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Galvanic Skin Response Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin. There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Akuport M1," which is a Galvanic skin response measurement device. This document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate device.

Unfortunately, the letter does not contain the detailed information required to answer your questions about acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert qualifications. The FDA 510(k) clearance process, especially for devices from 2002, often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance metrics to be submitted within the summary document.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". It does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number/qualifications of experts or adjudication methods.
• MRMC or standalone study results.
• The type of ground truth used or how it was established.

The "Indications For Use" section clearly states: "There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities." This further suggests that the clearance was based on the device's ability to technically measure galvanic skin response, similar to predicate devices, without needing to establish clinical efficacy or diagnostic accuracy through rigorous performance studies against specific acceptance criteria.

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