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FilmArray RP2/RP2plus Control Panel is intended for use as an external positive and negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Bordetella parapertussis, Chlamydia pneumonia, and Mycoplasma pneumoniae by BioFire's FilmArray® RP2 and RP2plus assays on the FilmArray® Torch Systems. FilmArray RP2/RP2plus Control Panel is composed of synthetic RNA designed for and intended to be used solely with the FilmArray® RP2 and RP2plus assays. This product is not intended to replace manufacturer controls provided with the test system.

FilmArray RP2/RP2plus Control Panel, P/N M315, is a quality control panel consisting of controls, FilmArray RP2/RP2plus Positive (Positive Control), P/N M31721, and FilmArray RP2/RP2plus Negative, (Negative Control), P/N M31621. The Positive Control contains noninfectious surrogate control material; a solution of synthetic RNA transcripts in buffers, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the FilmArray® RP2 and RP2plus assays (Table 1. below) on the FilmArray® 2.0 or FilmArray® Torch systems. The RNA in the Negative Control is non-specific RNA in buffers, stabilizers and preservatives. Each liquid control of FilmArray RP2/RP2plus Control Panel M265 is processed separately according to FilmArray® RP2 and RP2plus assays manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).

The document describes the FilmArray RP2/RP2plus Control Panel, an assayed quality control material for clinical microbiology assays. The acceptance criteria and the study proving the device meets these criteria are detailed, focusing on its performance in monitoring BioFire's FilmArray® RP2 and RP2plus assays.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FilmArray RP2/RP2plus Control Panel are implied by the performance metrics reported in the summary tables. The primary acceptance criteria appear to be:

• Correct Positive Control Result: All respiratory pathogen analytes in the Positive Control should be correctly detected.
• Correct Negative Control Result: No respiratory pathogens should be detected.
• Low Invalid Rate: A low or zero percentage of invalid results.

2. Sample Size and Data Provenance

The study involved both an internal and an external study.

• Internal Study (MMQCI):
  • Sample Size: 121 tests (60 Positive Controls, 61 Negative Controls)
  • Provenance: Retrospective data from MMQCI (Saco, Maine, USA) over 20 days, involving 4 pouch lots and 4 operators.
• External Study (Clinical Sites):
  • Sample Size: 180 tests (90 Positive Controls, 90 Negative Controls)
  • Provenance: Retrospective data from 3 CLIA-certified clinical sites (country not specified, but likely USA given FDA submission) between July and August 2017, over a period of 10 days, using 3 FilmArray RP2 pouch lots and multiple operators.

Combined Test Set Sample Size: 301 total tests (150 Positive Control, 151 Negative Control)

3. Number of Experts and Qualifications for Ground Truth

This device is an assayed quality control material for an in vitro diagnostic (IVD) test, not an AI or imaging device requiring expert interpretation of medical images. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of medical image interpretation (e.g., radiologists) does not apply here.

The "ground truth" for this device is the known composition of the control panel:

• Positive Control: Contains synthetic RNA transcripts for specific respiratory pathogens. The ground truth is that these pathogens should be detected.
• Negative Control: Contains non-specific RNA. The ground truth is that no specific respiratory pathogens should be detected.

The performance of the device is evaluated against this pre-defined, engineered ground truth. There are no "experts" establishing clinical diagnoses for the test set.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is pre-defined by the engineered composition of the control material, not through human interpretation or adjudication processes like 2+1 or 3+1 that are common in AI or diagnostic studies where human agreement is required to establish a consensus diagnosis for real patient data.

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

Not applicable. The device is a quality control material, not a diagnostic device that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its evaluation.

6. Standalone Performance

Yes, the performance data presented is for the standalone performance of the FilmArray RP2/RP2plus Control Panel when run on the BioFire FilmArray® RP2 and RP2plus assays. The results indicate how well the control panel itself triggers the expected (positive or negative) outcome on the assay. The study assesses the characteristics of the control material, not how the control material assists humans in interpreting an assay result. The control material validates the assay's performance, ensuring its reliability.

7. Type of Ground Truth Used

The ground truth used is the engineered composition or known content of the control materials.

• For the Positive Control, the ground truth is the presence of specific synthetic RNA sequences designed to be detected by the FilmArray® RP2/RP2plus assays.
• For the Negative Control, the ground truth is the absence of these specific RNA sequences.

This is a form of analytical gold standard based on the intentional design and manufacturing of the control reagents.

8. Sample Size for the Training Set

Not applicable. The FilmArray RP2/RP2plus Control Panel is a manufactured reagent product, not an AI algorithm that requires a training set. The performance studies described are for validation and verification of the manufactured product's consistency and effectiveness as a quality control.

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

Not applicable, as there is no training set for this type of device. The "ground truth" for the control materials is inherent in their design and manufacturing specifications.

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