(69 days)
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.
Not Found
This document is an FDA 510(k) clearance letter for the EAV Combi-2 device, a galvanic skin response measurement device. It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain the kind of detailed information about acceptance criteria or a study proving device performance that you're asking for.
The letter explicitly states: "There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities." This indicates that the regulatory clearance is for the device as a measurement tool, not for any diagnostic or performance claims based on the data it collects.
Therefore, I cannot provide the requested information from this document because it is not present. Here's why:
- Acceptance Criteria & Reported Performance: This information is not found in the 510(k) clearance letter. These are typically part of the 510(k) submission, not the clearance letter itself.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set): The document specifically states "There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities." This implies that a study demonstrating "performance" in the way you're asking about (e.g., diagnostic accuracy, reader improvement) was not required or submitted for this particular clearance, as the device is cleared only for measurement of galvanic skin response, not for making diagnoses or providing specific utility of the data.
To obtain the information you're looking for, you would typically need to review the actual 510(k) submission document (if publicly available) or a different type of regulatory submission (like a PMA, which requires clinical efficacy data).
§ 882.1540 Galvanic skin response measurement device.
(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.