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Use of HardyDisk™ Ceftaroline 30 µg for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftaroline. The concentration of Ceftaroline 30 µg has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoc, and Haemophilus influenza.

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The document provided is a 510(k) premarket notification letter for a medical device called "Hardy Disk Ceftaroline, 30μg," which is an antimicrobial susceptibility test disc. This document does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/ML powered device.

The FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and other compliance requirements for the manufacturer. The "Indications for Use" section lists the microorganisms against which the disc is active.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study detailed in the prompt, as this information is not present in the provided text.

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