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The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared RSV molecular assay.

The Sofia RSV FIA may be used with the Sofia or Sofia 2.

The Sofia RSV FIA test employs immunofluorescence technology that is used with Sofia for the rapid detection of RSV antigens. The Sofia RSV FIA test involves the disruption of RSV viral antigens. The patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the Cassette sample well. From the sample well, the specimen migrates through a test strip containing various unique chemical environments. If RSV viral antigens are present, they will be trapped in a specific location.

Note: Depending upon the user's choice, the cassette is either placed inside of Sofia or Sofia 2 for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (Read Now Mode).

Sofia or Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Test results will be displayed (Positive, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.

Sofia 2 is a microprocessor-controlled device about the size of a desk top telephone and weighs less than 3 pounds. Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate specific results.

The document describes the Sofia RSV FIA device and its performance, but it does not contain a detailed table of acceptance criteria and reported device performance with specific metrics like sensitivity and specificity, nor does it detail the specific clinical study design, sample sizes, and ground truth establishment methods for a clinical evaluation.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "Numerous studies were undertaken to document the performance characteristics of Sofia 2 and the Sofia RSV assay, as well as to compare the performance between Sofia and Sofia 2." The conclusion is that "These studies demonstrated equivalent performance of the Sofia RSV FIA on the Sofia and Sofia 2 analyzer."
While specific numerical acceptance criteria (e.g., "sensitivity must be >90%") are not explicitly stated within this document, the studies listed (Limit of Detection, Precision, Assay Development Time, Early Read, Method Comparison, Reproducibility) confirm the equivalence of the Sofia RSV FIA on Sofia 2 to the predicate device (Sofia RSV FIA on Sofia). This implies that the acceptance criteria for performance are met if the performance on Sofia 2 is comparable to the already cleared Sofia device.

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

The document mentions "a panel of clinical samples" for the Method Comparison study and "a panel of test samples at various RSV concentrations" for the Reproducibility study. However, the specific sample sizes for these test sets are NOT provided. The data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated in this document.

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

This information is not provided in the document. For an in vitro diagnostic device like Sofia RSV FIA, the "ground truth" for clinical samples is typically established by a reference method, such as viral culture or an FDA-cleared molecular assay for RSV, as mentioned in the "Indications for Use" for confirming negative results. Expertise would be in performing and interpreting these reference methods.

4. Adjudication Method for the Test Set

This information is not provided in the document, as it likely pertains to expert review of ambiguous cases, which is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not described in this document. This device is an in vitro diagnostic (IVD) test, which is a standalone algorithm-based test. The "readers" would be the Sofia/Sofia 2 instruments themselves, not human interpreters of AI output.

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

Yes, the studies described are standalone performance evaluations of the Sofia RSV FIA device (algorithm only), specifically when performed on the Sofia 2 analyzer, and comparing its performance to the Sofia analyzer. The device automatically scans the test strip and processes results using "method-specific algorithms." Humans load the cassette and read the displayed result.

7. The Type of Ground Truth Used

The "Indications for Use" section states: "A negative result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared RSV molecular assay." This indicates that the ground truth for clinical samples, especially for confirmation, would be established by these reference methods. For laboratory studies like LoD and Reproducibility, the ground truth would be based on known concentrations of RSV.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. For an IVD device like this, the "algorithm" is likely developed and refined during the product development phase (which would involve internal testing and optimization data, akin to a training set), but specific details on that are not provided in this regulatory submission summary for substantial equivalence. The studies described are performance validation studies.

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

Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not provided. If an algorithm was trained, the ground truth would typically be established through highly accurate reference methods (like viral culture or PCR) on a diverse set of samples.

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The BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV antigen from nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in neonatal and pediatric patients under the age of 20. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor™ System Reader.

The BD Flu A+B test is a chromatographic assay to qualitatively detect influenza A and B viral antigens in respiratory specimens. The patient specimen is mixed in a prefilled unitized tube containing RV Reagent C and added to the test device. RV Reagent C contains mucolytic agents that function to break down mucus in a patient specimen thereby exposing viral antigens and enhancing detection in the assay device. Processed specimens are expressed through a filter tip into a single sample well on the BD Flu A+B test device.

The specimen is mixed and added to the test device where influenza A or influenza B viral antigens bind to anti-influenza antibodies conjugated to detector particles on the BD Flu A+B test strip. The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by an antibody line on the membrane. The assay utilizes a proprietary enhanced colloidal-gold particle at the test lines as the means for identifying the presence of influenza A or B viral antigens.

