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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 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 preclude influenza viral infection and should not be used as the sole basis for treatment or other 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 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 A or influenza B viral antigens present in the specimen bind to anti-influenza antibodies coniugated 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.

The provided document describes the BD Veritor™ System for Rapid Detection of Flu A + B Laboratory Kit (K160164). However, it is a 510(k) summary for a modification to an already marketed device (K120049, K121797, K132256, K132693). The modification solely involves adding strain reactivity data to the labeling for two specific avian influenza strains (A/Northern Pintail/Washington/40964/2014 H5N2 and A/Gyrfalcon/Washington/41088-6/2014 H5N8).

The document does not contain acceptance criteria for the original device's performance, nor does it present a study demonstrating that the device meets such criteria. Instead, it states that the addition of strain reactivity data for the new strains did not alter the intended use or fundamental scientific technology of the device, and a risk analysis identified no new safety and effectiveness issues. Therefore, the device is considered substantially equivalent to the previously cleared predicate devices.

As such, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance based on this document, as this information pertains to the original device clearance, not this specific modification.

The document only discusses the change to the labeling and its impact.

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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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The Sofia Influenza A +B FIA employs immunofluorescence to detect influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash in fresh or transport media specimens from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay. Negative results do not prectude influenza virus infections and should not be used as for treatment or other management decisions. The test is intended for professional and laboratory use.

Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California 7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Mortality Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine". Performance characteristics may vary against other emerging influenza viruses.

If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with Sofia to detect influenza virus nucleoproteins. This test allows for the differential detection of influenza A and influenza B antigens.

The Sofia Influenza A+B FIA is a lateral-flow immunoassay that uses monoclonal antibodies that are specific for influenza antigens and have no known cross-reactivity to normal flora or other known respiratory pathogens.

Nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens (both fresh and in VTM) are used for this test. The patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the cassette sample well. From the sample well, the specimen migrates through a test strip containing various unique chemical environments. If influenza viral antigen is present, they will be trapped in a specific location.

Note: Depending upon the user's choice, the cassette is either placed inside Sofia for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia to be scanned (Read Now Mode).

Sofia will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Sofia will display the test results (Positive, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.

The provided text describes the 510(k) summary for the Sofia® Influenza A+B FIA device. Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided information.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity or specificity targets). Instead, it presents performance data from a clinical study to demonstrate "substantial equivalence" to a predicate device and suitability for use with viral transport media (VTM).

Therefore, the "acceptance criteria" can be inferred to be a demonstration of substantial equivalence and acceptable performance, particularly when using VTM, compared to the predicate device which only used fresh specimens. The provided text, however, does not include a direct comparison table of the proposed device's performance against the predicate device's performance metrics for all relevant parameters (like sensitivity and specificity). It mainly focuses on the new capability (VTM use) and the overall conclusion of substantial equivalence.

Inferred "Acceptance Criteria" (Demonstrated Substantial Equivalence and Acceptable Performance with VTM)

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size for the multi-center field clinical study. It only mentions that a "multi-center field clinical study was performed."
• Data Provenance: The study was a "multi-center field clinical study." While the specific countries are not mentioned, it's generally understood that such studies for FDA submissions typically include data from the United States, given the context of the FDA approval. The study collected data "during February through March 2011" making it retrospective in relation to the submission date of October 13, 2015.

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

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set.

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

An MRMC study was not done. The device, Sofia® Influenza A+B FIA, is an immunofluorescence assay read by an instrument (Sofia Analyzer), not a human visual interpretation. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this device. The results are displayed by the instrument as "Positive, Negative, or Invalid."

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

Yes, a standalone performance evaluation was done. The Sofia® Influenza A+B FIA is an automated system where the Sofia Analyzer scans the test strip and processes the results using "method-specific algorithms." The instrument then displays the results. This represents the algorithm's standalone performance.

7. The Type of Ground Truth Used

The ground truth for the clinical study is not explicitly stated in the provided text. However, for influenza diagnostic tests, the common "gold standards" or ground truths involve:

• Virus culture: This is mentioned in the "Indications for Use" as a recommended confirmation for negative test results ("confirmed by cell culture").
• FDA-cleared influenza A and B molecular assay: Also mentioned in the "Indications for Use" as a confirmation method.

