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510(k) Data Aggregation
(256 days)
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal.
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., S. pneumoniae, and clinically significant yeast.
The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 COMPACT has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.
Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 AST-Yeast Micafungin device, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Acceptance Standard (as per FDA Guidance Document: Antimicrobial Susceptibility Test (AST) Systems) | Reported Device Performance |
|---|---|---|
| Overall Essential Agreement (EA) | Not explicitly stated as a numerical threshold in the document, but "acceptable performance" is implied by the reported value. | 98.9% |
| Overall Category Agreement (CA) | Not explicitly stated as a numerical threshold in the document, but "acceptable performance" is implied by the reported value. | 96.6% |
| Reproducibility and Quality Control (QC) | "Acceptable results" | Demonstrated acceptable results |
Study Details
2. Sample size used for the test set and the data provenance:
- The document mentions "fresh and stock clinical isolates, as well as a set of challenge strains." However, the exact sample size (number of isolates or cases) used for the test set is not provided in the text.
- Data Provenance: The study involved an "external evaluation," implying data was collected from various sources, likely clinical laboratories. The country of origin is not specified, but the review is by the US FDA, suggesting data may be from the US or otherwise internationally relevant for US market approval. The data includes both retrospective (stock clinical isolates) and potentially prospective (fresh clinical isolates) components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not explicitly stated. The ground truth was established by a reference method (CLSI broth microdilution), not by human expert consensus or interpretation of the device results.
4. Adjudication method for the test set:
- Not applicable. Since the ground truth was established by a reference method (CLSI broth microdilution), there was no need for expert adjudication of the ground truth for the test set. The device's results were directly compared to the reference method.
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:
- No. This is an Antimicrobial Susceptibility Test (AST) device, an in vitro diagnostic (IVD) intended for automated measurement of MIC values. It is not an AI-assisted diagnostic imaging or interpretation device that would involve human readers or assess improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The VITEK® 2 AST-Yeast Micafungin system is an automated device designed to determine antifungal susceptibility. The study compared its performance directly against a reference method (CLSI broth microdilution), indicating a standalone performance evaluation of the device's algorithm and system.
7. The type of ground truth used:
- Reference method: The ground truth was established using the CLSI broth microdilution reference method, which is a widely accepted standard for antimicrobial susceptibility testing.
8. The sample size for the training set:
- Not provided. The document describes a performance evaluation of the device but does not detail the development or training of any underlying algorithms. It's possible the device uses pre-calibrated methods rather than a machine learning model that requires a distinct "training set" in the traditional sense, or this information was not deemed necessary for the 510(k) summary.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As the training set size is not given, the method for establishing its ground truth is also not described. If statistical methods are used for calibration, those would implicitly rely on data for which the ground truth (established by a reference method) is known.
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