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For in vitro diagnostic use:

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Tetracycline susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml and Resistant ≥ 16 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the "System U3™ for Tetracycline," which confirms its substantial equivalence to a legally marketed predicate device.

It includes:

• The device name and its intended use (in vitro diagnostic for antimicrobial susceptibility testing of non-fastidious Gram negative and Gram positive aerobic bacteria).
• The MIC breakpoints for Tetracycline (Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml, and Resistant ≥ 16 µg/ml).

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Details about experts used for ground truth or adjudication methods.
4. Information about MRMC comparative effectiveness studies.
5. Details about standalone algorithm performance.
6. The type of ground truth used in a study.
7. Sample size or ground truth establishment for a training set.

To answer your request, I would need a different document that details the device's validation studies, performance data, and the specific acceptance criteria used for its clearance.

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