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The ARK Levetiracetam II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers. Levetiracetam concentrations can be used as an aid in management of patients treated with levetiracetam.

The ARK Levetiracetam II Assay is a homogeneous immunoassay based on competition between drug in the specimen and levetiracetam labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly related to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenzyme NAD functions only with the bacterial enzyme used in the assay.

The ARK Levetiracetam II Assay consists of reagents R1 anti-levetiracetam monoclonal antibody with substrate and R2 levetiracetam labeled with bacterial G6PDH enzyme.

The provided text describes the performance of a diagnostic assay (ARK Levetiracetam II Assay), not an AI/ML-enabled medical device. Therefore, many of the requested criteria related to AI/ML evaluation (such as MRMC studies, training set details, expert ground truth establishment for AI) are not applicable.

However, I can extract the relevant acceptance criteria and performance data for this in-vitro diagnostic device:

Device Name: ARK Levetiracetam II Assay
Regulatory Class: Class II
Product Code: ORI
Intended Use: Quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers, as an aid in management of patients treated with levetiracetam.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• LoQ: 40 replicates (8 replicates x 5 runs) for each of 3 concentrations (pooled human serum supplemented with levetiracetam).
• Recovery: 6 replicates (3 replicates x 2 analytical runs) for each concentration (human serum negative for levetiracetam, spiked with drug).
• Linearity: 6 replicates (3 replicates x 2 analytical runs) for each dilution (human serum, spiked with drug and diluted).
• Method Comparison: 104 samples (levetiracetam concentrations 3.4 ug/mL to 98.3 ug/mL). No specific provenance (e.g., country of origin) is mentioned, but the samples are clinical human samples or quality control materials. The study is a prospective analytical study comparing two assays.
• Precision: 160 replicates per sample/control level (quadruplicate twice a day for 20 non-consecutive days) for tri-level controls and three human serum samples.
• Interfering Substances: 6 replicates (3 replicates x 2 analytical runs) for each interfering substance level in two known levetiracetam concentrations (human serum).
• Metabolites/Drug Interference: Not explicitly stated, but similar to interfering substances: "high concentration of each compound was spiked into normal human serum with known levels of levetiracetam."

The data provenance is from analytical studies conducted by the manufacturer, likely in a laboratory setting, using human serum/plasma samples/materials. The document does not specify country of origin for the samples/data, beyond "human serum/plasma". These are prospective analytical studies designed to characterize the device's performance.

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

This section is not applicable as the document describes an in-vitro diagnostic assay for quantitative determination of a drug. The "ground truth" for such an assay is established by the known concentrations of calibrators, controls, and spiked samples, and comparison to a legally marketed predicate device using analytical methods (e.g., spectrophotometry). There are no human "experts" establishing a "ground truth" in the sense of image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. This is an in-vitro diagnostic device providing quantitative measurements. There is no qualitative assessment or interpretation by multiple readers that would require an adjudication method.

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

No. This is an in-vitro diagnostic assay, not an AI/ML medical device where human readers interact with AI.

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

Yes, in essence. The performance studies (LoQ, Recovery, Linearity, Precision, Interference) demonstrate the "standalone" performance of the assay itself, as an automated clinical chemistry analyzer performs the measurements. There is no human-in-the-loop variable in the measurement process of an immunoassay. The output is a quantitative value, not a diagnostic interpretation that a human would then use as "assistance."

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is primarily:

• Known concentrations: For LoQ, Recovery, Linearity, Interfering Substances, Metabolites, and Drug Interference studies, concentrations of levetiracetam and potential interferents are precisely measured, prepared, or spiked into matrices.
• Reference Method/Predicate Device: For Method Comparison, the predicate ARK Levetiracetam Assay performed on the Roche/Hitachi 917 serves as the comparative "reference" for evaluating the substantial equivalence of the new assay. This is a common practice for IVD assays.

8. The Sample Size for the Training Set

Not applicable. This is a reagent-based immunoassay, not an AI/ML algorithm that requires a training set in the typical sense for machine learning. The "development" or "training" of such a diagnostic involves chemical formulation, antibody development, and optimization of reaction conditions, not data-driven model training.

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

Not applicable. As explained above, there is no AI/ML training set in this context.

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