(177 days)
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.
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.
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 Category | Specific Criteria/Endpoint | Reported 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 AEs | 6 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<0.0001). (Implicitly, the objective was ≥0.14 m/s improvement) |
| Effectiveness (Exploratory Endpoint - with device assistance) | Improvement in self-selected gait speed (10-Meter Walk Test with device) | Group mean change from baseline to post-training was +0.16 m/s (p<0.0001). |
| Improvement in walking endurance (6-Minute Walk Test with device) | Group mean change from baseline to post-training was +53.28 m (p<0.0001). |
Note: The primary effectiveness endpoint reported (+0.12 m/s) did not explicitly meet the stated objective of "≥0.14 m/s". However, the FDA's clearance indicates that the overall evidence was sufficient for substantial equivalence. The document highlights that the exploratory endpoints showed larger improvements with the device, and that the "study subjects achieved a mean clinically significant improvement (MCID) in gait speed as measured by the 10MWT, and in walking endurance as measured by the 6MWT."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The clinical study enrolled 53 subjects, of whom 41 completed the entire protocol. This effectively serves as the "test set" for the device's performance.
- Data Provenance: The study was conducted in the United States (Shirley Ryan AbilityLab, Northwestern University, Chicago, IL). It was a prospective, single arm, interventional, open-label, single center study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this device. The "ground truth" for the device's performance is objective physiological measurements (gait speed, walking endurance) and adverse event reporting, observed by medical professionals (licensed physical therapists and physicians) during rehabilitation sessions. It's not a diagnostic AI where experts label images or data for truth.
4. Adjudication Method for the Test Set
Not applicable. This is not an imaging or diagnostic study requiring adjudication of expert interpretations.
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 exoskeleton for physical assistance, not an AI for human reader enhancement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device itself performs its function (providing mechanical assistance), and its performance is evaluated with human-in-the-loop (the patient wearing it and being supervised by a healthcare professional). The document states the device is intended to assist ambulatory function "under the supervision of a trained healthcare professional." There is no "standalone algorithm" performance to report in this context.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance was based on:
- Objective functional mobility measures: 10-Meter Walk Test (10MWT) for gait speed and 6-Minute Walk Test (6MWT) for walking endurance. These are standardized, objective measures of physical performance.
- Adverse Event reporting: Clinical observation and documentation of any adverse events during the study.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI model requiring a training set in the typical sense. The clinical study of 41 subjects who completed the protocol served as the primary evidence.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as #8. The data collected from the 41 patients in the clinical study are the direct evidence of the device's performance in a real-world (rehabilitation) setting.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
April 21, 2022
Samsung Electronics Co., Ltd. % Kyoungju Kim Consultant MDLab Inc. Room 804, 161-17 Magokjungang-ro, Gangseo-gu, Seoul South Korea, 07788
Re: K213452
Trade/Device Name: GEMS-H Regulation Number: 21 CFR 890.3480 Regulation Name: Powered lower extremity exoskeleton Regulatory Class: Class II Product Code: PHL Dated: March 23, 2022 Received: March 24, 2022
Dear Kyoungju Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
Device Name GEMS-H
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✔ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Samsung Electronics Co., Ltd.
510(k) Summary
Submitter
Samsung Electronics Co., Ltd. Minhyung Lee, Ph.D. 129, Samsung-Ro, Yeongtong-Gu, Suwon-Si, Gyeonggido, 16677 South Korea Email: mhyung.lee@samsung.com Phone: +82-2-6147-3805 Fax: +82-2-6147-7980
Official Correspondent
MDLab Inc. Kyoungju Kim, Consultant. Room 804, 161-17, Magokjungang-ro, Gangseo-gu, Seoul South Korea. 07788 Email: kj.kim@mdlab.co.kr Phone: +82-10-2264-5341 Fax: 82-2-3664-0830
Device Information
- Trade Name: GEMS-H ●
- Common Name: Powered exoskeleton
- Classification Name: Powered lower extremity exoskeleton
- Product Code: PHL
- Panel: Neurology
- Regulation Number: 21 C.F.R. § 890.3480
- Device Class: Class II ●
- Date prepared: 04/11/2022 ●
Predicate Device
K181294, Honda Walking Assist Device (by Honda Motor Company, Ltd.)
