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The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method on the Dimension® clinical chemistry system is for the quantitative determination of lidocaine in serum or plasma. Lidocaine measurements may be used in the diagnosis and treatment of lidocaine overdose and in therapeutic drug monitoring.

The Dade Behring Dimension® Drug Calibrator II (DC49D) is a device intended for medical purposes for use on the Dimension® clinical chemistry system to establish points of parfonob to are used in determination of values in the measurement of substances in human specimens.

Method: The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® LIDO Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbition immunoassay (PETINIA) which uses a latex particle-lidocaine conjugate and monoclonal lidocaine specific antibody. Lidocaine present in the sample competes with lidocaine on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of lidocaine in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.

Calibrator: The Dade Behring Drug Calibrator 11 (DC49D) is liquid, bovine serum base product, packaged as ten vials to a carton, with two vials at each of five levels; each vial contains 5.0 mL. This same product, the Dade Behring Drug Calibrator II (DC49C), was previously cleared (K032574) for calibration of its associated methods on the Dimension® clinical chemistry system. The product remains unchanged except for the additional value assignment for the Lidocaine constituent.

Here's a breakdown of the acceptance criteria and the study details based on the provided text, formatted to address your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implicitly met by showing good agreement with the predicate. The performance is reported as a comparison to this predicate.

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

• Test Set Sample Size: 120 (for the split-sample comparative performance).
• Data Provenance: Not explicitly stated (e.g., country of origin). The data is from a "split-sample comparative performance" study, which by its nature is a prospective comparison of the new device against the predicate on the same samples.

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

Not applicable. This study did not involve establishing a ground truth through expert consensus. Instead, it compared the new device's measurements directly against those of a legally marketed predicate device. The predicate device's measurements served as the comparative standard.

4. Adjudication Method for the Test Set

Not applicable. As the study is a direct comparative measurement against a predicate, there was no need for adjudication by experts.

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

Not applicable. This is a study for an in vitro diagnostic (IVD) device (a laboratory test for measuring a substance in a sample), not an imaging or AI-assisted diagnostic device involving human readers or interpretation of medical cases.

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

Yes, in essence. The "Dimension® Lidocaine (LIDO) Flex® reagent cartridge method" is an automated in vitro diagnostic assay. Its performance (accuracy, precision, linearity, etc.) is evaluated inherently as a standalone system. The study performed here is a "standalone" comparison of its analytical performance against another standalone analytical system (the predicate device). There is no "human-in-the-loop" component for interpretation in the context of this device.

7. The Type of Ground Truth Used

The "ground truth" for the test set was the measurements obtained from the predicate device, the Dade Behring aca® LIDO analytical test pack method (K833379). This is a "comparison to a legally marketed device" or "predicate device comparison" type of ground truth for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This medical device (an in vitro diagnostic assay and calibrator) does not utilize machine learning or AI models, and therefore does not have a "training set" in that context. The development of the reagent cartridge and its parameters would have involved various optimization studies, but these are not referred to as a "training set" in the sense of AI/ML.

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

Not applicable, as there is no "training set" as defined for AI/ML models.

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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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This homogeneous lidocaine enzyme immunoassay is intended to be used for quantitative determination of lidocaine in human serum or plasma. Monitoring serum or plasma lidocaine concentration is the most effective means of improving the drug efficacy and minimizing the risk of toxicity for patients under lidocaine treatment for certain cardiac arrhythmias.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a Lidocaine Enzyme Immunoassay. It determines the device is substantially equivalent to previously marketed devices. However, it does not contain specific details about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

Such information would typically be found in the 510(k) submission itself, or in supplementary documents that describe the studies conducted to demonstrate substantial equivalence. The clearance letter only states that the FDA reviewed the submission and determined substantial equivalence based on the indications for use.

Therefore, I cannot provide the requested information from the given text. A 510(k) clearance letter acknowledges the review and decision, but does not usually include the detailed study results or acceptance criteria.

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