(266 days)
The Visage Cosmetic Surgery System is a bipolar high frequency electrosurgical device intended for general dermatologic surgery that may include skin resurfacing for the treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and hemostasis/coagulation. It is intended to be used in procedures using conductive solutions such as normal saline.
The Visage Cosmetic Surgery System is a bipolar, high frequency electrosurgical system designed for use in general dermatologic procedures where ablation and coagulation of soft tissue is desired. The System consists of three components: an electrosurgical generator called the Controller, the disposable Handpiece Tip, and the reusable Handpiece and Cable Unit. The Controller utilizes radio frequency (RF) energy as a power source. RF energy is delivered to the patient via the Handpiece and Cable unit and the Handpiece Tip. The Handpiece and Cable unit is designed to attach to the Controller and Handpiece Tip for patient treatment. The single use, sterile, Handpiece Tip is the patient contacting component of the System. The Handpiece Tip configuration ranges from single to multiple electrodes incorporating straight, screen, loop, and sheet shaped electrodes. The Visage Cosmetic Surgery System uses bipolar technology in the design of the Handpiece Tip eliminating the need for a patient contacting dispersive pad used in monopolar devices.
The provided text describes a 510(k) submission for the Visage™ Cosmetic Surgery System, focusing on its substantial equivalence to previously cleared predicate devices and an expansion of its indications for use to include skin resurfacing for the treatment of wrinkles, rhytids, and furrows.
However, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, or multi-reader multi-case studies.
Instead, it primarily focuses on the regulatory submission process, device description, intended use, and the FDA's clearance of the device based on substantial equivalence. It mentions a clinical study was conducted, but provides no details on its methodology, results, or acceptance criteria.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document states:
"The safety and effectiveness of the Visage Cosmetic Surgery System for skin resurfacing for the treatment of wrinkles, rhytids, and furrows was evaluated in accordance with an approved Investigational Device Exemption (IDE), No. G970168, "ArthroCare Dermal Electrosurgery System for Skin Resurfacing Clinical Study." The Visage Cosmetic Surgery System was found to be both safe and effective for skin resurfacing for the treatment of wrinkles, rhytids, and furrows."
This indicates a study was performed, but no details about its design, performance metrics, or data are included in this 510(k) summary.
§ 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.