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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., Acinetobacter spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae. Hardy Disk™ Norfloxacin are indicated for in vitro activity against a broad range of gram positive and gram negative bacteria.

HardyDisk™ Norfloxacin 10mcg is a type of HardyDisk™ Antimicrobial Sensitivity Disk.

The provided text is a 510(k) premarket notification letter from the FDA to Hardy Diagnostics for their HardyDisk™ Norfloxacin 10mcg product. It doesn't contain a detailed study report with acceptance criteria and a comprehensive study description. Instead, it provides the "Indications for Use Statement" for the device.

Therefore, I cannot directly extract the specific information requested about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies from this document. The letter indicates that the device has been found "substantially equivalent" to legally marketed predicate devices, which means it met the regulatory requirements for this type of device, but the specifics of that demonstration are not detailed here.

However, I can extract the "Indications for Use" which outlines what the device is intended for and implicitly suggests the types of organisms it would be tested against in a study:

Indications for Use Statement-HardyDisk™ Norfloxacin 10mcg

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.
• Acinetobacter spp.
• Listeria monocytogenes
• Enterococcus spp.
• Other streptococci
• By modified procedures:
  • Haemophilus influenzae
  • Neisseria gonorrhoeae
  • Streptococcus pneumoniae

HardyDisk™ Norfloxacin are indicated for in vitro activity against a broad range of gram positive and gram negative bacteria.

Based on the provided document, I cannot fill in the requested table and study details. The 510(k) clearance letter acknowledges that the device is substantially equivalent to a predicate, implying that performance criteria were met, but it does not present the study data itself.

To provide the requested information, a full study report from Hardy Diagnostics, likely submitted as part of their 510(k) application, would be needed. This document is merely the FDA's response letter.

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