(204 days)
The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Caspofungin with new FDA breakpoints and indications for testing Candida spp. on the Sensititre YeastOne Susceptibility System. Caspofungin has been shown to be active both clinically and in viro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis
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The provided text does NOT contain information about specific "acceptance criteria" for a device that uses AI/algorithm and a "study that proves the device meets the acceptance criteria". The document is an FDA 510(k) clearance letter for The Sensititre YeastOne Susceptibility System with Caspofungin.
This system is an in vitro diagnostic product for clinical susceptibility testing of Candida spp., which is a laboratory test to determine how effective an antifungal drug (Caspofungin) is against specific yeast organisms. It determines the minimum inhibitory concentration (MIC) rather than being an AI-driven image analysis or diagnostic device that relies on complex algorithms or human readers' interpretation of images.
Therefore, the requested information about AI model performance metrics, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document. The clearance is based on the system's ability to accurately determine susceptibility to Caspofungin compared to a legally marketed predicate device.
To answer your request based on the provided text, I must state that the document does not contain the specific details you're looking for regarding AI device acceptance criteria and study data.
§ 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).