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HardyDisk AST 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 Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

Use of HardyDisk AST Aztreonam/Avibactam 30/20μg (AZA50) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales to Aztreonam/Avibactam, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

HardyDisk AST Aztreonam/Avibactam at concentration 30/20μg demonstrated acceptable performance to determine the zone diameter (mm) of Aztreonam/Avibactam against the following microorganisms:

Enterobacterales (Citrobacter freundii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, Citrobacter koseri, Enterobacter spp., Klebsiella aerogenes, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Raoultella ornithinolytica, and Serratia spp.)

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Based on the provided FDA 510(k) clearance letter, the device in question is the "HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)", an antimicrobial susceptibility test disc. It describes the device's indications for use and states that it "demonstrated acceptable performance to determine the zone diameter (mm) of Aztreonam/Avibactam against" a list of Enterobacterales.

However, the provided document is an FDA 510(k) clearance letter and an "Indications for Use" form. Crucially, it does NOT contain the detailed performance study information, acceptance criteria, sample sizes, ground truth establishment methods, or expert details that you've asked for.

The letter confirms clearance based on "acceptable performance," but the specifics of how that performance was evaluated and what the acceptance criteria were are typically found in the full 510(k) submission, not in this clearance letter itself.

Therefore, I cannot provide the requested information from the given text. The text only states that the device demonstrated "acceptable performance." To answer your questions, I would need access to the actual performance study report that was part of the 510(k) submission.

To reiterate, the provided document does NOT contain the information needed to answer the questions about acceptance criteria and the study that proves the device meets them.

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