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Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes and some Streptococci, and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.

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The provided document is a 510(k) premarket notification letter from the FDA for a medical device: Oxoid Ticarcillin/Clavulanic Acid Antimicrobial Susceptibility Disc. This document primarily serves as an approval letter and an outline of the device's intended use. It does not contain detailed information about acceptance criteria, specific performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document refers to a 510(k) submission, which would contain such details, but the submission itself is not provided here.

The available information is limited to:

• Device Name: Ticarcillin/Clavulanic Acid Antimicrobial Susceptibility Disc
• Regulatory Class: II
• Product Code: JTN
• Indication for Use: Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include: Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes and some Streptococci, and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.

To answer your request, the actual 510(k) submission document would be required, which would typically include sections like "Substantial Equivalence Information," "Performance Data," and "Summary of Clinical Studies" or "Summary of Nonclinical Studies."

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