HAL for Medical Use (Lower Limb Type) orthotically fits to the lower limbs and trunk; the device is intended for individuals with spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B), who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL.

HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy.

In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.

HAL is intended to be used inside medical facilities while under trained medical supervision in accordance with the user assessment and training certification program

Device Description

HAL for Medical Use (Lower Limb Type) is a battery powered bi-lateral lower extremity exoskeleton that provides assistive torque at the knee and hip joints for gait training. HAL is comprised of a controller, a main unit, and sensor shoes. The device comes in 8 size variations (4 different leg lengths and 2 different hip widths) and weighs ~14 kg (30 lbs). The device uses legally marketed cutaneous electrodes (up to 18 electrodes) to record surface electromyography bioelectrical signals of the hip and knee extensor and flexor muscles when the device is used in Cybernic Voluntary Control (CVC) mode. This mode provides assistive torque at the corresponding joint (e.g., hip or knee) using sufface electromyography bioelectrical signals that are processed using a propriety signal processing algorithm. The propriety processing algorithm allows the device to detect surface electromyography bioelectrical signals to control the HAL device in CVC mode and provide visualization of the surface electromyography bioelectrical signals during biofeedback training. The assistive torque can be adjusted using three parameters: sensitivity level. torque turner. and balance turner. The device can also provide two additional modes: Cybernic Autonomous Control (CAC) mode and Cybernic Impedance Control (CIC) mode. CAC mode provides assistive torque leq trajectories based on postural cues and sensor shoe measurements. CIC mode provides torque to compensate for frictional resistance of the motor based on joint motion. CIC mode does not provide torque assistance for dictating joint trajectories. A trained medical professional (i.e., physician, physical therapist, etc.) can configure, operate, and monitor the device during gait training to make adjustments as needed.

Patients must exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. The patient must be supported by a Body Weight Support (BWS) system before donning the device and during device use. The BWS must not be detached from the patient before doffing this device. HAL is not intended to provide sit-stand or stand-sit movements. HAL is capable of gait speeds up to approximately 2 km/hour on level ground. HAL is not intended for sports or stairclimbing.

In preparation to using HAL, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.

HAL is intended to be used in conjunction with regular physiotherapy. HAL is intended to be used inside a medical facility under the supervision of trained medical professionals who have successfully completed the HAL training program.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HAL for Medical Use (Lower Limb Type), based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate, quantifiable table for clinical performance endpoints. Instead, it presents the results of two clinical studies and highlights whether the observed improvements are statistically and clinically significant. The key clinical measures used to demonstrate effectiveness are:

Acceptance Criteria (Implied by Clinical Significance)	Reported Device Performance (Average Improvement Post-Intervention)	P-value (vs. baseline)	Clinical Significance Thresholds (MCID)
10 Meter Walk Test (speed) improvement	0.20 m/s (DE-02 Study, 55 subjects)	<0.001	0.06 m/s
6 Minute Walk Test (distance) improvement	48.53 m (DE-02 Study, 55 subjects)	<0.001	36 m
WISCI II score improvement	1.69 levels (DE-02 Study, 55 subjects)	<0.001	Not explicitly stated as MCID
Adverse Events	No serious/severe adverse events observed/reported in either study, only mild and transient skin redness. (DE-01 & DE-02 Studies)	N/A	Absence of serious adverse events

Note: The "acceptance criteria" in the table above are inferred from the document's emphasis on demonstrating "statistically significant improvement" and improvement values exceeding "clinically significant" thresholds (MCID) for the 10MWT and 6MWT. For WISCI II, "mean gain of 1.69 levels" with a p-value of <0.001 suggests an accepted improvement. For adverse events, the lack of serious events and resolution of mild events indicates accepted safety.

