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The Alere BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. 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. Alere BinaxNOW Influenza A & B Card 2 must be read by the Alere Reader.

Performance characteristics for influenza A were established during the 2015-2016 influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A 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 Alere BinaxNOW® Influenza A & B Card 2 is an immunochromatographic membrane assay that detects influenza type A and B nucleoprotein antigens in respiratory specimens. Influenza specific antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. The test strip is mounted inside a cardboard, book-shaped hinged test card.

Swab specimens require a sample preparation step, in which the sample is eluted off the swab into Elution Solution. Sample is added to the top of the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of Sample Lines. Alere BinaxNOW® Influenza A & B Card 2 test results must be read by the Alere™ Reader.

The Alere™ Reader is an easy to use bench top instrument that can be used near patient and in laboratory settings which will interpret, capture and transmit test results. The Alere™ Reader is a camera based instrument that detects the presence and identity of the Alere BinaxNOW® Influenza A& B Card 2 assay, analyzes the intensity of the test and control lines and displays the results (positive, neqative or invalid) on a display screen. The screen is intended as a means of user interface informing the user how to operate the Reader and to display test results, including any errors. Data can be retrieved and downloaded by the operator at any time after testing and uploaded to the hospital LIS/LIM system, if desired. Operator ID and Subject ID can be entered manually or via the provided barcode scanner. An external printer can be attached via USB to the Alere™ Reader to print test results.

A table of the acceptance criteria and the reported device performance is not explicitly provided in the text. However, the study aims to demonstrate that a software modification to the Alere™ Reader does not negatively impact the performance of the Alere BinaxNOW® Influenza A & B Card 2.

The study compared the performance of the Alere BinaxNOW® Influenza A & B Card 2 with the new software modification to the legally marketed predicate device (K173502). The core of the study involved testing clinical samples and comparing the results from the modified device with the predicate device.

Here's an analysis of the provided information concerning the study and ground truth:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not directly presented as a table in the provided text. The submission describes a software modification to mitigate false positive results and states that the new device was compared to the predicate. To fully describe the acceptance criteria, one would typically need access to the original 510(k) submission (K173502) for the predicate device, as the current submission is a "Special 510k" focused on a software change, implying the goal is to maintain the performance of the predicate. The text states the study was performed to show that the modified software does not negatively impact performance and shows no statistically significant performance difference between the modified software and the predicate.

2. Sample Size used for the test set and the data provenance:

   • The text states: "An evaluation was performed using 123 positive and 115 negative clinical samples..." This indicates a total of 238 clinical samples were used in the evaluation.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The data is from retrospective clinical samples as they were "clinical samples that were previously tested" with the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.

4. Adjudication method for the test set: Not specified in the provided text.

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 Alere Reader is an automated instrument, and the study compares two versions of the software in the instrument, not human readers with or without AI assistance. The reader performs the interpretation, so there's no human reading component for comparison in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the evaluation described is a standalone performance of the algorithm within the Alere™ Reader. The device reads and interprets the test result without human intervention for the reading step (the user interface displays the result, but the reading itself is automated).

7. The type of ground truth used: The ground truth for the clinical samples was based on "previously tested" results with the predicate device, implying a comparison to the established performance of the predicate. For the initial predicate device (K173502), the ground truth for influenza detection would typically be established by cell culture or an FDA-cleared influenza A and B molecular assay, as stated in the Indications for Use: "Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay."

8. The sample size for the training set: Not specified. The submission describes a modification to existing software, implying the initial training would have occurred for the predicate device's software. This particular submission does not detail creation of a new training set.

9. How the ground truth for the training set was established: Not specified, as training set details are not provided in this document focused on a software modification. For the original validation of the predicate reader, the ground truth for training would likely have been established using well-characterized samples (e.g., confirmed by cell culture or molecular assay).

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The Alere BinaxNOW® Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. 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. Alere BinaxNOW® Influenza A & B Card 2 must be read by the Alere™ Reader.