Given the context, it is highly probable that a comparative method such as virus culture or an FDA-cleared molecular assay was used as the ground truth reference for the clinical performance study.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI development. The device is a lateral-flow immunoassay with an instrument reader. The "method-specific algorithms" within the Sofia Analyzer would be preset and validated, rather than "trained" on a specific dataset in the way a machine learning model is trained. Therefore, there's no explicitly stated training set for an AI/algorithm in this document.

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

As there is no mention of a "training set" for an AI or algorithm in the conventional sense, the establishment of ground truth for such a set is not applicable or described in the provided information.

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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 neqative 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.

This document describes an FDA 510(k) submission for the BD Veritor™ System for Rapid Detection of Flu A + B CLIA Waived Kit. This submission is for a modification to an already marketed device, primarily concerning the addition of strain reactivity data to the labeling. Therefore, the information provided below is extracted from the context of this modification rather than a de novo submission for a new device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity thresholds) that were set for this particular 510(k) amendment. This submission focuses on adding strain reactivity data to the device's labeling. Therefore, the "reported device performance" in this context refers to the strain reactivity data that was added. The original device would have had its own acceptance criteria and performance studies, which are not detailed in this specific document.

• A/California/02/2014 (H3N2)
• B/Brisbane/33/2008 (Victoria Lineage)
• B/Guangdong-Liwan/1133/2014 (Yamagata Lineage)
• B/Hong Kong/259/2010 (Victoria Lineage)
• B/Texas/02/2013 (Victoria Lineage)
• B/Utah/09/2014 (Yamagata Lineage) |

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

The document does not specify the sample size used for the testing of the new strains. It only states that "strain reactivity data" was added. The provenance of this data (e.g., country of origin, retrospective/prospective) is also not detailed for these specific strain reactivity tests.

However, the general performance characteristics for influenza A and B for the original device were "established during January through March of 2011" when specific influenza viruses were in circulation. This suggests the original validation involved prospective clinical samples from the U.S., but the details like sample size for that original validation are not in this document.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the strain reactivity data specifically, or for the original clinical validation. The device is for rapid detection of viral antigens, and ground truth for such devices typically relies on more definitive laboratory tests like viral culture or molecular assays, rather than expert consensus on interpretation of the device's results.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods for the test set, as its focus is on adding strain reactivity data, not on a clinical trial with human interpretation requiring adjudication.

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, nor is it relevant given the nature of this rapid diagnostic test described. The device is interpreted by a "BD Veritor™ System Reader" using a proprietary algorithm, not by human readers interpreting images.

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

Yes, this device inherently functions as a standalone (algorithm only) system in terms of result interpretation. The "BD Veritor™ System Reader" uses a "proprietary algorithm" to interpret the test strip and provide a result, subtracting non-specific signals. The human user's role is to perform sample preparation and insert the device into the reader, not to visually interpret the test lines.

7. The Type of Ground Truth Used

For the specific strain reactivity data added, the document does not explicitly state the ground truth method. However, for a device detecting influenza viral antigens, the standard ground truth for establishing performance (as referenced in the "Indications for Use" and "Intended Use" sections for negative results) would be:

• Viral Culture: Considered the traditional gold standard.
• FDA-cleared influenza A and B molecular assay: Modern standard for definitive diagnosis.

It's highly probable that these methods were used to confirm the presence and type of virus for the new strains tested for reactivity.

8. The Sample Size for the Training Set

The document does not provide information about a training set since this is a rapid diagnostic kit with a fixed detection mechanism. Machine learning models typically have training sets, but this device uses a proprietary algorithm within a reader that interprets optical signals from a lateral flow assay. The initial development of such an algorithm would involve internal validation and optimization, but the term "training set" in the context of deep learning is not applicable here.

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

As noted above, the concept of a "training set" in the context of a machine learning-based algorithm is not directly applicable to this device as described. The algorithm in the BD Veritor™ System Reader optically reads the test lines and performs calculations based on pre-defined cutoffs and signal subtraction. The "ground truth" for developing this reading algorithm would be based on expertly characterized positive and negative control samples, and samples with known viral loads and types, using methods like viral culture or molecular assays to confirm their status. The document does not detail this developmental process.

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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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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 Flu A+B test is a chromatographic assay to qualitatively detect influenza A and B viral antigens in respiratory specimens. The patient specimen is mixed in a prefilled unitized tube containing RV Reagent D and added to the test device. RV Reagent D 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 Flu A+B test device.

