(65 days)
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.
§ 890.1175 Electrode cable.
(a)
Identification. An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.(b)
Classification. Class II (special controls). The special controls consist of:(1) The performance standard under part 898 of this chapter, and
(2) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 890.9.