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The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorthoeae). 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 (MIC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The purpose of the 510(k) is specifically for the dalbavancin MTS at concentrations of 0.002-32 ug/mL interpreted after 16-20 hours incubation.

Dalbavancin has been shown to be active against the following bacteria, both clinically and in vitro according to the FDA label:

Staphylococcus aureus (including methicillin resistant strains) Enterococcus faecalis (vancomycin susceptible strains)

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 (MIC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The provided text describes the 510(k) premarket notification for the Liofilchem MIC Test Strip (MTS) - Dalbavancin at 0.002 - 32 µg/ml. While it outlines the device's indications for use and FDA's determination of substantial equivalence, it does not contain the detailed acceptance criteria and study data requested in the prompt.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts used to establish ground truth or their qualifications.
4. Details on an adjudication method.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
6. Information about a standalone algorithm performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. The sample size for the training set.
9. How ground truth for the training set was established.

The document is an FDA clearance letter, which confirms that the device has been found substantially equivalent to a predicate device. It briefly mentions that Dalbavancin has been shown to be active against certain bacteria "both clinically and in vitro according to the FDA label," but this statement refers to the drug's efficacy, not the performance of the MIC Test Strip device itself or details of a study assessing its accuracy.

Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria because the necessary information is not present.

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