The BD Flu A+B test devices are designed with five spatially-distinct zones including positive and negative control line positions, separate test line positions for the target analytes, and a background zone. The test lines for the target analytes are labeled on the test device as 'A' for Flu A position, and 'B' for Flu B position. The onboard positive control ensures the sample has flowed correctly and is indicated on the test device as 'C'. Two of the five distinct zones on the test device are not labeled. These two zones are an onboard negative control line and an assay background zone. The onboard negative control zone addresses non-specific signal generation and is not labeled on the test device. The remaining zone is used to measure the assay background and is also not labeled.

The BD Flu A+B assay incorporates an active negative control feature in each test to identify and compensate for sample-related, nonspecific signal generation. The BD Veritor™ System Reader uses a proprietary algorithm which subtracts nonspecific signal at the negative control line from the signal present at both the Flu A and Flu B test lines. If the resultant test line signal is above a pre-selected assay cutoff, the specimen is scored as positive. If the resultant test line signal is below the cutoff, the specimen is scored as negative. Use of the active negative control feature allows the BD Veritor™ System reader to correctly interpret test results that cannot be scored visually because the human eye is unable to accurately perform the subtraction of the nonspecific signal.

The provided text describes a 510(k) premarket notification for a modification to the BD Veritor™ System Flu A+B assay, specifically regarding the ability to test excess processed sample in the BD Veritor™ RSV clinical assay. This document does NOT contain a study that proves the device (BD Veritor™ System Flu A+B assay) meets acceptance criteria for its primary function. Instead, it focuses on demonstrating substantial equivalence for a modification related to cross-testing with another BD product (RSV assay).

Therefore, I cannot fulfill all your requests as the complete performance study data and acceptance criteria for the primary influenza detection function are not detailed in this submission. The document states that performance characteristics for the Flu A+B assay were established during specific influenza seasons, implying that studies were done, but the results and detailed acceptance criteria for those original studies are not provided here.

However, I can extract information related to the context of its performance and the type of information typically found in such submissions.

Here's a breakdown of what can be derived from the provided text, and where information is missing:

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

The provided document does not list specific acceptance criteria or detailed performance data for the BD Veritor™ System Flu A+B assay. It mentions that performance characteristics were "established" during certain influenza seasons but does not present the actual data (e.g., sensitivity, specificity, PPA, NPA values).

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

The document mentions that performance characteristics were established during:

• January through March of 2011 for nasopharyngeal (NP) washes/aspirates.
• January through April of 2012 for NP swabs in transport media.

It states these periods were when specific influenza viruses (A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage) were predominant, according to CDC reports. This implies the data was collected prospectively during active influenza seasons in the United States.

The sample size for the test set is NOT specified in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is NOT specified in this document. The ground truth method is implied to be viral culture or an FDA-cleared molecular assay (see point 7), but details on the experts involved in interpreting results or establishing ground truth are absent.

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

This information is NOT specified in this document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is a diagnostic device, not an AI-assisted interpretation device. The BD Veritor™ System Reader uses a proprietary algorithm to interpret test results by subtracting non-specific signals, but it does not involve human readers in the interpretation process in the way an MRMC study for imaging interpretation would. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

The device itself (BD Veritor™ System Flu A+B) operates in a "standalone" fashion in terms of interpretation, meaning the BD Veritor™ System Reader interprets the test strip results algorithmically without human visual interpretation.

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

The document 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."
• For the RSV assay (which the modification allows cross-testing with), it states: "It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay."

This strongly indicates that viral culture or FDA-cleared molecular assays were used as the ground truth.

8. The sample size for the training set

The document describes a modification to an existing device and does not provide information on the training set size for the original device's development or for the algorithmic interpretation by the BD Veritor™ System Reader.

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

This information is NOT specified in this document. As it's a 510(k) submission for a modification, details on the original device's development, including training set ground truth establishment, are typically not included unless directly relevant to the modification.

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The BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV fusion protein from a direct nasopharyngeal swab from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients under the age of 6 years. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor™ System Reader.

The BD RSV test is a chromatographic assay to qualitatively detect RSV fusion protein in samples processed from respiratory specimens. The processed specimen is added to the test device where RSV viral antigen binds to anti-RSV antibodies conjugated to detector particles on the RSV 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. 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.

