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The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for voriconazole in the dilution range of 0.008 - 16μg/ml for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of voriconazole is for: Candida albicans Candida krusei Candida parapsilosis Candida tropicalis

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This is an FDA 510(k) clearance letter for the Sensititre® YeastOne® Susceptibility plates with Voriconazole, not a study evaluating an AI/ML powered device. The document describes the device, its indication for use, and confirms its substantial equivalence to a legally marketed predicate device. As such, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, ground truth establishment, or AI/ML performance metrics.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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