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The BioFire® Global Fever Special Pathogens Panel is a qualitative, mucleic acid-based test intended for use with BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems. The BioFire Global Fever Special Pathogens Panel is for the simultaneous qualitative detection and identification of multiple bacterial, viral, and protozoan nucleic acids directly from EDTA whole collected from individuals with signs and or symptoms of acute febrile illness and known or suspected exposure to the target pathogens described below.

Pathogens identified:
Chikungunya virus Dengue virus (serotypes 1, 2, 3 and 4) Leishmania spp. that cause visceral leishmaniasis (e.g., L. donovani and L. infantum) Leptospira spp. Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale) West Nile virus

Pathogens presumptively identified:
Bacillus anthracis Crimean-Congo hemorrhagic fever virus Ebolavirus spp. Francisella tularensis Lassa virus Marburgvirus Yellow fever virus Yersinia pestis

Pathogens for which the panel provides presumptive identification results resting and confirmation procedures in consultation with the appropriate public health authorities for whom reports may be necessary.

Positive results do not rule out co-infections with pathogens not included on the BioFire Global Fever Special Pathogens Panel. Not all pathogens that cause acute febrile illness are detected by this test, and nectude infection with the pathogens targeted by the device and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Evaluation for more common causes of acute illness (e.g., infections of the upper and lower respiratory tract or gastroenteritis, as well as non-infectious causes) should be considered prith this panel. In the United States, patient travel history, exposure risk, and consultation of the CDC Yellow Book should be considered prior to use of the BioFire Global Fever Special Pathogens Panel as some pathogens are more common in certain geographical locations. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guided by the relevant public health authorities.

The BioFire Global Fever Special Pathogens Panel is indicatories having appropriate biosafety equipment, personal protective equipment (PPE), contamment facilities and persomel trained in the safe handling of diagnostic clinical specimens potentially containing any of the pathogens detected by this panel.

The BioFire Global Fever Special Pathogens Panel is indicated for use in laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities.

For In Vitro Diagnostic Use.

The BioFire® Global Fever Special Pathogens Panel is a multiplexed nucleic acid-based test designed to be used with BioFire® FilmArray® Systems (BioFire® FilmArray® 2.0 or BioFire® FilmArray® Torch). The BioFire Global Fever Special Pathogens Panel pouch contains freezedried reagents to perform nucleic acid purification and nested, multiplexed polymerase chain reaction (PCR) with DNA melt analysis. The BioFire Global Fever Special Pathogens Panel conducts tests for the identification of bacterial, viral, and protozoan pathogens from whole blood specimens collected in EDTA tubes (Table 1). Results from the BioFire Global Fever Special Pathogens Panel are available in about 1 hour.

Here's a breakdown of the acceptance criteria and study information for the BioFire Global Fever Special Pathogens Panel:

1. Table of Acceptance Criteria and Reported Device Performance

The application does not explicitly state "acceptance criteria" for PPA and NPA. However, it presents the clinical performance results in a way that suggests these are the key metrics for evaluating agreement with comparator methods. The "Expected percent agreement was >95%" in the reproducibility study might be inferred as a general target for performance. For this table, I'll use the Reported Clinical Performance Summary (Tables 4, 5, 6) as the "Reported Device Performance" against an implied high standard of agreement.

Note on "Acceptance Criteria": The document provides performance results but doesn't explicitly state quantitative acceptance criteria (e.g., "PPA must be >95%"). However, the high percentages and confidence intervals presented imply that high sensitivity and specificity are expected for proper function. The "Reproducibility" section mentions ">95%", which can serve as a proxy for the general expectation of performance accuracy.

2. Sample size used for the test set and the data provenance

• Prospective Clinical Study Test Set:
  • Sample Size: 2139 prospectively collected whole blood specimens.
  • Data Provenance: The specimens were collected between March 2018 and March 2021 from 11 undisclosed sites. The country of origin is not explicitly stated, but the mention of "CDC Yellow Book" in the "Indications for Use" suggests a relevance to North American (US) context, although the pathogens detected indicate global relevance. The data is prospective.
• Archived Specimen Study Test Set:
  • Sample Size: 416 archived specimens.
  • Data Provenance: The specimens were collected from undisclosed sites (Site 01: 199, Site 02: 82, Site 03: 135). The country of origin is not explicitly stated. The data is retrospective.
• Contrived Specimen Study Test Set:
  • Sample Size: 50 replicates for each analyte for which archived specimens were unavailable or insufficient. This resulted in varying total number of specimens tested per analyte (e.g., CCHF virus and Marburgvirus sp. had 100 replicates, others had 50).
  • Data Provenance: Contrived specimens were prepared using residual human whole blood. This is a laboratory-based study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Ground truth was established using "plate-based PCR comparator methods" and "additional PCR" for discrepant results. For archived specimens, they had "known analyte content" or "high likelihood of containing a given analyte." For contrived specimens, the "known composition of the contrived specimen" was the ground truth.

4. Adjudication method for the test set

The document describes "discrepancy testing" for samples where the BioFire Global Fever Special Pathogens Panel results differed from the initial comparator method results. For example:

• For Chikungunya virus, "Evidence of Chikungunya virus was found in 2/2 FP specimens by additional PCR."
• For Dengue virus, "15/17 FN specimens were positive upon BioFire Global Fever Special Pathogens Panel retest and by additional PCR, two were positive Global Fever Special Pathogens Panel retest, and eight were detected only by additional PCR."
• For Leptospira spp., "Evidence of Leptospira spp. was found in 1/1 FN specimens by BioFire Global Fever Special Pathogens Panel retest and by additional PCR, and in 3/4 FP specimens by additional PCR."
• For Plasmodium spp., similar retesting by the BioFire panel and "additional PCR" or "species-level comparator assay" was used.

