(72 days)
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.
| Performance Characteristic | Acceptance Criteria (Implied by Comparison to Predicate) | ONLINE TDM Tobramycin Performance | Predicate Device (COBAS INTEGRA Tobramycin) Performance |
|---|---|---|---|
| NCCLS Precision, Within run | Expected to be comparable or better than the predicate | ||
| Control 1 Mean (µg/ml) | N/A | 1.3 | 1.4 |
| Control 1 SD (µg/ml) | N/A | 0.05 | 0.04 |
| Control 1 CV% | N/A | 3.9 | 2.6 |
| Control 2 Mean (µg/ml) | N/A | 4.2 | 3.5 |
| Control 2 SD (µg/ml) | N/A | 0.04 | 0.07 |
| Control 2 CV% | N/A | 0.9 | 2.1 |
| Control 3 Mean (µg/ml) | N/A | 7.1 | 7.5 |
| Control 3 SD (µg/ml) | N/A | 0.04 | 0.14 |
| Control 3 CV% | N/A | 0.6 | 1.9 |
| NCCLS Precision, Total | Expected to be comparable or better than the predicate | ||
| Control 1 Mean (µg/ml) | N/A | 1.3 | 1.4 |
| Control 1 SD (µg/ml) | N/A | 0.07 | 0.09 |
| Control 1 CV% | N/A | 5.2 | 6.0 |
| Control 2 Mean (µg/ml) | N/A | 4.2 | 3.5 |
| Control 2 SD (µg/ml) | N/A | 0.07 | 0.16 |
| Control 2 CV% | N/A | 1.7 | 4.5 |
| Control 3 Mean (µg/ml) | N/A | 7.1 | 7.5 |
| Control 3 SD (µg/ml) | N/A | 0.09 | 0.30 |
| Control 3 CV% | N/A | 1.3 | 4.0 |
| Method Comparison | Strong correlation (r close to 1) and linear relationship (slope near 1, intercept near 0) with the predicate. | ||
| Linear Regression: ONLINE TDM Tobramycin Vs. COBAS FP Tobramycin | N/A | y = 1.04x + 0.20 | |
| r = 0.996 | |||
| SD (md 95) = 0.393 | N/A |
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.
§ 862.3900 Tobramycin test system.
(a)
Identification. A tobramycin test system is a device 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.(b)
Classification. Class II.