The Honda Walking Assist Device is a robotic exoskeleton that fits orthotically on the user's waist and thigh, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation institutes 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 0.4m/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 devices are not intended for sports.

Device Description

The Honda Walking Assist Device is a lightweight, robotic exoskeleton designed to help assist ambulatory function of stoke patients who meet the user assessment criteria, in rehabilitation institutes under the supervision of a trained healthcare professional. The device is worn around the user's waist and thighs, and assists with hip ioint flexion and extension. The device weighs 5.95lbs and has two motors that run on a single rechargeable battery. The device is equipped with angle and current sensors to monitor hip joint angle and torque output respectively. The assist torque is transmitted to the user's thighs via thigh frames. A trained healthcare professional, who operates the device, can change assist settings through software that runs on a mobile device.

AI/ML Overview

The provided text details the 510(k) premarket notification for the Honda Walking Assist Device, a robotic exoskeleton. This document primarily focuses on demonstrating substantial equivalence to a predicate device (Ekso Bionics® Ekso) rather than presenting a traditional acceptance criteria table with performance metrics for an AI medical device.

The study described is a clinical effectiveness study of the device itself, not a study proving an AI algorithm meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity). Therefore, the direct answers to some of your prompt's questions related to AI-specific evaluation (like ground truth establishment for AI training/test sets, MRMC studies, or standalone algorithm performance) are not explicitly present in the provided text, as this is a physical medical device clearance, not an AI algorithm clearance.

However, I can extract the relevant information from the document regarding the clinical study and the device's performance that supports its clearance.

Device: Honda Walking Assist Device

Acceptance Criteria and Reported Device Performance

As this is a physical medical device clearance and not an AI algorithm, specific "acceptance criteria" for metrics like sensitivity, specificity, or AUC as one would expect for an AI diagnostic device are not detailed. Instead, the "acceptance" hinges on demonstrating safety and effectiveness comparable to a predicate device, and improvement in a clinical outcome.

The primary endpoint for demonstrating effectiveness was the change in 10 Meter Walk Test (MWT) Self-selected Velocity (SSV) from baseline in gait speed.

Metric	Acceptance Criteria (Implied by Predicate Equivalence & Clinical Study Objective)	Reported Device Performance (Honda Walking Assist Group)
Primary Endpoint: Change in 10 Meter Walk Test, Self-selected Velocity (cm/s) from Baseline	Demonstrate improvement in gait speed.	Baseline: 69.91 (SD 3.03) cm/s
		Change from Baseline:
		* Mid (after 9 sessions): +8.87 (SD 2.59) cm/s
		* Post (after 18 sessions): +17.41 (SD 2.23) cm/s
		* 3 Month Follow Up: +19.16 (SD 4.37) cm/s
Safety	No significant adverse events.	No falls or significant adverse events were reported.

Study Details:

Sample size used for the test set and the data provenance:
- Test Set (Clinical Study): 50 participants total.
  - Honda Walking Assist (HWA) Group: 25 participants
  - Functional Task Specific Training (FTST) (Control) Group: 25 participants
- Data Provenance: The study was conducted at The Shirley Ryan AbilityLab (Chicago, Illinois, USA). It was a randomized controlled trial. The data appears to be prospective as it describes a clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a clinical effectiveness study of a physical device, not an AI algorithm evaluating medical images or data where "ground truth" is established by experts in the diagnostic sense.
- The "ground truth" for assessing device effectiveness is the objective measurement of gait speed using the 10 Meter Walk Test (MWT) Self-selected Velocity (SSV), which is a standard clinical assessment. The study was conducted "under the supervision of a trained healthcare professional." While not explicitly stated how many conducted the MWT measurements, it would be standard practice for trained healthcare professionals (e.g., physical therapists) to perform these assessments. The document emphasizes that "The trained healthcare professional must successfully complete a training program prior to use of the device" and that the study was conducted "under clinical supervision."
Adjudication method for the test set:
- Not applicable in the context of this study. The primary endpoint (gait speed) is an objective measurement rather than a subjective assessment requiring adjudication.
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, an MRMC study was not done. This study evaluated the direct impact of the robotic exoskeleton on patient gait, not the performance of an AI algorithm assisting human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this question is not applicable. The device itself (exoskeleton) operates with a human in the loop (the patient wearing it, supervised by a healthcare professional). The document describes software on a mobile device used by the healthcare professional to change assist settings, but this isn't presented as an AI algorithm with standalone diagnostic performance.
The type of ground truth used:
- The "ground truth" for evaluating the device's effectiveness was objective clinical measurement outcomes, specifically the change in 10 Meter Walk Test, Self-selected Velocity (SSV). Safety was assessed by monitoring and reporting adverse events, including falls.
The sample size for the training set:
- This question typically refers to the dataset used to train an AI algorithm. The provided text does not mention a separate "training set" in the context of an AI algorithm.
- For the device's clinical validation, the "training" refers to the intervention itself:
  - 18 total training sessions for both groups (HWA and FTST).
  - Each session was 45 minutes, 3 sessions/week, over 6-8 weeks.
How the ground truth for the training set was established:
- Not applicable as there is no AI algorithm training set described. The "training" for the device involved patients undergoing gait and stair training exercises facilitated by the device. Effectiveness was measured by the change in the 10 Meter Walk Test, as described above.

