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Electrode/extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.

Electrode/Extension Cables, Models ATAR™

The provided text is a 510(k) clearance letter from the FDA for Electrode/Extension Cables. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device's AI or algorithmic component.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. This document is a regulatory approval letter, not a study report.

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The Leadaway is to be used as a lead wire for electrotherapy devices.

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The provided documents are a letter from the FDA to Therapy Equipment, Inc. regarding the 510(k) premarket notification for "The Leadaway" device. The letter determines that the device is substantially equivalent to legally marketed predicate devices and states its intended use. However, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided. The document focuses solely on the regulatory approval of the device based on substantial equivalence.

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