Performance characteristics for influenza A were established during the 2015-2016 influenza season when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A 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 Alere BinaxNOW® Influenza A & B Card 2 is an immunochromatographic membrane assay that detects influenza type A and B nucleoprotein antigens in respiratory specific antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip is mounted inside a cardboard, book-shaped hinged test card.

Swab specimens require a sample preparation step, in which the sample is eluted off the swab into Elution Solution. Sample is added to the test strip and the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of Sample Lines. Alere BinaxNOW® Influenza A & B Card 2 test results must be read by the Alere™ Reader.

The Alere™ Reader is an easy to use bench top instrument that can be used near patient and in laboratory settings which will interpret, capture and transmit test results. The Alere™ Reader is a camera based instrument that detects the presence and identity of the Alere BinaxNOW® Influenza A& B Card 2 assay, analyzes the intensity of the test and control lines and displays the results (positive or invalid) on a display screen. The screen is intended as a means of user interface informing the user how to operate the Reader and to display test results, including any errors. Data can be retrieved and downloaded by the operator at any time after testing and uploaded to the hospital LIS/LIM system, if desired. Operator ID and Subject ID can be entered manually or via the provided barcode scanner. An external printer can be attached via USB to the Alere™ Reader to print test results.

This is a 510(k) premarket notification for a software modification to the Alere™ Reader, which is used with the Alere BinaxNOW® Influenza A & B Card 2 assay. The purpose of the submission is to introduce a "Walk Away" mode to the reader's software, alongside other minor enhancements. The underlying immunochromatographic assay (Alere BinaxNOW® Influenza A & B Card 2) itself remains unchanged.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on a software modification to the Alere™ Reader. It explicitly states: "There have been no changes to the Alere BinaxNOW® Influenza A & B Card 2 test." Therefore, the clinical performance (e.g., sensitivity, specificity) of the assay itself is not being re-evaluated or re-established by this specific submission, but rather the performance of the reader in interpreting those results.

The document discusses analytical performance for the reader with the new software. The acceptance criteria for the analytical studies were generally for the Alere™ Reader with the new software to maintain non-inferiority to the predicate reader (K162642) and to perform reliably in its new "Walk Away" mode.

Acceptance Criteria for Reader Performance (Implicit in comparative studies):

• Accuracy of Interpretation: The modified Reader should accurately interpret positive and negative results from the Alere BinaxNOW® Influenza A & B Card 2, consistently with the predicate device and visual interpretation.
• Timing Accuracy: The "Walk Away" mode should accurately time the 15-minute incubation period.
• Reliability: The Reader should operate reliably without significant errors or invalid results.

Reported Device Performance (from the document, primarily from the Analytical Performance section, not provided here but typically found in a full 510(k) submission):

• Analytical Sensitivity and Specificity: The document implies that the analytical performance (e.g., limit of detection, cross-reactivity) of the test card itself is unchanged, as the card hasn't been modified. The analytical performance of the reader with the new software would be demonstrated by its ability to accurately read a range of low-positive and negative samples consistently.
• Reader Equivalence: The submission aims to demonstrate that the modified Reader is substantially equivalent to the predicate (K162642) through comparative studies, which would show consistent reading of results between the two reader versions.
• "Walk Away" Mode Functionality: The new mode would have been tested to ensure it correctly times and reads the assay at the appropriate interval.

Since comprehensive performance data tables are not in the provided text, a complete table of acceptance criteria and reported numbers cannot be created. The document focuses on declaring substantial equivalence based on the software change.

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

The provided document describes the software modification and its comparison to the predicate device. It states, "The purpose of this Special 510k submission is to bring to market a modification of the software contained on the Alere™ Reader. There have been no changes to the Alere BinaxNOW® Influenza A & B Card 2 test."

This implies that the clinical performance data (sensitivity and specificity for influenza detection) would primarily come from the predicate device's original studies (K162642) or general knowledge of the Alere BinaxNOW® Influenza A & B Card 2 assay's performance.

