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The Sensititre® YeastOne™ MIC Susceptibility plate is an in vitro diagnostic product for determining the clinical susceptibility of Candida species. This 510(k) is for this MIC only panel, the antifungal agents at concentrations listed as follows: Antifungal Agent Dilution Range Fluconazole 0.125 - 256 5-Flucytosine 0.03 - 64 Itraconazole 0.008 - 16 Organisms with indications for testing include non-fastidious yeast isolates of Candida species.
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This document is a 510(k) premarket notification for the Sensititre® YestOne™ MIC Susceptibility Plate. It describes the device, its intended use, and the FDA's "substantially equivalent" determination. However, it does not contain the detailed acceptance criteria and study results typically found in a clinical study report or a more comprehensive summary of safety and effectiveness.
Therefore, requested information cannot be fully provided from the given input.
Here's an explanation of why and what information can be extracted:
- No detailed study information: The provided text is a summary of the FDA's decision to clear the device, not the underlying studies themselves. It confirms the device exists and is intended for susceptibility testing of Candida species against specific antifungal agents.
- "Substantially Equivalent": The core of a 510(k) is demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily proving efficacy against pre-defined acceptance criteria in a detailed clinical study in the same way a PMA would. While performance data is submitted for a 510(k), the specifics of that data (acceptance criteria, sample sizes for test/training, ground truth methods, expert qualifications, etc.) are usually in a separate, more comprehensive document that is not included here.
Information that can be extracted or inferred:
- Device Name: Sensititre® YestOne™ MIC Susceptibility Plate
- Regulation Number: 866.1640
- Regulation Name: Susceptibility Test Panel
- Product Code: NGZ
- Intended Use: Determining the clinical susceptibility of Candida species to Fluconazole, 5-Flucytosine, and Itraconazole.
- Antifungal Agents and Dilution Ranges (relevant for the device's function):
- Fluconazole: 0.125 - 256
- 5-Flucytosine: 0.03 - 64
- Itraconazole: 0.008 - 16
What cannot be answered from this document:
- Table of acceptance criteria and reported device performance: This document states the device is "substantially equivalent" but does not show the specific performance results (e.g., essential agreement, categorical agreement, very major errors, major errors, minor errors) that would typically be presented against defined acceptance criteria.
- Sample sizes (test/training sets): Not mentioned.
- Data provenance: Not mentioned. Studies are implied but not described.
- Number/qualifications of experts for ground truth: Not mentioned.
- Adjudication method for test set: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned and typically not applicable for this type of IVD device (which measures a characteristic, not an interpretation by a human reader).
- Standalone (algorithm only) performance: Not applicable as this is a physical susceptibility plate, not an AI algorithm.
- Type of ground truth used: For antimicrobial susceptibility testing, the "ground truth" (or reference method) is typically a standardized susceptibility test method (e.g., Clinical and Laboratory Standards Institute - CLSI reference broth microdilution). However, this document does not explicitly state which gold standard or reference method was used for comparison in the studies that underpin the 510(k).
- Sample size for training set: Not mentioned.
- How ground truth for training set was established: Not mentioned.
To answer your request thoroughly, you would need access to the actual "Summary of Safety and Effectiveness" (SSE) or the full 510(k) submission, which would detail the studies conducted to demonstrate substantial equivalence, including performance data and the methods used.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).