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HardyDisk™ Antimicrobial 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 described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes Enterococcus spp., other streptaceae and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.

HardyDisk™ Oxacillin is indicated for in vitro activity against Staphylococcur spp. and Streptococcus pneumoniae.

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The provided text is a 510(k) premarket notification letter from the FDA to Hardy Diagnostics regarding their HardyDisk™ Oxacillin 1mcg device. This document confirms the substantial equivalence of the device to existing predicate devices. However, the letter itself does not contain the detailed acceptance criteria for the device's performance, nor does it provide a report of a study that proves the device meets such criteria.

The letter indicates that the device is "substantially equivalent" to legally marketed predicate devices, implying that testing was conducted to demonstrate this equivalence. However, the specific details of that testing, including the acceptance criteria, study design, sample sizes, ground truth establishment, and expert qualifications, are not included in this document. Such information would typically be found in the 510(k) submission itself, which is not provided here.

Therefore, I cannot answer the questions based solely on the provided text. The document is a regulatory approval letter, not a scientific study report.

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