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The IMMAGE Immunochemistry System Gentamicin (GEN) reagent, when used in coniunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of cgentamicin in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Tobramycin (TOB) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of tobramycin in human serum or plasma by rate nephelometric inhibition immunoassay.

Becknan Drug Calibrator 3 Plus, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE™ Immunochemistry Systems for the calibration of Gentamicin and Tobramycin test systems.

The IMMAGE Immunochemistry System (TDM) GEN and TOB Reagents in conjunction with Beckman Drug Calibrator 3 Plus, are intended for use in the quantitative determination of gentamicin and tobramycin concentrations respectively in human serum and plasma samples on Beckman's IMMAGE Immunochemistry System.

The provided document describes the IMMAGE™ Immunochemistry System Therapeutic Drug Monitoring Reagents for Gentamicin (GEN) and Tobramycin (TOB). This document is a "Summary of Safety & Effectiveness" submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92. It is a 510(k) premarket notification.

However, it does not contain specific "acceptance criteria" for performance that would typically be described with explicit thresholds (e.g., "sensitivity must be >X%", "specificity must be >Y%"). Instead, it presents performance data (method comparison, stability, and imprecision) and states that this data supports "substantial equivalence to chemistry test systems already in commercial distribution." The "acceptance criteria" here appear to be implied by successful demonstration of equivalence to the predicate device (Abbott TDx Gentamicin and Tobramycin Reagents).

Here's an attempt to extract and interpret the information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, explicit acceptance criteria are not provided in the typical sense of quantitative minimums/maximums. The goal is "substantial equivalence" to the predicate device. The performance data presented are used to demonstrate this equivalence.

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

• Gentamicin: 135 samples
• Tobramycin: 94 samples
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the context of a 510(k) submission for a clinical diagnostic device implies these would be human serum/plasma samples, likely from a clinical setting. The specific nature (e.g., healthy vs. disease, patient demographics) is not detailed. The term "method comparison" suggests these were patient samples run on both the new device and the predicate device.

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

This type of device (therapeutic drug monitoring reagent) does not typically involve "experts" establishing a ground truth in the way an imaging AI device would. The "ground truth" for method comparison is the measurement obtained from the predicate device, the Abbott TDx system, which is an already marketed and accepted device for these analytes. There are no radiologists or similar experts involved in this type of ground truth establishment for a chemical assay.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is the predicate device's measurement. There is no human adjudication process involved in comparing two quantitative chemical assays in this manner.

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 is a diagnostic reagent for an automated immunoassay system, not an AI-assisted diagnostic tool that involves human readers interpreting results in a comparative study against an AI. The device itself performs the quantitative determination.

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

This is essentially the case. The IMMAGE system (including its reagents and internal algorithms for signal processing to determine concentration) operates as a standalone system to provide quantitative results for gentamicin and tobramycin. The data presented ("Method Comparison Study Results") reflects the performance of this system directly against the predicate.

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

The ground truth for the method comparison study was the measurements obtained from the predicate device, the Abbott TDx Gentamicin and Tobramycin Reagents systems. This is a common and accepted "ground truth" for demonstrating substantial equivalence of a new diagnostic assay to an established one.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning. This device is a chemical immunoassay system, not an AI/ML algorithm that undergoes explicit training in the way typically discussed for image recognition or predictive models. The system's "performance" is based on its chemical reactions and optical measurement principles. If there were any internal calibrators or controls used for system calibration or quality control, these are inherent to the system's operation but not a separate "training set" as in AI.

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

Not applicable, as there's no mention or indication of an AI/ML "training set" in the document. The "ground truth" inherent to the system's operation would be defined by the known concentrations of calibrated reference materials and controls used to ensure accurate measurement by the immunoassay.

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