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.
{4}------------------------------------------------
Indications for 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 rehabilitation institutions 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.
Substantial Equivalence Comparison
The subject and predicate device (K181294) have the same intended use, and nearly identical indications for use, and are similar in design, technology, functions, and principle of operation.
Both devices are intended to help assist ambulatory function in 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. Both are worn around the wearer's waist and thighs and assist with hip joint flexion and extension. They also have two motors that run on a single pack of rechargeable batteries. They are equipped with angle and current sensors to monitor hip joint angle and torque output respectively. Both devices provide an assistive torque that is transmitted to the wearer's thighs via thigh frames. Both devices can change assist settings through software that runs on a touchscreen tablet device.
The differences in technological characteristics between the subject and predicate are as follows:
- . Range of Motion: The GEMS-H has a smaller range of motion than predicate device. Since the GEMS-H's range of motion falls within the predicate's range, this difference does not raise different safety or effectiveness questions.
- Device Weight: The GEMS-H weighs less than the predicate due to its design. The difference in weight does not raise different questions of safety or effectiveness.
- Battery Specification: The GEMS-H can be operated from a minimum of 1 hour to a maximum of . 2 hours, while the predicate device only allows 1 hour of continuous operation. This difference does not raise different questions of safety or effectiveness.
- . Actuator specifications: The maximum torque of the GEMS-H is larger than that of the predicate. However, even though the motors of the GEMS-H are capable of producing a maximum of 12 Nm± 15%, the maximum torque will not be reached in all cases and for all patients. The trained physical therapist can monitor the torque in real time and change the setting on the tablet PC to control the generated maximum torque. In addition, any potential risk associated with the higher maximum torque is mitigated through the exclusion criteria that exclude patients with severe osteoporosis (as determined by a physician) from study participation. Likewise, the proposed labeling contains a contraindication for patients with heterotopic ossification or severe osteoporosis. As a result, this difference in maximum torque does not raise different questions of safety or effectiveness.
{5}------------------------------------------------
Samsung Electronics Co., Ltd.
The following table summarizes the similarities and differences between the subject and predicate devices.
| Subject Device | Primary Predicate Device | Differences/Similarity | |
|---|---|---|---|
| FDA 510(k) No. | K213452 | K181294 | |
| Company | Samsung Electronics Co., Ltd. | Honda Motor Company | |
| Trade/DeviceName | GEMS-H | Honda Walking Assist Device | |
| Regulation No. | 21 CFR 890.3480 | 21 CFR 890.3480 | Identical |
| Regulation Name | Powered exoskeleton | Powered exoskeleton | Identical |
| Regulatory Class | Class 2 | Class 2 | Identical |
| Product Code | PHL | PHL | Identical |
| Indication for use | The GEMS-H is a robotic exoskeleton that fitsorthotically on the wearer's waist and thighs,outside of clothing. The device is intended tohelp assist ambulatory function inrehabilitation institutions under thesupervision of a trained healthcareprofessional for the following population:· Individuals with stroke who have gait deficitsand exhibit gait speeds of at least 0.4 m/s andare able to walk at least 10 meters withassistance from a maximum of one person.The trained healthcare professional mustsuccessfully complete a training program priorto use of the device. The device is not intendedfor sports. | The Honda Walking Assist Device is a roboticexoskeleton that fits orthotically on the user'swaist and thigh, outside of clothing. The deviceis intended to help assist ambulatory functionin rehabilitation institutes under thesupervision of a trained healthcare professionalfor the following population:• Individuals with stroke who have gaitdeficits and exhibit gait speeds of at least 0.4m/s and are able to walk at least 10 meterswith assistance from a maximum of oneperson.The trained healthcare professional mustsuccessfully complete a training program priorto use of the device. The devices are notintended for sports. | Identical |
