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The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concernment of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Plazoni.cin at concentrations of 0.016-256 ug/mL should be interpreted at 16-20 hours of incubation.

MTSTM PLZ can be used to determine the MC of plazomicin against the microorganisms listed in the table below:

Plazomicin Activity According to the FDA Label

Clinical and in vitro

Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis

in vitro only Citrobacter freundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens

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

This document describes the FDA 510(k) clearance for the Liofilchem MTS Plazomicin 0.016-256 ug/mL device, which is an antimicrobial susceptibility test. The information provided focuses on the regulatory clearance process rather than a detailed study demonstrating acceptance criteria and performance against an AI model.

Therefore, I cannot provide a response that directly addresses the user's request for:

• A table of acceptance criteria and reported device performance related to an AI model.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details specifically for an AI model.

The provided document describes a traditional in vitro diagnostic device, not an AI-powered one. The "acceptance criteria" discussed in the document are related to the substantial equivalence determination for regulatory clearance against a predicate device, and the "performance" refers to the ability of the MTS Plazomicin strips to accurately determine MICs of antimicrobial agents, as established by standard microbiological methods.

Based on the provided text, none of the requested information regarding AI model performance, studies, or ground truth establishment is available. The document is a 510(k) clearance letter for an antimicrobial susceptibility test strip, not a study report for an AI-powered diagnostic device.

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