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The ONLINE TDM Tobramycin assay is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in human 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 ONLINE TDM Tobramycin assay is for the quantitative determination of tobramycin in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Tobramycin reagent kits.

This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the "ONLINE TDM Tobramycin" assay to a predicate device.

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state quantitative acceptance criteria for all performance characteristics. However, it states that "All of the evaluation studies gave acceptable results compared to the predicate device." The table below summarizes the reported performance for precision and method comparison.

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

• Method Comparison Test Set (ONLINE TDM Tobramycin Vs. COBAS FP Tobramycin):

  • Sample Size: N=55
  • Range: 0.2 - 9 µg/ml
  • Data Provenance: Not explicitly stated, but typically these studies are conducted with human serum or plasma samples within a lab setting. It is not specified if the data is retrospective or prospective.

• Method Comparison Test Set (COBAS FP Tobramycin Vs. COBAS FARA II - likely predicate's original validation data, included for context):

  • Sample Size: N=196
  • Range: 0.23 - 10 ug/ml
  • Data Provenance: Not explicitly stated.

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

• This information is not provided in the document. For in vitro diagnostic assays, "ground truth" is typically established by reference methods or comparison to a well-established, legally marketed predicate device, rather than expert consensus on individual cases.

4. Adjudication method for the test set:

• This information is not applicable/not provided as the study design focuses on quantitative comparison of assay results rather than subjective interpretations requiring 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:

• This is not an MRMC comparative effectiveness study involving human readers and AI assistance. The device is an in vitro diagnostic assay for quantitative measurement, not an imaging or interpretive AI device.

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

• Yes, the performance data presented (precision, method comparison) represents the standalone performance of the ONLINE TDM Tobramycin assay (algorithm/assay only) without human intervention in the result generation process, beyond standard laboratory procedures for running the assay.

7. The type of ground truth used:

• The ground truth (or reference standard) for evaluating the ONLINE TDM Tobramycin assay was the results obtained from the predicate device, COBAS INTEGRA Tobramycin (K964457). For method comparison, the predicate device's results are treated as the reference against which the new device's results are compared.

8. The sample size for the training set:

• This information is not applicable/not provided. The ONLINE TDM Tobramycin assay is a chemical assay, not an AI or machine learning model that requires a "training set" in the conventional sense. The "training" for such an assay involves the development and optimization of the reagent formulation and assay protocols, which is not quantified by a "sample size."

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

• This information is not applicable/not provided as the concept of a "training set" and "ground truth for training" does not directly apply to the development of this type of chemical assay. Assay development involves analytical validation against known standards and reference materials to ensure accuracy and precision.

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For in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of tobramycin in serum or plasma, as an aid in monitoring the therapeutic administration of this aminoglycoside.

IMMULITE® 2000 Tobramycin is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE® 2000 Automated Analyzer.

Here's an analysis of the provided text regarding the IMMULITE® 2000 Tobramycin device, structured to address your specific questions:

Acceptance Criteria and Study Details for IMMULITE® 2000 Tobramycin

The provided document describes the performance equivalence of the IMMULITE® 2000 Tobramycin device to a predicate device, Abbott AxSYM® Tobramycin, through a method comparison study. The primary acceptance criteria appear to be based on the statistical results of this comparison, demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the document implies acceptance based on the statistical outcomes of the method comparison demonstrating substantial equivalence to the predicate device.

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

• Sample Size for Test Set: 41 patient samples.
• Data Provenance: The document does not specify the country of origin. It indicates it was a comparison between the IMMULITE 2000 Tobramycin procedure and a "commercially available assay," suggesting clinical samples. The study is retrospective in the sense that the samples were collected and then analyzed by both methods for comparison.

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

• Not applicable. This was a method comparison study between two quantitative diagnostic devices. The "ground truth" for the test set was established by the measurements obtained from the predicate device (Abbott AxSYM® Tobramycin) rather than human expert interpretation or a separate gold standard.

4. Adjudication Method for the Test Set

• Not applicable. As this is a quantitative method comparison between two devices, there was no adjudication method involving human experts. The comparison relies solely on the numerical output of each analyzer.

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

• No. A MRMC comparative effectiveness study was not done. This device is a quantitative immunoassay with an automated analyzer, not an imaging device requiring human interpretation alongside AI assistance. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply.

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

• Yes. The study presented is effectively a standalone performance study. It evaluates the IMMULITE® 2000 system's ability to measure tobramycin concentrations on its own, with its results directly compared to another standalone device (Abbott AxSYM® Tobramycin). There is no human intervention or "in-the-loop" component discussed for the measurement process itself.

7. Type of Ground Truth Used

• The "ground truth" in this context is the measurements obtained from the legally marketed predicate device (Abbott AxSYM® Tobramycin). This is a common approach for demonstrating substantial equivalence for quantitative diagnostic assays.

8. Sample Size for the Training Set

• The document does not provide information regarding a separate training set or its sample size. The description focuses on the method comparison study using 41 patient samples. For immunoassay development, calibration and validation are typically performed using standards, controls, and characterized samples, but explicit "training set" details as might be described for AI/ML algorithms are not presented.

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

• As no training set is explicitly mentioned or detailed in the provided text, the method for establishing its "ground truth" is not available. Immunoassays like this are developed using established reference materials and chemical standards for calibration rather than a "ground truth" derived from expert consensus on complex data.

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