For the software modification itself, the typical studies would involve:

• Analytical Studies: Testing the new reader's ability to interpret positive and negative control cards, as well as cards with varying antigen concentrations (potentially low-positive). These studies would use a specific number of test cards, but this number is not provided in the excerpt.
• Comparison Studies (Reader vs. Predicate Reader): Testing both the modified reader and the predicate reader on the same set of test cards (potentially clinical samples or spiked samples) to ensure concordance. The sample size for such a comparison is not provided in the excerpt.

Data Provenance: Not explicitly stated for specific test sets related to the software modification. Clinical performance characteristics mentioned (for the assay) were established during the 2015-2016 influenza season.

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

For this type of submission (software modification to an existing reader for an IVD), the "ground truth" for the reader's performance would likely be:

• Reference Method for Assay Results: For clinical performance, a "gold standard" laboratory method like cell culture or an FDA-cleared molecular assay (as mentioned in the Indications for Use) would be used to establish the true presence/absence of influenza in patient samples. This is for the assay's performance, not the reader's.
• Visual Interpretation: For evaluating the reader's accuracy, human visual interpretation by trained personnel (who are considered "experts" in reading the specific lateral flow assay) would often serve as a comparison, or the positive/negative status of contrived samples would be known from spiking.

The document does not provide specific details on the number or qualifications of experts used to establish ground truth for the reader's performance in this particular 510(k) submission.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for test sets related to the software modification. For analytical studies comparing reader performance, adjudication might involve a third reader or a consensus if discrepancies arise between the reader and a human interpreter. However, this is not explicitly stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This device is an automated reader for a rapid influenza antigen test. It is not an AI-assisted diagnostic tool designed to improve human reader performance. The Alere™ Reader replaces human visual interpretation of the test card. Its purpose is to provide an objective, automated reading of the results from the immunochromatographic assay. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this device.

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

Yes, implicitly. The Alere™ Reader is a standalone device in the sense that it automatically interprets the test card and reports a result (positive, negative, or invalid) without human interpretation of the test lines. The human interaction is limited to inserting the card and reading the displayed result. The "algorithm" is the reader's software that analyzes the intensity of the test and control lines. The studies supporting this submission would evaluate the performance of this algorithm (software) in correctly reading the test cards.

7. The Type of Ground Truth Used

For the assay's (Alere BinaxNOW® Influenza A & B Card 2) clinical performance (established during the predicate device's evaluation), the indications for use state: "Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay." This indicates that cell culture or an FDA-cleared molecular assay would be considered the ground truth for determining actual influenza infection.

For the reader's performance (the focus of this specific 510(k) for software modification), the ground truth would likely be established by:

• Known concentrations of analyte: For analytical sensitivity.
• Visual interpretation by trained personnel: For concordance studies of the reader against human interpretation of the test card.
• Results from the predicate reader: For demonstrating substantial equivalence of the modified reader.

8. The Sample Size for the Training Set

The document does not provide information about a specific training set. The Alere™ Reader's software likely uses image processing and pattern recognition algorithms that would have been developed and refined using a dataset of test cards (a "training set") to learn to identify and interpret the presence and intensity of test and control lines. However, the size or nature of such a training set is not disclosed in this regulatory summary.

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

As with the training set size, the method for establishing ground truth for any training data used to develop the reader's software is not provided in this document. Typically, for such image-based interpretation systems, ground truth for training data would be established by:

• Manual annotation: Experienced individuals would visually inspect and label images of test cards (e.g., "positive for A," "negative," "invalid").
• Spiked samples with known concentrations: Cards created with precise amounts of antigen to represent known positive or negative results.
• Comparison to a gold standard: For cards from clinical samples, their true status would be confirmed by a reference method (e.g., PCR, cell culture).

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The Alere BinaxNOW® Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. 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. Alere BinaxNOW® Influenza A & B Card 2 must be read by the Alere™ Reader.

The Alere BinaxNOW® Influenza A & B Card 2 is an immunochromatographic membrane assay that detects influenza type A and B nucleoprotein antigens in respiratory specific antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. This test strip is mounted inside a cardboard, book-shaped hinged test card.

Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution. Sample is added to the top of the test strip and the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of Sample Lines. Alere BinaxNOW® Influenza A & B Card 2 test results must be read by the Alere™ Reader.

The Alere™ Reader is provided separately for result interpretation. The Alere™ Reader enables direct data entry of User ID, Subject ID, and retention of test results, but is interpretation only. All Alere BinaxNOW® Influenza A & B Card 2 assay steps are performed outside of the reader and the card assay is inserted at the 15 minute read time.

The Alere™ Reader is an easy to use bench top instrument that can be used near patient and in laboratory settings which will interpret, capture and transmit test results. The Alere™ Reader is a camera based instrument that detects the presence and identity of a completed Alere BinaxNOW® Influenza A & B Card 2 assay, analyzes the intensity of the sample and control line and displays the results (positive, negative or invalid) on a display screen is intended as a means of user interface informing the user how to operate the reader and to display test result, including any errors. Data can be retrieved and downloaded by the operator at any time after testing and uploaded to the hospital LIS/LIM system, if desired. Operator ID and Subject ID can be entered manually or via the provided barcode scanner. An external printer can be attached via USB to the Alere™ Reader to print test results.

Here's a summary of the acceptance criteria and study information for the Alere BinaxNOW® Influenza A & B Card 2 and Alere™ Reader, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but rather presents a clinical performance study against a comparator method (FDA-cleared influenza real-time Polymerase Chain Reaction (RT-PCR) assay). The reported device performance metrics are sensitivity and specificity.

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

• Sample Size: 565 evaluable specimens (from an initial 585 collected).
• Data Provenance:
  • Country of Origin: United States.
  • Type: Prospective clinical study conducted at twelve (12) U.S. study centers during the 2015-2016 respiratory season.
  • Patient Population: Patients presenting with flu-like symptoms.

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

The ground truth for the clinical study was established using an FDA-cleared influenza real-time Polymerase Chain Reaction (RT-PCR) assay as the comparator method. This is an objective laboratory test, not an expert consensus for the clinical study. Therefore, the concept of "experts" to establish ground truth in this context is not directly applicable in the same way it would be for image interpretation tasks.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by an RT-PCR assay, which is a definitive laboratory test, not subject to human adjudication for its 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

Not applicable. This device is an in vitro diagnostic (IVD) test read by an automated reader, not an AI-assisted human reader interpretation system. The Alere™ Reader is an automated instrument that interprets the test card; it does not assist human readers in interpreting results manually.

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

Yes, the clinical performance study evaluated the "Alere BinaxNOW® Influenza A & B Card 2 with results read by the Alere™ Reader." This represents the standalone performance of the combined device and reader system.

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

The ground truth used for the clinical performance study was an FDA-cleared influenza real-time Polymerase Chain Reaction (RT-PCR) assay. This is a molecular diagnostic method considered highly accurate for viral detection.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the device in the context of machine learning or AI algorithm development. The device is an immunochromatographic assay. The analytical studies (analytical sensitivity, reactivity, specificity) evaluate the inherent performance characteristics of the assay and reader, which are established through laboratory testing, not a dataset used to train an algorithm in the AI sense.

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

As noted in point 8, the concept of a "training set" in the context of an AI algorithm is not directly applicable here. The analytical studies involved:

• Analytical Sensitivity (LoD): Determined by evaluating different concentrations of known influenza virus strains. The "ground truth" was the known concentration of the virus producing positive results 95% of the time, verified against laboratory standards.
• Analytical Reactivity (Inclusivity): Determined by testing known influenza strains at specified concentrations, with the "ground truth" being the expected positive result for those strains.
• Analytical Specificity (Cross-Reactivity): Determined by testing various commensal and pathogenic microorganisms, with the "ground truth" being expected negative results.
• Interfering Substances: Tested with known substances at specified concentrations, with the "ground truth" being no effect on test performance.
• Reproducibility: Involved blind-coded specimens with known positive/negative status (likely derived from spiked samples or well-characterized clinical specimens) at low, moderate, and negative levels.

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The Alere BinaxNOW® Influenza A & B Card is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. 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.

