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HardyDisk" Antimicrohial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been Jeseribed for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Huemophilus influentae, Neisseria gonorrhoeae and Streptococcus pneumoniae. IlardyDisk™ Anuikach is indicated for gram nogative Enterobacteriaciae including Escherichla coli, Proteus spp., Providencia spp., Klebsiella-Enternhacler-Serratia spp., Citrobacter spp. Acinetobacter spp, and Pseudomonas aeruginosa. HardyDisk™ Amikacin is also active in vitro against Staphylococcus spp.

HardyDisk™ Amikacin 30mcg is an Antimicrobial Sensitivity Disk.

The provided document is a 510(k) clearance letter from the FDA for the HardyDisk™ Amikacin 30mcg. It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information required to answer your questions about acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The letter explicitly 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 (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means that the FDA's decision is based on a comparison to existing devices, not necessarily a new, detailed clinical study demonstrating performance against specific acceptance criteria in the manner you've outlined for AI/diagnostic devices. The 510(k) process primarily assesses substantial equivalence, not necessarily de novo clinical effectiveness studies for novel technologies.

Therefore, I cannot provide the requested information based solely on the text provided. The submission that led to this 510(k) clearance would contain the performance data and methodologies, but that information is not part of this FDA clearance letter.

To fully answer your questions, one would need access to the actual 510(k) submission (K993993) document itself, which is typically much more extensive than just the clearance letter.

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