(85 days)
The Gyrus ENT Somnoplasty Generator, in combination with Gyrus ENT Somnoplasty Electrodes, is intended for use in the coagulation of soft tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
The Gyrus ENT Somnoplasty Generator with the Gyrus ENT Soft Tissue Coagulating Electrodes is indicated for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The Gyrus ENT Somnoplasty Generator has controls for maximum temperature, energy delivered and time of energy delivery. The unit readouts for total energy delivered, has temperature for two impedance. and thermocouples. Connectors on the front panel include connector for active electrode and dispersive electrode. The foot pedal is connected on the back panel. Accessories included with the generator are a power cable and a footswitch.
The provided documents are a 510(k) summary for the Gyrus ENT Somnoplasty Generator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical trial to prove safety and efficacy against pre-defined acceptance criteria. Therefore, the documents do not contain information regarding detailed acceptance criteria, a specific study proving the device meets those criteria, or the other specific details requested (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).
The 510(k) process relies on performance validation testing to show substantial equivalence. The summary states:
"Performance validation testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use."
However, the specific details of this "performance validation testing" are not included in the provided summary. This validation would typically involve bench testing to ensure the device performs as intended and comparably to the predicate device, but not a clinical study with detailed acceptance criteria as one might find for a novel device or a PMA submission.
Therefore, I cannot provide the requested table and information based on the given text.
§ 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.