Summary

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December 14, 2018

Honda Motor Company, Ltd. % Mark DiPietro Assistant Vice President, Power Equipment Division American Honda Motor Company, Inc. 4900 Marconi Drive Alpharetta, Georgia 30005

Re: K181294

Trade/Device Name: Honda Walking Assist Device Regulation Number: 21 CFR 890.3480 Regulation Name: Powered lower extremity exoskeleton Regulatory Class: Class II Product Code: PHL Dated: November 16, 2018 Received: November 16, 2018

Dear Mark DiPietro:

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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181294

Device Name

Honda Walking Assist Device

Indications for Use (Describe)

The Honda Walking Assist Device is a robotic exoskeleton that fits orthotically on the user's waist and thigh, outside of clothing. The device is intended to help assist ambulatory function institutes 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 0.4m/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 devices are 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)

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Image /page/3/Picture/0 description: The image shows the word "HONDA" in all capital letters. The text is a bold, sans-serif font and is colored red. The background is white, providing a strong contrast that makes the word easily visible.

510(k) Summary

Administrative Information

Device Name	Honda Walking Assist Device
	Company:	Honda Motor Company, Ltd.1-4-1, Chuo, Wako-shiSaitama, 351-0193Japan
ApplicantInformation	Contact:	Kazushi Hamaya
	Title:	Department Manager
	Email:	Kazushi_hamaya@hm.honda.co.jp
	Phone Number:	+81 80 4900-4527
CorrespondentInformation	Company:	American Honda Motor Company, Inc.4900 Marconi DriveAlpharetta, Georgia 30005United States of America
	Contact:	Mark DiPietro
	Title:	Assistant Vice President
	Email:	Mark_DiPietro@ahm.honda.com
	Phone Number:	+1 (678) 339-2623
PreparationDate	December 11, 2018
DeviceClassification	Trade Name:	Honda Walking Assist Device
	CommonName:	Exoskeleton
	ClassificationName:	Powered Lower ExtremityExoskeleton
	Product Code:	PHL
	Device Class:	Class II
	Regulation:	21 CFR 890.3480

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Device Description

Indications for Use

Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4m/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 devices are not intended for sports.

Comparison of Technological Characteristics to the Predicate

PredicateDevice	Manufacturer	Device Name	510(k)Number
Ekso Bionics®, Inc.	Ekso™ (Version 1.1) &Ekso GT™ (Version 1.2)	K161443

For simplicity, we will refer to the Ekso™ (Version 1.1) and Ekso GT™ (Version 1.2) devices as "Ekso." The table below highlights comparisons between the Honda Walking Assist Device and the predicate device, Ekso. These comparisons consider device intended use, indications for use, operating procedures and technological characteristics. Although there are some key differences between Ekso and the Honda

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Walking Assist Device, these differences do not raise different questions of safety or effectiveness.

