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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 nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System 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 for use outside of the U.S. Negative test results do not preclude 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™ Flu 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 mixed in 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 in 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 A or 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 eye is unable to accurately perform the subtraction of the nonspecific signal.

Here's an analysis of the provided text, focusing on acceptance criteria and a study proving device performance, as per your request:

Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) premarket notification for a CLIA-waived kit, specifically for a labeling change to add strain reactivity data. It does not contain detailed acceptance criteria for the initial device's performance or a full study report proving those criteria were met for the initial clearance. However, it does reference "Performance characteristics for influenza A and B were established during January through March of 2011".

Given that specific performance values (sensitivity, specificity, etc.) and explicit acceptance criteria are not presented in this document for the initial device clearance, I cannot create a table of acceptance criteria and reported device performance.

The new information being added to the labeling is strain reactivity data for specific influenza strains. This isn't a performance claim against a general population but rather a demonstration of the device's ability to detect particular viral subtypes.

Regarding the studies mentioned in the document:

This document describes an amendment to an already cleared device (BD Veritor System for Rapid Detection of Flu A + B CLIA waived Kit). The primary focus of this specific submission (K160161) is to add additional strain reactivity data to the labeling, not to re-evaluate the device's overall clinical performance.

The document states: "The labeling has been changed to reflect the addition of strain reactivity data for the following strains: A/Northern Pintail/Washington/40964/2014 (H5N2) and A/Gyrfalcon/Washington/41088-6/2014 (H5N8)." It explicitly notes that "Additions made to the labeling to add additional strain testing did not change the intended use of the device or the fundamental scientific technology."

Therefore, the "study" described or referenced in this particular document primarily pertains to:

• Strain Reactivity Testing: Testing the existing device with specific novel influenza strains (H5N2 and H5N8) to confirm detection and add this information to the labeling. Details of this specific testing (sample size, ground truth, etc.) are not provided in this document.

The document also refers to the original performance characteristics established in 2011: "Performance characteristics for influenza A and B were established during January through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage were the predominant influenza viruses in circulation..." However, the details of that study are not provided here.

Based on the provided text, I can only address aspects relevant to the type of information requested, indicating when details are absent or not applicable to this specific submission.

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

   • Not provided in this document. This document focuses on supplemental strain reactivity data for an already cleared device, not the initial clinical performance metrics and acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • For the new strain reactivity data (H5N2, H5N8): Not specified in this document.
   • For the original performance characteristics (2011): Not specified in this document. The document mentions "January through March of 2011" and predominant influenza viruses, suggesting a prospective or retrospective clinical study, but no details on sample size or data origin (country) are given here.

3. 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)

   • Not specified in this document. For influenza rapid tests, ground truth for clinical studies would typically be established by viral culture or a molecular assay, not human expert consensus like in imaging. For strain reactivity, it would be based on positive controls of the specific strains.

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

   • Not applicable/Not specified. Adjudication methods are typically used when human interpretation of a diagnostic is the "ground truth" or part of the comparison. For assays like this, the reference method (e.g., PCR, viral culture) provides the definitive result.

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 a rapid chromatographic immunoassay, not an AI-powered diagnostic that assists human readers. It's a standalone test with an optical reader.

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

   • Yes, this is a standalone device. The BD Veritor™ System Reader uses a proprietary algorithm to interpret the test strip results. The text describes this algorithm: "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." This is a automated interpretation without human intervention in the result reading process.

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

   • Not explicitly stated in this document for the original studies. For influenza diagnostics, the common ground truth methods are:
     • Viral Culture: Considered the "gold standard" for live virus detection.
     • FDA-cleared molecular assay (e.g., PCR): Highly sensitive and specific.
   • The "Indications for Use" section and "Intended Use" section state: "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." This strongly implies that these methods were used as the reference standard (ground truth) for the original performance evaluation.
   • For the new strain reactivity, the ground truth would be the known presence or absence of the specific influenza strains in controlled samples.

8. The sample size for the training set

   • Not specified in this document. The document discusses clinical performance characteristics and new strain reactivity, not the development of a machine learning model with distinct training/test sets in the AI sense. The "proprietary algorithm" for reading the strip would have been developed and "trained" on a dataset of test strip results, but details are not provided.

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

   • Not specified in this document. As mentioned above, this isn't an AI/ML development context where human experts label data for an algorithm. The "ground truth" for calibrating the reader's algorithm would be derived from known positive and negative samples, likely confirmed by a reference method like viral culture or PCR.

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