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The Roche ONLINE TDM Lidocaine assay is for the quantitative determination of lidocaine in human serum or plasma on automated clinical chemistry analyzes. Lidocaine is an antiarrhythmic agent administered intravenously by either injection or continuous infusion. It is indicated in the acute management of ventricular arritythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Lidocaine reagent kits.

The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with lidocaine and rapidly aggregate in the presence of a lidocaine antibody solution. When a sample containing lidocaine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to lidocaine concentration is obtained, with the maximum rate of aggregation at the lowest lidocaine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.

Acceptance Criteria and Device Performance Study for Roche ONLINE Lidocaine Assay

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details a comparison study between the Roche ONLINE TDM Lidocaine assay and a predicate device (Roche COBAS INTEGRA Lidocaine), as well as a comparison to an FPIA method. The acceptance criteria are implicitly derived from the comparison to these established methods, demonstrating "acceptable results" and "substantial equivalence."

Note: The document states that "All of the evaluation studies gave acceptable results compared to the predicate device," indicating the overall acceptance criteria were met.

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

• Test Set (comparison to predicate device): N = 99
• Test Set (comparison to FPIA method): N = 69
• Data Provenance: Not explicitly stated regarding country of origin or specific demographic details. The studies were conducted by Roche Diagnostics Corporation in Indianapolis, IN, suggesting the data is likely from the United States. The studies are described as "evaluation studies," implying they were specifically conducted for the premarket notification and are thus prospective in nature, as they assess the performance of the new device.

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

This type of in vitro diagnostic device (immunoassay for drug concentration) does not typically rely on "experts" in the same way an imaging or diagnostic AI system would. The "ground truth" for drug concentration in serum or plasma is established by validated analytical methods. In this case, the predicate device (Roche COBAS INTEGRA Lidocaine Assay) and an FPIA method (Fluorescence Polarization Immunoassay, a common method for therapeutic drug monitoring) served as the reference or "ground truth" for comparison. Therefore, no external "experts" were used to establish ground truth in this context; rather, established and validated analytical techniques served this role.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" was established by reference analytical methods, not by human interpretation or consensus that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. This study is for an in vitro diagnostic assay, which measures a quantitative analyte concentration, not an imaging or interpretive diagnostic task that would typically involve multiple readers.

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

Yes, this study represents the standalone performance of the Roche ONLINE TDM Lidocaine assay. This is an automated immunoassay designed to provide a quantitative result without direct human interpretation of the assay's output for each measurement. Human involvement is limited to sample loading, instrument operation, and result review, but the assay itself generates the lidocaine concentration.

7. The Type of Ground Truth Used

The ground truth used was analytical reference methods:

• The Roche COBAS INTEGRA Lidocaine Assay (the predicate device)
• An FPIA (Fluorescence Polarization Immunoassay) method

These methods are well-established and validated for determining lidocaine concentrations in biological samples.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the Roche ONLINE TDM Lidocaine assay in the context of machine learning. As an immunoassay, the device's performance is based on its chemical and optical principles, not on being "trained" on a dataset in the way an AI algorithm would be. The development and optimization of the assay reagents and parameters would have occurred during the assay's R&D phase, but this is distinct from "training a model."

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

Not applicable, as there is no "training set" in the machine learning sense for this immunoassay device. The performance characteristics were evaluated against established analytical reference methods.

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