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Hutchinson Technology Incorporated's InSpectra St02 Tissue Oxygenation Monitor is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). The InSpectra St02 Tissue Oxygenation Monitor is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The InSpectra StO2 Tissue Oxygenation Monitor is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). The InSpectra StO2 is composed of the following components: Monitor and Optical Cable and The InSpectra StO2 Sensor.

The provided text does not contain information about specific acceptance criteria or a study that evaluates the device against these criteria in a detailed manner. The document is a 510(k) summary for the InSpectra StO2 Tissue Oxygenation Monitor, and while it states that "All test results verify that the device meets or exceeds all predetermined specifications," it does not elaborate on what those specifications or the "extensive testing" entailed.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, or adjudication methods based on this text. The other information requested, such as MRMC studies, standalone performance, and ground truth establishment, is also absent from these documents.

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