Here's a summary of the acceptance criteria and study details for the BD Veritor™ System for Rapid Detection of RSV, based on the provided text:

Acceptance Criteria and Device Performance

Study Information:

1. Sample size used for the test set and the data provenance:
   • Test Set Sample Size:
     • Analytical Sensitivity (LoD): 60 or more replicates per viral strain. For VR-1400, 80 replicates were used.
     • Analytical Specificity: Bacteria/yeast tested at approx. 5 x 10⁸ CFU/mL; viruses at 10⁶ TCID₅₀/mL or greater. Specific numbers of tests for each microorganism are not given, but a list of ~40 bacteria/fungi and ~20 viruses were tested.
     • Interfering Substances: Specific concentrations for each substance listed. Number of tests per substance not explicitly stated.
     • Clinical Studies: 523 evaluable specimens (out of 540 collected).
       • Age distribution: 305 (

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The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients less than 19 years of age. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by virus culture or an FDA-cleared RSV molecular assay.

The Sofia RSV FIA test employs immunofluorescence technology that is used with the Sofia Analyzer for the rapid detection of RSV antigens. The Sofia RSV FIA test involves the disruption of RSV viral antigens. The patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the Cassette sample well. From the sample well. the specimen migrates through a test strip containing various unique chemical environments. If RSV viral antigens are present, they will be trapped in a specific location.

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

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

The provided text describes the 510(k) summary for the Sofia® RSV FIA device, but it does not contain the specific acceptance criteria or the detailed results of the multi-center field clinical study that would allow for a complete table of acceptance criteria and reported device performance. The summary mentions that "Sensitivity and specificity were calculated" but does not provide the actual values or the criteria they were measured against.

Therefore, I cannot fulfill Request 1 directly from the provided text. I will answer the other requests based on the available information.

Here's a breakdown of the information that can be extracted and a note on what is missing:

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

MISSING: The document states that "Sensitivity and specificity were calculated" in the multi-center field clinical study, but it does not report the actual sensitivity and specificity values, nor does it specify any pre-defined acceptance criteria that these values were compared against. Without these numbers, a table cannot be created.

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

• Sample Size for Test Set: Not explicitly stated in terms of a specific number of patients or specimens for the multi-center field clinical study. It only mentions that "nasopharyngeal swab and nasopharyngeal aspirate/wash specimens, both fresh and after storage in transport media" were used.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: The study is described as a "multi-center field clinical study," which generally implies a prospective collection of data in a real-world clinical setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

MISSING: The document does not specify the number of experts used or their qualifications for establishing the ground truth for the clinical study.

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

MISSING: The document does not describe any adjudication method used for the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

NOT APPLICABLE/NOT PERFORMED: The Sofia RSV FIA is an instrumented immunofluorescence assay, not an AI-based diagnostic image analysis device or a system requiring human interpretation with or without AI assistance in the way an MRMC study would typically evaluate. The Sofia Analyzer processes results using "method-specific algorithms" and displays "Positive, Negative, or Invalid" results. The study described focuses on the device's analytical and clinical performance against a predicate device, not on human reader performance.

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

YES (Implicitly): The device functions as a standalone diagnostic. The Sofia Analyzer "scans the test strip and measures the fluorescent signal by processing the results using method-specific algorithms" to display "Positive, Negative, or Invalid" results. This is an algorithmic determination without direct human interpretation of the underlying signal, fitting the definition of standalone performance. The clinical study evaluated the performance of this system (device + analyzer algorithm) against a reference standard.

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

The intended use statement specifies that "Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by virus culture or an FDA-cleared RSV molecular assay."

Based on this, it is highly probable that the ground truth for the clinical study was established by either virus culture or an FDA-cleared RSV molecular assay as a reference method. The document implicitly supports this by recommending these methods for confirmation of negative results.

8. The sample size for the training set

NOT APPLICABLE/NOT PROVIDED: The document does not mention a "training set" in the context of machine learning. The device is an immunofluorescence assay with an analyzer that processes results using "method-specific algorithms." These algorithms are likely pre-programmed and validated, rather than being "trained" on a large dataset in the sense of deep learning models. The studies described are for analytical validation and clinical performance evaluation.

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

NOT APPLICABLE/NOT PROVIDED: As no "training set" for a machine learning algorithm is discussed, this information is not applicable.

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The BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV fusion protein from nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients under the age of 20 years. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor ™ System Reader.

The BD RSV test is a chromatographic assay to qualitatively detect RSV fusion protein in samples processed from respiratory specimens. The processed specimen is added to the test device where RSV viral antigens bind to anti-RSV antibodies conjugated to detector particles on the RSV 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. 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.

