(19 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates.
This 510(k) is for Plazomicin in the dilution range of 0.06-128 ug/ml for testing non-fastidious gram negative organisms on the Sensititre 18 - 24 hour MIC panel.
Plazomicin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:
- o Escherichia coli
- o Klebsiella pneumoniae
- o Proteus mirabilis
- o Enterobacter cloacae
The following in vitro data are available, but their clinical significance is unknown.
- Gram-negative Bacteria
- o Citrobacter freundii
- o Citrobacter koseri
- o Klebsiella aerogenes
- o Klebsiella oxytoca
- o Morganella morganii
- o Providencia stuartii
- o Serratia marcescens
- o Proteus vulgaris
Not Found
The provided text is related to an FDA 510(k) clearance for an antimicrobial susceptibility test system (Sensititre with Plazomicin). It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device that would require such details (e.g., performance metrics like sensitivity, specificity, or AUC, and details on ground truth, expert adjudication, or training sets).
The document is primarily focused on:
- Granting 510(k) clearance for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Plazomicin.
- Indicating the device's intended use for clinical susceptibility testing of non-fastidious isolates, specifically for Plazomicin against certain gram-negative organisms.
- Listing the organisms against which Plazomicin has shown activity.
- Regulatory information and disclaimers.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML device from this document. This document pertains to a traditional in vitro diagnostic product, not an AI/ML powered medical device.
§ 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).