This indicates an adjudication method that involves retesting with the device and/or additional PCR/comparator methods for discrepant results, rather than explicitly stating an "X+Y" consensus model among human experts.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a diagnostic assay (nucleic acid-based test), not an AI-assisted interpretation tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this submission.

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

Yes, the performance studies (clinical, archived, contrived) evaluate the BioFire Global Fever Special Pathogens Panel as a standalone device (algorithm only). The device provides automated test interpretation and report generation, and the "user cannot access raw data" (Table 2). This means the performance metrics (PPA, NPA) reflect the algorithm's detection capabilities without human intervention in the interpretation process.

7. The type of ground truth used

The ground truth for the test sets was primarily established by:

• Comparator methods (e.g., plate-based PCR/additional PCR): For both prospective clinical and archived specimens.
• Known composition: For contrived specimens, where the analytes were intentionally spiked into the samples.
• Discrepancy testing: For cases where the device result and initial comparator result differed, further testing (usually additional PCR) was performed to resolve the discrepancy and establish the final ground truth.

8. The sample size for the training set

The document does not specify the sample size for a training set. The BioFire Global Fever Special Pathogens Panel is a diagnostic assay, and while its development would involve internal validation and optimization, the provided performance data relates to its analytical and clinical performance after development, rather than the data used for machine learning model training.

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

Since a "training set" in the context of the requested information (e.g., for an AI model) is not explicitly mentioned or relevant to this type of device submission, the document does not describe how ground truth for a training set was established. The performance studies presented are for the finished device's evaluation against established laboratory methods.

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The BioFire® Global Fever Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems. The BioFire Global Fever Panel detects and identifies selected bacterial, viral, and protozoan nucleic acids directly from EDTA whole blood collected from individuals with signs and/or symptoms of acute illness or recent acute febrile illness and known or suspected exposure to the following target pathogens: chikungunya virus (serotypes 1, 2, 3 and 4), Leptospira spp., and Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale). Evaluation for more common causes of acute febrile illness (e.g., infections of the upper and lower respiratory tract or gastroenteritis, as well as non-infectious causes) should be considered prior to evaluation with this panel. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities.

Positive results do not rule out co-infections with pathogens not included on the BioFire Global Fever Panel. Not all pathogens that cause acute febrile illness are detected by this test, and negative results do not rule out the presence of other infections. In the United States, patient travel history and consultation of the CDC Yellow Book should be considered prior to use of the BioFire Global Fever Panel as some pathogens are more common in certain geographical locations.

For In Vitro Diagnostic Use.

The BioFire Global Fever Panel is a multiplexed nucleic acid-based test for the detection and identification of six pathogens which cause acute febrile illness (AFI) from whole blood specimens on BioFire FilmArray systems. The BioFire Global Fever Panel detects and identifies the following pathogens: chikungunya virus, dengue virus, Leptospira spp., and Plasmodium spp., including species differentiation between P. falciparum and P. vivax/ovale. The BioFire Global Fever Panel was originally described and was granted De Novo classification in DEN200043.

The BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel is an assayed quality control intended for monitoring the diagnostic performance of the BioFire Global Fever Panel. The Control Kit consists of Positive and Negative External Controls in a FilmArray Control Injection Vial format. The Positive External Control contains external assayed quality control material consisting of a set of non-infectious DNA segments dried on the filter of a FilmArray Control Injection Vial and detected by the Global Fever Panel. The Negative External Control contains no DNA and is also provided in the Control Injection Vial format. Analysis of the controls is carried out by specific pouch modules that are included in the BioFire Global Fever Panel Pouch Module Package. The BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel was fully described and cleared in K202382.

The purpose of this submission is to add BioFire FilmArray Torch as an additional instrument system for use with the BioFire Global Fever Panel and BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel, which were previously marketed for use with BioFire FilmArray 2.0 Systems. The FilmArray Torch is a modular configuration of the FilmArray 2.0 that minimizes instrument footprint by stacking up to twelve individual FilmArray Torch Modules on top of a single FilmArray Torch System Base. This 510(k) request describes modifications to the BioFire Global Fever Panel Pouch Module Package software and validation efforts to support adding FilmArray Torch Systems to the intended use of both the BioFire Global Fever Panel and associated BIOFIRE SHIELD Control Kit.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" in a separate section. Instead, the performance data is presented as a comparison to the predicate device (BioFire FilmArray 2.0 system), implying that non-inferiority or comparable performance to the established predicate is the implicit acceptance criterion.

