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510(k) Data Aggregation

    K Number
    K143559
    Device Name
    XP1000 RF
    Manufacturer
    BTL INDUSTRIES, INC
    Date Cleared
    2015-06-11

    (177 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K120510
    Why did this record match?
    Device Name :

    XP1000 RF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The XP1000 RF device is indicated for temporary reduction in circumference of the abdomen.

    The XP1000 RF is indicated for temporary reduction in circumference of the abdomen.

    Device Description

    The XP1000 RF system is designed for temporary reduction in circumference of the abdomen by means of high-frequency electromagnetic field. The multi-jointed arm firmly supports the applicator during treatment. Large knobs lock and unlock the joints to make positioning the applicators to the patient quick, easy and secure. The control unit consists of the control system and the electronic system. The control system contains the main microcomputer and software for control of the entire equipment; the electronic system contains the complete electromagnetic field generation. Easy-to-use color touch screen allows for maximum operator comfort. A large control knob is provided to increase and decrease output power. The XP1000 RF system is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office. The XP1000 RF consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, user interface with 8.4" color touch screen, applicator on a multi-jointed arm.

    AI/ML Overview

    The document describes the XP1000 RF device, which is an electrosurgical cutting and coagulation device and accessories indicated for the temporary reduction of abdominal circumference.

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

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Primary Efficacy Outcome Measure)Reported Device Performance (XP1000 RF Treatment Group)
    ≥3 cm waist circumferential reduction in more than 80% of subjects.Achieved ≥3 cm waist circumferential reduction in more than 80% of subjects.
    Mean circumferential reduction of XP1000 RF Treatment Group ≥1 cm than the mean circumferential reduction of the Placebo Group at the 30-day Follow Up evaluation point.The mean circumferential reduction was ≥1 cm than the mean circumferential reduction of the Placebo Group at the 30-day Follow Up evaluation point.
    Acceptance Criteria (Secondary Objective - Safety)Reported Device Performance
    Absence of adverse events (AE) associated with the treatment procedure.No adverse events were recorded.

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

    • Sample Size (Test Set): 60 subjects (40 in the XP1000 RF Treatment Group and 20 in the Sham/Placebo Group). All but one subject completed the study.
    • Data Provenance: The document does not specify the country of origin of the data. The study was a "double-blinded study," indicating it was a prospective clinical trial.

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

    The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for assessing the waist circumference measurements. However, in clinical trials involving objective measurements like waist circumference, the "ground truth" is typically established by trained clinical staff following a standardized measurement protocol rather than a panel of experts. The data appears to be quantitative measurements.

    4. Adjudication Method for the Test Set:

    The document does not specify an adjudication method like 2+1 or 3+1. Given that the primary outcome is a quantitative measurement (waist circumference reduction) and it was a double-blinded study, it's highly probable that measurements were taken by trained personnel, and statistical analysis was used to compare the groups. Adjudication methods are more commonly used for subjective assessments.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

    No, an MRMC comparative effectiveness study was not done. The study described is a clinical trial comparing a treatment group to a placebo group in terms of an objective physical measurement (waist circumference reduction).

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

    This question is not applicable to the XP1000 RF device. The device is a physical medical device (electrosurgical cutting and coagulation device) that performs a physical intervention on a patient, not an AI algorithm. The study assesses the device's clinical efficacy in reducing abdominal circumference in human subjects.

    7. The Type of Ground Truth Used:

    The ground truth used was objective quantitative measurements of waist circumference. These measurements were taken at baseline and at 30-day and 90-day follow-up evaluations.

    8. The Sample Size for the Training Set:

    This question is not applicable. The XP1000 RF is a physical medical device, not an AI algorithm that requires a training set in the typical sense of machine learning. The clinical study described is for validating the device's effectiveness and safety, not for training a model.

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

    This question is not applicable for the reasons stated in point 8.

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