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HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffision 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., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candidas spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

Use of HardyDisk™ AST Sulbactam 10/10ug (SUD20) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Sulbactam.

HardyDisk™ AST Sulbactam/Durlobactam at concentration 10/10ug can be used to determine the zone diameter (mm) of Sulbactam/Durlobactam against the following microorganisms for which Sulbactam has been shown to be active both clinically and in vitro: Acinetobacter baumannii-calcoaceticus complex (ABC).

HardyDisk™ AST Sulbactam/Durlobactam 10/10μg (SUD20)

I am sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter and an Indications for Use statement for the HardyDisk™ AST Sulbactam/Durlobactam 10/10µg (SUD20).

While it mentions the device's purpose (antimicrobial susceptibility testing) and the microorganisms it tests against, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample size for test sets or data provenance.
• Information on experts used to establish ground truth or adjudication methods.
• Any mention of a multi-reader, multi-case (MRMC) comparative effectiveness study.
• Information about standalone algorithm performance.
• The type of ground truth used (beyond implying susceptibility testing).
• Sample size for the training set or how its ground truth was established.

This document confirms the device's clearance and intended use but does not delve into the underlying performance studies and acceptance criteria details that would typically be found in a more comprehensive submission summary or clinical study report.

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