(120 days)
The Gyrus G3 System is intended for use for ablation. resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery coagulation of soft tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
The Bipolar Generator section of the G3 RF Workstation is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including:
- Adenoidectomy .
- Cysts .
- Head, Neck, Oral, and Sinus Surgery
- Mastoidectomy
- Myringotomy with effective Hemorrhage Control
- Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal
- Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass
- Papilloma Keloids
- Submucosal Palatal Shrinkage
- Tonsillectorny
- Traditional Uvulopalatoplasty (RAUP)
- Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring
- Uvulopaiatopharyngoplasty (UPPP)
- Parotidectomy
- Radical Neck Disection
The Gyrus Somnoplasty TCRF Generator section of the G3 RF Workstation with the Temperature Controlled Radio-frequency (Somnoplasty®) Electrodes is indicated for coagulation of soft tissue including:
The coagulation of enlarged tonsils in patients 13 years of age and older; the reduction of the incidence of airway obstructions, e.g., base of tongue, soft palate, etc., in patients suffering from UARS or OSAS: tissue coagulation in the inferior turbinates; and tissue coagulation in the uvula/soft palate which may reduce the severity of snoring in some individuals.
The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment and familiar with potential complications that may arise during or following fead and Neck surgery.
The Gyrus G3 System Generator has two principal modes of operation:
- The monopolar mode has controls for maximum temperature and energy delivered. The unit has readouts for total energy delivered, impedance. temperature for two thermocouples and time of energy delivery.
- -The bipolar mode has controls for output waveform type and power. The unit has readouts for set power and waveform.
Connectors on the front panel include the monopolar connector for active electrode and dispersive electrode and separate dual bipolar connectors for PlasmaCision electrodes and bipolar instruments. The foot pedal is connected on the back panel.
Accessories included with the generator are the electrodes, connector cable, footswitch and a power cable.
The provided text is related to a 510(k) Premarket Notification for the Gyrus G3 Generator System & Accessories, an electrosurgical device. It outlines the device's description, intended use, and a comparison to predicate devices, but does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (algorithm only) study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on regulatory approval (510(k)) based on substantial equivalence to predicate devices and states that "performance testing has been done to validate the performance of the device," but it does not detail the specifics of such testing, acceptance criteria, or study results.
§ 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.