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The BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE R Panel) is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab (NPS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19.

The following organism types are identified and differentiated using the SPOTFIRE R Panel:

Viruses: Adenovirus Coronavirus (seasonal) Coronavirus SARS-CoV-2 Human metapneumovirus Human rhinovirus/enterovirus Influenza A virus Influenza A virus A/H1-2009 Influenza A virus A/H3 Influenza B virus Parainfluenza virus Respiratory syncytial virus

Bacteria: Bordetella parapertussis Bordetella pertussis Chlamydia pneumoniae Mycoplasma pneumoniae

Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and/or symptoms of respiratory infection are indicative of the identified microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment management decisions.

Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, or lower respiratory tract infection that may not be detected by an NPS specimen. Positive results do not rule out coinfection with other organisms. The agent(s) detected by the SPOTFIRE R Panel may not be the definite cause of disease.

Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

The BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE R Panel) simultaneously identifies 15 different respiratory viral and bacterial pathogens in nasopharyngeal swabs (NPS) from individuals with signs and symptoms of respiratory tract infection (see Table 1) . The SPOTFIRE R Panel is compatible with the BIOFIRE® System, a polymerase chain reaction (PCR)-based in vitro diagnostic system for infectious disease testing. The SPOTFIRE System Software executes the SPOTFIRE R Panel test and reports the test results. The SPOTFIRE R Panel was designed to be used in CLIA-waived environments.

A test is initiated by loading Hydration into one port of the SPOTFIRE R Panel pouch and a NPS specimen mixed with the provided Sample Buffer into the other port of the SPOTFIRE R Panel pouch and placing it in the SPOTFIRE System. The pouch contains all of the reagents required for specimen testing and analysis in a freezedried format; the addition of Hydration and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the SPOTFIRE System Software guides the user through the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.

The SPOTFIRE System contains coordinated systems of inflatable bladders and seal points, which act on the pouch to control the movement of liquid between the pouch blisters. When a bladder is inflated over a reagent blister, it forces liquid from the blister into connecting channels. Alternatively, when a seal is placed over a connecting channel it acts as a valve to open or close a channel. In addition, electronically-controlled pneumatic pistons are positioned over multiple plungers in order to deliver the rehydrated reagents into the appropriate times. Two Pettier devices control heating and cooling of the PCR reactions and the melt curve analysis.

Nucleic acid extraction occurs within the SPOTFIRE R Panel pouch using mechanical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the SPOTFIRE system performs a nested multiplex PCR that is executed in two stages. During the first stage, the SpotFire system s a single, large volume, highly multiplexed reverse transcription PCR (tt-PCR) reaction. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent double-stranded DNA binding dye (LC Green® Plus, BioFire Diagnostics). The solution is then distributed to each well of the array. Array wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 2nd stage PCR, or nested PCR, is performed in singleplex fashion in each well of the conclusion of the 2nd stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data.

The SPOTFIRE System Software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the panel.

Here's a breakdown of the requested information, based on the provided FDA 510(k) summary for the BIOFIRE® SPOTFIRE® Respiratory (R) Panel:

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

While explicit acceptance criteria (e.g., "PPA must be >95%") are not directly stated as pass/fail thresholds in this summary but rather derived from the observed performance of the predicate device, we can infer the expected performance based on the clinical evaluation results. The reported performance is shown in the "Clinical Performance" section.

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

• Prospective Clinical Evaluation:

  • Sample Size: 1120 valid Nasopharyngeal Swab (NPS) specimens (out of 1215 enrolled).
  • Data Provenance: Five geographically distinct urgent care or emergency department study sites. Four in the US and one in the UK. Data was collected prospectively from December 2020 to June 2021. Both fresh (861 specimens) and immediately frozen (259 specimens) samples were included, with no performance difference observed.

• Testing of Preselected Archived Specimens:

  • Sample Size: 542 valid archived NPS specimens (out of 562 obtained).
  • Data Provenance: Frozen archived NPS specimens obtained from 15 external laboratories worldwide. Retrospectively tested at four US clinical sites.

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

The document states, "The performance of the SPOTFIRE R Panel was evaluated by comparing the test results with those from FDA-cleared multiplexed respiratory pathogen panels." These panels serve as the comparator (ground truth), but the document does not specify:

• The number of experts
• Their specific qualifications (e.g., radiologist with 10 years of experience)
• The process by which those experts, if any, established the ground truth for the comparator methods. It relies on the prior FDA clearance of the comparator devices for their accuracy. Discrepant results were investigated using "additional molecular method" or "standard of care," but the specific expertise applied to these investigations is not detailed.

4. Adjudication Method for the Test Set

The document mentions "investigations of discrepant results are summarized in the footnotes." Discrepant results (FN and FP) were retested with the SPOTFIRE R Panel, or further investigated using an "additional molecular method" or "standard of care." However, a specific "adjudication method" involving multiple expert readers/reviewers (e.g., 2+1, 3+1) is not described. The ground truth relies on the comparator molecular methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as the BIOFIRE® SPOTFIRE® Respiratory (R) Panel is a nucleic acid test (PCR-based in vitro diagnostic system), not an AI-powered diagnostic imaging device that assists human readers. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance was not performed.

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

This is an algorithm-only (device-only) performance study. The device is an in vitro diagnostic test that provides a qualitative result (positive/negative) for the presence of specific nucleic acids. The performance data presented (PPA, NPA) directly reflect the device's ability to detect these targets without human interpretation of the raw data. The "SPOTFIRE System Software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the panel."

7. The Type of Ground Truth Used

The ground truth for the clinical studies was established by comparison to FDA-cleared multiplexed respiratory pathogen panels (molecular methods). For discrepant results, "additional molecular method" or "standard of care" was used as further reference. For analytical performance (Limit of Detection, Inclusivity, Specificity), the ground truth was based on known concentrations of characterized isolates (e.g., TCID50/mL, CFU/mL, copies/mL).

8. The Sample Size for the Training Set

The document describes pre-market validation studies for a device, which typically involves analytical and clinical performance testing. It does not specify a "training set" in the context of machine learning model development. The data described (prospective and archived clinical specimens, analytical samples) are primarily for validation/testing of the device's performance based on its defined reagent and instrument protocols. The device's underlying "algorithm" (PCR and melt curve analysis interpretation) is inherent to its design and not typically "trained" in the same way an AI model is.

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

Since there is no "training set" described in the context of an AI/ML model for this device, this question is not applicable. The device's mechanisms are based on established molecular biology principles (PCR and melt curve analysis) rather than iterative learning from a labeled dataset.

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