The document also details numerous non-clinical performance criteria which are met through bench testing to ensure safety and functionality:

Stopper Strength Test: Conformance maintained after 100 cycles, expected to endure impact.
Consecutive Landing Test: All 3 samples withstood 3,000,000 cycles without failure, demonstrating sufficient durability.
Effective Output Test (Torque & Angular Velocity): Output found to meet specifications and be within human tolerance for angular velocity.
Driving Parts Performance Test: Actual torque output compared to intended torque falls within criteria range.
Joint angle measurement: Accuracy verified to meet specifications.
Body trunk absolute angle measurement: Sufficiently detects stable posture for safety and effectiveness.
Plantar load measurement: Sufficiently detects planting and lifting to determine leg phase for safety and effectiveness.
Surface Electromyography Bioelectrical signal measurement performance: Accuracy for all measurements (input impedance, common-mode rejection ratio, frequency characteristics) verified to meet specifications.
Ankle Durability Test: All 3 samples withstood 300,000 impacts (5 years' worth) without failure, demonstrating sufficient durability.

Study Details

2. Sample Size and Data Provenance

DE-01 Clinical Study (Pilot Study):

Test Set Sample Size: 8 subjects
Data Provenance: Prospective, conducted at BG University Hospital Bergmannsheil (Germany, inferred from "Bergmannsheil").

DE-02 Clinical Study:

Test Set Sample Size: 55 subjects
Data Provenance: Prospective, conducted at BG University Hospital Bergmannsheil (Germany, inferred from "Bergmannsheil").

3. Number of Experts and Qualifications for Ground Truth

The clinical studies involved human assessment of functional outcomes (10MWT, 6MWT, WISCI II). While these are quantitative measures, the execution of the tests and interpretation would be by trained medical professionals. The document states: "The training was supervised by a physiotherapist and a medical doctor." This indicates at least two types of qualified experts were involved in the clinical assessment and potentially in establishing the "ground truth" (i.e., the measured functional scores). Specific years of experience are not provided.

4. Adjudication Method

The document does not explicitly describe an adjudication method for the clinical outcomes. Since the endpoints (10MWT speed, 6MWT distance, WISCI II score) are objective measurements, it is likely that standard clinical protocols were followed for their assessment, which inherently involves some level of consensus or single objective measurement by the supervising medical staff. Formal multi-expert adjudication for "ground truth" as might be seen in image classification is not applicable here.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. The studies were single-arm, uncontrolled interventional studies designed to show improvement within the patient group (before vs. after intervention with HAL) rather than comparing performance against other devices or human readers. The clinical studies focus on the patient's functional improvement without the HAL device after a training intervention, suggesting an "algorithm only without human-in-the-loop performance" in terms of the test subjects' measurement, but the intervention itself is human-in-the-loop (supervised by medical professionals).

6. Standalone (Algorithm Only) Performance

The clinical effectiveness studies (DE-01 and DE-02) do assess a form of standalone performance in the sense that the primary endpoints (10MWT, 6MWT, WISCI II) are measured without wearing the HAL device after the training intervention. This means they are measuring the residual functional improvement in the patient's own ambulation capability after HAL-assisted gait training, rather than the performance of the HAL device itself during use.

The non-clinical bench testing, however, is a form of standalone performance evaluation for the device's mechanical and electrical components and its internal measurement systems (e.g., joint angle sensing, EMG signal measurement accuracy).

7. Type of Ground Truth Used

The ground truth for the clinical studies is functional outcome measures as assessed by standard clinical tests:

10 Meter Walk Test (speed)
6 Minute Walk Test (distance)
Walking Index for Spinal Cord Injury II (WISCI II) score

These are objective, quantifiable measures of ambulation capability.

8. Sample Size for the Training Set

The document does not specify a separate "training set" in the context of machine learning model development. The HAL device (Lower Limb Type) is a powered exoskeleton that uses bioelectrical signals and postural cues. While it has a "propriety signal processing algorithm," the document doesn't detail if this algorithm was "trained" on a specific dataset of patients or how large that dataset was. The clinical studies (N=8 and N=55) represent validation/testing of the device's overall effectiveness in improving patient ambulation and its safety.