| Body coverage | Worn around the waist & thighs | Worn around the waist & thighs | Identical |
| Mobility aid | Optional (e.g., walker, cane, harness) | Optional (e.g., walker, cane) | Similar |
| Device limit onpatient's gait speed | None | None | Identical |
| Type of Surface fortraining | Smooth, cement, carpet | Smooth, cement, carpet | Identical |
| Subject Device | Primary Predicate Device | Differences/Similarity | |
| Height of Patient | 61 in to 75 in (1.55 m to 1.91 m) | 55 in to ~79 in (1.4 m to 2.0 m) | Similar |
| Weight of Patient | 99 lbs (45 kg) up to 220 lbs (100 kg) and BMI< 35 kg/ m² | <220 lbs (100 kg) | Similar |
| Control Method | Handheld interface to allow physical therapistto control and operate the device remotely | Handheld interface for physical therapist | Identical |
| Device Range ofMotion | Hip: 100° flexion to 40° extension | Hips: 113° flexion to 47° extension | Different. The subject device has a smallermotion range than the predicate device. Thisdifference does not raise different safety oreffectiveness questions. |
| Device Weight | 4.7 lbs (2.1 kg) | 5.95 lbs (2.7 kg) | Similar. The GEMS-H weighs less than thepredicate device; the difference in weight doesnot raise different questions of safety oreffectiveness. |
| Batteryspecifications | • Rechargeable lithium ion.• 21.6V, 2,950 mAh,• 2 hr charge time• Minimum 2 Hr. of continuous walking* (withgain = 7, delay = 0.25 s)• Minimum 1 Hr. of continuous walking* (withgain = 8, delay = 0.25 s)* at a walking speed of about 1.9 ~ 2.5 MPH(0.8 ~ 1.1 m/s) | • Rechargeable lithium ion,• 22.2 V, 1 A-h,• 2 hr charge time• 1 hr continuous operation | Similar.The GEMS-H can be operated from aminimum of 1 hour to a maximum of 2 hours,while the predicate device only allows 1 hourof continuous operation. This difference doesnot raise different questions of safety oreffectiveness. |
| ActuatorSpecifications | 2 motors (2 at hip)12 Nm ± 15% max torque | 2 motors (2 at hip)4 Nm max torque | Different.The maximum torque of the GEMS-H is largerthan that of the predicate. However, eventhough the motors of the GEMS-H are capableof producing a maximum of 12 Nm± 15%, thisis the maximum allowable torque and is notrecommended for all patients under all trainingconditions. Rather, the trained physicaltherapist shall monitor the torque in real timeand change the setting on the tablet PC to |
| Subject Device | Primary Predicate Device | Differences/Similarity | |
| control the generated maximum torque. Inaddition, any potential risk associated with thehigher maximum torque is mitigated throughthe exclusion criteria that exclude patients withsevere osteoporosis (as determined by aphysician) from study participation. Likewise,the proposed labeling contains acontraindication for patients with heterotopicossification or severe osteoporosis. As a result,this difference in maximum torque does notraise different questions of safety oreffectiveness. | |||
| Training Program | Yes | Yes | Identical |
| CertificationProgram | Yes | Yes | Identical |
| Feedback | Visual & auditory feedback on both thehandheld controller & device | Visual & auditory feedback on both thehandheld controller & device | Identical |
| Fall Detection andMitigation | None | None | Identical |
| Failsafe Feature | Motor torque disables; device becomespassive | Motor torque disables; device becomes passive | Identical |
| OperatingTemperature | 32°F to 86°F (0°C to 30°C) | 32 °F to 86 °F (0 °C to 30 °C) | Identical |
| Operating | 30% to 85% RH | 30% to 85% | Identical |
| Patient population | Individuals with stroke who have gait deficitsand exhibit gait speeds of at least 0.4 m/s andare able to walk at least 10 meters withassistance from a maximum of one person. | Individuals with stroke who have gait deficitsand exhibit gait speeds of at least 0.4 m/s andare able to walk at least 10 meters withassistance from a maximum of one person. | Identical |
{6}------------------------------------------------
Samsung Electronics Co., Ltd.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "SAMSUNG" in a bold, sans-serif font. The letters are all capitalized and are a dark blue color. The background is white, which makes the text stand out. The logo is simple and recognizable.
Samsung Electronics Co., Ltd.
{8}------------------------------------------------
Non-Clinical Testing
The subject device was tested to the following standards.