CATEGORY	HONDA WALKINGASSIST DEVICE(HWA)	EKSO BIONICS®,INC. - EKSO	Substantial EquivalenceComments
510(k) Number	K181294	K161443	N/A
Product Code	PHL	PHL	[SAME]
Sub-Product Code	N/A	N/A	[SAME]
Regulation Name	Powered LowerExtremity Exoskeleton	Powered LowerExtremity Exoskeleton	[SAME]
Device Class	Class II	Class II	[SAME]
Regulation	21 CFR 890.3480	21 CFR 890.3480	[SAME]
Indications forUse	The Honda WalkingAssist Device is a roboticexoskeleton that fitsorthotically on the user'swaist and thigh, outsideof clothing. The device isintended to help assistambulatory function inrehabilitation institutesunder the supervision of atrained healthcareprofessional for thefollowing population:• Individuals with strokewho have gait deficitsand exhibit gaitspeeds of at least0.4m/s and are able towalk at least 10meters with assistancefrom a maximum ofone person.The trained healthcareprofessional mustsuccessfully complete atraining program prior touse of the device. Thedevices are not intendedfor sports.	The Ekso™ is intendedto perform ambulatoryfunctions in rehabilitationinstitutions under thesupervision of a trainedphysical therapist for thefollowing population:• Individuals withhemiplegia due tostroke (upperextremity motorfunction of at least4/5 in at least onearm)• Individuals withspinal cord injuries atlevels T4 to L5(upper extremitymotor function of atleast 4/5 in botharms)• Individuals withspinal cord injuries atlevels of C7 to T3(ASIA D with upperextremity motorfunction of at least4/5 in both arms)The therapist mustcomplete a trainingprogram prior to use ofthe device. The devicesare not intended forsports or stair climbing.	[SIMILAR]• HWA may be used during stairtraining in rehabilitationinstitutes under the supervisionof a therapist who is withinphysical reach of device users,consistent with the userassessment and trainingcertification program. Patientswho require more than minimalcontact by the therapist shouldnot use the device. HWA stairtraining was performed duringclinical testing, during which nofalls or serious adverse eventswere reported• HWA is not intended forindividuals with spinal cordinjuries• HWA users must beambulatory• The above factors do not raisedifferent questions of safetyand effectiveness since theHWA risk profile is notsubstantially different.
Device Weight	5.95 lbs (2.7 kg)	50 lbs (23 kg)	[DIFFERENT]
CATEGORY	HONDA WALKINGASSIST DEVICE(HWA)	EKSO BIONICS®,INC. - EKSO	Substantial EquivalenceComments
			• Lighter HWA weight does notraise different questions ofsafety and effectiveness
Body Coverage	Worn around the waist &thighs	Worn over legs & upperbody with rigid torso	[SIMILAR]• HWA is not worn above thewaist or below the knees• HWA users can wear bracing(e.g. an Ankle-Foot Orthosis)• Reduced HWA body coverageor the use of supplementarybracing does not raise differentquestions of safety andeffectiveness
Mobility Aid	Optional (e.g., walker,cane)	Walker, crutches, cane	[DIFFERENT]• HWA does not require amobility aid• The absence of a mobility aidwith HWA does not raisedifferent questions of safetyand effectiveness. The HWA isindicated for ambulatoryindividuals and intended to beused with a trained healthcareprofessional in a rehabilitationinstitute.
Patient Population	• Individuals with strokewho have gait deficitsand exhibit gait speedsof at least 0.4m/s andare able to walk atleast 10 meters withassistance from amaximum of oneperson.	• Individuals withhemiplegia due tostroke (upperextremity motorfunction of at least 4/5in at least one arm)• Individuals with spinalcord injuries at levelsT4 to L5 (upperextremity motorfunction of at least 4/5in both arms)• Individuals with spinalcord injuries at levelsof C7 to T3 (ASIA Dwith upper extremitymotor function of atleast 4/5 in botharms)	[DIFFERENT]• HWA users must beambulatory• HWA is only for stroke patients• Differences were addressed inthe clinical study and do notraise different questions ofsafety and effectiveness
Device limit onuser's gait speed	None	~2 km/hr	[DIFFERENT]• HWA does not limit gait speed• The above factor does notraise different questions ofsafety and effectiveness sincea trained healthcareprofessional screens
CATEGORY	HONDA WALKINGASSIST DEVICE(HWA)	EKSO BIONICS®,INC. - EKSO	Substantial EquivalenceComments
			evaluates and measures HWAusers for the proper gait speed
Type of Surfacefor Training	Smooth, cement, carpet	Smooth, cement, carpet	[SAME]
Device Range ofMotion (ROM)	• Hips: 113° flexion to 47°extension	• Hips: 135° flexion to20° extension• Knees: 130° flexion to0° extension• Ankles: 10° flexion to10° extension	[SIMILAR]• HWA hip joint ROM iscomparable
User HeightRequirement	1.4 m to 2.0 m(~55 in to ~79 in)	1.58 m to 1.88 m(~62 in to ~74 in)	[SIMILAR]
User WeightRequirement	≤220 lbs (100 kg)	≤220 lbs (100 kg)	[SAME]
BatterySpecifications	• Rechargeable Li-Ion• 22.2 V, 1 A-h• 1 hr continuousoperation• 2 hr charge time	• Rechargeable Li-Ion• 48.1 V, 30 A peakcurrent• 1 hr continuousoperation• 1 hr charge time	[SIMILAR]• HWA outputs smaller voltage &current values• HWA requires a differentcharge time• Varied HWA battery specs donot raise different questions ofsafety and effectiveness
ActuatorSpecifications	• 2 motors (2 at hip)• 4 Nm max torque	• 4 motors (2 hip, 2knee)• ~[40 to 70] Nm maxtorque	[DIFFERENT]• HWA has two motors• HWA outputs much less torque• Reduced HWA motor torquedoes not raise differentquestions of safety andeffectiveness
Control Method	• Handheld interface forphysical therapist	• Handheld interface forphysical therapist• Weight shift to initiatesteps	[DIFFERENT]• HWA does not detect userweight shift• HWA does not initiate steps• Different HWA control methodsdo not raise different questionsof safety and effectiveness
Life Cycle	3 years	4 years	[SIMILAR]• HWA has a different usable life• Shorter HWA usable life doesnot raise different questions ofsafety and effectiveness
Training Program	Yes	Yes	[SAME]
CertificationProgram	Yes	Yes	[SAME]
Device Feedbackto the User	Visual & auditoryfeedback on both thehandheld controller &device	Provides visual feedbackon the handheldcontroller & auditoryfeedback	[SAME]
Fall Detection &Mitigation	None	None	[SAME]
CATEGORY	HONDA WALKINGASSIST DEVICE(HWA)	EKSO BIONICS®,INC. - EKSO	Substantial EquivalenceComments
Failsafe Features	Motor torque disables;device becomes passive	In event of power failure- knees become lockedand hips free (similar totypical passive legbraces)	[SIMILAR]• HWA does not impede jointrange of motion (ROM)• Unrestricted joint ROM doesnot raise different questions ofsafety and effectiveness
OperatingTemperature	32 °F to 86 °F(0 °C to 30 °C)	10 °F to 95 °F(-12 °C to 35 °C)	[SIMILAR]• HWA has a different range ofoperating temperature• Reduced HWA operatingtemperature does not raisedifferent questions of safetyand effectiveness
OperatingHumidity	30% to 85%	Not Available	[SIMILAR]• HWA probably has a similarrange of tolerable humidity• The above factor does notraise different questions ofsafety and effectiveness

