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The ESP Culture System II is an automated system for the detection of microbial growth from blood and other normally sterile body fluids, and for the detection of mycobacteria from various sources. The system may be used for the susceptibility testing of Mycobacterium tuberculosis with the drugs rifampin (1μg/ml), isoniazid ( 0.1 and 0.4ug/ml), and ethambutol (5 and 8ug/ml) The inoculum source for the susceptibility testing can originate from an ESP Myco seed bottle, or a McFarland No. 1 equivalent cell suspension created from colonies grown on an agar source.

The ESP Culture System II is an automated system for the detection of microbial growth from blood and other normally sterile body fluids, and for the detection of mycobacteria from various sources. The system may be used for the susceptibility testing of Mycobacterium tuberculosis with the drugs rifampin (1μg/ml), isoniazid ( 0.1 and 0.4ug/ml), and ethambutol (5 and 8ug/ml) The inoculum source for the susceptibility testing can originate from an ESP Myco seed bottle, or a McFarland No. 1 equivalent cell suspension created from colonies grown on an agar source.

This document is a 510(k) clearance letter from the FDA for a medical device called the "ESP Culture System II - Myco Susceptibility Testing." It does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, and study design.

Therefore, I cannot provide the requested information based on the input text. The document is primarily a regulatory approval and does not delve into the specifics of the performance study.

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