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

• Test Set for BioFire Global Fever Panel (Table 3):

  • Sample Size: For each analyte (e.g., Leptospira interrogans), there were 3 concentrations tested (Moderate Positive, Low Positive, Negative). Each concentration was tested with 3 FilmArray 2.0 systems and 3 FilmArray Torch systems. On each system, 30 replicates were run.
    • For a single analyte and concentration, 30 replicates/system * 3 systems = 90 replicates for each platform.
    • Total replicates per analyte (3 concentrations): 90 replicates/platform * 3 concentrations = 270 replicates for each platform.
    • Total replicates across all analytes and concentrations for comparison: 1080 replicates on FilmArray 2.0 and 1080 replicates on FilmArray Torch.
    • The exact number of unique "samples" (batches of contrived material) is not specified, but the number of test runs is clear.
  • Data Provenance: The replicates are "contrived samples containing representative pathogens... at concentrations near the limit of detection (LoD)" and "negative samples containing no analyte." The exact country of origin is not stated, but the study was conducted by BioFire Defense, LLC (Salt Lake City, UT, USA). It is a prospective study as new testing was performed to evaluate the FilmArray Torch system.

• Test Set for BIOFIRE SHIELD Control Kit (Table 4):

  • Sample Size:
    • Positive External Controls: 135 replicates (45 replicates/system * 3 FilmArray Torch systems).
    • Negative External Controls: 135 replicates (45 replicates/system * 3 FilmArray Torch systems).
    • Total: 270 replicates.
  • Data Provenance: Details are for the BioFire FilmArray Torch platform only. The data is prospective, generated specifically for this evaluation.

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

For both studies (BioFire Global Fever Panel and BIOFIRE SHIELD Control Kit), the ground truth was established by the known concentration/presence of the analyte in the contrived samples or controls. While operators performed the tests, there is no mention of "experts" establishing the ground truth of the test material, as it's an analytical performance study using characterized samples.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method in the context of expert review. The "expected result" for each test run (Detected/Not Detected) was based on the known composition of the contrived samples or control materials.

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

This type of study was not performed, nor is it applicable. The device is an in vitro diagnostic test that provides automated interpretation and report generation. There is no "human reader" component in the interpretation of the results to be improved by AI assistance. The document explicitly states: "Automated test interpretation and report generation; user cannot access raw data."

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

Yes, a standalone study was done. The BioFire Global Fever Panel runs on the FilmArray system, which is an automated device. The performance data presented in Table 3 and Table 4 reflects the algorithm's performance (i.e., the device's ability to detect and identify targets) directly on the FilmArray Torch system, without human intervention in the result interpretation. The objective of this submission was to evaluate the performance of the existing panel on a new instrument system (FilmArray Torch), which itself is automated.

7. The Type of Ground Truth Used

The ground truth used was known composition of contrived samples/controls. This means:

• For positive samples, the specific analytes and their concentrations (e.g., 3xLoD, 1xLoD) were pre-determined.
• For negative samples and controls, the absence of the target analyte was pre-determined.

8. The Sample Size for the Training Set

The document does not provide information on a training set. This submission is for adding a new instrument system (BioFire FilmArray Torch) for an already existing and cleared device (BioFire Global Fever Panel). The "BioFire Global Fever Panel was originally described and was granted De Novo classification in DEN200043." Therefore, any initial development and potential "training" (if applicable for the underlying algorithm) would have occurred during the development phase for DEN200043, and those details are not part of this 510(k) summary. The current study is a verification/validation for expanded instrument compatibility.

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

As no training set information is provided in this document, the method for establishing its ground truth is also not available here.

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The BioFire® COVID-19 Test 2 is a qualitative nested multiplexed RT-PCR in vitro diagnostic test intended for use with the BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems. The BioFire COVID-19 Test 2 detects nucleic acids from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs (NPS) from symptomatic individuals suspected of COVID-19 by their healthcare provider.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in NPS specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out co-infection with other pathogens.

Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. The BioFire COVID-19 Test 2 is intended for use by trained medical and laboratory professionals in a laboratory setting or under the supervision of a trained laboratory professional.

For In Vitro Diagnostic Use.

The BioFire COVID-19 Test 2 is a multiplexed nucleic acid-based test for the detection of SARS-CoV-2 RNA from nasopharyngeal swabs (NPS) eluted in either transport medium or saline. The test was originally described and cleared in K211079. The BioFire COVID-19 Test 2 uses BioFire FilmArray technology and is for use with BioFire FilmArray 2.0 and BioFire FilmArray Torch instruments. Once the sample is injected into the FilmArray pouch is loaded into the Film Array instrument which performs all aspects of testing including nucleic acid extraction, reverse-transcription, and nested PCR with melt analysis. The currently cleared version of the test uses three SARS-CoV-2 assays and returns a 'SARS-CoV-2 Detected' call if one or more of the SARS-CoV-2 assays are positive.

The purpose of this submission is to display results for four additional SARS-CoV-2 assays which are currently present on the test, but for which results are masked through software. The assays are being unmasked as a mitigation against the risk of future SARS-CoV-2 variants affecting the sensitivity of the BioFire COVID-19 Test 2 due to mutations in assay primer regions. Note that to date BioFire Defense has not identified any variants that are predicted to affect the performance of the three-assay version of BioFire COVID-19 Test 2 described in K211079. These changes are being requested preemptively. The calling scheme when using the seven total SARS-CoV-2 assays will remain unchanged: one or more positive SARS-CoV-2 assay results will return an overall 'SARS-CoV-2 Detected' result.

Here's a breakdown of the acceptance criteria and the study details for the BioFire COVID-19 Test 2 based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a Special 510(k) submission where the primary change is the unmasking of four additional SARS-CoV-2 assays within an already cleared device (BioFire COVID-19 Test 2, K211079). Therefore, the "acceptance criteria" are implied by demonstrating equivalence to the predicate device's performance. The re-analysis of prior studies with the modified software is used to show this equivalence.

