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The Browne MVI Ethylene Oxide Indicator is a process indicator designed to indicate, through a visible color change, when the device has been exposed to an ethylene oxide sterilization process.

The Browne MVI EO Indicator is a paper strip with indicator ink pads on each end which is used to monitor ethylene oxide sterilization cycles. The indicator ink changes color from orange to red after exposure to an ethylene oxide sterilization process. After inclusion in an ethylene oxide sterilization cycle, the color of the indicator ink pads is compared to a reference spot which matches the red color of the exposed strip.

The provided document, a 510(k) summary for the Browne MVI Ethylene Oxide Indicator, details performance testing primarily against the ANSI/AAMI ST60-1996 standard. However, it does not provide specific acceptance criteria or detailed study results in a format that allows for a table of reported device performance values against numerical criteria.

The document states:
"The Browne MVI EO Indicator conforms to the applicable requirements of ANSI/AAMI ST60-1996 'Sterilization of health care products - Chemical indicators - Part 1: General requirements'."

This indicates that the device met the requirements of the specified standard, but the specific numerical targets and the device's measured performance against those targets are not present in this summary. Therefore, a table of acceptance criteria and reported device performance cannot be generated with the provided information.

Similarly, the other requested information regarding sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or training set details are not included in this regulatory summary. These types of details are typically found in the full study reports, which are not part of this 510(k) summary.

Therefore, based solely on the provided text, the specific details requested cannot be extracted. The document confirms that performance testing was done and that the device conforms to an industry standard, but it does not provide the granular data necessary to answer your specific questions.

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