(20 days)
The MegaDyne reusable patient return electrode is to be used as a general purpose return electrode in any electrosurgical application in which a standard monopolar electrosurgical generator is used.
The MegaDyne reusable patient return electrode is constructed of a layer of conductive material, laminated between two sheets of dielectric plastic material. An insulated and strain-relieved two conductor cable connects the device to a standard monopolar electrosurgical unit (ESU). The capacitive patient return electrode is large enough to extend at least half the length and the full width of a typical patient torso. Sizes for both adult and pediatric patients are available. This device is not intended to be attached to the patient. In typical use, this device will lay on an operating room table with the patient laying on top, on the side labeled "patient side". A disposable plastic sheath is placed over the device, which is replaced after each procedure, to allow for easy clean up between patients and to provide a second layer of dielectric protection. A test wand is available as an accessory. The test wand is intended to be used for periodic electrode inspections. The test wand identifies electrical deficiencies in the return electrode outer dielectric laver.
This 510(k) summary describes a traditional medical device (patient return electrode), not a software as a medical device (SaMD) or an AI/ML-based device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, training sets, and ground truth establishment is not applicable in the context of AI/ML evaluation.
The provided text focuses on the device's physical description, intended use, and safety information as per a 510(k) submission for a conventional electrosurgical accessory.
However, I can extract the safety information that acts as a performance criterion for this device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Current density |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.