Search Results

The Vermed A10005 electrode is designed to measure muscle activity from the surface of the skin. The A10005 can be used for Sleep Studies, surface EMG, NCS and EP.

The Vermed A10005 electrode is designed to measure muscle activity from the surface of the skin. The A10005 electrode is provided in a NON-STERILE format only, and should be used on the surface of the skin.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Vermont Medical, Inc. for their "Multipurpose Neuroplus Electrode, Model A10005". This document primarily discusses the regulatory approval of the device and its intended use.

It does not contain any information about acceptance criteria for a study, nor does it describe a study that proves the device meets specific performance criteria. The letter confirms substantial equivalence to a predicate device, which is a regulatory pathway, not a detailed performance study report.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document.

Ask a specific question about this device