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The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT-PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV.

Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Conversely, positive results do not rule-out bacterial infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.

The Lyra RSV + hMPV Assay can be performed using ether the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR Instrument, or the Cepheid SmartCycler II System.

The Lyra RSV + hMPV Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® or NucliSENS® EMAG® automated extraction platform. A multiplex RT-PCR reaction is then performed in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing either the Cepheid SmartCycler® II, the Applied Biosystems 7500 Fast DX, or the Life Technologies QuantStudio" Dx. Identification of RSV and hMPV and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of RSV and hMPV and the PRC.

The acceptance criteria and the study proving the device meets these criteria for the Lyra RSV + hMPV Assay are detailed below. It's important to note that the provided documents primarily describe a change to an existing device (the addition of a new extraction platform, BioMerieux NucliSENS EMAG) and compare its performance to the previously cleared predicate device. Therefore, the "acceptance criteria" and "reported device performance" are framed around this equivalency.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the information provided, the overall acceptance criterion is equivalent performance of the modified Lyra RSV + hMPV Assay (with the new extraction platform) to the predicate device (Quidel RSV+hMPV Assay using the original extraction platform). The performance is assessed through "non-clinical and clinical verification and validation activities."

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

The exact sample sizes for the "Limit of Detection Equivalency Study" and "Clinical Equivalence Study" are not explicitly stated in the provided 510(k) summary.

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The nature of "clinical equivalence study" typically implies prospective or retrospectively collected clinical samples, but details are lacking.

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

This information is not provided in the given text. For a PCR-based assay like this, ground truth is typically established using a highly sensitive and specific reference method (e.g., another validated PCR assay or sequencing), rather than expert clinical consensus in the traditional sense of image interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the given text. Given that this is a molecular diagnostic assay, adjudication methods like N+1 for expert review (common in imaging studies) are generally not applicable. Instead, the "ground truth" would be determined by the reference method itself.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for medical imaging interpretation where different human readers interpret cases, often with and without AI assistance. This device is a molecular diagnostic assay (RT-PCR) and does not involve human interpretation of complex images in the same way.

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

Yes, implicitly. The device itself is an in vitro diagnostic test, specifically a Real-Time PCR assay. Its performance (qualitative detection of RNA) is inherently "standalone" as it produces a result without direct human interpretive input during the assay itself. The studies ("Limit of Detection Equivalency Study" and "Clinical Equivalence Study") would evaluate the accuracy of the assay's output against a reference method, which is a standalone performance assessment.

7. The Type of Ground Truth Used

The type of ground truth used is not explicitly stated but can be inferred to be a highly reliable reference method, likely another validated molecular diagnostic test (e.g., gold standard PCR assay or culture/sequencing) for detecting RSV and hMPV. For Limit of Detection studies, ground truth would be established by precisely quantifying viral RNA in samples.

8. The Sample Size for the Training Set

This information is not applicable in the context of this device. The Lyra RSV + hMPV Assay is a Real-Time PCR assay, which is a biochemical reaction-based test, not an AI/Machine Learning algorithm that requires a "training set" in the traditional sense. The "training" for such an assay involves optimization of reagents, primers, probes, and reaction conditions.

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

This information is not applicable as there is no "training set" in the context of an AI/ML algorithm for this device. The development of the assay involves establishing analytical ground truth through various laboratory experiments to ensure the primers and probes are specific and sensitive to the target viruses, and that the internal control functions correctly.

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