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BD Respiratory Viral Panel for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT- PCR) test intended for the simultaneous, qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and/or respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-COV-2, influenza, and RSV can be similar.

BD Respiratory Viral Panel for BD MAX™ System is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and/or RSV infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV- 2, influenza A, influenza B, and RSV viral nucleic acid are generally detectable in NPS and ANS specimens during the acute phase of infection.

Positive results do not rule out co-infection with other organisms. The agent(s) detected by the BD Respiratory Viral Panel for BD MAX™ System may not be the definitive cause of disease.

Negative results do not preclude SARS-CoV-2, influenza B, and/or RSV infection.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

BD Respiratory Viral Panel-SCV2 for BD MAX™ System:

BD Respiratory Viral Panel-SCV2 for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. SARS-CoV-2 viral RNA is generally detectable in NPS and ANS specimens during the acute phase of infection.

The BD Respiratory Viral Panel-SCV2 for BD MAX™ System is intended for use as an aid in the diagnosis of SARS-CoV-2 infection if used in conjunction with other clinical and epidemiological information, and laboratory findings.

Positive results do not rule out co-infection with other organisms. The agent detected by the BD Respiratory Viral Panel-SCV2 for BD MAX™ System may not be the definitive cause of disease.

Negative results do not preclude SARS-CoV-2 infection.

The results of this test should not be used as the sole basis for diagnosis, treatment management decisions.

The BD Respiratory Viral Panel (BD RVP) and BD Respiratory Viral Panel-SCV2 (BD RVP-SCV2) along with the BD MAXTM System are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, Total Nucleic Acid (TNA) extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors RNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test results. For the BD Respiratory Viral Panel for BD MAX™ System and BD Respiratory Viral Panel-SCV2 for BD MAX™ System, a test result may be called as POS, NEG or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure.

The provided text describes the analytical and clinical performance evaluation of two molecular diagnostic devices: the BD Respiratory Viral Panel (BD RVP) for BD MAX System and the BD Respiratory Viral Panel-SCV2 (BD RVP-SCV2) for BD MAX System. Both are real-time RT-PCR tests for detecting respiratory viruses in nasopharyngeal and anterior nasal swab specimens.

Here's an analysis of the acceptance criteria and study proving device performance, based on the provided text:

Important Note: The provided text is a summary of a 510(k) premarket notification. As such, it reports performance data but does not explicitly state "acceptance criteria" in the format of a pre-defined table with specific percentage goals for PPA and NPA. Instead, the reported performance itself serves as the demonstration that the device is "substantially equivalent" to predicate devices, implying that the observed performance would be considered acceptable by the FDA for the given intended use. For this response, I will interpret "acceptance criteria" as the performance metrics and results deemed sufficient for clearance.

1. Table of Acceptance Criteria (Interpreted) and Reported Device Performance

Given that this is a 510(k) submission, the "acceptance criteria" are not explicitly listed with numeric targets in the document. Instead, the reported performance is presented to demonstrate substantial equivalence to legally marketed predicate devices. The implicit acceptance criteria are the high percentages of Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) achieved by the device when compared to a composite reference method (ground truth).

The primary performance data comes from clinical evaluation studies for both the BD RVP and BD RVP-SCV2.

BD Respiratory Viral Panel (BD RVP) for BD MAX System - Clinical Performance Summary

BD Respiratory Viral Panel-SCV2 (BD RVP-SCV2) for BD MAX System - Clinical Performance Summary

For BD RVP-SCV2 clinical performance, the text refers to the same clinical study results as BD RVP, but only for SARS-CoV-2.

• SARS-CoV-2 (NP Swab): PPA 34.6% (541/1562), NPA not explicitly listed but implied from overall subject data. This seems to be a positivity rate, not an agreement rate. The clinical performance summary tables (Table 28 and 29) for SARS-CoV-2 are the relevant ones.
  • NP (Overall): PPA 98.9%, NPA 97.7%
  • ANS (Overall): PPA 98.4%, NPA 97.7%
    (These are the same as reported for the full BD RVP, which makes sense as SCV2 is a subset).

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

BD Respiratory Viral Panel (BD RVP) for BD MAX System:

• Prospective Clinical Evaluation:

  • Sample Size:
    • 2,005 subjects enrolled.
    • Test Set: 1,562 nasopharyngeal swabs (NPS) and 1,566 anterior nasal swabs (ANS).
    • For performance calculations, slightly fewer compliant specimens were used:
      • NPS: 1,545 for SARS-CoV-2, 1,562 for Flu A, Flu B, and RSV.
      • ANS: 1,561 for SARS-CoV-2, 1,564 for Flu A, Flu B, and RSV.
  • Data Provenance:
    • Country of Origin: United States (six geographically distinct U.S. study sites) and Europe (two geographically distinct sites).
    • Retrospective or Prospective: Primarily Prospective. Specimens were collected between January and August 2022.
      • January to early April 2022: Prospective archived/frozen (Category II).
      • Mid-April to August 2022: Prospective fresh (Category I).

