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The ONLINE TDM N-acetylprocainamide assay is for the quantitative determination of Nacetylprocainamide in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained from this device are used in the diagnosis and treatement of Nacetylprocainamide overdose and in monitoring the levels of N-acetylprocainamide to help ensure appropriate therapy.

The ONLINE TDM N-acetylprocainamide assay is for the quantitative determination of N-acetylprocainamide in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM N-acetylprocainamide reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of N-acetylprocainamide in human serum or plasma. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay.

Here's a breakdown of the acceptance criteria and study information for the ONLINE TDM N-acetylprocainamide device based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document doesn't explicitly state numerical "acceptance criteria" in the typical sense (e.g., "sensitivity must be >90%"). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device, meaning its performance characteristics (precision, method comparison, etc.) are "acceptable" and comparable to the predicate. Therefore, the "reported device performance" is the direct evidence of meeting this established equivalence.

Study Conclusion: The document states, "All of the performance characteristics including precision, lower detection limit, specificity, and interfering substances, method comparisons, and linearity provided acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE TDM N-acetylprocainamide assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA N-acetylprocainamide assay."

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

• Sample Sizes:
  • Precision (NCCLS): The sample size for controls for the precision study is not explicitly stated as a number of individual samples, but NCCLS guidelines for precision studies typically involve multiple replicates (e.g., 20 or more) tested over several days. The results are reported as Means, Standard Deviations (SD), and Coefficient of Variation (CV%) for three different control levels.
  • Method Comparison: N = 54 patient samples were used for the comparison between the ONLINE TDM N-acetylprocainamide and the COBAS FP N-acetylprocainamide (predicate).
• Data Provenance: The document does not specify the country of origin for the data or whether the data was retrospective or prospective. Typically, for a 510(k) submission of this type, the data would be generated from internal laboratory studies (prospective) using a mix of patient samples and spiked controls.

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

This information is not applicable to this type of device (an in vitro diagnostic assay for drug level measurement). For these devices, "ground truth" for method comparison is established by comparing the candidate device's results against a previously cleared, established, and accepted method (the predicate device) or a reference method. It does not involve human expert consensus in the way a diagnostic imaging or pathology device might.

4. Adjudication Method for the Test Set:

This is not applicable as there is no human interpretation or subjective assessment involved that would require an adjudication process. The comparison is objective (numerical results from an automated analyzer).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance:

This is not applicable. This is an in vitro diagnostic assay, not an AI-powered image analysis or diagnostic support tool for human readers. Therefore, no MRMC study was performed, and there is no "human-in-the-loop" component in the interpretation of the results from this device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The performance shown (precision, method comparison, etc.) is the standalone performance of the assay on the automated clinical chemistry analyzers. As an in vitro diagnostic test, the device provides a quantitative numerical result; its "performance" is inherently "algorithm only" in the sense that it automates the measurement process. There is no human interpretation of the assay's direct output (e.g., reading a strip or visually interpreting a color change that would require a human-in-the-loop consideration).

7. The Type of Ground Truth Used:

The "ground truth" for the method comparison study was the results obtained from the predicate device, the COBAS INTEGRA N-acetylprocainamide (K951595). For precision studies, the "ground truth" is the inherent precision observed when repeatedly testing known control materials.

8. The Sample Size for the Training Set:

This information is not provided and is generally not applicable in the context of traditional in vitro diagnostic assays like this one. These assays are based on established biochemical reactions (homogeneous enzyme immunoassay) and spectrophotometric measurement, not on machine learning models that require "training sets." The development and optimization of such assays involve rigorous chemical and laboratory testing to define reagent formulations, reaction conditions, and calibration curves, but this isn't referred to as a "training set" in the machine learning sense.

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

As discussed above, the concept of a "training set" and "ground truth" for it, in the AI/machine learning sense, does not apply to this type of traditional IVD device. The assay's performance and accuracy are established through analytical validation studies (like precision, linearity, method comparison) against known standards and predicate methods.

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