9. How the Ground Truth for the Training Set was Established

Given that a specific "training set" for an AI/algorithm is not detailed, the ground truth establishment method for such a set isn't provided. The "propriety signal processing algorithm" is mentioned as processing surface electromyography bioelectrical signals to control the device and provide visualization for biofeedback. How this algorithm was developed or optimized (i.e., its "training" process and associated "ground truth") is not disclosed in this regulatory summary.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

December 17, 2017

CYBERDYNE Inc. Yohei Suzuki Head of Production Department 2-2-1 Gakuen-Minami Tsukuba, 305-0818 Jp

Re: K171909

Trade/Device Name: HAL for Medical Use (Lower Limb Type) Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL, HCC Dated: November 29, 2017 Received: November 29, 2017

Dear Yohei Suzuki:

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. 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.

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

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Michael J. Hoffmann -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) K171909

Device Name HAL for Medical Use (Lower Limb Type)

Indications for Use (Describe)

HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gat training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy.

HAL is intended to be used inside medical facilities while under trained medical supervision in accordance with the user assessment and training certification program

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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510(k) Summary

510(k) Number: K171909

5.1 Applicant Information

Date Prepared:	December 15, 2017
Company Name andAddress:	CYBERDYNE Inc.2-2-1, Gakuen-Minami,Tsukuba-Shi, Ibaraki-Ken 305-0818 Japan
Contact Person:	Mr. Yohei SuzukiHead of Production DepartmentPhone: +81-29-869-8453FAX: +81-29-869-8443Email: suzuki_yohei@cyberdyne.jp

5.2 Device Information

Device Name:	HAL for Medical Use (Lower Limb Type)
Common or Usual Name:	Powered Exoskeleton
Classification Name:	Powered Lower Extremity Exoskeleton (primary)Biofeedback Device (secondary)
Regulation Number:	21 CFR 890.3480 (primary)21 CFR 882.5050 (secondary)
Device Class:	II
Product Code:	PHL
Secondary Product Code:	HCC

5.3.1 Legally Marketed Predicate Device

510(k) Number:	K131798
Primary Predicate	Primary
Applicant:	Argo Medical Technologies, Inc.
Device Name:	ReWalk
Regulation Number:	21 CFR 890.3480
Product Code:	PHL
Device Class:	II

5.3.2 Legally Marketed Reference Device

510(k) Number:	K971708
Applicant:	J & J Engineering Inc.
Device Name:	Physiological Monitoring & Biofeedback Training Device
Regulation Number:	21 CFR 882.5050
Product Code:	HCC
Device Class:	II

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5.4 Device Description

5.5 Indications for Use

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HAL is intended to be used inside medical facilities while under trained medical supervision in accordance with the user assessment and training certification program.

5.6 Non-Clinical Performance Data

The subject devices demonstrate conformance with the following recognized standards:

AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 ●
IEC 60601-1-2:2007 ●
IEC 60601-1-6:2013 ●
IEC 62133:2012, IEC 60335-1:2010, IEC 60335-2-29:2010 and ANSI/UL 1012:2010 ●
IEC 62304:2006 and IEC 62304:2015 ●
. IEC 62366:2014

The subject device underwent bench testing as part of required performance verification and validation activities. Results show that the subject device has met pre-defined design and performance acceptance criteria. Results of all non-clinical testing support the safety and effectiveness of the subject devices.

Testing	Objective(s) and Study Design
Stopper StrengthTest	<Objective(s)>To evaluate the durability of the mechanical stopper of the actuator thatlimits the maximum angle and verify that it endures the mechanical forcethat can be applied by the patient
	Conformance with acceptance criteria was maintained after 100 cycles. Themechanical stopper is expected to endure the impact in the joints.
	ConsecutiveLanding Test
	All 3 samples withstood 3,000,000 [cycles] of landing impact, and therewere no missing parts, cracks/chips of the exterior, loosening of screws,abnormal noises, looseness, operational malfunctions, and
	loosening/detachment/deformation of the connectors. The assumedmaximum steps of HAL is 1,000,000[cycles] so it is sufficiently durable.

