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The MTS (MC Test Strip) Lefamulin 0.016 - 256 µg/mL is a quanttative method intended for the in vitro determination of animicrobal susceptbility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Lefamilin at concentrations of 0.016 - 256 ug/mL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.

Lefamulin has been shown to be active both clinically and in viro against these bacterial species according to the FDA drug approved label:

Gram-positive bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates)

Gram-Negative bacteria Haemophilus influenzae

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

The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria.

The document is a 510(k) clearance letter from the FDA for a device named "MTS Lefamulin 0.016- 256 μg/mL." It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use of the device, which is a quantitative method for the in vitro determination of antimicrobial susceptibility of bacteria using Lefamulin.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample size, ground truth details, MRMC study, etc.) from the given text.

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