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The Rotor-Gene Q MDx instrument with Rotor-Gene Q software version 2.1.0 or higher is a real-time nucleic acid amplification and detection system which measures nucleic acid signals from amplified DNA using fluorescent detection.

The Rotor-Gene Q MDx instrument is intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests in clinical laboratories.

The Rotor-Gene® Q MDx is a real-time PCR analyzer designed for rapid thermal cycling and real-time detection of PCR assays. The Rotor-Gene Q MDx uses a centrifugal rotary design for thermal cycling where each tube spins in a chamber of moving air, keeping all samples at a uniform temperature. Detection is performed as each tube aligns with the detection optics, where the sample is illuminated and the fluorescent signal is rapidly collected from a single, short optical pathway.

The QIAGEN GmbH Rotor-Gene® Q MDx is a real-time PCR analyzer intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests in clinical laboratories. As an instrument, its performance is assessed in conjunction with specific assays. The provided summary focuses on the instrument itself and refers to a separate submission for the assay's performance.

Here's an analysis of the provided information based on your request:

1. A table of acceptance criteria and the reported device performance

The provided document describes the device, its intended use, and notes that the analytical and clinical performance of the Rotor-Gene Q MDx instrument is assessed for each assay to be run on this system. It explicitly states that the artus® Infl A/B RG RT-PCR assay is being submitted separately and refers to that submission for detailed performance data.

Therefore, specific acceptance criteria and reported device performance for the Rotor-Gene Q MDx instrument in isolation (e.g., regarding thermal cycling uniformity or detection sensitivity as inherent characteristics of the instrument) are not detailed in this document. The performance metrics listed are for the assay that runs on the instrument.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to the artus® Infl A/B RG RT-PCR assay 510(k) submission for full testing details, which includes "Testing of prospectively collected and banked specimens."

• Sample Size for Test Set: Not specified in this document. It would be in the assay's submission.
• Data Provenance: "prospectively collected and banked specimens." Country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given document. It would typically be detailed in the specific assay's submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the given document. It would typically be detailed in the specific assay's submission.

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

The Rotor-Gene Q MDx is a real-time PCR instrument, not an AI software or imaging device used by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.

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

The Rotor-Gene Q MDx is an instrument that performs real-time PCR. Its performance is inherent to its functionality (thermal cycling, fluorescence detection) when used with an assay. The concept of "standalone algorithm performance" without human intervention, as typically understood in AI-based devices, does not directly apply here in the same way. The instrument itself operates independently once a user initiates a run.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the associated artus® Infl A/B RG RT-PCR assay, the document indicates "Testing of prospectively collected and banked specimens." While the specific "ground truth" method (e.g., culture, another FDA-approved PCR test, clinical diagnosis) is not detailed in this document, it implies clinical samples with a reference standard.

8. The sample size for the training set

This information is not provided in the given document. For a PCR instrument, the concept of a "training set" in the context of machine learning (AI) is generally not applicable. Instead, the instrument's design and calibration are based on engineering principles and verified through analytical studies. For the assay run on the instrument, there would be analytical validation data (e.g., sensitivity, specificity, LOD) established using various samples, but these are not typically referred to as a "training set."

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

As noted in point 8, the concept of a "training set" and associated "ground truth" as typically used for AI devices is not directly applicable to this PCR instrument. Any "ground truth" would be related to the analytical and clinical validation of the assays running on the instrument, and those details are referred to a separate submission.

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