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VITEK® 2 Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species and 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 antifungal agents. VITEK® 2 Yeast Fluconazole has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal.

Active in vitro and in clinical infections Candida albicans Candida parapsilosis Candida tropicalis

The following in vitro data are available, but their clinical significance is unknown. Candida dubliniensis Candida guilliermondii Candida lusitaniae

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, Staphylococus spp., Enterococcus spp. and clinically significant yeast.

VITEK 2 AST - Yeast Fluconazole is designed for an antifungal susceptibility testing of Candida species and 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 antifungal agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

The VITEK® 2 AST-Yeast Fluconazole device is intended for antifungal susceptibility testing of Candida species to determine in vitro susceptibility to antifungal agents.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the total number of isolates tested. It mentions an "external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains."
• Data Provenance: The document does not explicitly state the country of origin. It indicates the test set included both "fresh and stock clinical isolates and stock challenge strains," implying both newly acquired clinical samples and previously collected and stored isolates, as well as specific challenge strains used for validation. This suggests a blend of retrospective (stock isolates) and potentially prospective (fresh clinical isolates) data.

3. Number of Experts and Qualifications:

• This information is not provided in the document. The study compares the device's performance to the CLSI broth microdilution reference method, which is a standardized laboratory method, not typically adjudicated by medical experts for routine results.

4. Adjudication Method:

• None explicitly mentioned as the study compares to a reference laboratory method rather than expert consensus on images or clinical cases.

5. MRMC Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done for this device. The study evaluates the device's performance against a reference laboratory method (CLSI broth microdilution), not human reader performance.

6. Standalone Performance:

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The VITEK® 2 System automatically performs the filling, sealing, incubation, and reading of the cards, generating MIC values and interpretive categories. The device's performance (Essential Agreement and Category Agreement) was assessed against the reference method.

7. Type of Ground Truth Used:

• Standard Reference Method: The ground truth was established by comparing the VITEK® 2 AST-Yeast Fluconazole results to the CLSI broth microdilution reference method, as defined in the Class II Special Controls Guidance Document.

8. Sample Size for the Training Set:

• This information is not provided in the document. The submission focuses on the performance of the final device against a reference standard.

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

• This information is not provided in the document. As this is a premarket notification for an antimicrobial susceptibility test, the "training set" would likely refer to internal development and optimization phases rather than a formal, separately documented training set with established ground truth as would be common for AI/ML-based diagnostic devices. The performance evaluation presented is against a known reference method.

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