(31 days)
The VITEK® Gram Negative Susceptibility Test is intended to be used with the VITEK® System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylooocus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. VITER® Gram Negative Moxifloxacin is designed for antimicrobial susceptibility testing of Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, and Proteus mirabilis. VITEK Gram Negative Moxifloxacin is for qualitative testing only. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
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This document is a 510(k) premarket notification decision letter from the FDA for the VITEK® Gram Negative Moxifloxacin antimicrobial susceptibility testing device. It does not contain a detailed study report with specific acceptance criteria and performance data in the structured format requested.
Therefore, most of the information requested in your prompt cannot be extracted directly from this document. The document primarily confirms that the device is substantially equivalent to a legally marketed predicate device.
However, I can extract the following limited information:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The letter only states that the device is "substantially equivalent" but does not detail the specific performance metrics or acceptance criteria used to make that determination, nor does it present the device's reported performance against such criteria.
2. Sample size used for the test set and the data provenance:
This information is not present in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not present in the provided document. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic imaging tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device described is an "automated quantitative or qualitative susceptibility testing" system, implying it performs in a standalone manner (without human-in-the-loop performance for the actual susceptibility reading/interpretation). However, the details of the study proving this standalone performance are not provided in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not present in the provided document. For antimicrobial susceptibility testing, the ground truth would typically be established by a reference method, often a manual broth microdilution or agar dilution method according to CLSI (Clinical and Laboratory Standards Institute) guidelines.
8. The sample size for the training set:
This information is not present in the provided document.
9. How the ground truth for the training set was established:
This information is not present in the provided document.
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”