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ACE® Phenobarbital Reagent is intended for use in the quantitative determination of phenobarbital in human serum.

ACE® Phenobarbital Reagent is intended for the quantitative determination of phenobarbital in serum using the ACE® clinical chemistry analyzer.

The ACE® Phenobarbital Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenobarbital and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD' to NADH.

Here's an analysis of the provided text regarding the ACE® Phenobarbital Reagent, detailing its acceptance criteria and the study that proves its performance:

ACE® Phenobarbital Reagent: Acceptance Criteria and Performance Study

The ACE® Phenobarbital Reagent is an enzyme immunoassay intended for the quantitative determination of phenobarbital in human serum. This 510(k) premarket notification (K973536) demonstrates substantial equivalence to a predicate device, the DRI Phenobarbital Enzyme Immunoassay (K946210).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device and standard performance metrics for such assays. The reported performance of the Proposed Device (ACE® Phenobarbital Reagent) is compared against that of the Predicate Device for substantial equivalence.

Note: The reported performance of the Proposed Device meets the general expectations for substantial equivalence, as indicated by the FDA's approval. While some metrics like %CV are slightly higher for the proposed device, the overall correlation and range are considered acceptable for its intended use.

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

• Sample Size for Test Set (Correlation Study):
  • For the correlation study comparing the ACE® Phenobarbital Reagent to the Hitachi 717, a sample size of N=45 was used.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for an IVD, it is generally assumed that these studies are conducted in a controlled lab environment, likely in the country of the submitter (USA, based on the address). The studies are typically prospective evaluations of device performance.

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

This type of diagnostic device (a reagent for determining drug levels) does not typically involve human expert interpretation of results to establish ground truth in the same way an imaging device might. The "ground truth" for the test set is established by the comparative method itself (the Hitachi 717, an existing clinical chemistry analyzer), which is presumed to be accurate and reliable for phenobarbital measurement. Therefore, no human experts were involved in establishing ground truth for the test set in this context.

4. Adjudication Method for the Test Set

Not applicable. As explained in point 3, the ground truth for this type of quantitative assay is established by comparison to a reference method (the Hitachi 717), not by expert adjudication.

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 device is a diagnostic reagent for measuring drug levels, not an imaging or AI-assisted diagnostic tool that would involve human readers or AI assistance.

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

Yes, in essence, the performance assessment described is a standalone evaluation of the reagent on the ACE® clinical chemistry analyzer. The results are quantitative measurements, and the accuracy is assessed by correlation with another established analytical method (Hitachi 717), not by human interpretation or intervention in the measurement process itself.

7. The Type of Ground Truth Used

The ground truth for the performance assessment was established by comparison to a recognized commercial Phenobarbital assay/Hitachi 717. This is a form of comparative analytical truth, where the performance of the new device is benchmarked against an already validated and commonly used method for measuring phenobarbital concentrations.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of a machine learning or AI algorithm. For this type of chemical assay, method development and optimization would rely on laboratory experiments and validation studies. The N=45 for the correlation study and the samples used for precision studies (not explicitly quantified beyond showing %CVs) represent the data used for performance validation, which is more akin to a test set in clinical chemistry.

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

Not applicable in the context of a traditional chemical immunoassay. The development and optimization of the ACE® Phenobarbital Reagent would involve standard chemical and analytical validation processes to ensure accurate and precise measurement of phenobarbital, rather than establishing "ground truth" for a training set in the AI sense.

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