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510(k) Data Aggregation

    K Number
    K020429
    Device Name
    AB BELT PRO
    Manufacturer
    THE DEZAC GROUP
    Date Cleared
    2002-09-13

    (217 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K983964,K010335
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ab Belt Pro device is indicated for use for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for developing a firmer abdomen.

    Device Description

    The Ab Belt Pro is a single channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles for the purposes of improving abdominal muscle tone, strengthening the abdominal muscles and developing a firmer abdomen. It comprises an electronic stimulation controller module which generates the required electrical stimulation signals and an abdominally worn electrode belt which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called the Ab Belt Pro, a powered muscle stimulator. The purpose of this notification is to demonstrate that the Ab Belt Pro is substantially equivalent to a legally marketed predicate device, the Slendertone™ Flex (K010335).

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

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not contain a table of acceptance criteria or reported device performance in the way typically expected for a detailed clinical or performance study. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

    The "acceptance criteria" here are implied by the criteria for substantial equivalence to the predicate device:

    Acceptance Criteria (Implied)Reported Device Performance (Ab Belt Pro)
    Same indications for use as predicate device"The Ab Belt Pro device has the same indications for use as the predicate device." (Indications listed as: improvement of abdominal muscle tone, strengthening of abdominal muscles, developing a firmer abdomen.)
    Equivalent technological characteristics and instructions for use as predicate device"The Ab Belt Pro device has equivalent technological characteristics and instructions for use, as compared to the predicate device."
    Meets mandatory performance standard identified in 21 CFR 898"The device meets the mandatory performance standard identified in 21 CFR 898."
    Biocompatibility of electrodes established"The biocompatibility of the electrodes has been established."
    Conductive gel is legally-marketed"The conductive gel is a legally-marketed gel cleared through 510(k) number K983964."

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

    Not applicable. This document is a 510(k) submission focused on substantial equivalence, not a clinical trial report with a test set of patients. There is no mention of a test set, sample size, or data provenance from a prospective or retrospective study on human subjects for the Ab Belt Pro's performance in achieving its indicated uses. The testing mentioned refers to technical compliance and biocompatibility.

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

    Not applicable. As there is no clinical test set described, there are no experts used to establish ground truth for a test set in the context of device efficacy. The "experts" involved would be those performing testing for technical standards compliance or biocompatibility, but these are not clinical experts establishing ground truth for treatment outcomes.

    4. Adjudication method for the test set

    Not applicable. No clinical test set or efficacy study on human subjects is described, so no adjudication method is mentioned.

    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 a muscle stimulator, not an AI-powered diagnostic or imaging interpretation tool. Therefore, an MRMC study related to readers and AI assistance is not relevant or described.

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

    Not applicable. This device is a physical muscle stimulator and does not involve algorithms in the context of diagnostic or interpretive performance.

    7. The type of ground truth used

    For the purpose of substantial equivalence, the "ground truth" implicitly refers to:

    • The established regulatory requirements and standards (e.g., 21 CFR 898).
    • The characteristics and established safety/efficacy profile of the predicate device (Slendertone™ Flex: K010335).
    • Biocompatibility standards and prior clearance of the conductive gel.

    There is no mention of ground truth established through expert consensus on muscle toning, pathology results, or patient outcomes data for the Ab Belt Pro itself to demonstrate its effectiveness in the 510(k) application. This is because 510(k) focuses on equivalence, not de novo demonstration of safety and efficacy.

    8. The sample size for the training set

    Not applicable. As this is not an AI/ML device, there is no concept of a "training set" in the context of an algorithm.

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

    Not applicable. See point 8.

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