• Retrospective Clinical Evaluation:

  • Sample Size:
    • NPS: 240 frozen retrospective nasopharyngeal swabs.
    • Nasal Swabs: 187 frozen retrospective nasal swabs.
  • Data Provenance:
    • Country of Origin: Not explicitly stated within the retrospective section, but implied to be part of the broader US/Europe context from the prospective study.
    • Retrospective or Prospective: Retrospective. Specimens collected between December 2019 and January 2022 (for NPS) and February 2021 and February 2023 (for nasal swabs) from external sources. These were "archived, frozen specimens".

BD Respiratory Viral Panel-SCV2 for BD MAX System:

• The text states: "In the BD Respiratory Viral Panel-SCV2 for BD MAX™ System clinical study, reportable results from specimens compliant at the specimen and PCR levels were obtained from 8 geographically diverse sites. Nasopharyngeal and nasal specimens totaled 1.566 respectively." This refers to the same clinical study data as the broader BD RVP, specifically focusing on SARS-CoV-2 results from that dataset.

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

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

Instead, the ground truth for the clinical evaluation (test set) was established by comparison to highly sensitive molecular assays (NAATs).

• For SARS-CoV-2: A composite method of "two out of three highly sensitive molecular assays (NAATS) that are FDA authorized under EUA for SARS-CoV-2."
• For influenza B and RSV: "an FDA-cleared high sensitivity RT-PCR assay."

This indicates an analytical or "reference method" based ground truth rather than a human expert consensus.

4. Adjudication Method for the Test Set

The adjudication method relies on a "two out of three" rule for SARS-CoV-2 and a single FDA-cleared RT-PCR assay for influenza B and RSV.

• SARS-CoV-2: "Any specimen that tested positive by two EUA assays was considered positive for SARS-CoV-2, whereas any specimen that tested negative by two EUA assays was considered negative."
• Influenza B and RSV: Comparison to a single "FDA-cleared high sensitivity RT-PCR assay."

No explicit 2+1 or 3+1 human expert adjudication method is mentioned, as the ground truth derivation is assay-based.

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

No, an MRMC comparative effectiveness study was not done. This device is a diagnostic assay (RT-PCR test), not an AI-assisted imaging product. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply. The performance is assessed on the device's ability to accurately detect specific viral nucleic acids.

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

While the term "algorithm" is used to describe the software interpreting PCR data, the entire device (BD MAX System with the viral panel) is an automated system. The performance data presented (PPA, NPA) is the standalone performance of the device without human interpretation of the raw PCR signals for diagnosis. The BD MAX™ System software "automatically interprets test results" (page 7). Therefore, the clinical performance described is the standalone performance.

7. The Type of Ground Truth Used

The ground truth used was reference method comparison / composite molecular assay results:

• SARS-CoV-2: Composite reference method using results from "two out of three highly sensitive molecular assays (NAATs) that are FDA authorized under EUA for SARS-CoV-2." (Page 42)
• Influenza A, Influenza B, and RSV: An "FDA-cleared high sensitivity RT-PCR assay." (Page 42)

This is a form of "analytical ground truth" established by other validated diagnostic tests, rather than pathology, expert consensus on images, or long-term clinical outcomes.

8. The Sample Size for the Training Set

The document does not explicitly state a separate "training set" sample size for the assay's development in the context of a statistical machine learning model.

However, it mentions: "As the product undergoes product development, the data is supplemented, and the algorithm is adjusted ('trained') using viral cultures spiked into clinical background matrices at levels surrounding the limit of detection and expected clinical range." (Page 30, and repeated on Page 40 for SCV2). This refers to internal development and optimization using contrived samples, not a distinct, pre-defined "training set" of patient data for a typical AI/ML model for regulatory submission.

Performance data for the submission is based on the "test set" (clinical evaluation studies described in section 2) and analytical studies.

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

As noted above, there isn't a "training set" ground truth in the sense of independently verified patient data used to directly train a submitted AI model. Instead, the "algorithm" (how the BD MAX software interprets PCR signals to call positive/negative) was "adjusted ('trained')" using:

• Viral cultures spiked into clinical background matrices at various concentrations (e.g., around the Limit of Detection and expected clinical range).
• These are contrived samples with a known (positive or negative) status and precise viral concentrations.

The ground truth for these internal development/training stages would be the known concentration of spiked viral material.

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