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Non-Clinical Performance Testing

As part of our overall R&D process, several performance tests were conducted to demonstrate device safety, effectiveness and usability. The table below gives a broad overview of our bench testing and device development criteria. Testing was conducted according to a combination of internal criteria and international technical standards. The device passed all criteria under an assumed 3-year life cycle.

CATEGORY	DESCRIPTION
Durability	• Component & bulk system worst case loading
Vibration	• Component & bulk system worst case oscillations
Thermal	• Component & bulk system temperature & humidity cycles• Component exposure to thermal shock
Impact	• Component free-fall drop testing
ParticulateResistance	• Component exposure to dust particles
Disinfection	• Bulk system exposure to medical grade cleaning substances
QualityManagement	• Bulk system development per ISO 13485
Risk Management	• Bulk system development per ISO 14971
Usability	• Bulk system development per IEC 60601-1-6 & IEC 62366-1

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CATEGORY	DESCRIPTION
Biocompatibility	• Component testing for In Vitro Cytotoxicity (ISO 10993-5),Skin Sensitization (ISO 10993-10), Intracutaneous Reactivity(ISO 10993-10) & Acute Systemic Toxicity (ISO 10993-11)
Battery Life Cycle	• Battery certification testing per IEC 62133 & IEC 60601-1-2
ElectromagneticCompatibility (EMC)	• EMC certification testing per IEC 60601-1-2
Electrical Safety	• Electrical safety testing per ANSI/AAMI IEC 60601-1:2005(Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012& IEC 60950-1
Software &Cybersecurity	• Software verification, validation & hazard analysis per IEC62304 & FDA guidelines (MAJOR Level of Concern)
Radio FrequencyWirelessTechnology	• Bluetooth module certification testing per EN 300 328 & EN301 489-1/-17 (FCC compliant module)

Clinical Testing - Study #1

The table below summarizes a study of the Honda Walking Assist Device for stroke patients. The objectives were to compare the safety and effectiveness of the Honda Walking Assist Device compared to task-specific gait training.