The specimen is mixed and added to the test device where influenza A or influenza B viral antigens bind to anti-influenza antibodies conjugated to detector particles on the BD Flu A+B test strip. The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by an antibody line on the membrane. The assay utilizes a proprietary enhanced colloidal-gold particle at the test lines as the means for identifying the presence of influenza A or B viral antigens. The BD 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 and is not labeled on the test device. The remaining zone is used to measure the assay background and is also not labeled.

The BD 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 which 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 is scored as positive. If the resultant test line signal is below the cutoff, the specimen is scored 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.

The BD Veritor™ System Reader measures the amount of light reflected from various zones along the assay strip. The measurement of the assay background zone is an important factor during test interpretation as the reflectance is compared to that of the control and test zones. A background area that is white to light pink indicates the device has performed correctly. The instrument analyzes the reflectance data to provide the proper interpretation.

The provided document describes a Special 510(k) submission for a modification to the BD Veritor™ System for Rapid Detection of Flu A+B. The modification involves updating the product insert with new strain reactivity data, which did not change the intended use or fundamental scientific technology of the device.

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

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

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

• Test Set Sample Size:

  • Viruses: 9 Flu A strains and 5 Flu B strains (total of 14 strains).
  • Replicates: 10-fold dilutions from the stock were tested in triplicate. This means 14 strains * an unspecified number of 10-fold dilutions * 3 replicates. The exact number of dilutions isn't specified, but it's more than just 14 individual tests.

• Data Provenance:

  • Country of Origin of Data: The study was conducted at the R/D laboratories in San Diego, CA, USA.
  • Retrospective or Prospective: Not explicitly stated, but the study was conducted to confirm reactivity to new strains forecasted for the 2015/2016 Influenza Season and other available strains (CDC and WHO). This suggests a prospective testing approach for these specific strains. The primary clinical performance for the original device was established "during January through March of 2011" (mentioned in the "Indications for Use" section), but this specific submission focuses on new strain reactivity, which implies a prospective evaluation of freshly acquired or newly relevant strains.

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)

The ground truth for the test set was established by viral culture and titration, not clinical expert consensus. The viral material was obtained from the WHO Collaborating Centre for Surveillance, Epidemiology and Control of Influenza and the US Centres for Disease Control, and some were amplified and titred following procedures outlined in the WHO Manual on Animal Influenza Diagnosis and Surveillance (2002). The study was conducted "under the direction of Richard Anderson Ph.D. at the R/D laboratories." The expertise involved is in virology and laboratory methods for viral quantification (TCID50, EID50, HA), not clinical diagnosis by medical experts.

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

Not applicable. The ground truth was established by laboratory methods (viral culture and titration) and objective instrument readings, not by human interpretation or adjudication processes involving multiple experts making subjective judgments. The device itself uses a "proprietary algorithm which subtracts nonspecific signal at the negative control line from the signal present at both the Flu A and Flu B test lines" to score results.

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 MRMC comparative effectiveness study was done. This device is a rapid chromatographic immunoassay read by an instrument (BD Veritor™ System Reader), not by human readers interpreting images or complex data that would typically involve an MRMC study. The focus is on the device's ability to detect different viral strains, not on human interpretive performance.

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

Yes, a standalone study was performed. The BD Veritor™ System Reader automatically interprets the test strip signals using its proprietary algorithm without human-in-the-loop decision-making for the result itself. The study focused on the device's ability to objectively detect the viral antigens at specific concentrations.

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

The ground truth used was based on laboratory-confirmed viral presence and quantification via methods like TCID50 (Tissue Culture Infectious Dose 50%), CEID50 (Chicken Embryo Infectious Dose 50%), EID50 (Egg Infectious Dose 50%), and HA (Hemagglutination assay) titers. This is a form of highly objective, laboratory-based "pathology" in the context of infectious disease diagnostics.

8. The sample size for the training set

The document does not explicitly state a sample size for a training set. This submission is for a modification to an already cleared device, focusing on analytical reactivity to new strains. The device's core algorithm and performance characteristics (established in previous 510(k) clearances, K112277, K132259, K132692) would have been based on extensive development and potentially training data, but those details are not provided in this document for this modification. The current study is an analytical verification rather than a de novo development or clinical training study.

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

As no training set is explicitly discussed in this document, the method for establishing its ground truth is also not detailed. For the analytical study described, the "ground truth" (i.e., the known presence and concentration of specific viral strains) was established through laboratory methods of viral culture, amplification, and titration, as detailed in point 3 above.

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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 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 management decisions. The test is not intended to detect influenza C antigens.

