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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. 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 conjuqated 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 nonspecific 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 neqative 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 provided 510(k) summary (K132692) for the BD Veritor™ System Flu A+B assay, while detailing the device and its intended use, does not contain a clinical study or performance data against specific acceptance criteria for a new device submission.

Instead, this submission is for a modification to an already marketed device (BD Veritor™ System for Rapid Detection of Flu A+B POC kit, K112277, K132239). The stated purpose of this 510(k) is to "add additional strain testing" data for H3N2v and other strains to the product insert's Analytical Strain Reactivity tables. The document explicitly states: "Risk analysis was not conducted to add this analytical sensitivity information to the product insert as no new issues of safety and effectiveness were identified for this addition to the product insert." This implies that the core performance characteristics were established in previous submissions (K112277, K132239) and are not re-evaluated here through a new clinical study with specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this specific 510(k) summary.

However, based on the information provided, here's what can be gathered, along with an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

As this 510(k) is for an update to labeling with additional analytical sensitivity data for specific strains, no new clinical performance acceptance criteria are defined or reported in this document. The document focuses on "Analytical Strain Reactivity tables" for H3N2v and other strains, which are typically analytical sensitivity data, not clinical performance. Clinical performance, including sensitivity and specificity in symptomatic patients, would have been established and reviewed in the predicate device submissions (K112277, K132239).

Therefore, a table of clinical acceptance criteria and reported device performance as typically seen for a new device approval is not applicable to this specific submission. The "reported device performance" here is the addition of analytical sensitivity data to the existing product insert.

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

• Test Set Sample Size: Not applicable/not provided for a new clinical study in this submission. This submission does not detail a new clinical test set. The analytical strain reactivity data would involve laboratory-prepared samples at various concentrations, not a patient-based test set.
• Data Provenance: Not specified for the analytical sensitivity data, though general performance characteristics were established during "January through March of 2011" when specific influenza viruses were predominant in the United States (according to CDC reports). This suggests retrospective or prospective clinical data from the predicate device would have originated from US patients. However, the added strain data for this 510(k) is analytical, not clinical.

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

Not applicable. As this involves analytical sensitivity data (detection of specific viral strains in a lab setting) and not a clinical study requiring expert interpretation of diagnostic images or patient data, experts for ground truth establishment in this context are not described. The "ground truth" for analytical sensitivity is typically the known presence and concentration of the virus in the prepared samples.

4. Adjudication method for the test set

Not applicable for the analytical sensitivity data described in this submission. Adjudication methods are typically used in clinical studies where there might be discrepancies in expert readings or comparison to a gold standard, which is not the focus here.

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. The BD Veritor™ System Flu A+B assay is a rapid chromatographic immunoassay that uses a proprietary algorithm for interpreting signals, but it is not an AI-assisted diagnostic tool in the typical sense of computer vision or complex decision support for human readers. It's an automated reader for an immunoassay. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

Yes, in a sense. The "BD Veritor™ System Reader" uses a "proprietary algorithm which subtracts nonspecific signal... 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." This describes an automated, standalone interpretation of the test strip by the device's algorithm. The output (positive/negative) is machine-determined based on the signal readings.

7. The type of ground truth used

For the analytical sensitivity data being added to the labeling, the ground truth is the presence and concentration of specific influenza viral strains (e.g., H3N2v) in laboratory-prepared samples. This would be established by standard microbiological techniques and confirmed viral presence.

For the clinical performance data (from the predicate devices), the ground truth for Flu A+B detection would typically be viral culture or an FDA-cleared influenza A and B molecular assay, as stated in the intended use: "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."

8. The sample size for the training set

Not applicable/not provided. As this submission describes an analytical sensitivity update for an existing immunoassay interpretation algorithm, there's no mention of a "training set" in the context of machine learning. The algorithm's cutoff values would have been established during the development of the predicate device, likely using a different methodology.

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

Not applicable/not provided, for the same reasons as point 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 nasopharyngeal and nasal swabs of 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 distinquished 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 neqative 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. 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 eve is unable to accurately perform the subtraction of the nonspecific signal.

The provided text is a 510(k) summary for the BD Veritor™ System Flu A+B assay POC kit. It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a detailed study report that proves the device meets those criteria with performance metrics such as sensitivity and specificity from a clinical trial.

The document mentions "Performance characteristics for influenza A and B were established during January through March of 2011..." but does not elaborate on these characteristics, the study design, sample sizes, ground truth establishment, or expert involvement. The primary change described in this 510(k) submission is the addition of analytical sensitivity (LOD) reactivity data for A/Anhui/1/2013 H7N9 and Strain Reactivity tables to the labeling, not a new clinical performance study for the original indications.

Therefore, many of the requested details cannot be extracted from this specific document.

Here's an attempt to answer based only on the provided text, highlighting what is not available:

Acceptance Criteria and Device Performance Study for BD Veritor™ System Flu A+B assay POC kit (K132259)

This 510(k) submission primarily addresses the addition of analytical sensitivity data for a new strain (A/Anhui/1/2013 H7N9) to the labeling of an already legally marketed device. It does not provide the detailed clinical performance study for the original device or specific acceptance criteria met by a clinical study. It refers to "Performance characteristics for influenza A and B were established during January through March of 2011" but does not provide the details of those characteristics or the study that established them.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided 510(k) summary. The document states that performance characteristics were established but does not present them or the acceptance criteria they were measured against.