- Electrical safety testing according to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, ● C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- Electromagnetic compatibility (EMC) testing according to IEC 60601-1-2:2014
- Usability engineering test according to IEC 60601-1-6:2013
- Vibration testing and thermal shock testing
- Battery safety testing according to IEC 62133-2:2017 Edition 1.0
- Software Verification and validation testing according to IEC 62304:2015 ●
- . Radio frequency wireless technology according to the procedure given in FCC Rules Part 15 Subpart B and FCC Rules Part 15 Subpart C, 15.247
- ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
- Particulate resistance (IP20) according to IEC 60529:2013, Edition 2.2
- . Biocompatibility Testing such as In Vitro Cytotoxicity (ANSI AAMI ISO 10993-5:2009/(R)2014), Skin Sensitization (ANSI AAMI ISO 10993-10:2010/(R)2014) and Intracutaneous Reactivity (ANSI AAMI ISO 10993-10:2010/(R)2014)
- . Performance testing such as cyclic loading testing vibration testing, thermal shock testing, driving part durability testing, Velcro testing and worst-case frame testing
- Other Bench testing such as Safety according to the Range of Motion, Max. angular velocity, Max. Torque Test, Static Torque Tracking Performance, Providing Assistive Torque Test at DOC Walking Mode for Walking and Stopping, Generation of assistive torque patterns according to the change in option during DOC mode test, Continuous use time and Noise.
Clinical Testing
Samsung conducted a prospective, single arm, interventional, open-label, single center study with the GEMS-H in stroke patients. The study enrolled 53 subjects, of whom 41 completed the entire protocol. Each subject completed 18 indoor sessions of training with the GEMS-H in the outpatient clinic with a licensed physical therapist.
A summary of the clinical trial is provided below.
| Title | Safety and Effectiveness on Functional Mobility Following Samsung GaitEnhancing and Motivating System-Hip (GEMS-H) Device Training in Sub-Acuteand Chronic Stroke: A Pivotal Study | |
|---|---|---|
| Protocol Number | 00210372 | |
| Methodology | Prospective, single arm, interventional, longitudinal, open-label, single center | |
| Study Period | February 12, 2020 to July 27, 2021 | |
| Study Center(s) | Shirley Ryan AbilityLab, Northwestern University, Chicago, IL | |
| Objectives | The objective of this study was to assess safety and effectiveness of task-specificgait training in addition to balance and function mobility training in the strokepopulation while using the GEMS-H (developed by Samsung Electronics Co.,Ltd.) in assistance mode only. | |
| Endpoints | Primary endpoints1) Safety was evaluated in terms of adverse events (AEs). AEs were evaluatedat the time of their occurrence to determine severity and whether they weredevice-related.2) Effectiveness was evaluated in terms of improvement of ≥0.14 m/s in thegroup mean change in self-selected gait speed on the 10-meter walk test(10MWT) without the device, following 18 sessions of training using theGEMS-H device in assist mode, compared to baseline.Exploratory endpoints (main)1) Effect of walking without the GEMS-H at baseline to walking with the deviceat mid and post-training on gait speed using the 10MWT and measurement ofwalking endurance using the 6MWT. | |
| Number ofSubjects | 41 | |
| Diagnosis andMain InclusionCriteria | 1) ≥ 30-days post stroke2) Male and female adults, ages 18-85 years3) Initial gait speed of ≥ 0.4 m/s and ≤ 0.8 m/s4) Adequate cognitive function (Mini-Mental State Examination [MMSE] score >17)5) Ability to walk at least 10 m with maximum 1 person assist6) Physician approval for patient participation7) Able to safely fit into device specification and tolerate minimum assistance | |
| Study Product(s),Dose, Route,Regimen | GEMS-H | |
| Duration ofadministration | After baseline testing was completed, subjects began 18 training sessions with theGEMS-H in the outpatient clinic with a licensed physical therapist. The trainingsessions were customized for each individual subject. Each session included 30minutes of gait task specific training. And an additional 15 minutes is used to focuson patient-specific goals related to functional mobility and balance. If appropriate,the 15 minutes could also be used for additional gait training. Training sessions | |
| were conducted indoors only. Training sessions occurred 2-3 times a week for 6–8 weeks to complete the training protocol. | ||
| Environment ofuse | Outpatient clinic (Indoors) with smooth, cement, carpet surfaces, stairs, slopes lessthan 5 degrees, and treadmills. | |
| Statisticalmethods | 10MWT, 6MWT, Balance and functional mobility | |
| Primary endpoint | ||
| Safety: | ||
| Over the course of the study, 738 training sessions were completed by the 41–subjects (18 training sessions per study subject). Thirty-four AEs werereported for an overall AE rate of 4.6 %. | ||
| Six AEs were determined to be possibly device-related for a potential device––related AE rate of 0.8 %. No AEs were determined to be probably or definitelyrelated to the device. | ||