The BD Flu A+B test is a chromatographic assay to qualitatively detect influenza A and B viral antigens in respiratory specimens. The patient specimen is mixed in a prefilled unitized tube containing RV Reagent C and 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 Flu A+B test device.

The specimen is mixed and added to the test device where influenza A or influenza B viral antigens bind to anti-influenza antibodies conjugated to detector particles on the BD Flu A+B test strip. The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by an antibody line on the membrane. The assay utilizes a proprietary enhanced colloidal-gold particle at the test lines as the means for identifying the presence of influenza A or B viral antigens. The BD 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 and is not labeled on the test device. The remaining zone is used to measure the assay background and is also not labeled.

The BD 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 which 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 is scored as positive. If the resultant test line signal is below the cutoff, the specimen is scored 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.

The BD Veritor™ System Reader measures the amount of light reflected from various zones along the assay strip. The measurement of the assay background zone is an important factor during test interpretation as the reflectance is compared to that of the control and test zones. A background area that is white to light pink indicates the device has performed correctly. The instrument analyzes the reflectance data to provide the proper interpretation.

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:

Acceptance Criteria and Device Performance

The acceptance criteria for this study were focused on the ability of the BD Veritor Flu A+B assay system to provide a positive instrumented read for samples of new influenza virus strains. The "reported device performance" reflects the successful detection of all tested strains.

Study Details

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

• Sample Size for Test Set: 14 influenza virus strains (9 Flu A strains and 5 Flu B strains).
• Data Provenance: The viral material was obtained from the WHO Collaborating Centre for Surveillance, Epidemiology and Control of Influenza and the US Centers for Disease Control (CDC). Two strains were provided by the National Institute for Biological Standards and Control (UK). The study was conducted at the R/D laboratories in San Diego, CA, USA. This was a prospective study specifically designed to test the reactivity of the device against these new strains.

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

• Number of Experts: The document does not explicitly state the number of experts used to establish the ground truth for the test set. However, the viral material was provided by recognized expert organizations (WHO, CDC, NIBSC), implying that the characterization and titering of these virus strains were performed by qualified virologists or equivalent experts within those institutions.
• Qualifications of Experts: Not detailed for individual experts, but the providing organizations are leading authorities in influenza surveillance and characterization.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving multiple readers for the test set results. The BD Veritor System Reader uses a proprietary algorithm to interpret test results by subtracting non-specific signals. The "acceptance criteria was the ability of the BD Veritor test to detect these additional Flu strains," which suggests a direct measurement of instrument output against known viral presence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted. This study focused on the analytical performance (reactivity and limit of detection) of the device itself against specific viral strains, not on human reader performance with or without AI assistance. The BD Veritor System Reader automatically interprets the results, removing the subjective human-in-the-loop element for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone study was performed. The BD Veritor System Reader automatically interprets test results based on its proprietary algorithm without human interpretation of the signal. The "instrumented read" and the calculation of LODs by the device confirm its standalone performance. The document explicitly states: "The BD Veritor™ System Reader uses a proprietary algorithm which 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 is scored as positive. If the resultant test line signal is below the cutoff, the specimen is scored as negative."

7. Type of Ground Truth Used

The ground truth used was the presence and quantified titer of specific influenza viral strains. These strains were obtained from reputable public health organizations (WHO, CDC, NIBSC) and their titers (e.g., CEID50/mL, EID50/mL, TCID50/mL, HA) were known and confirmed through standard virological methods (e.g., MDCK cell culture, Reed-Muench formula for TCID50 calculation).

8. Sample Size for the Training Set

The document does not specify a training set or its sample size. This particular submission is a Special 510(k) for a device modification (labeling update with new strain reactivity data) for an already cleared device (K120049, K121797, K132256, K132693, K133138). The BD Veritor™ System uses a proprietary algorithm, but the details of its original development and training data are not part of this specific submission. This study is an analytical validation testing the device's ability to detect newly identified or relevant strains.

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

As no specific training set is detailed in this document, the method for establishing its ground truth is not provided. For the current analytical validation study, the ground truth was established by acquiring known, characterized influenza viral materials with quantified titers from established public health and research institutions.

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TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasopharyngeal swab samples in symptomatic patients. This test is not intended for the detection of influenza C viruses. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens.

This is an FDA 510(k) clearance letter for the TRU FLU device, not a study report. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.