Here's a breakdown of the acceptance criteria and study details for the BD Veritor™ System for Rapid Detection of RSV, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate table. However, based on the clinical study results and comparisons, the implicit criteria are high sensitivity and specificity relative to viral cell culture.

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

• Sample Size for Test Set: 1146 prospectively collected specimens.
  • 440 Nasopharyngeal Wash / Aspirates (NPWA)
  • 706 Nasopharyngeal Swabs (NPS)
• Data Provenance: From five U.S. trial sites during the 2011-2012 respiratory season. The data is prospective, as indicated by "prospectively collected specimens."

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

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that the ground truth was "an FDA cleared D3 Duet™ DFA on R-Mix cell culture," which is a laboratory method, not directly human experts.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance (or in this case, instrumented read) was not explicitly described. This is a point-of-care diagnostic device with an instrumented reader, not an AI for image analysis where human readers' performance might be augmented. The device itself performs the interpretation.

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

Yes, this study represents a standalone evaluation of the device. The BD Veritor™ System for Rapid Detection of RSV test is an "instrumented read" system where the results are "interpreted by the BD Veritor™ System Reader... [which] applies specific algorithms to determine the presence or absence of any target analyte(s)." The clinical study compares this instrument's performance directly against the reference method (viral cell culture), indicating a standalone assessment.

7. The Type of Ground Truth Used

The primary ground truth used was viral cell culture (specifically, an "FDA cleared D3 Duet™ DFA on R-Mix cell culture"). For some discrepant results (BD Veritor RSV Positive, Viral Cell Culture negative specimens), an "FDA cleared Prodesse Pro Flu+ molecular assay" was used as a secondary confirmation method.

8. The Sample Size for the Training Set

The document does not specify a separate training set size. The device uses "pre-set thresholds" and "specific algorithms" but the development and training details for these algorithms are not provided in this summary. The clinical study described is for validation/testing, not training.

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

Since a dedicated training set is not explicitly mentioned, the method for establishing ground truth for any internal algorithm development (if applicable) is not detailed in this 510(k) summary. The provided performance data pertains to the validation of the final device.

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The QuickVue RSV 10 test is an immunoassay that allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens for symptomatic pediatric patients (less than six years old). The test is intended for use as an aid in the rapid diagnosis of acute RSV infection. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by cell culture. The test is intended for professional and laboratory use.

The QuickVue RSV 10 test is a lateral-flow immunoassay that uses monoclonal antibodies that are specific for RSV antigens. The test is specific to RSV antigen with no known cross-reactivity to normal flora or other known respiratory pathogens. Nasopharyngeal swabs and nasopharyngeal aspirate/wash serve as specimens for this test. For a liquid specimen such as a nasopharyngeal aspirate/wash, the specimen is added directly to the reagent tube and rehydrates the reagent. When a nasopharyngeal swab is used, the reagent is first rehydrated with the provided reagent solution and the swab specimen is then inserted into the reagent tube. The reagent interacts with the specimen and facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The test strip is placed in the reagent tube for 10 minutes. During this time, the specimen will react with the reagents in the test strip. If the specimen contains RSV antigens, a pink-to-red Test Line, along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. If RSV antigen is not present, or is present at very low levels, only a blue procedural Control Line will appear.

The QuickVue® RSV 10 is an immunoassay for rapid, qualitative detection of respiratory syncytial virus (RSV) antigen in nasopharyngeal specimens from symptomatic pediatric patients (less than six years old).

Here's an analysis of its acceptance criteria and supporting study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity/specificity thresholds). Instead, it presents the performance data against a predicate device and states that "These studies demonstrated the substantial equivalence of the QuickVue RSV 10 test to existing products already marketed." Substantial equivalence is the primary regulatory standard for 510(k) devices.

To infer the performance that was found acceptable, we look at the provided comparator data. The "Summary of Performance Data" indicates that sensitivity and specificity were calculated against viral culture, which is generally considered the gold standard for RSV detection at the time of this submission. While the exact numerical performance metrics (sensitivity, specificity) are not provided in the snippet, their calculation against viral culture is highlighted as a key study.

Table of Performance (Based on information provided, specific values are not available in the extract):

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided text for the multi-center field clinical study.
• Data Provenance: The multi-center field clinical study implies data was collected from multiple clinical sites. The country of origin is not specified but given the submitter (Quidel Corporation, San Diego, CA) and the FDA filing, it is likely the U.S. The study was a prospective multi-center field clinical study.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications for establishing the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. The study focuses on the device's performance against a gold standard (viral culture) and its equivalence to a predicate device, not on how human readers improve with AI assistance (as this is not an AI device).

