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The QMS® Tobramycin assay is intended for the quantitative determination of tobramycin in human serum or plasma on automated clinical chemistry analyzers.

The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy.

The QMS® Tobramycin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti- tobramycin monoclonal antibody and R2: tobramycin -coated microparticles. A six-level set of QMS® Tobramycin Calibrators (A through F) is used to calibrate the assay.

Here's a breakdown of the acceptance criteria and study information for the Seradyn QMS® Tobramycin assay, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

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The Chiron Diagnostics ACS:180 Tobramycin Assay is for the quantitative determination of tobramycin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence Systems. Monitoring the patient's serum or plasma tobramycin levels is important both to ensure that the drug is present in therapeutic concentrations and to avoid toxicity.

The Chiron Diagnostics ACS:180 Tobramycin assay is a competitive immunoassay using direct, chemilumenescent technology. Tobramycin in the patient sample competes with acradinium ester-labeled tobramycin in the Lite Reagent for a limited amount of monoclonal mouse anti-tobramycin antibody, which is covalently coupled to the paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of tobramycin present in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.

Here's a summary of the acceptance criteria and study details for the Chiron Diagnostics ACS:180 Tobramycin Assay, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 293 samples.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not provided. The "ground truth" for the accuracy study was an "alternate fluorescence polarization (FPIA) method," which is a laboratory method, not expert-based.

3. Adjudication method for the test set:

   • Not applicable. The comparison was against a laboratory method.

4. 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:

   • No. This device is an automated immunoassay for drug level measurement, not an AI-assisted diagnostic imaging or interpretation tool involving human readers.

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

   • Yes. The performance described for the ACS:180 Tobramycin assay is its standalone, automated performance.

6. The type of ground truth used:

   • Alternative Method Comparison: The accuracy of the ACS:180 Tobramycin assay was assessed by comparing its results against an "alternate fluorescence polarization (FPIA) method." This constitutes a comparative method study, where the FPIA method serves as the reference or "ground truth."

7. The sample size for the training set:

   • Not provided. The document describes performance data, but does not detail the development or training of the assay (which, in this context, refers to the development of the immunoassay reagents and calibration, not an AI model).

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

   • Not provided. As this is not an AI/machine learning model in the conventional sense, the concept of a "training set" and its "ground truth establishment" as typically applied to AI does not directly apply in the same way. The development of an immunoassay involves optimizing reagent concentrations, antibody specificity, and calibration using known standards, but these details are not in the provided summary.

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The TOBR FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The TOBR method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-tobramycin conjugate and tobramycin-specific monoclonal antibody.

This document does not contain all the requested information, but here's an analysis of what is available:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the device's performance in a tabular format. However, it provides comparative performance data against a predicate device.

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

• Sample Size: 141 samples
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It simply says "One hundred forty-one samples were tested."

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

Not applicable or not provided. The ground truth for this device (measuring tobramycin levels) would likely be based on a reference standard or the predicate device's accepted measurement, not expert consensus in the human interpretation sense.

4. Adjudication Method for the Test Set:

Not applicable or not provided. This is a quantitative measurement device; adjudication methods are typically used for qualitative or interpretive tasks involving multiple human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a point-of-care or lab-based diagnostic device for measuring a chemical compound, not an imaging or interpretive AI system evaluated with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, this is a standalone device. The performance metrics provided (slope, intercept, correlation coefficient) describe the algorithm's analytical performance on its own, comparing its measurements to those of the predicate device. There is no human intervention in the "measurement" process described.

7. Type of Ground Truth Used:

The "ground truth" for the performance evaluation appears to be the measurements obtained by the aca® TOBRA test pack, which is the predicate device. The study aims to demonstrate substantial equivalence to this already cleared device.

8. Sample Size for the Training Set:

Not provided. The document describes a comparison study, not the development or training of an algorithm.

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

Not applicable as training set information is not provided.

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