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The Liofilchem® MIC Test Strip (MTS) 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 concentration gradient of an antimicrobial agent, which is used to determine inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The Meropenen-vaborbactam MTS at concentrations of 0.016/8 - 2568 ug/mL should be interpreted at 16-20 hours of incubation.

Meropenem-vaborbactam has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label:

Enterobacter cloacae species complex Escherichia coli Klebsiella pneumoniae

Meropenem/vaborbactam has been shown to be active in vitro against susceptible isolates of the following microorganisms:

Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Proteus mirabilis Providencia spp. Serratia marcescens

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine 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 describes the Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam, for determining antimicrobial susceptibility.

Here's a breakdown of the requested information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format. It refers to the device being "substantially equivalent" to legally marketed predicate devices, implying that its performance meets established standards for antimicrobial susceptibility tests.

However, the "Indications for Use" section lists the active concentrations of Meropenem-vaborbactam (0.016/8 - 256/8 ug/mL) and specifies an incubation time of 16-20 hours. It also lists the bacteria against which the drug has shown activity, both clinically and in vitro.

Based on the provided text, a direct table of acceptance criteria and reported device performance cannot be generated as quantitative performance metrics are not included. The information focuses on regulatory approval and indications for use rather than detailed study results.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not include information about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The provided text does not include information about the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The provided text does not include information about the adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The provided text does not include information about whether an MRMC comparative effectiveness study was done or any effect sizes related to human reader improvement with AI assistance. This device is an antimicrobial susceptibility test strip, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The provided text describes the device as a "quantitative method" using a "specialized paper impregnated with a pre-defined concentration gradient" and "manual reading procedures." This indicates it is a standalone device without an algorithm in the typical sense of a software-based AI system, and its performance is inherently linked to manual interpretation. No information on an "algorithm only" performance study is present.

7. The Type of Ground Truth Used

The "Indications for Use" section states: "Meropenem-vaborbactam has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label..." and "Meropenem/vaborbactam has been shown to be active in vitro against susceptible isolates of the following microorganisms..."

This suggests that the ground truth relies on established clinical and in vitro activity data for Meropenem-vaborbactam against specific bacterial strains. This would typically involve microbiology laboratory gold standards for determining bacterial susceptibility (e.g., broth microdilution, agar dilution, or other validated reference methods).

8. The Sample Size for the Training Set

The provided text does not include information about the sample size for the training set.

9. How the Ground Truth for the Training Set Was Established

The provided text does not include information on how the ground truth for any training set was established. Given it's a quantitative method using a test strip for antimicrobial susceptibility, the "training" (if applicable, for method development) would likely involve comparison to established reference AST methods.

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