Search Results

The SYNERGY LT is a 2 channel electromyograph which provides facilities for EMG and Evoked Potentials testing for a range of clinical applications.

SYNERGY LT is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment.

The SYNERGY LT is a 2 channel electromyograph which provides facilities for EMG and Evoked Potentials testing for a range of clinical applications.

The provided document is a 510(k) clearance letter from the FDA for a device called "SYNERGY LT," an electromyograph. It does not contain information about acceptance criteria, detailed study designs, or performance metrics. Therefore, I cannot extract the requested information.

The letter explicitly states that the device is "substantially equivalent" to previously marketed devices and is subject to general controls. This type of clearance typically relies on demonstrating equivalence rather than proving new performance against specific acceptance criteria through novel studies.

Therefore, I am unable to populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device