6. Standalone Performance

Yes, a standalone performance study was done. The "multi-center field clinical study" aimed to "document the performance characteristics of the test," including sensitivity and specificity, by comparing the device's results directly to viral culture. This is a standalone assessment of the algorithm's (or, in this case, the test's) ability to detect RSV.

7. Type of Ground Truth Used

The primary ground truth used for the clinical study was viral culture.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning, as this is not an AI/ML device. It's a serological immunoassay. Therefore, there's no training set in that sense. The analytical studies involved panels of test samples at various RSV concentrations for reproducibility and analytical performance, but these are not a "training set."

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

As noted above, there is no "training set" in the AI/ML context for this device. For the analytical studies, the ground truth was established by preparing test samples with known RSV concentrations.

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The Directigen™ EZ RSV test is a rapid chromatographic immunoassay for the direct and qualitative detection of Respiratory Syncytial Virus (RSV) antigen in nasopharyngeal washes, nasopharyngeal aspirates, nasopharyngeal swabs and nasopharyngeal swab/washes from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of Respiratory Syncytial Virus (RSV) infections in neonatal and pediatric patients under the age of 20. It is recommended that negative test results be confirmed by cell culture.

The Directigen EZ RSV antigen detection test is a chromatographic assay to detect RSV antigens extracted from various specimens of symptomatic patients. The speed and workflow of the Directigen EZ RSV test make it applicable as a "STAT" RSV antigen detection test, providing rapid, relevant information to assist with antiviral intervention and other clinical or support decisions.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BD Directigen™ EZ RSV assay:

This 510(k) submission (K101514) is for a modification to an already legally marketed device, the BD Directigen™ EZ RSV assay (K022133). The modification is specifically the change of controls from liquid to dry swabs. Therefore, the studies presented focus on demonstrating that these new dry controls perform equivalently and are as stable as the previously approved liquid controls, rather than a full efficacy study of the assay itself.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for the stability and performance studies of the dry swab controls. It only states "Data to date from accelerated stability studies" and "Confirmatory real time stabilities" for stability, and "Dry swabs perform comparably in the assay" for performance.

Data Provenance: Not explicitly stated, but these are likely internal validation studies conducted by the manufacturer (Becton, Dickinson and Company). The document does not indicate country of origin for the data or if it's retrospective or prospective, though performance and stability studies are generally prospective.

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

Not applicable in the context of this submission. The ground truth here is the established performance of the previous liquid controls and the expectation that the new dry controls should match that performance. There is no mention of external experts being used for this comparison.

4. Adjudication Method for the Test Set

Not applicable. This submission concerns the performance of controls, not diagnostic interpretations requiring 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-powered diagnostic system, and it does not involve human readers interpreting results in a way that typically necessitates an MRMC study.

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

Not applicable. This is an in vitro diagnostic device, not an algorithm. The "standalone" performance here refers to the device's ability to accurately detect the RSV antigen using the new controls in laboratory settings, which is what the performance studies aimed to demonstrate.

7. The Type of Ground Truth Used

The ground truth used for these studies is the performance characteristics of the legally marketed predicate device's liquid controls. The goal was to establish that the new dry controls yield equivalent or better results (in terms of stability and assay performance) compared to the established liquid controls.

8. The Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic assay with modified controls, not a machine learning algorithm requiring a "training set" in the conventional sense. The "training" for the device would have implicitly happened during its original development (K022133), but this document focuses on the validation of the control modification.

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

Not applicable, as there isn't a "training set" for an algorithm. For the original assay's development, the ground truth would have been established through a combination of clinical samples confirmed by a gold standard method (e.g., cell culture for RSV detection). However, this information is not part of this specific 510(k) submission which only addresses the control modification.

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The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) F-protein antigens in nasal wash/aspirate, nasopharyngeal aspirate and nasopharyngeal swab samples. It is an in vitro diagnostic assay that aids in the rapid diagnosis of RSV infections in symptomatic patients 21 years of age and younger. A negative test is presumptive and it is recommended that all negative results be confirmed by cell culture or direct specimen fluorescence assay (DSFA). Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional use.

The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples from symptomatic patients 21 years of age and younger. A wash/aspirate or swab sample is mixed with Sample buffer and applied into the sample well of the Test Cartridge. The sample migrates along the strip. Fluorescent-dyed latex (test) particles. coated with anti-RSV antibodies bind to RSV antigens, if present in the sample. As the sample migrates along the strip, RSV-bound particles are captured at the RSV detection zone, and additional particles are captured at the internal standard zone.

