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HardyDisk™ Imipenem Antimicrobial Sensitivity Disks are used for scmi-quantitative in vitro susceptibility testing py the agar diffusion test procedure (Kirby-Baucr) of rapidly growing and certain tastidious bacterial pathogens. Standardized methods for agar diffusion testing have becn described list Enterobacteriaceae, Staphylococcus spp., Pscudomonus spp., Acinetobacter spp., Enterneonesus spp. other streptococci and, by modified procedures, Haemophilus influenzac, and Streptococcus pneumonine.

HardyDisk™ Imipenem 10mcg

I'm sorry, but I cannot provide the requested information as the provided text does not contain details about acceptance criteria, device performance, study design, or ground truth establishment.

The document is an FDA 510(k) clearance letter for the HardyDisk™ Imipenem 10mcg, an antimicrobial susceptibility disk. It states that the device is substantially equivalent to legally marketed predicate devices and is approved for marketing.

While the document identifies the device and its intended use, it does not include any study data, performance metrics, or details about how "acceptance criteria" were met. It solely confirms regulatory clearance based on substantial equivalence.

Therefore, I cannot extract any of the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance data.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

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