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FilmArray PneumonialPneumoniaplus Control 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 bacteria: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus agalactiae, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumonila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus on the FilmArray Pneumonia Panel or Pneumonia Panel plus assays performed on FilmArray Pneumonia/ Pneumoniaplus Control is composed of synthetic DNA and RNA designed for and intended to be used solely with the FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays. This product is not intended to replace manufacturer internal controls provided with the test system.

FilmArray Pneumonia/Pneumoniaplus Control, P/N M340, is a quality control panel consisting of 2 controls, FilmArray Pneumoniaplus Positive (Positive Control), P/N M34235, and FilmArray Pneumonia/Pneumoniaplus Negative Control), P/N M34135. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA and RNA in buffers, stabilizers and preservatives. The DNA and RNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the respiratory pathogens and antimicrobial resistance genes detected and identified by the FilmArray® Pneumonia Panel and Pneumonia Panel plus assays (see Table 1. below) on the FilmArray® systems. The Negative Control contains only buffers, stabilizers and preservatives. Each liquid control of FilmArray Pneumonia/Pneumoniaplus Control is processed separately according to FilmArray® Pneumonia Panel or Pneumonia Panel plus assays manufacturer's Instructions for Use for patient samples (Sputum) obtained from individuals suspected of lower respiratory tract infection. Each tube of control contains sufficient liquid for a single use.

The document describes the FilmArray Pneumonia/Pneumoniaplus Control, a quality control material intended to monitor the performance of in-vitro laboratory nucleic acid testing procedures conducted with the FilmArray Pneumonia Panel or Pneumonia Panel plus assays.

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

1. Table of Acceptance Criteria and Reported Device Performance

While explicit "acceptance criteria" against which individual performance metrics (e.g., minimum percentage correct results) are not provided in the document, the studies demonstrate consistent high performance. The "Total Percent Correct" for both external and internal testing can be considered the device performance. The objective is for the controls to consistently produce the correct positive or negative results.

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

• Test Set (Overall): 308 tests of FilmArray Pneumonia/Pneumoniaplus Control.
  • External Study: 185 samples.
  • Internal Study: 123 samples.
• Data Provenance: The studies were conducted by Maine Molecular Quality Controls, Inc. (MMQCI) for the internal portion, and at 3 CLIA-certified clinical sites for the external portion. This indicates a mix of controlled laboratory (internal) and real-world clinical (external) settings within the United States. The data is prospective, as it explicitly states the studies were performed over defined periods (e.g., 60 days for internal, 10 days for external).

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

This information is not applicable in this context. The "ground truth" for a quality control material like this is inherent in its design: a positive control should produce a positive result for specific targets, and a negative control should produce a negative result. There are no "experts" involved in determining the ground truth for the control itself, as it is a manufactured reference material with known components.

4. Adjudication Method for the Test Set

The document mentions that for initial false positive or false negative results, a single retest was performed, and all retests produced the correct results. This indicates an informal adjudication through retesting, rather than a formal expert-based adjudication process.

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

This is not applicable. The device is a quality control material for in-vitro diagnostic assays, not an AI-powered diagnostic device for human interpretation or a device that assists human readers.

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

This is not applicable. The device is a quality control material, not an algorithm or an AI device. Its performance is evaluated by how accurately an assay (FilmArray Pneumonia Panel) detects its known synthetic components.

7. The Type of Ground Truth Used

The ground truth used is the known composition of the control material.

• The Positive Control contains synthetic DNA and RNA corresponding to the genome segments of targeted respiratory pathogens and antimicrobial resistance genes. Therefore, the "ground truth" is that these targets should be detected.
• The Negative Control contains only buffers, stabilizers, and preservatives, with no target nucleic acids. Therefore, the "ground truth" is that no targets should be detected.

8. The Sample Size for the Training Set

This is not applicable. The FilmArray Pneumonia/Pneumoniaplus Control is a quality control material, not an algorithm developed through machine learning. Therefore, there is no "training set" in the context of AI or algorithm development.

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

This is not applicable for the reasons stated in point 8. The "ground truth" (known composition) for the control material itself is established during its manufacturing and characterization by Maine Molecular Quality Controls, Inc., where the synthetic DNA/RNA components are precisely designed and incorporated into the positive control, and the negative control is formulated to be free of these target analytes.

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