Since this is a submission for a software modification to unmask existing assays and not a de novo submission establishing new performance benchmarks, the acceptance criteria are largely defined by matching or showing no significant degradation from the predicate device's performance.

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

The document states that no additional testing was performed for this submission. Instead, all study data previously submitted in K211079 were re-analyzed using the updated software.

Therefore, the "test set" for this specific submission is the re-analysis of data from the original K211079 (and potentially EUA200044) studies.

• Clinical Testing (DF-SDY-030617):
  • Sample Size: 69 positive samples, 454 negative samples. (Total = 523 samples)
  • Data Provenance: Prospective Clinical Evaluation. The document does not explicitly state the country of origin, but generally, FDA submissions for predicate devices are expected to include data from diverse geographic regions within the US, or from regions with comparable patient populations.
• Bench Testing: Sample sizes vary per study. For example:
  • LoD studies (DF-SDY-029904, DF-SDY-030331) involve serial dilutions and replicates.
  • Specificity/Exclusivity (DF-SDY-029903, DF-SDY-030333) involve testing a panel of organisms/viruses.
  • Reproducibility (DF-SDY-030398) involves testing replicates across multiple sites.

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

The ground truth for the clinical samples (DF-SDY-030617) would typically be established by a reference method, most commonly another FDA-authorized RT-PCR assay. The document does not specify the number or qualifications of experts involved in determining the ground truth for the clinical samples. For molecular diagnostics, "expert consensus" is less common for ground truth than established reference tests.

For bench testing studies (e.g., LoD, inclusivity, exclusivity), the ground truth is based on the known concentration of spiked analytes or the known identity of the assayed organisms/viruses, which does not typically involve human experts establishing ground truth in the same way as clinical image interpretation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set regarding human interpretation, as the device is an in vitro diagnostic (IVD) molecular test for direct detection of SARS-CoV-2 RNA. Results are determined by the instrument and its software.

For the clinical study, the reference method used to establish positive/negative status for the clinical samples would be the "adjudication." However, the method (e.g., comparison to a composite reference standard, or another cleared test) is not detailed here.

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 an in vitro diagnostic (IVD) device that performs a laboratory test. It does not involve human readers interpreting images or data with or without AI assistance. The output is a "SARS-CoV-2 Detected" or "SARS-CoV-2 Not Detected" result.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, the performance presented is standalone/algorithm only. The BioFire COVID-19 Test 2 is an IVD automated system. The results are generated directly by the device's software based on its internal processes (nucleic acid extraction, RT-PCR, melt analysis) without human interpretation of raw data. The study validates the device's ability to detect SARS-CoV-2 RNA independently. The phrasing "Software uses results from 7 assays" further confirms this.

7. The Type of Ground Truth Used

• Clinical Testing (DF-SDY-030617): The ground truth for the prospective clinical evaluation samples would most commonly be established by a highly sensitive and specific reference molecular assay (e.g., another FDA-cleared or EUA RT-PCR test for SARS-CoV-2), possibly combined with clinical diagnosis, but the document does not explicitly state this.
• Bench Testing:
  • LoD, Reactivity (Inclusivity): Ground truth is based on the known concentration and identity of specific SARS-CoV-2 strains/genomic material spiked into negative matrix.
  • Specificity (Exclusivity): Ground truth is based on the known identity of other respiratory pathogens or commensals tested.
  • Interfering Substances: Ground truth is based on the known presence of potential interfering substances without SARS-CoV-2.
• In Silico Analysis: Ground truth is based on publicly available genetic sequence databases (e.g., GISAID for SARS-CoV-2 variants).

8. The Sample Size for the Training Set

The document does not mention a separate training set for this submission. The purpose of this submission is to unmask existing assays on an already established device. The performance data presented are from validation and verification studies (effectively "test sets") previously conducted for the predicate device. For the original development of the BioFire COVID-19 Test 2 assays, various internal optimization and calibration steps (which could be considered analogous to "training") would have occurred, but these details are not part of this 510(k) summary.

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

As no specific "training set" is described for this 510(k) modification, this question is not directly applicable. For the initial development of the assays, the ground truth would have been established through a combination of:

• Bioinformatics: Designing primers and probes based on known SARS-CoV-2 sequences.
• Analytical studies: Testing synthetic targets and cultured virus at known concentrations.
• Clinical studies: Initial evaluation with patient samples where SARS-CoV-2 status was determined by a reference method.

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The BioFire COVID-19 Test 2 is a qualitative nested multiplexed RT-PCR in vitro diagnostic test intended for use with the BioFire FilmArray 2.0 and BioFire FilmArray Torch Systems. The BioFire COVID-19 Test 2 detects nucleic acids from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs (NPS) from symptomatic individuals suspected of COVID-19 by their healthcare provider.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in NPS specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic in necessary to determine patient infection status. Positive results do not rule out co-infection with other pathogens.

Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. The BioFire COVID-19 Test 2 is intended for use by trained medical and laboratory professionals in a laboratory setting or under the supervision of a trained laboratory professional.

