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The Idylla™ Respiratory (IFV-RSV) Panel is an in vitro assay intended for the qualitative detection of nucleic acids for Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, H275Y mutation of Influenza A subtype 2009 H1, Influenza B and Respiratory Syncytial Virus (A and B) from nasopharyngeal swabs in viral transport media of adult and pediatric patients. The test uses the Idylla™ system to aid in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings.
Negative results do not preclude respiratory virus infection or co-infection with other viruses and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Performance characteristics for Influenza A were established when influenza A/2009 H1 and H3 were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL3+ facility is available to receive and culture specimens.

The Idylla™ Respiratory (IFV-RSV) Panel is a self-contained molecular diagnostic test designed to work with the IdyllaTM System. The assay is performed using a single-use, disposable, multi-chambered fluidic cartridge. This includes hands-off sample preparation/purification, reverse transcription and real-time, multiplex Polymerase Chain Reaction (PCR) for the detection of viral RNA. All steps in this process are fully automated and completely integrated and results are available in less than 50 minutes.
The Idylla™ Respiratory (IFV-RSV) Panel identifies virus-specific nucleic acids for Influenza (IFV) A virus, Influenza B virus, and Respiratory Syncytial Virus (RSV). The IFV-RSV Panel targets the following genes within the viruses: matrix gene (Influenza A and Influenza B); hemagglutinin gene (Influenza A subtypes H1 and H3, Influenza A subtype 2009 H1); neuraminidase gene (H275Y mutation of 2009 H1); fusion protein gene RSV (A and B). The System amplifies a targeted region of interest generating a change in fluorescent signal, which is measured and applied against predetermined criteria to provide a qualitative result. The automated process steps in the panel are:
Sample processing: Utilizing the automated process of Idylla™ fluidics, sample and Sample Processing Control (SPC) comes in contact with the lysis buffer to release the RNA and solubilize proteins, creating a lysate. Binding buffer is mixed with the lysate to aid in the binding of nucleic acids. Purified RNA is subsequently subject to a RT-PCR reaction within the Cartridge.
RT-PCR: Reverse Transcription, amplification and fluorescent detection of viral targets occur during the RT-PCR cycling. RT-PCR reagents are present in a stable formulation in five PCR chambers located within the Cartridge. The Test contains reagents for the simultaneous detection of a sample processing control and detection of various IFV and RSV targets. Detection of these specific targets is performed using fluorescent labeled probes. All amplification, detection of fluorescence, and the interpretation of the signals are done automatically by the Idylla™ instrument system.

Here's an analysis of the acceptance criteria and study as requested, based on the provided document:

Acceptance Criteria and Device Performance for Idylla™ Respiratory (IFV-RSV) Panel

The acceptance criteria for the Idylla™ Respiratory (IFV-RSV) Panel are stated as "at least 90% positive percent agreement (PPA) with a lower bound of the two-sided 95% CI greater than 80% for all targets."
For negative results, the criterion is "negative percent agreement (NPA) exceeding 99% with a lower bound of 95% (two-sided) confidence interval exceeding 90% for all targets."

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is reported across two clinical studies: a multi-site prospective study and an additional retrospective study. The tables below summarize the initial reported performance and the re-evaluated performance after sequencing of discordant samples, comparing them to the acceptance criteria.

Table 1.1: Prospective Study Performance vs. Acceptance Criteria (excluding H275Y mutation due to specific sample handling)

Table 1.2: Combined Prospective and Retrospective Study Performance vs. Acceptance Criteria (after re-evaluation of discordant results by sequencing)

The conclusion states that after re-evaluation of discordant results by bidirectional sequencing, ALL targets demonstrated at least 90% PPA with a lower bound of the two-sided 95% CI greater than 80%. For NPA, the combined study results also met and exceeded acceptance criteria.

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

• Total Test Set Sample Size:

  • Prospective Samples: 1014 subjects were collected. After exclusions, 960 samples were usable for the 200 µL VTM testing and 929 for the 500 µL VTM testing. This included 214 fresh samples and 800 archived samples.
  • Retrospective Samples: 419 patient samples tested at 200 µL (408 reported results) and 449 patient samples tested at 500 µL (418 reported results).
  • Contrived H275Y Mutation Samples: 40 samples (processed, blinded, and tested). These were excluded from the agreement measures of other targets.

• Data Provenance:

  • Prospective Samples:
    • Collected during the 2015-2016 IFV-RSV season (fresh samples).
    • Stored samples from the 2012-2013 and 2013-2014 IFV and RSV seasons (archived samples), collected under a separate protocol.
    • Multi-site study: Samples were distributed across four external sites for testing.
  • Retrospective Samples:
    • Archived banked retrospective clinical collections.
    • Tested at an in-house facility.

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

The document does not explicitly state the number of experts used to establish the ground truth. However, it indicates:

• The "comparator" methods were an FDA-cleared Nucleic Acid Amplification Test (NAAT), and for retrospective samples, Culture/NAAT/Sequencing.
• Bi-directional sequencing at an independent reference laboratory was used to confirm and/or analyze discordant results between the Idylla™ Panel and the reference method.
• The qualifications of the individuals interpreting the sequencing results are not provided (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The primary ground truth appears to be based on an FDA-cleared Nucleic Acid Amplification Test (NAAT). Discrepancies between the Idylla™ device and this comparator were adjudicated using bi-directional sequencing performed at an independent reference laboratory. This suggests a form of resolution by a higher-tier method for discordant results, rather than a strict 2+1 or 3+1 consensus process among human readers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of a diagnostic device against a comparator method, not on the improvement of human reader performance with AI assistance. The device is an in vitro diagnostic assay, an automated molecular test, not an AI-assisted diagnostic tool for human interpretation.

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

Yes, this was a standalone performance study. The Idylla™ Respiratory (IFV-RSV) Panel is described as a "self-contained molecular diagnostic test designed to work with the Idylla™ System." The assay is "fully automated and completely integrated," and "all amplification, detection of fluorescence, and the interpretation of the signals are done automatically by the Idylla™ instrument system." This confirms it's an algorithm-only (automated system) performance evaluation without human-in-the-loop for result interpretation.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

• FDA-cleared Nucleic Acid Amplification Test (NAAT) results (for prospective samples).
• Culture, NAAT, and Sequencing (for retrospective samples).
• Bi-directional sequencing at an independent reference laboratory for the adjudication of discordant results.

This represents a form of reference standard comparison, relying on established molecular and culture methods, with sequencing as the ultimate arbiter for discrepancies.

8. The Sample Size for the Training Set

The document does not specify the sample size for a training set. The descriptions provided are for the clinical performance evaluation (i.e., test set) of the device, which is typically conducted after the device's development and internal validation (training) phases are complete. Since this is an IVD assay, it's likely proprietary internal development data, not typically disclosed in 510(k) summaries unless specifically required or relevant to the clinical study design.

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

Given that the document does not mention a training set or its size, it also does not describe how the ground truth for a training set was established. The entire document focuses on the validation against clinical samples (test set) using established comparator methods and sequencing as ground truth reference.

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