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

This information is not available in the provided 510(k) summary. The text mentions "Performance characteristics for influenza A and B were established during January through March of 2011," but does not detail the sample size or provenance of the data from this establishment.

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

This information is not available in the provided 510(k) summary.

4. Adjudication method for the test set

This information is not available in the provided 510(k) summary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This information is not available in the provided 510(k) summary. The device is described as read by a "System Reader" which uses a proprietary algorithm, suggesting it's not a human-interpreted visual read in the final determination.

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

The device description implies a standalone algorithm's role, as "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." This suggests the interpretation of the test strip is done by the algorithm. However, no specific "standalone performance study" details (e.g., sensitivity, specificity of the algorithm alone) are provided.

7. The type of ground truth used

The intended use statement suggests that for negative results, confirmation by "viral culture or an FDA-cleared influenza A and B molecular assay" is recommended. This implies that for the original performance characteristics, such methods (viral culture or molecular assays) would likely have been used as the ground truth. However, this is an inference, and the document does not explicitly state how ground truth was established for the performance studies it references.

8. The sample size for the training set

This information is not available in the provided 510(k) summary.

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

This information is not available in the provided 510(k) summary.

Summary of What is Known from the Provided Text:

• Device: BD Veritor™ System Flu A+B assay POC kit, a rapid chromatographic immunoassay for direct and qualitative detection of influenza A and B viral nucleoprotein antigens.
• Intended Use: Aid in diagnosis of influenza A and B viral infections from nasopharyngeal and nasal swabs of symptomatic patients. It differentiates between Flu A and Flu B.
• Key Technology: Uses an active negative control feature and a proprietary algorithm in the BD Veritor™ System Reader to interpret test results by subtracting non-specific signal.
• Basis for 510(k): Substantial equivalence to the predicate device (K112277). The modification primarily concerns updating labeling with analytical sensitivity data for the A/Anhui/1/2013 H7N9 strain and strain reactivity tables.
• Performance Reference: "Performance characteristics for influenza A and B were established during January through March of 2011" against specific prevalent strains (A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage). Details of these characteristics and the studies are not included in this document.
• H7N9 Data: While new analytical sensitivity data for A/Anhui/1/2013 H7N9 was added, the labeling includes a disclaimer that "performance characteristics of this device with clinical specimens that are positive for the novel avian influenza A(H7N9) virus have not been established." This means the new data is analytical (LOD) and not clinical performance.

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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. 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 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.

This 510(k) summary describes a modification to an existing device, the BD Veritor™ System Flu A+B assay Clinical kit, primarily to update labeling with analytical sensitivity data for a new Influenza A strain (A/Anhui/1/2013 H7N9) and add strain reactivity tables. It explicitly states that no new issues of safety and effectiveness were identified for this addition and that the change did not change the intended use of the device or the fundamental scientific technology.

Therefore, the document does not contain details about a study designed to establish acceptance criteria for the original device or to demonstrate that the original device meets such criteria through clinical performance. Instead, it focuses on the analytical performance related to detecting specific influenza strains to ensure the updated labeling is accurate.

Given this, I cannot provide a table of acceptance criteria and reported device performance from this document for the overall device's clinical efficacy, nor details about a comprehensive clinical study as typically conducted for initial device clearance. The information provided heavily relates to analytical performance in detecting specific viral strains for labeling purposes, rather than a full clinical performance study for the entire device.

However, I can extract information related to the analytical performance presented for the labeling update, and other study-related details where available based on the document.

Here's the breakdown based on the provided text, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for clinical performance metrics (like sensitivity/specificity targets). Instead, it discusses the establishment of analytical sensitivity (Limit of Detection - LOD) for specific influenza strains to enrich the product labeling.

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

• Test Set Sample Size: Not explicitly stated for the analytical sensitivity (LOD) and strain reactivity testing.
• Data Provenance: The new data relates to cultured virus (A/Anhui/1/2013 H7N9) testing. The document also mentions general clinical performance characteristics for the original device were established:
  • For NP washes/aspirates: January – March 2011, United States (predominant strains: A/2009 H1N1, A/H3N2, B/Victoria, B/Yamagata).
  • For NP swabs in transport media: January – April 2012, United States (predominant strains: A/2009 H1N1, A/H3N2, B/Victoria, B/Yamagata).
  • These dates and predominant strains suggest prospective collection of clinical samples during influenza seasons in the US for the original device's performance characterization, but detailed methodology for that original study is not provided in this 510(k) summary. The current 510(k) is about adding analytical data for a new strain.

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

Not applicable/Not provided for the analytical sensitivity and strain reactivity additions. This type of testing typically involves laboratory-based methods rather than expert clinical consensus for "ground truth".

4. Adjudication Method for the Test Set

Not applicable/Not provided. The analytical tests would follow standardized laboratory protocols for determining LOD and reactivity, not clinical adjudication.