Effective OutputTest	<Objective(s)>This test consists of two tests, each with different objectives below:A. Effective torque test: To verify that the actuator meets specifications foreffective output torque by measuring the effective output torque to the input(electrical current).B. Maximum angle velocity test: To verify that the maximum angularvelocity, generated when maximum torque is output, is within the range ofthat tolerable by the human knee joint.
	A. Effective torque output test: The output was verified to meet thespecification. It was also within the range required by risk management.B. Maximum angular velocity test: The angular velocity was verified to bewithin a range that the human body can tolerate.
Driving PartsPerformance Test	To Measure the actual torque output against the torque output intended bythe control algorithm, and confirm that it meets the performance criteria.
	The test results show that the actual torque output compared to the torqueoutput intended by the control algorithm falls within the criteria range, andthe performance of the driving parts meets the expected results.
Joint anglemeasurement	To test the accuracy of joint angle sensing.
	Accuracy of joint angle measurement was verified to meet specification.
Body trunkabsolute anglemeasurement	To test the accuracy of body trunk absolute angle sensing.
	The measurement results show that the body trunk absolute anglemeasurement of the device can sufficiently detect the stable posture in theforward/backward directions of the patient, thus ensuring the safety andeffectiveness of the device.
Plantar loadmeasurement	To test the accuracy of plantar load measurement.The measurement results show that the plantar force measurement of thedevice can sufficiently detect the planting and lifting of the sole, to enablethe device to determine what phase (swing/support) each leg is in, thusensuring the safety and effectiveness of the device.
SurfaceElectromyographyBioelectrical signalmeasurmentperformance	To test the accuracy of surface electromyography bioelectrical signalmeasurement performance. The tests included an assessment of inputimpedance, common-mode rejection ratio, and frequency characteristics.Accuracy for all measurements were verified to meet specifications.
Ankle Durability
Test	Test the durability of the mechanical systems of the ankle parts againstrepeated impacts in a twisting direction, simulating impacts applied to theparts during a turning movement. Confirm whether missing parts,cracks/chips of the exterior, loosening of screws, abnormal noises,looseness do not occur after 5-years worth (service life of HAL) ofconsecutive impacts.
	All 3 samples withstood 300,000 [times] of impact, and there were nomissing parts, cracks/chips of the exterior, loosening of screws, abnormalnoises, looseness. The ankle part of the device is sufficiently durable.

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5.7 Clinical Performance Data

[Pilot Study]

Site	BG University Hospital Bergmannsheil
PatientPopulation	Chronic spinal cord injury $(97.2\pm88.4$ months since injury)
Objective	To determine whether locomotor training with the exoskeleton HAL® is safe to useand can increase functional mobility in chronic paraplegic patients after SCI.
InclusionCriteria	traumatic SCI with chronic incomplete paraplegia or complete paraplegia afterlesions of the conus medullaris/ cauda equine with zones of partial preservation(ZPP). patients must present motor functions of hip and knee extensor and flexormuscle groups in order to be able to trigger the exoskeleton.
ExclusionCriteria	Non traumatic SCI pressure sores severe limitation of range of motion (ROM) regarding hip and knee joints cognitive impairment body weight > 100kg non-consolidated fractures mild or severe heart insufficiency
Duration	June ~ September 2013
Design andProtocol	Study method: InterventionalBasic Design: Single armRandomization: Non-randomizedBlinding: Open (no blinding)Control: UncontrolledDuring this study, the patients underwent a BWSTT (Body Weight SupportedTreadmill Training) five times per week using the HAL.The treadmill system (Woodway USA, Inc., Waukesha, WI, USA) includes a bodyweight support system with a harness. During treatments, the velocity of the treadmillwas set individually between comfortable and maximum speed tolerated by thepatients. Approximately 50% of each patient's body weight needed to be supportedby the harness system, individually reduced during the following sessions astolerated without substantial knee buckling or toe drag.

