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510(k) Data Aggregation

    K Number
    K180709
    Device Name
    truSculpt RF Device; truSculpt; truSculpt 3D
    Manufacturer
    Cutera, Inc.
    Date Cleared
    2018-06-06

    (79 days)

    Product Code
    PBX,GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K162512,K163415
    Predicate For
    K221407
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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 < 0.001). The 18-month circumferential-measurement data when compared with the 12-week circumferential-measurement data showed a 0.17 ± 0.49 cm increase in circumference of the abdomen for this cohort of 15 subjects (p = 0.36), suggesting long-term maintenance of reduction.
    Safety: Incidence and severity of treatment-related adverse effects developing after the final 12-week follow-up visit of C-16-TS11. (At which point all treatment-related expected side effects had resolved without medical intervention).No treatment-related adverse effects were observed or reported developing after the 12-week follow-up visit of C-16-TS11.

    2. Sample Size Used for the Test Set and Data Provenance

    • Non-invasive Lipolysis Study (C-17-TS13):

      • Sample Size: 12 subjects (92% females, 8% males; aged 24-58 years).
      • Data Provenance: Single-center, prospective, non-randomized, open-label study conducted in an unspecified country (likely USA, given FDA submission). The study involved subjects scheduled for abdominoplasty surgery, and biopsies were harvested during these surgeries.

    • Long-term Follow-up Circumferential Reduction Study (C-17-TS15):

      • Sample Size: 15 subjects were enrolled for the 18-month follow-up (out of 46 potential subjects from the previous study C-16-TS11).
      • Data Provenance: Single-center, observational, prospective study. Follow-up data collected 18 months after initial treatment in a previous study (C-16-TS11). Country of origin is unspecified, but likely USA.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • Non-invasive Lipolysis Study (C-17-TS13):

      • Number of Experts: One
      • Qualifications: "board-certified dermatopathologist"

    • Circumferential Reduction Study (C-17-TS15): The ground truth was based on physical measurements (circumferential measurements) taken by study personnel, not interpreted by experts in the same way as histological slides.

    4. Adjudication Method for the Test Set

    • Non-invasive Lipolysis Study (C-17-TS13): Not explicitly stated. Given that a single "board-certified dermatopathologist" performed the examination, it implies direct assessment rather than a formal adjudication process between multiple readers. However, the study design included treated vs. contralateral (untreated) control areas on the same subject, effectively allowing for internal comparison.
    • Circumferential Reduction Study (C-17-TS15): Not applicable for measurements. The initial C-16-TS11 study (data previously submitted) included comparative outcomes from treatment and sham treatment arms.

    5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

    • No MRMC comparative effectiveness study was done to evaluate human readers' improvement with AI vs. without AI assistance. The truSculpt RF device is not an AI-assisted diagnostic device, but rather a therapeutic device.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    • This question is not applicable as the truSculpt RF is a physical device used by a human practitioner for treatment, not an AI algorithm. The performance studies evaluate the device's effect on patients.

    7. The Type of Ground Truth Used

    • Non-invasive Lipolysis Study (C-17-TS13):
      • Ground Truth: Histological evaluation (biopsies examined by a board-certified dermatopathologist) for evidence of adipocyte necrosis and inflammatory response. This is a form of pathology ground truth.
    • Circumferential Reduction Study (C-17-TS15):
      • Ground Truth: Quantitative physical measurements (circumferential measurements of the abdomen). This is a form of outcomes data.

    8. The Sample Size for the Training Set

    • The provided text describes clinical studies for validation, not the development of an AI algorithm with a distinct training set. Therefore, this information is not applicable in the context of this device and report.

    9. How the Ground Truth for the Training Set Was Established

    • As this is not an AI/algorithm-based device with a separate training set, this information is not applicable.
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