The BioFire COVID-19 Test 2 is a multiplexed nucleic acid-based test designed to be used with BioFire® FilmArray® Systems (BioFire® FilmArray® 2.0 or BioFire® FilmArray® Torch). The BioFire COVID-19 Test 2 consists of the BioFire COVID-19 Test 2 pouch which contains freeze-dried reagents to perform nucleic acid purification and nested, multiplexed polymerase chain reaction (PCR) with DNA melt analysis. The BioFire COVID-19 Test 2 conducts three independent tests for the detection of SARS-CoV-2 RNA in nasopharyngeal swabs (NPS) eluted in transport medium or saline. Results from the BioFire COVID-19 Test 2 are available in about 45 minutes.

A test is initiated by loading Hydration Solution into one port of the pouch and a NPS specimen mixed with the provided Sample Buffer into the other port of the pouch. The pouch contains all the reagents required for specimen testing and analysis in a freeze-dried format; the addition of Hydration Solution and the Sample Buffer rehydrates the reagents. After the pouch is prepared, the FilmArray Software on the FilmArray System guides the user through the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, selecting the appropriate protocol, and initiating the run on the FilmArray System.

The FilmArray instruments contain a coordinated system 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 to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier devices control heating and cooling of the pouch to drive the PCR reactions and subsequent melt.

Nucleic acid extraction occurs within the FilmArray pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, a nested multiplexed PCR is executed in two stages. During the first stage, a single, large volume, multiplexed reverse transcription PCR (rt-PCR) reaction is performed. 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 Defense, LLC). The solution is then distributed to each well of the arrav. 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 and melt, or nested PCR, is performed in each well of the array. At 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 array captures fluorescent images of the PCR2 reactions The FilmArray software automatically analyzes the results of each DNA melt curve and the results of the internal pouch controls to provide a final test interpretation.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Performance Test Set:

  • Sample Size: 523 specimens (after exclusions). Initially 534 were assigned a study code. 11 excluded (7 for not meeting storage/comparator result, 4 for insufficient volume/no BioFire COVID-19 Test 2 result).
  • Data Provenance: Prospective clinical study conducted at three study sites in the United States over four months (July-October 2020) during the COVID-19 pandemic. Specimens were residual after standard of care (SoC) testing.

• Analytical Performance Test Sets:

  • Limit of Detection (LoD): 20 replicates for each LoD concentration tested (USA-WA1/2020 infectious and heat-inactivated). Contrived samples.
  • NPS in Saline Sensitivity Validation: 20 contrived samples.
  • FDA SARS-CoV-2 Reference Panel: Blinded samples from the FDA Reference Panel.
  • Inclusivity: Triplicate samples for each of 5 SARS-CoV-2 variants. Spiked into pooled NPS specimens.
  • Exclusivity: Panel of 77 viruses and organisms.
  • Interference: Samples with SARS-CoV-2 at 1x LoD, plus potentially interfering substances.
  • Reproducibility: 6 replicates per sample (moderate positive, low positive, negative), tested at 3 locations over 5 days (total 90 replicates per sample, 270 valid test results).
  • Specimen Storage: 10 contrived samples per storage condition/time point.

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

• Clinical Performance Study: The ground truth was established by comparison with a BioFire RP2.1 comparator result. This predicate device was authorized under EUA202392 and later granted de novo classification DEN200031. The text does not specify the number or qualifications of experts involved in determining the ground truth for SoC or BioFire RP2.1 results.

4. Adjudication Method for the Test Set

• Clinical Performance Study: The text describes the comparison method: "A BioFire COVID-19 Test 2 result ('Detected' or 'Not Detected') was considered True Positive (TP) or True Negative (TN) only when it agreed with the BioFire RP2.1 comparator result." This indicates a direct comparison to a single reference (BioFire RP2.1). There is no mention of an adjudication process (e.g., 2+1, 3+1) involving multiple human readers for discrepancies.

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

• No, an MRMC comparative effectiveness study was not done. The study focuses on the diagnostic performance of the device itself (standalone) compared to a predicate device, rather than the effect of the device on human reader performance.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire clinical and analytical performance evaluation described focuses on the BioFire COVID-19 Test 2 algorithm's performance without specific mention of human-in-the-loop assistance influencing the reported performance metrics. The device automates nucleic acid purification and PCR, with the FilmArray software analyzing results to provide a final interpretation.

7. Type of Ground Truth Used

• Clinical Performance Study: The ground truth for the clinical performance was established using results from a legally marketed predicate device, the BioFire RP2.1 (which itself was authorized under EUA and later de novo classified). Additionally, for one FN and one FP case, the text mentions "SoC and Central Reference Lab (CRL) testing" as further evidence, suggesting a form of expert or established laboratory consensus for those specific cases.
• Analytical Studies: The ground truth for analytical studies (LoD, inclusivity, exclusivity, interference, reproducibility, specimen storage) was based on known concentrations of spiked SARS-CoV-2 material, known panels of other organisms/viruses, and known concentrations of interfering substances.

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set for the BioFire COVID-19 Test 2 algorithm. This information is typically proprietary to the manufacturer and not usually included in a 510(k) summary unless specifically requested or if the device utilizes machine learning that requires detailed training data descriptions.

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

• The document does not provide information on how the ground truth for the training set was established. As with the training set size, this detail is typically not openly disclosed in a 510(k) summary. For molecular diagnostic tests using RT-PCR, algorithm development often relies on a combination of known positive and negative samples, synthetic constructs, and potentially early clinical samples, with ground truth established through well-characterized reference methods (e.g., sequencing, highly sensitive RT-PCR assays, or expert consensus on clinical samples).

