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510(k) Data Aggregation

    K Number
    K213452
    Device Name
    GEMS-H
    Manufacturer
    Samsung Electronics Co., Ltd.
    Date Cleared
    2022-04-21

    (177 days)

    Product Code
    PHL
    Regulation Number
    890.3480
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K181294
    Why did this record match?
    Device Name :

    GEMS-H

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

    The GEMS-H is a robotic exoskeleton that fits orthotically on the wearer's waist and thighs, outside of clothing. The device is intended to help assist ambulatory function in rehabilitations under the supervision of a trained healthcare professional for the following population:

    · Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4 m/s and are able to walk at least 10 meters with assistance from a maximum of one person.

    The trained healthcare professional must successfully complete a training program prior to use of the device. The device is not intended for sports.

    Device Description

    The GEMS-H is a lightweight, robotic exoskeleton designed to help assist ambulatory function of stroke patients who meet the assessment criteria, in rehabilitations under the supervision of a trained healthcare professional. The GEMS-H device provides assistance to the patient during hip flexion and extension.

    The device is worn over clothing around the wearer's waist and fastened with Velcro straps to assists hip flexion and extension. The device weighs 4.7 lbs (2.1 kg) and has two motors that run on a single rechargeable battery. The device is equipped with joint angle and electrical current sensors to monitor hip joint angle and torque output, respectively.

    The assist torque is transmitted to the wearer's thighs via thigh support frames. A trained healthcare professional, who operates the device, can change assist settings through software that runs on the tablet PC.

    AI/ML Overview

    This document describes the premarket notification (510(k)) for the Samsung GEMS-H, a powered lower extremity exoskeleton. The information provided primarily focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria related to an AI's performance.

    Based on the provided text, the device itself (GEMS-H exoskeleton) is the subject of the regulatory review, and the "study" described is a clinical trial to assess its safety and effectiveness in assisting ambulatory function in stroke patients. There is no mention of an AI component requiring specific performance acceptance criteria for an algorithm or model.

    Therefore, many of the requested points regarding AI acceptance criteria, ground truth establishment, expert adjudication, and MRMC studies are not applicable directly to this document's content, as it's not about an AI-powered diagnostic or predictive device.

    However, I can extract information related to the device's clinical performance and the study design:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the device are defined in terms of safety and effectiveness, based on a clinical trial.

    Acceptance Criteria CategorySpecific Criteria/EndpointReported Device Performance
    Safety (Primary Endpoint)Adverse Events (AEs)34 AEs reported for an overall AE rate of 4.6% across 738 training sessions.
    Device-related AEs6 AEs possibly device-related (0.8%). No AEs determined to be probably or definitely device-related.
    Effectiveness (Primary Endpoint)Improvement in self-selected gait speed (10-Meter Walk Test without device)Group mean change from baseline to post-training was +0.12 m/s (p
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