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The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Gentamicin reagent kits.

The Roche ONLINE Gentamicin Assay is an in vitro diagnostic reagent system designed for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers. The device is used to diagnose and treat gentamicin overdose and monitor drug levels for appropriate therapy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a formal table with pass/fail thresholds. Instead, it presents performance characteristics (precision and method comparison) of the new device and compares them to a legally marketed predicate device (COBAS INTEGRA Gentamicin Assay). The statement "All of the evaluation studies gave acceptable results compared to the predicate device" implies that the new device's performance characteristics were deemed equivalent to those of the predicate.

Below is a table summarizing the reported device performance, with the implicit acceptance criteria being performance comparable to the predicate device.

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

• Sample Size for Test Set:
  • For the method comparison study comparing the Roche/Hitachi 917 to the COBAS INTEGRA 700 (new device vs. predicate), the sample size was N = 112.
  • For the comparison of the predicate device (COBAS INTEBRA Gentamicin) to COBAS FARA II Gentamicin assay, the sample size was N = 145. This appears to be a historical comparison for the predicate, not directly reflecting the current test set for the new device.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It is implied to be data collected specifically for this 510(k) submission, likely prospective, given the nature of performance evaluation studies for new devices.

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

This type of information is not applicable to this device. The Roche ONLINE Gentamicin Assay is an in vitro diagnostic device that quantifies a drug concentration in biological samples. The "ground truth" for its performance is established by comparison to a reference method or a legally marketed predicate device, and through analytical performance characteristics like precision, not by expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable to this device. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers interpret data, and discrepancies need to be resolved. This device performs a quantitative chemical analysis, not interpretation.

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

This is not applicable to this device. MRMC studies are relevant for AI-powered diagnostic tools that assist human readers in tasks like image interpretation. The Roche ONLINE Gentamicin Assay is a laboratory assay for drug concentration measurement and does not involve human readers for interpretation in this context, nor does it use AI.

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

Yes, a standalone performance study was conducted. The entire evaluation, including method comparison and precision, assesses the performance of the device (reagent system on an automated analyzer) without human intervention in the analytical process itself. The numbers reported (e.g., correlation coefficient, CV%) directly reflect the algorithm/assay's performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation was established by:

• Comparison to a Legally Marketed Predicate Device: The Roche ONLINE Gentamicin Assay was compared to the COBAS INTEGRA Gentamicin Assay, which serves as a recognized standard in the market. The predicate's results are considered the comparative "truth" or reference.
• Analytical Performance Metrics: Intrinsic analytical performance characteristics such as precision (within-run and total CV%) are fundamental to establishing the reliability and "truthfulness" of the measurements.

8. The Sample Size for the Training Set

This is not applicable to this device in the context of an AI/machine learning training set. The Roche ONLINE Gentamicin Assay is a chemical assay, not an AI or machine learning algorithm that requires a "training set." Its calibration involves calibrator materials with known concentrations, but this is a standard chemical assay procedure, not an AI training process.

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

This is not applicable for the same reasons as point 8. The "ground truth" for calibration in a chemical assay is established through the gravimetric preparation of calibrators with certified concentrations or by comparison to definitive reference methods.

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