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-assisted diagnostic tool.

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

The BD Veritor™ System Reader uses a "proprietary algorithm" to interpret test results by subtracting non-specific signal. The document states: "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 implies the "reader" (which performs the algorithm-based interpretation) operates in a standalone manner to provide results, effectively without human-in-the-loop performance for the final interpretation of the test strip signal. Specific performance metrics for this algorithm alone are not detailed in this summary, but its function is described as essential for accurate test interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the analytical sensitivity and strain reactivity data added: The ground truth would be the known presence and concentration of the cultured virus or specific viral strains, confirmed by reference laboratory methods.

For the original clinical performance of the device (referenced for historical context but not the subject of this 510(k) modification): The indication states, "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 suggests that viral culture or FDA-cleared molecular assays likely served as the ground truth for establishing the original clinical performance characteristics.

8. The Sample Size for the Training Set

Not applicable/Not provided. This 510(k) summary is for a modification based on analytical testing, not a new device requiring a training set for model development. The original device's development (which is not detailed here) might have involved internal validation data, but that's not described as a "training set" in this context.

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

Not applicable/Not provided for the reasons stated above.

Summary of Device Performance (from the document's new information context):

The core change in this 510(k) is the addition of data for Analytical Sensitivity (LOD) and Strain Reactivity tables for A/Anhui/1/2013 H7N9 to the product labeling. This indicates that the device has been analytically demonstrated to detect this specific novel avian influenza strain in a cultured setting. The document explicitly includes a disclaimer required by the FDA: "Although this test has been shown to detect the novel avian influenza A(H7N9) cultured virus, the performance characteristics of this device with clinical specimens that are positive for the novel avian influenza A(H7N9) virus have not been established." This clarifies that while analytical detection is shown, clinical performance with patient samples of H7N9 was not part of this submission.

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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/aspirates of 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. 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 samples processed from respiratory specimens. The processed specimen is added to the test device where influenza A or influenza B viral antigens bind to antiinfluenza antibodies conjugated to detector particles on the A+B test strip. The antigenconjugate complex migrates across the test strip to the reaction area and is captured by an antibody line on the membrane. Results are interpreted by the BD Veritor™ System Reader, a portable electronic device which uses a reflectance-based measurement method to evaluate the line signal intensities on the assay test strip, and applies specific algorithms to determine the presence or absence of any target analyte(s). A liquid crystal display (LCD) on the instrument communicates the results to the operator.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a set of predefined thresholds. However, it presents the performance characteristics of the BD Veritor™ System for Rapid Detection of Flu A+B test during clinical studies. The "performance" column will reflect the PPA and NPA values achieved by the device.

Note: While specific acceptance criteria are not called out, the FDA's clearance indicates that the observed performance was deemed acceptable for the intended use.

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

• Prospective Test Set:
  • Sample Size: 1471 evaluable clinical specimens (from an initial 1502 collected)
  • Data Provenance: Multi-center clinical studies conducted at two U.S. trial sites and one Hong Kong trial site during the 2010-2011 respiratory season.
• Retrospective Test Set:
  • Sample Size: 249 evaluable retrospective specimens (from an initial 263 collected)
  • Data Provenance: Retrospective specimens, likely from banked samples, but specific origin beyond "retrospective" is not detailed.

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

The document does not mention the use of human experts to establish the ground truth for the clinical test sets. The ground truth was established by an "FDA-cleared influenza A and B molecular assay (PCR)."

4. Adjudication Method for the Test Set:

Not applicable, as the ground truth was established by a laboratory assay (PCR) and not by expert review requiring adjudication.

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

No, an MRMC comparative effectiveness study was not conducted. This study focuses on the standalone performance of the BD Veritor™ System compared to PCR, not on how human readers' performance improves with or without the device.

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

Yes, the study primarily assessed the standalone performance of the BD Veritor™ System for Rapid Detection of Flu A+B test. The device uses an "opto-electronic reader" to interpret results and apply algorithms, reporting a positive, negative, or invalid result on an LCD screen. This means the interpretation is automated by the device, making it a standalone assessment.

7. The Type of Ground Truth Used:

The ground truth used for the clinical studies (both prospective and retrospective) was an FDA-cleared Influenza A and B molecular assay (PCR).

8. The Sample Size for the Training Set:

The document does not explicitly state a separate training set size for the device's algorithms. The performance data presented is for the evaluation of the final device. For in-vitro diagnostic devices like this, the "training" (development and optimization) often happens with internal validation sets and analytical studies (like LOD, specificity, cross-reactivity) rather than a distinctly separated "training set" in the machine learning sense, before being tested on independent clinical cohorts.

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

As a distinct "training set" is not explicitly mentioned for algorithmic development in the provided document, the method for establishing its ground truth is also not described. However, for any internal development and validation, the ground truth would typically be established using confirmed reference methods, similar to the PCR used for the clinical evaluation. Analytical studies (LOD, specificity, cross-reactivity) involved known concentrations of viral strains and specific microorganisms, which serve as a form of ground truth for characterizing the device's analytical capabilities.

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