(27 days)
The Modified Contact Heat-Evoked Potential (CHEPS) is indicated finaloations in evaluating the functionality of human pain reception and transmission of sensory pathways.
The Modified Contact Heat-Evoked Potential Stimulator (CHEPS) is an advanced, computerized thermal stimulator designed for advanced pain research. This non-invasive device can be used as a stimulator for creating sensation and pain stimuli, in the sensory nerves fibers.
This document is a 510(k) summary for a medical device called the "Modified Contact Heat-Evoked Potential Stimulator (CHEPS)". It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study details, or performance metrics for the device.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on regulatory approval based on substantial equivalence, not on performance studies against specific criteria.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).