(127 days)
The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Micafungin in the dilution range of 0.008 – 16 µg/ml is intended for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of Micafungin is for: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis
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The provided text is a 510(k) clearance letter for the Sensititre® YeastOne® Susceptibility System with Micafungin. It does not contain the detailed study information required to answer the specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in the way a clinical study report would.
The document states the device's "Indications for Use" and that it is "substantially equivalent" to legally marketed predicate devices, but it does not present the results of a primary study with acceptance criteria and a detailed breakdown of performance metrics. Instead, it refers to general controls provisions of the Act and the device's classification.
Therefore, based solely on the provided text, I cannot provide the requested information for the following reasons:
- Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria for the device's performance (e.g., specific percentages for essential agreement or categorical agreement) nor does it provide a table of reported device performance metrics against such criteria.
- Sample Size and Data Provenance (Test Set): The document does not describe a test set or its sample size.
- Number of Experts and Qualifications (Ground Truth for Test Set): The process of establishing ground truth for a test set is not outlined.
- Adjudication Method: No adjudication method is mentioned as a study is not detailed.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is not mentioned as the device is an in vitro diagnostic (IVD) antimicrobial susceptibility test, not an imaging AI device requiring human reader interpretation in the same way.
- Standalone Performance: The document does not present standalone algorithm performance data.
- Type of Ground Truth Used: The method for determining the "true" susceptibility for any study is not described. For antimicrobial susceptibility testing, this would typically involve a reference method, but it is not detailed here.
- Sample Size for Training Set: No training set is mentioned as a study is not detailed.
- How Ground Truth for Training Set was Established: Not applicable as no training set is mentioned.
In summary, the provided document is a regulatory clearance letter, not a study report. It confirms the device's equivalence and indications for use but does not delve into the detailed methodology or results of the performance studies that would have been submitted to the FDA to support the 510(k) application.
§ 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).