This document describes the RAMP® RSV Assay, a qualitative immunochromatographic test for detecting Respiratory Syncytial Virus (RSV). The study presented focuses on its analytical and clinical performance.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Diagnostic Hybrids, Inc. device, D3 Duet DFA RSV/Respiratory Virus Screening Kit, is intended for the qualitative detection and identification of respiratory syncytial virus, while screening for influenza A virus, influenza B virus, adenovirus, and parainfluenza virus types 1, 2 and 3 viral antigens, in nasal and nasopharyngeal swabs and aspirates or in cell culture. The assay detects viral antigens by immunofluorescence using monoclonal antibodies (MAbs), from patients with signs and symptoms of respiratory infection.

It is recommended that specimens found to be negative after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

Performance characteristics for influenza A virus detection and identification were established when influenza A (H3N2) and influenza A (H1N1) were the predominant influenza A strains circulating in the United States. Performance characteristics for influenza A virus detection and identification were established when influenza A H3N2 and influenza A H1N1 were the predominant influenza A strains circulating in the United States. 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 a 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 Diagnostic Hybrids, Inc. device, D3 Duet DFA RSV/Respiratory Virus Screening Kit, uses a blend of viral antigen-specific murine MAbs. MAbs for RSV are directly labeled with R-phycoerythrin (R-PE) for the rapid detection and identification of RSV. MAbs for influenza A virus, influenza B virus, adenovirus, and parainfluenza virus types 1, 2, and 3 are directly labeled with fluorescein isothiocyanate (FITC), for rapid detection of these agents.

Kit components:

• D3 Duet DFA RSV/Respiratory Virus Screening Reagent
• Normal Mouse Gamma Globulin DFA Reagent
• Respiratory Virus Antigen Control Slides
• Wash Solution Concentrate
• Mounting Fluid

The cells to be tested, derived from a clinical specimen or cell culture, are placed onto a glass slide and allowed to air dry. The cells are fixed in acetone. The D3 Duet DFA RSV/Respiratory Virus Screening Reagent is added to the cells which are then incubated for 15 to 30 minutes at 35° to 37°C in a humidified chamber or humidified incubator. The stained cells are then washed with the diluted wash solution, a drop of the supplied Mounting Fluid is added and a coverslip is placed on the prepared cells. The cells are examined using a fluorescence microscope. The respiratory syncytial virus infected cells will fluoresce golden-yellow, while cells infected with any of the other six viruses will fluoresce apple-green. Uninfected cells will contain no fluorescence but will be stained red by the Evans Blue counter-stain. If only golden-yellow fluorescent cells are present the specimen can be reported as positive for respiratory syncytial virus antigen. If only apple-green fluorescent cells are present, the particular virus is identified using the individual reagents from the D3 Ultra DFA Respiratory Virus Screening & ID Kit (D3 Ultra) on new, separate cell preparations. If both golden-yellow and apple-green are present, the additional virus may be identified using the individual reagents from the D3 Ultra on new, separate cell preparations.

Here's a breakdown of the acceptance criteria and study details for the D' DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets for sensitivity and specificity in the provided text. Instead, the study uses the legally marketed predicate device (D3 Ultra DFA Respiratory Virus Screening & ID Kit) as the comparator, and "100% agreement" is repeatedly cited as the performance goal versus this comparator. The device met this implicit acceptance criterion by demonstrating 100% agreement in both positive and negative percentage agreements across various virus types and specimen sources.

*IAFVBAPF123 refers to Influenza A virus, Influenza B virus, Adenovirus, and Parainfluenza virus types 1, 2, and 3.

2. Sample Sizes and Data Provenance

• Direct Fresh Specimens (Test Set):
  • Total Initial Specimens: 1203
  • Excluded Specimens: 17 (due to site deviations, duplicate specimen, insufficient cell numbers, or high background)
  • Analyzed Specimens: 1187
  • Data Provenance: Prospective, collected at three study sites in the United States.
• Cultured Specimens (Test Set):
  • Total Specimens: 298 frozen specimens
  • Data Provenance: Retrospective (frozen specimens), from a fourth study site. All specimens were derived from nasopharyngeal specimens. The age distribution of individuals is provided on page 13.

