(28 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Preamble: Substantial equivalence to Abbott AxSYM® Tobramycin | Demonstrated through method comparison and linear regression analysis. |
| Strong linear correlation (r value) | r = 0.981 |
| Agreement in measured concentration ranges | IMMULITE 2000 Mean: 3.76 µg/mL |
| Abbott AxSYM® Mean: 4.10 µg/mL | |
| Linear regression equation indicating proportionality | (IMMULITE 2000) = 0.96 (Abbott AxSYM® Tobramycin) - 0.18 µg/mL |
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.
§ 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.