However, I can extract the following:

1. Trade/Device Name and Regulation:

• Trade/Device Name: TRU FLU
• Regulation Number: 21 CFR 866.3330
• Regulation Name: Influenza virus serological reagents

2. Intended Use and Type of Test:

• TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasopharyngeal swab samples in symptomatic patients.
• The test is not intended for the detection of influenza C viruses.
• Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay.
• Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Regarding your specific points:

• 1. A table of acceptance criteria and the reported device performance: This document does not contain this information. A 510(k) clearance letter acknowledges substantial equivalence to a predicate device, but the detailed performance data and acceptance criteria are typically found in the 510(k) summary or the full submission, not in the clearance letter itself.
• 2. Sample sized used for the test set and the data provenance: Not available in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available in this document.
• 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: This device is an immunochromatographic assay, not an AI-powered diagnostic device, so an MRMC study with AI assistance would not be applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a manual rapid diagnostic test, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): The document only states that "Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay," implying that these methods would likely serve as the ground truth in performance studies. However, the specific ground truth used for the clearance study is not detailed here.
• 8. The sample size for the training set: Not available in this document, and likely not applicable in the same way as an AI algorithm (though training for test development and validation would have occurred).
• 9. How the ground truth for the training set was established: Not available in this document.

To obtain the detailed information you are looking for, you would need to access the full 510(k) summary and potentially the performance data included in the submission, which are typically available through the FDA website or by request.

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The Alere™ Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. 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 Alere™ Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in nasal swab specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a Test Strip.

Nasal swab samples are added to a Coated Reaction Tube to which an extraction reagent has been added. An Alere™ Influenza A & B Test Strip is then placed in the Coated Reaction Tube holding the extracted liquid sample. Test results are interpreted at 10 minutes based on the presence of pink-to-purple colored Sample Lines. The yellow Control Line turns blue in a valid test.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Alere™ Influenza A & B Test:

The Alere™ Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens. It's intended to aid in the rapid differential diagnosis of influenza A and B viral infections.

Acceptance Criteria and Device Performance

The provided document details the performance of the Alere™ Influenza A & B Test against viral culture as the ground truth. While explicit "acceptance criteria" are not stated as target thresholds in this document, the reported performance metrics are presented against the comparison method. We can infer the implied acceptance would be that the device demonstrates adequate diagnostic accuracy (sensitivity and specificity) to be useful for its intended purpose.

Here's the performance as reported in the clinical study:

Study Details

2. Sample Size and Data Provenance

• Test Set Sample Size: A total of 470 prospective nasal swab specimens were evaluated.
• Data Provenance:
  • Country of Origin: The study was conducted at seven U.S. trial sites.
  • Retrospective/Prospective: The study was a "multi-center, prospective, clinical study conducted at seven U.S. trial sites during the 2008-2009 respiratory season."

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or specific qualifications of experts used to establish the ground truth (viral culture). Viral culture itself is a laboratory gold standard, and its interpretation would typically be performed by trained laboratory personnel or microbiologists.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for discordant results between the Alere™ Influenza A & B Test and viral culture for the primary clinical study. However, for the 19 samples where the Alere™ test was negative but culture was positive for influenza B, an investigational RT-PCR assay was used. "Ten (10) of these samples were negative for influenza B by PCR," suggesting a form of secondary confirmation for these specific discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. This device is a rapid diagnostic test (immunochromatographic assay), not an AI-assisted diagnostic tool for image interpretation or complex data analysis that would typically involve human readers interpreting results.

6. Standalone Performance

Yes, the clinical study directly assesses the standalone performance (algorithm only, without human-in-the-loop performance) of the Alere™ Influenza A & B Test. The reported sensitivity, specificity, and invalid rate are for the device itself against the viral culture.

7. Type of Ground Truth Used

The primary ground truth used for the clinical study was viral culture.
For discordant Influenza B results (Alere negative, culture positive), an investigational RT-PCR assay was used as a secondary confirmation method.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size in the context of device development for this immunochromatographic assay. Such devices are typically developed through analytical studies and optimization of reagents, rather than machine learning models that require distinct training sets. The "Analytical Sensitivity" section involved testing various concentrations of influenza viruses, which could be considered part of the development and optimization process, but not a typical "training set" in the AI sense.

9. How Ground Truth for the Training Set Was Established

As there is no explicit "training set" in the context of a machine learning algorithm, the concept of establishing ground truth for a training set does not directly apply here. The analytical studies (Analytical Sensitivity, Analytical Reactivity, Analytical Specificity) used well-characterized viral strains and microorganisms, where their presence and concentration served as the known "ground truth" for evaluating the immunoassay's performance characteristics. This would involve laboratory-established concentrations and identification of these biological agents.