Caution: Assay sensitivity for nasal wash/aspirate samples was determined primarily using archived specimens. Users may wish to establish the sensitivity of these specimens on fresh samples.

The Alere BinaxNOW® Influenza A & B Card is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory specimens. These antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. This test strip is mounted inside a cardboard, book-shaped hinged test card.

Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution, saline or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Device: Alere BinaxNOW® Influenza A & B Card

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a structured table format with specific thresholds. However, the performance summary provides quantitative results against a reference standard (Cell Culture/DFA), which implicitly serve as the criteria the device aims to meet. The implicit acceptance criteria would be for the sensitivity and specificity values to be within acceptable ranges for a rapid diagnostic test, generally aiming for high specificity to minimize false positives and reasonable sensitivity. The study results demonstrate these performance characteristics for the device.

Here's a table summarizing the reported device performance for the clinical studies, which can be interpreted as demonstrating the device meets implicit acceptance criteria for sensitivity and specificity:

Implicit Acceptance Criteria (Demonstrated Performance)

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

Prospective Study:

• Sample Size: 846 specimens (nasopharyngeal and nasal swabs).
• Data Provenance: Multi-center clinical studies conducted at a central testing laboratory outside the US during the 2004 respiratory season and at three US trial sites during the 2005-2006 respiratory season.

Retrospective Study:

• Sample Size: 293 frozen clinical samples.
• Data Provenance: Clinical samples collected from symptomatic patients at multiple physician offices, clinics, and hospitals located in the Southern, Northeastern, and Midwestern regions of the United States and from one hospital in Sweden.

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

The document refers to "Cell Culture / DFA" (Direct Fluorescent Antibody) as the comparative method for establishing ground truth. This indicates that the ground truth was established by laboratory testing using established and validated methods, rather than clinical expert consensus. Therefore, the concept of "number of experts" or their "qualifications" in the traditional sense of clinical adjudication by physicians is not directly applicable here. The experts would be the laboratory personnel performing and interpreting the cell culture and DFA, who are presumed to be qualified in these laboratory techniques.

4. Adjudication Method (for the test set)

The adjudication method used for the comparison was against Cell Culture / DFA. This means that discrepancies between the device's results and the Cell Culture / DFA results would be evaluated against the "gold standard" of Cell Culture / DFA without a specified clinical adjudication process detailed in the submission. The text does not mention a 2+1, 3+1, or similar expert adjudication process for discordant results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the provided document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. The study focuses on the standalone performance of the Alere BinaxNOW® Influenza A & B Card compared to laboratory reference methods.

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

Yes, the studies presented are standalone performance studies of the Alere BinaxNOW® Influenza A & B Card. The results show the performance of the device itself (immunochromatographic assay) in detecting influenza antigens, without human interpretation being the primary variable of interest. While human operators interpret the results (presence/absence of pink-to-purple lines), the study assesses the diagnostic accuracy of the test product against the reference standard. The "Reproducibility Study" involved multiple operators interpreting cards, indicating that human interpretation is part of the device's use, but the primary clinical performance studies (sensitivity/specificity vs. Cell Culture/DFA) evaluate the device's diagnostic capability. The "Analytical Sensitivity" section involved 12 different operators interpreting cards, further indicating that the interpretation by human users is part of the device's intended use and evaluation.

7. The type of Ground Truth Used

The primary ground truth used for both prospective and retrospective clinical studies was Cell Culture / DFA (Direct Fluorescent Antibody). This is a widely accepted and established laboratory method for influenza virus detection.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This is common for rapid diagnostic devices like the Alere BinaxNOW® Influenza A & B Card, which are developed based on established immunological principles and optimized through R&D, rather than being "trained" in the machine learning sense on a distinct dataset. The clinical studies described are validation studies for the finalized device.

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

As noted in point 8, there is no explicit "training set" mentioned in the context of machine learning. Therefore, the establishment of ground truth for a training set is not applicable here. The device's performance was evaluated against the gold standard of Cell Culture/DFA in clinical validation studies.

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