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The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

The ARCHITECT iGentamicin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma.

The ARCHITECT iGentamicin assay is a one-step immunoassay for the quantitative determination of gentamicin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. In the ARCHITECT iGentamicin assay, sample, anti-gentamicin coated paramagnetic microparticles, and gentamicin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-gentamicin coated microparticles bind to the gentamicin present in the sample and to the acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of gentamicin in the sample and the RLUs detected by the ARCHITECT i System optics.

The provided text describes a 510(k) submission for the ARCHITECT iGentamicin assay and its calibrators. It outlines the intended use, device description, and a summary of analytical performance studies conducted to demonstrate substantial equivalence to a legally marketed predicate device (AxSYM Gentamicin). However, it does not contain specific acceptance criteria values or detailed results of the studies in a manner that would allow for the construction of the requested table and comprehensive answers to all questions.

Here's an attempt to answer based on the available information, with significant limitations due to the missing data:

Acceptance Criteria and Device Performance

The document states that the ARCHITECT iGentamicin assay is "substantially equivalent to the AxSYM Gentamicin assay in terms of analytical performance data in this 510(k) submission." This implies that the acceptance criteria for each validation study would have been defined to demonstrate this equivalence, likely by showing that the performance of the new device is within predefined statistical limits compared to the predicate. However, the specific numerical acceptance criteria and the reported device performance values are not detailed in the provided text.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the given text. The text only lists the types of studies performed (e.g., Precision, Linearity, Method Comparison).

Study Details Based on Available Information:

1. A table of acceptance criteria and the reported device performance:

   • Cannot be fully constructed as the specific numerical acceptance criteria and reported performance values are not provided in the input text. The text only lists the types of studies performed without their results or target specifications.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not specified in the provided text. The document lists "Method Comparison (Correlation)" as one of the studies, which would typically involve a test set of patient samples. However, details on sample size, origin, or retrospective/prospective nature are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable/Not specified. This device is an in vitro diagnostic (IVD) assay for quantitative determination of gentamicin. Ground truth for such assays is typically established through a reference method or validated analytical techniques, not by expert consensus (e.g., radiologists interpreting images). The text does not mention expert involvement in establishing ground truth for the analytical performance studies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. Adjudication methods are typically used in clinical studies where subjective interpretation (e.g., image reading) is involved. For an IVD assay's analytical performance, the "ground truth" (or reference values) for samples are typically determined by highly accurate and precise analytical methods, not through an adjudication process involving multiple human 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 submission is for an in vitro diagnostic (IVD) reagent kit and calibrator, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study or assessment of human reader improvement with AI is not relevant to this submission.

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

   • Yes, implicitly. The ARCHITECT iGentamicin assay, as an automated chemiluminescent microparticle immunoassay (CMIA), operates as a standalone analytical system to produce quantitative results. Its "performance" refers to the accuracy, precision, linearity, and other analytical characteristics of the assay itself, independent of human interpretation or assistance beyond operating the instrument and processing samples. The "Summary of Analytical Performance" directly addresses its standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the "Method Comparison (Correlation)" study, the "ground truth" would be the results obtained from the legally marketed predicate device, AxSYM Gentamicin assay, or a recognized reference method. The study would aim to demonstrate correlation and agreement between the new device's results and this established reference. For other analytical studies (Precision, Linearity), the "ground truth" is derived from known concentrations of analytes in control materials or reference standards.

8. The sample size for the training set:

   • Not specified. As an IVD assay based on established chemical and immunological principles, it's unlikely that the "training set" in the sense of machine learning applies directly here. If "training" refers to method development and optimization, the sample sizes used for such internal studies are not detailed in this summary.

9. How the ground truth for the training set was established:

   • Not applicable in the context of machine learning training. If "training set" refers to samples used during assay development and optimization, the "ground truth" for these samples would typically be established using highly accurate and precise analytical methods, often a reference method or gravimetrically prepared standards with known concentrations. The specific details are not provided in this regulatory summary.

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