(24 days)
The VANC FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure vancomycin, an antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
The VANC method is based on a Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-vancomycin conjugate and vancomycin-specific monoclonal antibody.
This document describes a 510(k) submission for the Vancomycin FLEX™ Reagent Cartridge. The information provided is for a medical device (reagent cartridge) and not an AI algorithm. Therefore, many of the requested fields regarding AI algorithm performance (e.g., sample size for AI test set, adjudications, MRMC studies, standalone AI performance) are not applicable.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence and Correlation) | Reported Device Performance (VANC FLEX™ vs. aca® VANC) |
|---|---|
| Close agreement with a legally marketed predicate device (aca® VANC). Typically, this involves good correlation (e.g., R-value > 0.95 or 0.975 depending on assay) and an acceptable bias (slope near 1, intercept near 0). | Slope = 0.95 |
| Intercept = - 0.33 | |
| Correlation Coefficient = 0.987 | |
| Clinical utility for measuring vancomycin in plasma and serum for diagnosis/treatment of overdose and monitoring therapy. | Demonstrated through substantial equivalence to aca® VANC, and the reported correlation supports this. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 231 samples
- Data Provenance: Not explicitly stated. The nature of a 510(k) comparison study often involves retrospective or prospectively collected clinical samples, but the document doesn't specify. No country of origin is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a chemistry analyzer, the "ground truth" for comparison is typically another well-established, legally marketed assay, or a reference method. It does not involve human expert interpretation of images or clinical data in the way an AI algorithm might. The aca® VANC test pack serves as the comparator, and its results are considered the "truth" for this comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used for establishing ground truth in AI studies where human experts disagree. In this case, quantitative results from one chemistry analyzer are compared directly to another.
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 comparison between two in vitro diagnostic (IVD) reagent cartridges, not an AI system. There are no human readers or AI assistance involved in the measurement process described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device (reagent cartridge/system) performance study, not an AI algorithm study. The "standalone" performance is what is reported (the VANC FLEX™ cartridge's measurements compared to the predicate device).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Comparator Device Results: The "ground truth" for this study is effectively the quantitative results obtained from the aca® VANC test pack on the aca® discrete clinical analyzer. This is a well-established, FDA-cleared predicate device.
8. The sample size for the training set
- Not Applicable. This is not an AI algorithm, so there is no "training set." The device is a chemical reagent and an analyzer, whose performance is determined by its chemical and mechanical design, not by learning from data.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for this type of medical device, this question is not relevant.
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.