Fifty participants with chronic stroke and moderate gait impairments were randomized to receive functional, task-specific gait training (FTST) or over-ground gait training with the Honda Walking Assist Device (HWA), delivered in 18 sessions over 6-8 weeks. Training sessions were comprised of gait training and stair training, all performed and assessed within a rehabilitation institute under clinical supervision. The primary endpoint was the change in 10 Meter Walk Test (MWT) Self-selected Velocity (SSV) from baseline in gait speed. Adverse events were monitored/assessed, before and after every data collection session, through study completion. Both groups exhibited improvements in clinical outcomes after training and at a 3-month follow up. There were no significant adverse events during the study.

The results from the HWA group were reviewed to support the use of the device for assisting ambulation function and stair training in rehabilitation institutes. The data demonstrates the HWA device helps assist the ambulatory function of stroke patients who exhibit sufficient ambulatory function to operate the device safely and effectively under the supervision of a healthcare professional in a rehabilitation institute. The data also addresses special controls 21 CFR 890.3480(b)(6) by assessing the level of supervision needed and appropriate environment for use.

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TRIAL REGISTRATION	URL: http://www.clinicaltrials.govIdentifier: NCT01994395
TRIAL DESIGN	Randomized Controlled Trial
TRIAL SITE	The Shirley Ryan AbilityLab (Chicago, Illinois, USA)
CONDITION	Stroke
TEST GROUPS	Functional Task Specific Training (FTST) – Control	Honda Walking Assist (HWA) – Intervention
INTERVENTION	18 total training sessionswithout HWA device• 45min training sessions• 3 sessions/week• 6-8 weeks duration	18 total training sessionswith HWA device• 45min training sessions• 3 sessions/week• 6-8 weeks duration
TOTALSUBJECTS(n=50)	Groups	FTST (n=25)	HWA (n=25)
	Age	$62 \pm 3$ years	$60 \pm 2$ years
	Gender	9 female, 16 male	8 female, 17 male
	Hemiparesis	12 right-side, 13 left-side	13 right-side, 12 left-side
	Stroke Latency	$5.4 \pm 0.8$ years	$7.1 \pm 1.5$ years
	Initial Gait Speed	$0.65 \pm 0.02$ m/s	$0.7 \pm 0.03$ m/s
CLINICAL OUTCOMEASSESSMENTS	• Pre (before study)• Mid (after 9 sessions)• Post (after 18 sessions)• Follow-Up (3 months after study)
	10 Meter Walking Test, Self-selected VelocityUnits: cm/sMean (SD)
HWA RESULTS(n = 25)	Baseline: 69.91 (3.03)Change from BaselineMid: +8.87 (2.59)Post: +17.41 (2.23)3 Month Follow Up: +19.16 (4.37)
	No falls or significant adverse events were reported

Training Certification

The Honda Walking Assist Device (HWA) is an adjustable exoskeleton that allows fitting of the main waist frame and thigh frames to the user's dimensions. A mobile app, which runs on a touchscreen tablet, is provided with the device and is used by the

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physical therapist to select the user settings and dynamically adjust the amount of assistance provided by the device during set up.

To ensure appropriate utilization, therapists are required to complete a certification training prior to using the device with their patients. This 8-hour training course is divided into two 4-hour sessions. The HWA training activities will allow therapists to:

Screen, evaluate and measure patients for HWA use ●
Configure the HWA device and tablet accessory for patients ●
Fit the exoskeleton to patients for proper donning and doffing ●
Safely guard and cue patients while using the HWA ●
Complete 2-3 practice training sessions with the exoskeleton ●
Demonstrate competence during emergency situations ●
Become familiar with available resources for technical support

Statement of Substantial Equivalence

Based on comparisons of technological characteristics, intended use, indications for use, bench testing and clinical evidence, we conclude that the Honda Walking Assist Device is appropriate for its intended use and is considered substantially equivalent to the identified predicate device. We believe that any differences in comparisons do not raise different questions of safety and effectiveness.

Regulation Number and Section

§ 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).