test device are not labeled. These two zones are an onboard negative control line and an assay background zone. The onboard negative control zone addresses non-specific signal generation. The remaining zone is used to measure the assay background.

The BD Veritor™ Flu A+B assay incorporates an active negative control feature in each test to identify and compensate for sample-related, nonspecific signal generation. The BD Veritor™ System Reader uses a proprietary algorithm that subtracts nonspecific signal at the negative control line from the signal present at both the Flu A and Flu B test lines. If the resultant test line signal is above a pre-selected assay cutoff, the specimen scores as positive. If the resultant test line signal is below the cutoff, the specimen scores as negative. Use of the active negative control feature allows the BD Veritor™ System reader to correctly interpret test results that cannot be scored visually because the human eve is unable to accurately perform the subtraction of the nonspecific signal.

Here's a breakdown of the acceptance criteria and study information for the BD Veritor™ System for Rapid Detection of Flu A + B Laboratory Kit, based on the provided document:

This document is a 510(k) summary for a modification to an already cleared device (K120049, K121797, K132256, K132693, K133138, K151301). The modification is specifically the addition of strain reactivity data for several influenza strains. Therefore, the core performance characteristics (sensitivity, specificity) of the device against a general population of influenza A and B are likely not re-evaluated in this specific submission. Instead, the focus is on demonstrating that the device still performs as expected with these new strains, effectively confirming continued substantial equivalence.

Given this context, the acceptance criteria and supporting "study" are focused on strain reactivity, not a full clinical performance study for initial clearance.

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

The document doesn't explicitly state quantitative acceptance criteria for strain reactivity, such as a minimum viral titer or a specific detection rate. However, the implicit acceptance criterion for the added strain reactivity data is that the device demonstrates reactivity to these strains, supporting that the device can still detect relevant circulating influenza viruses. The reported performance is simply the list of strains for which reactivity data has been added to the labeling.

2. Sample size used for the test set and the data provenance

The document does not specify a "sample size" in terms of number of patient specimens for these strain reactivity studies. Instead, it refers to specific influenza strains. These would typically be cultured viral samples, likely tested at various concentrations to determine the limit of detection. The data provenance is implied to be laboratory testing of isolated viral strains. There is no information about the country of origin of the data or if it was retrospective or prospective in a clinical setting; it's likely laboratory-based in-vitro testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of strain reactivity study. Ground truth for viral strains is typically established through viral culture and sequencing, which would be performed in a laboratory by virologists or molecular scientists, not "experts" in the context of clinical interpretation.

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

Not applicable. Adjudication methods are typically for clinical studies where human interpretation of medical images or diagnostic tests is involved to establish a ground truth when a definitive gold standard is not available or to resolve discrepancies. For laboratory-based strain reactivity testing, the "truth" of the strain identification and concentration is determined through established virological and molecular methods.

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. This device is an immunoassay, not an AI-assisted diagnostic device, and this submission is not a comparative effectiveness study. It's a submission for adding strain reactivity data to the device labeling.

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

The BD Veritor™ System is a standalone diagnostic device. The BD Veritor™ System Reader uses a "proprietary algorithm that subtracts nonspecific signal at the negative control line from the signal present at both the Flu A and Flu B test lines" to provide a definitive positive/negative result. This implies an algorithm-only determination of the test result after the specimen is processed by the device. The human role is performing the test and reading the output from the device reader. The strain reactivity testing described would be solely based on the device's ability to detect the viral antigens of these strains, i.e., standalone performance.

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

The ground truth for the strain reactivity study is the identity and concentration of each specific influenza virus strain, confirmed typically by viral culture and molecular methods (e.g., genetic sequencing) in a laboratory setting. This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device, being an immunoassay, is not an AI/machine learning device that requires a training set in the conventional sense. The "training" or development of the immunoassay itself relies on antigen-antibody interactions and assay optimization.

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

Not applicable. (See #8).

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