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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for the BioSign Flu A+B device, which indicates that the device has been deemed substantially equivalent to a legally marketed predicate device. It discusses regulatory information, but not the technical data from performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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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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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.

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This document is a 510(k) clearance letter for the BioSign® Flu A+B immediate from the FDA to Princeton Biomeditech Corporation. It confirms the device's substantial equivalence to legally marketed predicate devices. The document also includes the device's intended use. However, it does not contain the detailed information about acceptance criteria, study design, or performance metrics requested in the prompt.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is primarily a regulatory approval notice, not a performance study report.

Ask a specific question about this device

The BioSign® Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngcal aspirate/wash specimens obtained from patient with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is 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 management decisions. The test is intended for professional and laboratory use.

BioSign® Flu A+B is an immuno-chromatographic test for the rapid, qualitative detection of influenza A and B. The test device has two test lines, thereby allowing the separate identification of type A and/or type B viral antigens from the same specimen.

In the test procedure, a specimen is collected and placed into the Extraction Well of the test device containing extraction solution for one minute, during which time antigen is extracted from disrupted virus particles. The test device is then raised, tapped and laid back down onto a level surface to allow the solution in the Extraction Well to migrate through the pads containing lyophilized detector antibodies conjugated to gold dye and then through the test membrane. If influenza antigens are present in the specimen, they will react with anti-influenza antibody coupled to gold dye particles, migrate through the membrane as antigen-antibody-dye complexes, bind to the immobilized anti-influenza antibody on the membrane, and generate a colored line in the Test line position (A and/or B). The rest of the sample and unbound/bound dye complexes continue to migrate to the Control line position, where antibody to the antiinfluenza antibody is immobilized, and anti-influenza antibody-unbound/bound dye complexes form the Control line (internal procedural control).

Here's an analysis of the provided 510(k) summary, extracting the requested information:

The device under review is the BioSign® Flu A+B / Status™ Flu A & B, an immuno-chromatographic test for the rapid, qualitative detection of influenza A and B antigens.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly set by the reported performance (sensitivity and specificity) when compared against viral culture as the reference method. The document presents performance for different sample types (nasopharyngeal aspirate, nasopharyngeal swab, nasal swab).

Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not explicitly state numerical "acceptance criteria" thresholds, but rather reports the observed performance and implies these values were sufficient for regulatory clearance. The wide confidence intervals in some cases suggest that the performance might vary.

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

• Sample Size for Test Set:
  • Total Patients: 862
  • Nasopharyngeal Aspirate: 253 cases
  • Nasopharyngeal Sample: 251 cases
  • Nasal Swab Sample: 358 cases
    (Note: The sum of individual sample types is 862, matching the total number of patients, indicating these might be overlapping or distinct subsets of samples from the same patient pool, or simply different sample types evaluated from the overall patient population.)
  • Archived Samples: 80 samples for both Flu A and Flu B verification (Columbia NY Presbyterian Hospital).
• Data Provenance:
  • Country of Origin: USA (samples collected at 5 sites in the USA).
  • Retrospective or Prospective: Prospective clinical study, with additional testing on "Archived Samples" which would be considered retrospective.

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

The document does not specify the number of experts used to establish the ground truth or their qualifications. The ground truth method was viral culture, and it's common for laboratory professionals to perform and interpret viral cultures, but no details on their expertise are provided.

4. Adjudication Method for the Test Set

The primary reference method for initial comparison was viral culture. For samples that produced discrepant results between the BioSign® Flu A+B test and viral culture, a third, more definitive method was used for resolution: proFLU plus by Prodesse (real-time RT-PCR, or PCR). This constitutes an adjudication method, where ambiguous cases are resolved by a higher-tier test. The document refers to the results from the PCR as "further analyzed" or used to identify cases that were "positive by both BioSign and PCR" or "negative by both BioSign and PCR".

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study design is typically used for image-based diagnostic aids where human readers interpret results with and without AI assistance to assess the impact of AI on reader performance. The BioSign® Flu A+B is a rapid diagnostic test, not an AI-powered diagnostic imaging device.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done for the device. The reported sensitivity and specificity values directly reflect the performance of the BioSign® Flu A+B device itself, without any human interpretation adjustments beyond standard operation and reading of a rapid diagnostic test. The entire clinical study section, including the performance tables, represents the standalone performance of the device against the ground truth.

7. Type of Ground Truth Used

The type of ground truth used was primarily viral culture, which is a laboratory-based method for identifying and growing viruses. For discrepant results, real-time RT-PCR (proFLU plus by Prodesse) was used as a confirmatory or adjudicating ground truth.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. This type of device (rapid diagnostic test) is typically developed and optimized during its R&D phase using various sample sets, but the clinical study described is primarily for validation/testing of the finalized device.

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

As no explicit training set is described, the method for establishing ground truth for a training set (if one existed in the R&D phase) is not provided. The ground truth for the clinical test set was established by viral culture (and PCR for discrepants), as described in point 7.

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