| Effectiveness: | ||
| The group mean change from baseline to post-training (after 18 sessions) for–self-selected gait speed (10 Meter Walk Test) measured without the devicewas +0.12 m/s (p<0.0001). | ||
| Exploratory endpoints (main) | ||
| Summaryconclusions | Effectiveness: | |
| The group mean change from baseline measured without the device to post–training (after 18 sessions) measured with the device for assessing mobilityassist (10 Meter Walk Test) was +0.16 m/s (p<0.0001). | ||
| The group mean change from baseline measured without the device to post–training (after 18 sessions) measured with the device for assessing mobilityassist (6 Minute Walk Test) was +53.28 m (p<0.0001). | ||
| ※ The exploratory endpoints evaluated ambulatory function in stroke patientswearing the device through assessing the group mean change in the 6MWT andthe 10MWT from baseline (without the device) to post-training (with thedevice). The study subjects achieved a mean clinically significant improvement(MCID) in gait speed as measured by the 10MWT, and in walking endurance asmeasured by the 6MWT. | ||
| The clinical study did not have a control arm to exclude placebo effect or tosupport a comparative claim relative to conventional rehabilitation treatment.Therefore, this device is not intended for functional improvement after stroke. | ||
| NCT number | NCT04285060 |
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
Samsung Electronics Co., Ltd.
The results from the clinical study support the use of the GEMS-H for use in stroke patients to help assist ambulatory function in rehabilitation institutions under the supervision of a trained physical therapist. The data also address the special controls in 21 CFR § 890.3480(b)(6) by assessing the level of supervision necessary and the appropriate use environment.
Training Program
The GEMS-H should be used only by trained healthcare professionals who have successfully completed a training program provided by Samsung Electronics.
The healthcare professional will be trained on the basic features of the GEMS-H, and the training is designed to enable the user to perform the following tasks:
- Properly set up the device ●
- Assemble the device in all available configurations
- Identify the safe environments for the device use
- . Operate the device in simulated use environments representative of indicated environments and use
- Screen, evaluate, and measure patients
- Properly fit the device to the patient
- Use the mobile application
- Understand and use the operating mode and its parameters appropriate for the patient ●
- Safety features during operation of the device ●
- Use the safety checklist ●
- . Perform physical checks
- Understand and use all safety features of the device ●
Conclusion
The GEMS-H has the same intended use as the predicate, and the technological differences do not raise different questions of safety or effectiveness. The non-clinical data submitted in the 510(k) demonstrate that the GEMS-H is at least as safe and effective as the Honda Walking Assist Device. Accordingly, the GEMS-H is substantially equivalent to the predicate.
§ 890.3480 Powered lower extremity exoskeleton.
(a)
Identification. A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) Design characteristics must ensure geometry and materials composition are consistent with intended use.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
(i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use;
(ii) Simulated use testing (
i.e., cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present;
(iv) The accuracy of device features and safeguards; and
(v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance.
(6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for:
(i) Level of supervision necessary, and
(ii) Environment of use (
e.g., indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments representative of indicated environments and use.
(8) Labeling for the Physician and User must include the following:
(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk.
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations;
(B) Instructions on fitting the patient;
(C) Instructions and explanations of all available programs and how to program the device;
(D) Instructions and explanation of all controls, input, and outputs;
(E) Instructions on all available modes or states of the device;
(F) Instructions on all safety features of the device; and
(G) Instructions for properly maintaining the device.
(iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness.
(iv) Pertinent non-clinical testing information (
e.g., EMC, battery longevity).(v) A detailed summary of the clinical testing including:
(A) Adverse events encountered under use conditions,
(B) Summary of study outcomes and endpoints, and
(C) Information pertinent to use of the device including the conditions under which the device was studied (
e.g., level of supervision or assistance, and environment of use (e.g., indoors and/or outdoors) including obstacles and terrain).