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The Liofilchem® MTS™ (MIC Test Strip) Omadacycline 0.002-32 ug/mL is a quantiative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine thilotiory concentration (MC) in ug/mL of antimicrobial agents against baceria as tested on agar media using overnight incubation and manual reading procedures.

The MTSTM Omadacycline at concentrations of 0.002-32 µg/mL should be interpreted at 16-20 hours of incubation.

MTS™ Omadacycline can be used to determine the MC of ornadacycline against the following bacteria. Omadacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

Gram-Positive bacteria Staphylococcus aureus Staphylococcus lugdunensis Enterococcus faecalis

Gram-Negative bacteria Enterobacter cloacae Klebsiella pneumoniae

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

Gram-Positive bacteria

Enterococcus faecium (vancomycin-susceptible and -resistant isolates)

Gram-Negative bacteria Escherichia coli Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca

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

This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Specifically, the document is a regulatory approval for the "MTS Omadacycline 0.002-32 ug/mL" device, which is an antimicrobial susceptibility test.

The document states that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use of the device and information about regulatory compliance.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as tables of acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, are not present in this regulatory clearance letter.

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