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Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Gentamicin 120µg these include Enterococcus spp. Gentamicin 120 Susceptibility Test Discs are for detection of 'high level antibiotic resistance'.

Oxoid Gentamicin Susceptibility Test Disc

This document is a 510(k) clearance letter from the FDA for the Oxoid Gentamicin Antimicrobial Susceptibility Test Disc. It does not contain the detailed study information required to answer the prompt. The letter merely states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information, such as acceptance criteria, device performance, sample sizes, ground truth establishment, or details about any comparative effectiveness studies, based on the provided text. This information would typically be found in the 510(k) submission itself, not in the clearance letter.

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