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MTSTM (MIC Test Strip) Levofloxacin 0.002-32 ug/mL is a quantitative method intended for the in viro determination of antimicrobial susceptbility of bacteria. MTS™ consists of specialized paper impremated with a pre-defined concentration eracient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures.

MTS™ Levofloxacin at concentrations of 0.002 - 32 ug/mL should be interpreted at 16-20 hours of incubation.

MTSTM Levofloxacin can be used to determine the MIC of levofloxacin against the following bacteria.

Levofloxacin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved abel: Gram-negative bacteria

Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens

Levofloxacin has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label:

Gram-negative bacteria Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii

MTS™ consists of specialized paper impremated with a pre-defined concentration eracient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures.

The provided text is a 510(k) clearance letter from the FDA for a device called "MTS™ Levofloxacin 0.002-32 µg/mL." This device is an antimicrobial susceptibility test (AST) and determines the minimum inhibitory concentration (MIC) of levofloxacin against certain bacteria.

This document does NOT contain information about an AI/ML-driven medical device or any study that would typically involve acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, AUC). It describes a traditional in-vitro diagnostic (IVD) device for antimicrobial susceptibility testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert consensus, adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device. These concepts are not applicable to the information contained in this 510(k) clearance.

The "study that proves the device meets the acceptance criteria" in the context of this document would refer to the analytical and clinical performance studies conducted by the manufacturer (Liofilchem s.r.l.) to demonstrate that their MTS™ Levofloxacin device is substantially equivalent to a legally marketed predicate device. This typically involves:

• Analytical Performance: Studies to show the accurate and precise determination of MIC values (e.g., reproducibility, precision, linearity).
• Clinical Performance: Studies to demonstrate agreement between the MTS™ Levofloxacin device and a reference method (e.g., broth microdilution) in determining the susceptibility of bacterial isolates to levofloxacin. This generally falls into categories like:
  • Essential Agreement (EA): The percentage of isolates for which the MIC value obtained by the test device is within ±1 doubling dilution of the reference method.
  • Categoryical Agreement (CA): The percentage of isolates for which the susceptibility category (susceptible, intermediate, resistant) determined by the test device matches that of the reference method.
  • Major Discrepancies (MD): When the reference method classifies an isolate as susceptible and the test device classifies it as resistant.
  • Very Major Discrepancies (VMD): When the reference method classifies an isolate as resistant and the test device classifies it as susceptible.

The acceptance criteria for such an IVD device are typically based on established CLSI (Clinical and Laboratory Standards Institute) guidelines or similar regulatory standards for AST devices, focusing on acceptable rates of agreement and low rates of discrepancies.

In summary, the provided text does not describe an AI medical device; therefore, an answer fitting the requested format for such a device cannot be generated from this document.

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