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The FilmArray Global Fever Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray Global Fever Panel detects and identifies selected bacterial, viral, and protozoan nucleic acids directly from EDTA whole blood collected from individuals with signs and/or symptoms of acute febrile illness or recent acute febrile illness and known or suspected exposure to the following target pathogens: Leptospira spp., chikungunya virus, dengue virus (serotypes 1, 2, 3 and 4), and Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale). Evaluation for more common causes of acute febrile illness (e.g., infections of the upper and lower respiratory tract or gastroenteritis, as well as non-infectious causes) should be considered prior to evaluation with this panel. Results are meant to be used in conjunction with other clinical. epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities.

Positive results do not rule out co-infections with pathogens not included on the FilmArray Global Fever Panel. Not all pathogens that cause acute febrile illness are detected by this test, and negative results do not rule out the presence of other infections. Patient travel history and consultation of the CDC Yellow Book should be considered prior to use of the FilmArray Global Fever Panel as some pathogens are more common in certain geographical locations.

The FilmArrav Global Fever Panel is a multiplex nucleic acid-based test designed to be used with the FilmArray 2.0 system ("FilmArray system" or "FilmArray instrument"). The FilmArray Global Fever Panel includes a FilmArray Global Fever Panel pouch (pouch) which contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex polymerase chain reaction (PCR) with DNA melt analysis. The FilmArray Global Fever Panel simultaneously conducts six tests for the identification of bacterial, viral, and protozoan organisms from whole blood specimens collected in EDTA tubes. Results from the FilmArray Global Fever Panel are available within about one hour.

A test is initiated by loading Hydration Solution into one port of the pouch and a whole blood or positive blood culture specimen mixed with the provided Sample Buffer and protease into the other port of the pouch and placing it in the FilmArray Instrument. The pouch contains all the reagents required for specimen testing and analysis in a freeze-dried format; the addition of Hydration Solution and the Sample Buffer rehvdrates the reagents. After the pouch is prepared, the FilmArray Software on the FilmArray system guides the user through the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, selecting the appropriate protocol, and initiating the run on the FilmArray system.

The FilmArray instruments contain a coordinated system of inflatable bladders and seal points. which act on the pouch to control the movement of liguid 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 blisters at the appropriate times. Two Peltier devices control heating and cooling of the pouch to drive the PCR reactions and the melt curve analysis.

Nucleic acid extraction occurs within the FilmArray pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, a nested multiplex PCR is executed in two stages. During the first stage, a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction is performed. 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 Defense, LLC). 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 each well of the array. At 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 array captures fluorescent images of the PCR2 reactions and software interprets the data.

The FilmArray 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 acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally demonstrated through the successful performance in the analytical and clinical studies. While explicit "acceptance criteria" are not listed in a separate table, the reported performance metrics (PPA, NPA, agreement rates) indicate the achieved levels that were deemed acceptable.

Study Design and Proof of Meeting Acceptance Criteria:

The detailed performance characteristics section (L. Performance Characteristics) outlines the studies conducted to demonstrate the device meets these criteria. The approval of the De Novo request signifies that the FDA found these results acceptable and the device adequately characterized for its intended use, with appropriate mitigations for identified risks.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Study):

  • Total Eligible Specimens: 1875 whole blood specimens.
  • Category I (Prospective, Fresh): 1469 (78.3%) specimens.
  • Category II (Prospective, Frozen): 406 (21.7%) specimens.
  • Data Provenance: Multicenter study conducted at ten geographically distinct study sites, including two in the United States, and sites in Africa, Southeast Asia, and Central & South America. Data was collected prospectively (March 2018 - September 2019).

• Analytical Studies (Reproducibility, LoD, etc.): Sample sizes for these studies are distinct and smaller than the clinical study.

  • Reproducibility: 270 valid test results (90 replicates per sample, 3 samples, 3 sites, 5 days, 2 operators, 3 instruments, rotating pouch lots).
  • Detection Limit: "m replicates" tested for confirmation, and "x replicates" initially. Specific numerical values are redacted.
  • Inclusivity/Cross-reactivity/Interference: "replicates" (number often redacted) of spiked samples.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or specific qualifications of experts used to establish the ground truth for the clinical test set.

• Clinical Study Ground Truth: The ground truth for the clinical samples was established using "well-validated nested PCR assays followed by bi-directional Sanger sequencing."

  • "Two comparator assays were utilized for each assay target with positive result from both assays considered positive."
  • "If the results of the two comparator assays for a particular analyte disagreed, the samples were subjected to repeat comparator testing with samples determined as positive if at least 2/3 replicates were positive for a single comparator assay."
  • This implies a laboratory-based method for ground truth, rather than human expert consensus on clinical presentation.

• Assay Cut-off Validation (post-analytical/clinical studies): "a final validation of the melt ranges was performed and included review of data from the Inclusivity study and clinical studies. The observed sensitivity and specificity rates for the individual melt curves and assay calls as compared to expert annotation was greater than 99.8% and 99.9% respectively."

  • This indicates that "expert annotation" was used to validate the final melt ranges of the software's interpretation of results, suggesting these experts were likely highly specialized in nucleic acid analysis or molecular diagnostics. Specific number or qualifications are not provided beyond "expert annotation."