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	The patients underwent a 90-day period of HAL training (five per week), including amean number of sessions of 51.7565.6. The training was performed on a treadmillwith individually adjustable body weight support and speed, recording walking speed,time, and distance. It included a 10-m walk test (10MWT) before and after eachsession and regular physiotherapy that lasted approximately 90 minutes. The trainingwas supervised by a physiotherapist and a medical doctor.
Intervention	90 days (5 times/week)
Sample size(N)	8
Results	Significant improvements have been especially shown in the functional abilitieswithout the HAL for over ground walking obtained in the 6MWT and the 10MWT.While the TUG-Test was not significant after Bonferronni correction (a = 0.00625),the results show a trend toward improvement, and an increase in the WISCI II scoreof three patients is also promising.
	Endpoint	n	AverageImprovement	Paired T-test	WilcoxonSigned-RankTest	95% Cl
	10MWT(speed)	8	0.23±0.14 m/s	P = 0.0025	P < 0.01	[0.13, 0.33]
	TUG test	8	17.16±19.01 s	P = 0.0379	P < 0.02	[3.99, 30.33]
	6MWT(distance)	8*	93.25±39.40 m	P = 0.0003	P < 0.01	[65.95, 120.55]
	Wisci II	8	1.125	P = 0.0796	N/A	[0.05, 2.20]
	*Only three patients were able to walk for 6 minutes before training, but all 8 patientswere able to walk for 6 minutes after the intervention.
AdverseEvents	No serious/severe adverse events occurred/observed●●Two cases of mild adverse events were observed. In both cases, skin rednessdue to electrodes was observed but patients recovered naturally shortly afterelectrodes were removed.
Manuscripts	The Spine Journal, titled "Voluntary driven exoskeleton as a new tool for●rehabilitation in chronic spinal cord Injury -A pilot study"

Site	BG University Hospital Bergmannsheil
PatientPopulation	Chronic spinal cord injury ( $6.85\pm5.12$ years since injury), SCI C2-L5, ASIA D, C, andASIA A with Zones of Partial Preservation
Objective	To examine functional outcomes as a function of age and lesion level in patients withchronic incomplete SCI (iSCI) or chronic complete SCI (cSCI) with zones of partialpreservation (ZPP) by using the HAL as a temporary training tool.
InclusionCriteria	• SCI with chronic incomplete paraplegia or tetraplegia at any spinal cord lesionlevel (ASIA C/D) or chronic complete paraplegia (ASIAA) at lesion levels T11 orlower, AND
ExclusionCriteria	patients must present motor functions of hip and knee extensor and flexor muscle groups in order to be able to trigger and control the exoskeleton. Absence of residual motor functions in the lower extremities pressure sores severe limitation of range of motion (ROM) regarding hip and knee joints cognitive impairment body weight > 100kg non-consolidated fractures epilepsy severe heart insufficiency
Duration	January 2012~ June 2016
Design andProtocol	Study method: InterventionalBasic Design: Single armRandomization: Non-randomizedBlinding: Open (no blinding)Control: UncontrolledDuring this study, the patients underwent a BWSTT (Body Weight Supported Treadmill Training) five times per week using the HAL.The patients underwent a 90-day period of HAL training (five per week), including a mean number of sessions of 58.78±2.37. The training was performed on a treadmill with individually adjustable body weight support and speed, recording walking speed, time, and distance.A 10-m walk test (10MWT) without the HAL was performed before and after each session in addition to regular physiotherapy.Training effects (e.g., 10 MWT, 6 MWT, WISCI-II) were assessed at the baseline, week 6, and week 12, without HAL assistance (i.e., exoskeleton is not worn during testing).
Intervention	90 days (5 times/week)
Sample size(N)	55
Results	Overall, a time reduction of 47% in the 10MWT, self-selected speed (10MWTsss) (< 50 years = 56% vs ≥ 50 years = 37%) and an increase of 50% in the 6MinWT were documented. Age had a nonsignificant negative influence on the 10MWTsss. Despite a few nonsignificant subgroup differences, participants improved across all tests. Namely, patients with iSCI who had spastic motor behavior improved to a nonsignificant, lesser extent in the 6MinWT.The level of assistance captured in the Walking Index for Spinal Cord Injury II (WISCI II) testing pre and post gaiting training reflects the test setup used during 10 MWT test pre and post gait training, respectively. There were instances where the amount of assistance used during the 6 MWT test differed slightly from the WISCI-II Score.The results of the intervention were compared to the established MCID. The average 10MWT improvement was 0.20 m/s with 95% confidence inter of [0.16, 0.25], a value that is more than three times the MCID of 0.06 m/s. The average 6 MWT improvement was 48.53m with 95% confidence interval of [37.35, 59.71], a value that is also larger than the MCID of 36m. It can therefore be said that the improvements

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seen in both the 10 MWT and the 6 MWT are clinically significant. Furthermore, the WISCI II scores showed a mean gain of 1.69 levels. At the end of the study, 24 of 55 patients (43.6%) were less dependent on walking aids.

