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510(k) Data Aggregation

    K Number
    K151179

    Validate with FDA (Live)

    Device Name
    ZELTIQ CoolSculpting System
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Date Cleared
    2015-09-22

    (141 days)

    Product Code
    OOK
    Regulation Number
    878.4340
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    DEN090002,K120023,K142491
    Predicate For
    K160259
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CoolSculpting System is a skin cooling or heating device is indicated for cold-assisted lipolysis (breakdown of fat) of the submental area, thigh, abdomen, and flank, or "love handles" in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the submental area, thigh, abdomen and flank.

    Cooling with the device may also be used to minimize pain and thermal injury during laser and dermatological treatments and act as a local anesthetic for procedures that induce minor local discomfort.

    The CoolSculpting System is also indicated for use to provide localized thermal therapy (hot or cold) to minimize pain post-trauma and post-surgery, and for temporary relief of minor aches, pains, and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm and for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.

    The ZELTIO Pretreatment Skin Wipe and Gel/Gelpad facilitate thermal contact of the device with a patient's skin by mitigating minor variances in device-to-skin contact.

    Device Description

    The CoolSculpting System is a portable thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The CoolSculpting System consists of a control unit, detachable vacuum and surface applicators, as well as supplies such as liners, gelpads, skin wipes, cycle cards, foam borders and securement system, and software which includes functions to collect patient data, monitor tissue during cooling and minimize the risk of damage to tissue.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Endpoint)Reported Device Performance (Result)
    Primary Safety Endpoint:The primary safety endpoint was met.
    Incidence of device- and/or procedure-related adverse events.No device- or procedure-related adverse events were categorized as serious adverse events (SAE) or unanticipated adverse device effects (UADE). Four device- and/or procedure-related adverse events reported: 2 incidents of prolonged erythema, 1 incident of hyperpigmentation, and 1 incident of subject report of fullness sensation in back of throat due to swelling. All adverse events resolved by the final follow-up at 12 weeks post-final treatment. Anticipated and transient side-effects (erythema, edema, numbness) observed, all resolved over the course of the study.
    Primary Efficacy Endpoint:The primary efficacy endpoint was met.
    Correct identification of pre-treatment vs. 12-week post-final treatment images for discernible fat layer reduction by 3 blinded independent reviewers. (Pre-established 80% criterion for success)Overall correct identification rate by the 3 reviewers was 91% for the per-protocol population (n=58).
    Secondary Efficacy Endpoint:
    Reduction in fat layer thickness as measured by ultrasound at 12 weeks post-final treatment.Statistically significant (p<0.0001) reduction of 0.20 cm (analyzed on 57 subjects).
    Subject satisfaction as assessed by a questionnaire administered at 12 weeks post-final treatment.83% of subjects were satisfied with the treatment. 80% reported they would recommend the treatment to a friend.

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

    • Test Set Sample Size:

      • Safety analysis: 60 subjects initially enrolled (60 initial treatments). 59 subjects re-treated.
      • Primary photographic efficacy endpoint analysis (per-protocol): 58 subjects.
      • Secondary ultrasound efficacy endpoint analysis (per-protocol): 57 subjects.
      • Subject satisfaction questionnaire: Not explicitly stated the denominator for the 83% and 80% figures, but it implies the subjects enrolled in the study.

    • Data Provenance:

      • Type: Prospective, multi-center, open-label, non-randomized, interventional cohort study.
      • Country of Origin: Not explicitly stated, but the FDA approval under IDE G140083 and IRB approval suggest it was conducted within the US or under US regulatory oversight.

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

    • Number of Experts: 3 blinded independent reviewers.
    • Qualifications of Experts: Not specified in the provided text.

    4. Adjudication Method for the Test Set

    • The text describes the primary efficacy endpoint as "correct identification of pre-treatment vs. 12-week post-final treatment images by 3 blinded independent reviewers." It states the "overall correct identification rate by the 3 reviewers was 91%". This implies a consensus or majority vote approach, but the exact adjudication method (e.g., 2 out of 3, or if individual reviewer scores were aggregated) is not explicitly detailed beyond "overall correct identification rate."

    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

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI assistance was not done.
      • This study evaluates a medical device (CoolSculpting System) for fat reduction, not an AI or imaging diagnostic tool. The "blinded independent reviewers" were assessing photographic changes, not analyzing images with or without AI assistance.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • No, a standalone (algorithm-only) performance study was not done, as this is a physical medical device for treatment, not an algorithm.

    7. The Type of Ground Truth Used

    • For Primary Efficacy (Photographic Assessment): Expert consensus from 3 blinded independent reviewers comparing pre- and post-treatment photographs for discernible fat layer reduction.
    • For Secondary Efficacy (Ultrasound Measurement): Objective measurement of fat layer thickness (in cm) by ultrasound.
    • For Secondary Efficacy (Subject Satisfaction): Self-reported subject satisfaction via a questionnaire.

    8. The Sample Size for the Training Set

    • Not applicable. This is a study for a physical medical device, not a machine learning algorithm requiring a separate training set. The study described is a clinical trial to demonstrate efficacy and safety.

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

    • Not applicable, as there is no training set mentioned in the context of an AI/ML model for this device.
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