4. Adjudication Method for the Test Set

• The primary method for establishing ground truth for the clinical test set was through two comparator nested PCR assays followed by Sanger sequencing.
• Discrepancy Resolution/Adjudication: "Samples for which false positive and/or false negative results (i.e., discrepant results) were obtained when comparing the FilmArray Global Fever Panel results to the comparator method results were further investigated."
  • This investigation typically involved:
    1. Examination to determine if additional testing on Global Fever Panel or with comparator assays could detect the analyte (if near or below detection threshold).
    2. Evaluation by "at least one additional PCR test that used different primers than the Global Fever Panel assay or the comparator assays."
    3. When possible, "unresolved discrepancies were evaluated with additional PCR testing that could be verified by sequence analysis."
  • This describes a multi-step, laboratory-based adjudication process for discrepant results, leveraging additional molecular methods. It is not a 2+1 or 3+1 human reader adjudication, but rather a technical/laboratory adjudication.

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

• No, an MRMC comparative effectiveness study was not performed.
• This device is an in vitro diagnostic (IVD) nucleic acid amplification test, and its performance is evaluated against a molecular gold standard (comparator PCR and sequencing), not through human reader interpretation of images or other data. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply here.

6. Standalone Performance

• Yes, the performance characteristics described in Section L (Performance Characteristics) represent the standalone performance of the FilmArray Global Fever Panel algorithm and system. This includes analytical performance (reproducibility, LoD, specificity, etc.) and the clinical performance (PPA, NPA) which compares the device's output directly to the "ground truth" established by the comparator molecular methods. The system automatically interprets the results of each DNA melt curve analysis and combines data with internal controls to provide a test result.

7. Type of Ground Truth Used

• For the clinical study, the primary ground truth was established by molecular comparator testing: "well-validated nested PCR assays followed by bi-directional Sanger sequencing." This is a highly objective, laboratory-based method for detecting and identifying specific nucleic acid sequences.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for a "training set".
• This is a molecular diagnostic assay where algorithms (e.g., for melt curve analysis) are likely developed based on known principles of PCR and fluorescence, and validated with a range of characterized samples (analytical studies). There isn't a traditional "training set" in the context of deep learning models for medical image analysis, which require large datasets for supervised learning. Instead, the "initial melt ranges" were determined by "mathematical modeling using known sequence variations... as well as data from testing of clinical specimens and known isolates."

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

• As a molecular diagnostic, the "training" (or development/refinement) data for the device's interpretive algorithm (e.g., Melt Detector software Tm values, fluorescence values, and melt curve analysis) would primarily come from:
  • Well-characterized isolates and contrived samples: Used to define expected melt curves, Tm values, and limits of detection. This includes the extensive analytical studies detailed (e.g., inclusivity, cross-reactivity, precision, LoD).
  • Mathematical modeling: Based on known sequence variations of target organisms.
  • Data from clinical specimens: Likely used to fine-tune and validate the interpretive algorithm (as indicated by the "final validation of the melt ranges" including "review of data from the Inclusivity study and clinical studies" against "expert annotation"). This implies that known positive and negative samples, rigorously characterized by molecular methods (and potentially expert review for complex cases), would inform the algorithm's development.

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The FilmArray® Global Fever Panel External Control Kit contains Positive External Controls intended for use as assayed quality controls to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of FilmArray® Global Fever Panel targets on FilmArray® 2.0 systems. The Global Fever Panel External Control Kit is designed for and intended to be used solely with the FilmArray Global Fever Panel. This product does not replace manufacturer internal controls provided as part of the Global Fever Panel device.

The FilmArray Global Fever Panel External Control Kit contains Positive and Negative External Controls. The Positive External Control has been optimized to be detected by all pathogen assays contained in the Global Fever Panel (Table 1). The Negative External Control contains no nucleic acid and a successful run will be negative for all assays on the panel. These controls are not intended to replace the internal FilmArray Global Fever Panel pouch controls (RNA process control and second stage PCR array control). The Global Fever Panel External Control Kit contains no biological hazards and is 100% non-infectious.

The External Controls are referenced in the Ouick Guide and product literature as Control Injection Vials. The use of room-temperature stable External Controls contained within an injection vial simplifies the workflow and allows for use of the External Controls in settings where access to refrigeration may be limited. Each individually packaged, ready-to-use FilmArray Global Fever External Control is processed separately according to the Instructions for Use, and follows the procedure as outlined in the Quick Guide for the FilmArray Global Fever External Control Kit. Each External Control Injection Vial is intended for a single use.

The Global Fever Panel External Control Kit is designed to mitigate the risk of control contamination and misuse when evaluating clinical samples on the FilmArray 2.0 System.

