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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/Cephalothin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 8 µg/ml, Intermediate 16 µg/ml and Resistant ≥ 32 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. 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 from K984581 does not contain the specific details required to answer your request about acceptance criteria and a study proving the device meets them.

The document is an FDA 510(k) clearance letter for a device called "System U3™ for Cephalothin". It outlines the regulatory clearance process and includes the intended use for the device. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, or training sets.
• Information on ground truth establishment, expert qualifications, or adjudication methods.
• Any mention of comparative effectiveness studies (MRMC) or standalone algorithm performance.

The document states "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This indicates the FDA reviewed data provided by the manufacturer (AB BIODISK) that demonstrated equivalence to a previously cleared device, but the specifics of that data and the acceptance criteria used are not detailed in this clearance letter.

To provide the information you requested, I would need access to the actual 510(k) submission from AB BIODISK, which would contain the study results and the acceptance criteria used to demonstrate substantial equivalence. This public document only acts as an approval letter.

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