3. Number of Experts and Qualifications

The document does not explicitly state the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "Radiologist with 10 years of experience"). However, it mentions that the D3 Duet device was compared against a "cleared DSFA device" (D3 Ultra DFA Respiratory Virus Screening & ID Kit) as the comparator. This implies that the ground truth for the clinical studies was established by laboratory personnel using the predicate device, which is a standard immunofluorescence assay.

4. Adjudication Method

The document does not specify an adjudication method like 2+1 or 3+1. The results are presented as direct comparisons between the D3 Duet and the "D3 Ultra Final Identification," implying that the D3 Ultra's results served as the reference standard without further expert adjudication beyond its own established interpretation protocol.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was done. This device is a diagnostic kit read by a single trained technician, not an AI system designed to assist human readers. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable.

6. Standalone Performance

Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was done for the D3 Duet. The entire clinical performance section (pages 11-14) reports the performance of the D3 Duet device independently against the predicate device (D3 Ultra) as the gold standard.

7. Type of Ground Truth Used

The ground truth for the clinical studies was established using a cleared comparator device, specifically the D3 Ultra DFA Respiratory Virus Screening & ID Kit. This is a form of reference standard testing using an established laboratory method (immunofluorescence assay) for viral antigen detection. For the cultured specimens, cell culture methods were also employed.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/algorithm. Instead, the device is a diagnostic kit based on monoclonal antibodies. Therefore, there is no sample size for an algorithm training set. The various analytical and non-clinical performance studies (precision, detection limit, analytical reactivity, analytical specificity) act as development and validation steps for the kit itself, rather than training for an AI.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" for an AI/algorithm, this point is not applicable. The development and validation of the D3 Duet kit relied on established laboratory techniques for virus isolation, identification using cell cultures, reference viral strains, and bacterial/fungal cultures. These methods served as the "ground truth" during the development and analytical validation of the antibody blend and assay performance.

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TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples. It is designed to test specimens from symptomatic patients aged 5 years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture.

TRU RSV is a rapid, single-use, qualitative lateral-flow immunoassay screening test. The test kit includes a Test Strip attached to a plastic frame or holder, a Conjugate Tube containing a lyophilized bead of colloidal gold-linked monoclonal antibodies to RSV fusion protein and nucleoprotein, Sample Diluent/Negative Control, and plastic transfer pipettes. The Test Strip carries a nitrocellulose membrane with dried capture antibodies. The holder caps the Conjugate Tube during testing and disposal. The conjugate bead is rehydrated with Sample Diluent, sample is added and mixed, and the Test Strip is inserted. If RSV antigens are present, they bind to the conjugate and are captured at the Test Line, forming a pink-red line. An internal control line indicates proper flow.

Here's a summary of the acceptance criteria and study details for the Meridian Bioscience TRU RSV device, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined acceptance criteria metrics (e.g., "Sensitivity must be >X%, Specificity must be >Y%"). Instead, the study aims to demonstrate substantial equivalence to the predicate device and the "standard reference method - tissue culture." The "Correlation" metric appears to be the primary indicator of performance used in the individual site tables.

Therefore, the table below reflects the reported performance to demonstrate this equivalence. The overall results across all sample types and frozen/fresh conditions are used for the main reported device performance.

Note on "Overall" Reported Performance Calculation: The provided document breaks down performance by fresh/frozen and sample type. I calculated a weighted average for the overall device performance based on the totals from the provided tables (Fresh Wash/Aspirate Total, Frozen Wash/Aspirate Total, Fresh Swab Total, Frozen Swab Total).

• Positive (Overall): 72 (Fresh Wash) + 88 (Frozen Wash) + 13 (Fresh Swab) + 46 (Frozen Swab) = 219
• Negative (Overall): 111 (Fresh Wash) + 161 (Frozen Wash) + 107 (Fresh Swab) + 26 (Frozen Swab) = 405
• TRU RSV Positive (Overall): 85 (Fresh Wash) + 91 (Frozen Wash) + 19 (Fresh Swab) + 34 (Frozen Swab) = 229
• TRU RSV Negative (Overall): 98 (Fresh Wash) + 158 (Frozen Wash) + 101 (Fresh Swab) + 38 (Frozen Swab) = 395
• Total Tested (Overall): 183 (Fresh Wash) + 249 (Frozen Wash) + 120 (Fresh Swab) + 72 (Frozen Swab) = 624 (Note: The document states 625 samples, one was "invalid" in Fresh Wash/Aspirate Site 1.)

