(79 days)
The truSculpt RF energy is intended to provide topical heating tissue temperature for the treatment of selected medical conditions, such as relief of pain and increase in local circulation.
Additionally, the 2 MHz setting for the 40 cm handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen.
The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
The truSculpt RF Device consists of a console, one or more RF handpieces that connect to the console with an umbilical cable, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. The truGlide is a separate mechanical roller that can be used as a massager.
Here's a summary of the acceptance criteria and study information for the truSculpt RF Device, based on the provided text:
Device: truSculpt RF Device
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the clinical study endpoints and the "Summary Results" in the study tables.
| Acceptance Criteria (Implicit from Study Endpoints) | Reported Device Performance |
|---|---|
| Non-invasive Lipolysis (Study C-17-TS13) | |
| Efficacy: Histological evaluation of tissue for selective fat necrosis, with sparing of the dermis and epidermis, following truSculpt treatment vs. untreated contralateral control. | Met endpoints. Epidermal and dermal tissues were unaffected by RF treatment and were equivalent and indistinguishable in all subject biopsies. Biopsies from the control areas showed normal subcutaneous adipose tissue structures with no indication of changes from the contralateral RF treatment area. Biopsies from treated areas showed adipocyte necrosis and/or inflammatory immune cell response. Acute inflammation was present immediately and out to 20 days. Peak adipocyte death and fat necrosis observed 30 days post-treatment. |
| Safety: Incidence and severity of adverse device effects during the study period, including subject pain level during RF treatment. | No adverse events were observed. Immediate responses included mild to moderate erythema and edema, which resolved with no intervention. |
| Circumferential Reduction (Study C-17-TS15, follow-up to C-16-TS11) | |
| Efficacy: Difference in circumferential measurement at the 18-month follow-up visit when compared with the baseline and 12-week follow-up visits, as measured and reported in C-16-TS11 (K162512). | The difference between the circumferential measurements recorded during the 18-month follow-up visit when compared with the subjects' baseline circumferential measurements showed a **sustained reduction in the circumference of the abdomen of 2.30 ± 0.51 cm (p |
§ 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.