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The BioSign Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. The test is intended for professional and laboratory use. Performance characteristics for influenza were established during the 2007-2009 influenza seasons when influenza A viruses A/New Caledonia/20/99 (H1N1), A/Solomon Islands/3/2006 (H1N1), A/Brisbane/59/2007 (H1N1), A/California/07/2009 (H1N1), A/Wisconsin/67/2005 (H3N2), A/Brisbane/10/2007 (H3N2), and influenza B viruses B/Ohio/01/2005, B/Florida/4/2006, B/Brisbane/60/2008 were the predominant influenza viruses in circulation according to the Flu Activity & Surveillance report by CDC. Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL+3 facility is available to receive and culture specimens.

The modification presented in this 510(k) is the addition of influenza A/Vietnam/1194/2004 (H5N1) and influenza A/Anhui/01/2005 (H5N1) along with their respective analytical sensitivity concentrations, to the Analytical Inclusivity section of the package insert. The avian influenza A (H5N1) viruses, A/Vietnam/1194/2004 (H5N1) and A/Anhui/01/2005 (H5N1) were obtained from CDC as a non-infectious form with known titer. Analytical sensitivity is reported as the lowest dilution/concentration of the virus that the BioSign Flu A+B Test is able to detect.

The provided text describes a 510(k) summary for a modification to an existing influenza test device, the BioSign Flu A+B. The modification involves adding two specific avian influenza A (H5N1) strains and their analytical sensitivity concentrations to the package insert.

Here's an analysis based on your request:

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

The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, the acceptance criteria for this specific modification are implicit: the device must be able to detect the new H5N1 strains at a certain analytical sensitivity, and this information needs to be added to the product labeling.

The reported device performance for the new H5N1 strains is their "analytical sensitivity concentrations," which are reported as "the lowest dilution/concentration of the virus that the BioSign Flu A+B Test is able to detect." However, the exact numerical concentrations for A/Vietnam/1194/2004 (H5N1) and A/Anhui/01/2005 (H5N1) are not provided in this specific 510(k) summary, only that they were determined.

Since explicit acceptance criteria are not given, and only the type of performance metric is mentioned for the modification, a direct table comparing explicit acceptance criteria to reported performance for the modification cannot be fully generated from this text. The underlying assumption is that demonstrating any detectable analytical sensitivity for the new strains is sufficient for their inclusion in the labeling, given this is primarily an information update rather than a redesign or a change to the core diagnostic performance for general influenza A/B.

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

For the specific modification concerning the H5N1 strains:

• Sample size: Not explicitly stated. The text mentions that the viruses were obtained in a non-infectious form with a known titer, and "analytical sensitivity is reported as the lowest dilution/concentration of the virus that the BioSign Flu A+B Test is able to detect." This implies a series of dilutions were tested, but the number of replicates or different samples tested at each dilution is not specified.
• Data provenance:
  • Country of origin: The H5N1 viruses were obtained from the CDC (Centers for Disease Control and Prevention), which is a US-based agency. The viruses themselves are A/Vietnam/1194/2004 and A/Anhui/01/2005.
  • Retrospective or prospective: This study is best described as an analytical study or in-vitro technical validation using prepared samples, rather than a clinical study with retrospective or prospective patient data. The viruses were obtained and then tested in a controlled laboratory setting.

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 analytical validation study. The "ground truth" for the H5N1 strains was their known presence and concentration (titer) as determined by the CDC. This is a technical standard rather than an expert interpretation.

4. Adjudication method for the test set

Not applicable. This was an analytical sensitivity study, not a clinical study involving human interpretation or adjudication of diagnostic results. The "result" (detection or non-detection) at various dilutions would be objectively observed, not adjudicated by a panel.

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 is not an AI/CAD device. It is an in vitro diagnostic (IVD) rapid test for influenza. There are no human readers in the context of an MRMC study and no AI assistance involved.

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

Not applicable. This is not an algorithm or AI device. The device itself performs the detection. The analytical sensitivity study evaluates the device's inherent ability to detect the target analytes.

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

The ground truth for the H5N1 strains was defined by the known titer/concentration of the non-infectious viral material provided by the CDC. This is essentially a "reference standard" or "analytical standard" rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This device is an IVD rapid test. There is no machine learning or AI model involved that would require a "training set." The device's performance is based on its biochemical reactions.

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

Not applicable, as there is no training set for this type of device.

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