Using these counts for the combined data (excluding the invalid case):

• True Positives (TP): 64 (Fresh Wash) + 79 (Frozen Wash) + 12 (Fresh Swab) + 33 (Frozen Swab) = 188

• False Positives (FP): 21 (Fresh Wash) + 12 (Frozen Wash) + 7 (Fresh Swab) + 1 (Frozen Swab) = 41

• True Negatives (TN): 90 (Fresh Wash) + 149 (Frozen Wash) + 100 (Fresh Swab) + 25 (Frozen Swab) = 364

• False Negatives (FN): 8 (Fresh Wash) + 9 (Frozen Wash) + 1 (Fresh Swab) + 13 (Frozen Swab) = 31

• Sensitivity: TP / (TP + FN) = 188 / (188 + 31) = 188 / 219 = 85.8%

• Specificity: TN / (TN + FP) = 364 / (364 + 41) = 364 / 405 = 89.9%

• Correlation (Accuracy): (TP + TN) / (TP + TN + FP + FN) = (188 + 364) / (188 + 364 + 41 + 31) = 552 / 624 = 88.5%

It's important to note that the site-specific and fresh/frozen breakdowns show some variability, and the total sensitivity/specificity for each category were often presented with wide confidence intervals.

The overall summary for each type in the table 6 summary are:

• Fresh Wash/Aspirate Total: Sensitivity 88.9%, Specificity 81.1%, Correlation 84.2%
• Frozen Wash/Aspirate Total: Sensitivity 89.8%, Specificity 92.5%, Correlation 91.6%
• Fresh Swab Total: Sensitivity 92.3%, Specificity 93.5%, Correlation 93.3%
• Frozen Swab Total: Sensitivity 71.7%, Specificity 96.2%, Correlation 80.6%

Study Details

1. Sample Size Used for Test Set and Data Provenance:

   • Test Set Size: 625 samples.
   • Data Provenance: Clinical samples from symptomatic patients aged 5 years or less, collected in the US.
     • 304 samples: Collected during the 2006-07 season and tested fresh.
     • 321 samples: Collected during the 2006 and earlier seasons and tested as frozen/thawed.
   • Specimen Types: Nasal wash, nasopharyngeal aspirate, nasal swabs, nasopharyngeal swabs.

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

   • The primary ground truth for the clinical study was established using tissue culture as the "standard reference method." The document does not specify the number or qualifications of experts interpreting the tissue culture results, but it implies this was done by each laboratory's established internal method.
   • For discrepant results between TRU RSV and tissue culture, Direct Specimen Fluorescence Assay (DSFA) or Polymerase Chain Reaction (PCR) assays were used as additional confirmatory methods. Again, the number of experts interpreting these results is not specified.

3. Adjudication Method for the Test Set:

   • The study used a hierarchical adjudication method for discrepant results. When the TRU RSV result differed from the tissue culture result, the samples were "tested by Direct Specimen Fluorescence Assay (DSFA) or by a Polymerase Chain Reaction (PCR) assay." The results of these confirmatory tests (DSFA or PCR) were then used to clarify the true RSV status of the sample, as indicated in the postscripts to Tables outlining discrepant results. This suggests an adjudication process where a third, more definitive test was used to resolve discrepancies between the index test and the primary reference standard.

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focuses on evaluating the standalone performance of the TRU RSV device against a reference method (tissue culture). It does not appear to assess the improvement of human readers with AI assistance versus without.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, this was a standalone performance study. The TRU RSV is a rapid, qualitative, lateral-flow immunoassay that provides a visual result (pink-red lines). The performance evaluation section describes the device's accuracy compared to tissue culture, independently of human interpretation variations (beyond the initial reading of the test, though the reproducibility study suggests consistency in reading).

6. Type of Ground Truth Used:

   • The primary ground truth used was tissue culture.
   • For discrepant samples, DSFA (Direct Specimen Fluorescence Assay) and PCR (Polymerase Chain Reaction) were used as confirmatory methods to establish a more definitive ground truth.

7. Sample Size for the Training Set:

   • The document does not detail a separate "training set" in the context of device development or machine learning. For an immunoassay like TRU RSV, the development process (e.g., antibody selection, reagent formulation) relies on laboratory optimization rather than a distinct "training set" of clinical samples. The clinical study described served as a validation or test set to demonstrate pre-market performance.

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

   • As there's no mention of a traditional "training set" in the context of machine learning, this question is not explicitly addressed. The development of such diagnostic assays typically involves extensive analytical studies (e.g., analytical sensitivity, specificity, interference) using characterized samples and isolates, rather than a clinical "training set" with established ground truth in the same way as AI/ML algorithms.

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