• Negative External Controls are tested using the Negative External Control protocol, which monitors for contamination from both external control material and target pathogens; it will fail if either is detected.
• The Positive External Contains DNA sequences that produce signature amplicon melting temperature (Tm) values distinct from the amplicon Tm values produced by each of the pathogens detected by the Global Fever Panel. By design, the Positive ECM will not be detected when using the Global Fever Panel Whole Blood Protocol, and reciprocally, amplified pathogen-specific nucleic acid will not be detected when using the Positive External Control Protocol. Through modification of the sequence between the inner primers for each ECM target, the Tm value of the amplicon is shifted to higher or lower Tm values relative to the expected Global Fever Panel target amplicon while running the same Global Fever Panel pouches with the same physical pouch manipulation in the FilmArray 2.0 Instrument. Positive External Control-specific pouch module software detects the expected shifted Tm values as being from ECM amplicon, thereby evaluating the performance of the FilmArray 2.0 System. Also, the modification of the ECM sequence mitigates possible contamination events and does not cause false positives in clinical samples. In the unlikely event that Positive ECM or ECM amplicon is introduced into a patient sample, the resulting amplification Tm value(s) is not detected within the pathogen(s) Tm window in the Global Fever Panel Whole Blood Protocol. where different Tm windows are used to detect amplified pathogen sequence.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FilmArray Global Fever Panel External Control Kit:

Note: This document describes an external control kit for an in vitro diagnostic device, not a diagnostic device itself. As such, some of the typical criteria for diagnostic devices (like sensitivity, specificity for patient outcomes, or MRMC studies) are not directly applicable or reported in the same way. The focus here is on the performance of the control kit in monitoring the primary diagnostic device.

Acceptance Criteria and Device Performance for FilmArray Global Fever Panel External Control Kit

1. Table of Acceptance Criteria and Reported Device Performance

Explanations of Implicit Criteria:

• For a quality control material, the primary acceptance criteria are its ability to consistently produce the expected positive or negative results, and for negative controls, its ability to detect contamination.
• The document implies that a "passed" rate of ≥95% is acceptable for field performance and multi-site reproducibility. For repeatability, 100% pass rates are shown, indicating a high standard for within-lab consistency.
• Low Tm standard deviation and CV for positive controls are implicit acceptance criteria for consistent amplification and melting characteristics.

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

• Clinical Testing (Field Use):
  • Sample Size: 317 External Control tests (160 Positive, 157 Negative).
  • Data Provenance: Prospective, collected between July 2019 and January 2020, from "six sites" (implied to be clinical laboratories). The country of origin is not explicitly stated but assumed to be the US based on FDA submission.
• Repeatability:
  • Sample Size: 90 External Control tests (45 Positive, 45 Negative).
  • Data Provenance: In-house study, one operator, one kit lot, one instrument, over 14 days. Retrospective based on experimental design.
• Multi-Site Reproducibility:
  • Sample Size: 270 External Control tests (135 Positive, 135 Negative).
  • Data Provenance: Multi-site study involving "three sites," "three External Control kits," "three reagent pouch lots," "two operators and three FilmArray 2.0 instruments at each site." This is a prospective experimental study.

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

• This device is an external control kit, not a diagnostic device for patient samples. Therefore, the "ground truth" is based on the expected output of the control material (i.e., Positive Control = "Passed" with expected amplicon melts, Negative Control = "Passed" with no amplicon melts/no pathogen detection).
• The "truth" is inherent in the design of the control material (synthetic DNA designed to produce specific signals or no signal) and the proper functioning of the FilmArray 2.0 system. No human experts were used to establish ground truth in the traditional sense of disease diagnosis for these control materials. The system itself determines "passed" or "failed" based on pre-programmed criteria for the control.

4. Adjudication Method for the Test Set

• Not applicable in the traditional sense. The device (FilmArray 2.0 System) with its specific "External Control-specific protocols" internally adjudicates whether a run "passed" or "failed" based on expected amplicon melt curves (for positive) or absence of melts and pathogen detection (for negative). The results are "overall passed or failed results."
• For the clinical testing study, if a control failed, the site "immediately tested a new External Control and obtained the expected result," suggesting internal site-level re-testing but not a formal expert adjudication of the initial failed result. The cause of failure (e.g., user error, contamination) was noted where apparent.

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

• No MRMC study was done. This is an in vitro diagnostic control kit, not an AI-assisted diagnostic imaging or pathology device. The "reader" here is the automated FilmArray 2.0 system. The study focuses on the performance and reliability of the control kit itself.

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

• The performance data presented could be considered standalone algorithm performance in the context of the FilmArray 2.0 instrument processing the control material. The instrument's software interprets the results of the control runs and determines if they "passed" or "failed" based on programmed criteria for the specific control and panel. Human intervention is primarily in performing the test, not in interpreting the primary outcome of the control run.

7. The Type of Ground Truth Used

• The ground truth used is expert design specification and expected performance for a quality control material.
  • Positive Controls: Designed with "dried synthetic DNA segments" to produce expected amplicon melting temperature (Tm) values, specific for the External Control melt range and distinct from pathogen Tm values. Ground truth is that these segments should amplify and produce these specific Tm values.
  • Negative Controls: Designed to contain "no DNA" and be non-reactive. Ground truth is that these should not produce any amplification or pathogen detection.
• This is not pathology, outcomes data, or expert consensus on clinical findings, but rather a verification that the control material itself performs as designed and intended to monitor the system's performance.

8. The Sample Size for the Training Set

• Not applicable / No specific training set mentioned. For an in vitro diagnostic control kit, the "training" typically involves the development and calibration of the control material and the associated instrument software during the design phase. The document describes verification and validation studies (clinical, repeatability, reproducibility), which assess the final product's performance, rather than a separate training set for a machine learning algorithm.

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

• Not applicable. As the device is not an AI/ML algorithm that undergoes a training process with a specific ground truth dataset, this question does not directly apply. The "ground truth" for the development of the control kit and its interpretation by the FilmArray system would have been established internally during product development based on molecular biology principles, assay design, synthetic DNA characteristics, and instrument calibration standards.

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