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510(k) Data Aggregation

    K Number
    K223110
    Device Name
    truSculpt iD
    Manufacturer
    Cutera Inc.
    Date Cleared
    2022-11-03

    (31 days)

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

    The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as relief of pain and muscle spasms and increase in local circulation.

    Additionally, the 2MHz setting for the 40 cm2 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 iD device consists of a console, one or more RF handpieces that connect to the console with umbilical cables, 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

    The provided text describes a 510(k) premarket notification for the truSculpt iD device, which includes a new 2 cm² RF applicator. The focus of the performance data is on demonstrating the safety and effectiveness of this new applicator for therapeutic heating.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Maintain therapeutic temperatures on the skin surface with the 2 cm² RF applicatorThe 2 cm² RF applicator maintained therapeutic temperatures of 40°-45°C on the skin surface.
    Maximum skin temperatures do not exceed 45°C during treatment with the 2 cm² RF applicatorMaximum skin temperatures did not exceed 45°C during the course of the treatment with the 2 cm² RF applicator.

    2. Sample size used for the test set and the data provenance

    • Sample Size: 3 human subjects.
    • Data Provenance: The study was conducted on human subjects, implying a prospective study. The country of origin is not specified in the provided text.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    The document does not mention the use of experts to establish ground truth for the skin temperature testing. The criteria for therapeutic temperature (40°-45°C) and maximum safe temperature (45°C) are established medical knowledge for this type of device. The test appears to directly measure these physical parameters.

    4. Adjudication method for the test set

    Not applicable. The study involved direct measurement of skin temperature, not subjective evaluations requiring adjudication.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic or imaging device that would typically involve human readers.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

    Not applicable. This is a physical device that performs a therapeutic action, not a software algorithm. The "performance data" refers to the device's physical interaction with human tissue.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    The ground truth for this specific performance testing is objective physiological measurements: skin temperature values. The criteria (40°-45°C therapeutic, ≤45°C maximum) are based on established safety and efficacy thresholds for therapeutic heating devices.

    8. The sample size for the training set

    Not applicable. This is not a machine learning or AI device that requires a training set. The performance testing is a direct validation of the device's physical characteristics.

    9. How the ground truth for the training set was established

    Not applicable as there is no training set mentioned or implied for this device.

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