Endpoint	n	Pre-(measurementwithout HAL)	Post- (measurementwithout HAL)	p
10MWT(speed)	55	$70.45\pm61.50$ s	$35.22\pm30.80$ s	<0.001
6MWT(distance)	55	$97.81\pm95.80$ m	$146.34\pm118.13$ m	<0.001
WISCI II	55	$9.35\pm5.12$	$11.04\pm4.52$	<0.001
AdverseEvents	Five cases of mild adverse events were observed. In all cases, skin redness due to electrodes was observed but patients recovered naturally shortly after electrodes were removed. One subject had fallen from his wheelchair while at home, and suffered a femoral neck fracture. The incident was not related to the use of the device, and the subject was dropped from the study due to inability to continue. One subject had a pressure ulcer on her left ankle that developed while horseback riding. The incident was not related to the use of the device, and the treatment was suspended until the ulcer healed.
Manuscripts	JNS Neurosurgical Focus, titled “Against the odds: what to expect in rehabilitation of chronic spinal cord injury with a neurologically controlled Hybrid Assistive Limb exoskeleton. A subgroup analysis of 55 patients according to age and lesion level.”

5.8.1 Comparison of Intended Use/Indications for Use

Indications for Use
Subject Device	Predicate Device
HAL for Medical Use (Lower Limb Type)	ReWalk (K131798)
HAL for Medical Use (Lower Limb Type)orthotically fits to the lower limbs and trunk; thedevice is intended for individuals with spinalcord injury at levels C4 to L5 (ASIA C, ASIA D)and T11 to L5 (ASIA A with Zones of PartialPreservation, ASIA B), who exhibit sufficientresidual motor and movement-related functionsof the hip and knee to trigger and control HAL.	The ARGO ReWalk orthotically fits to thelower limbs and part of the upper bodyand is intended to enable individuals withspinal cord injury at levels T7 to L5 toperform ambulatory functions withsupervision of a specially trainedcompanion in accordance with the userassessment and training certificationprogram. The device is also intended toenable individuals with spinal cord injuryat levels T4 to T6 to perform ambulatory

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HAL is a gait training device intended totemporarily help improve ambulation uponcompletion of the HAL gait trainingintervention. HAL must be used with a BodyWeight Support system. HAL is not intendedfor sports or stair climbing. HAL gait training isintended to be used in conjunction with regularphysiotherapy.	functions in rehabilitation institutions inaccordance with the user assessmentand training certification program. TheReWalk is not intended for sports or stairclimbing.
In preparation for HAL gait training, thecontroller can be used while the exoskeleton isnot donned to provide biofeedback trainingthrough the visualization of surfaceelectromyography bioelectrical signalsrecorded.
HAL is intended to be used inside medicalfacilities while under trained medicalsupervision in accordance with the userassessment and training certification program

5.8.2 Similarities and Differences of Intended Use/Indications for Use (IFU)

The subject device is intended for an expanded range of Spinal Cord Injury patients when compared to the predicate device. In addition to the training requirements, contraindication, warnings, precautions, the subject device mitigates risks of device use by:

Limiting device use to inside medical facilities
Requiring the use of a Body Weight Support system ●
Requiring vital capacity and pulse oximetry testing for C5-C4 SCI patients before and ● after device use
Requiring blood pressure and heart rate monitoring for all patients prior to standing. ● while standing, and after walking

These requirements do not raise new questions of safety and effectiveness.

In preparation for using HAL, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded at the hip and knee extensor and flexor muscles. The biofeedback training is provided in preparation to using HAL and does not raise new questions of safety or effectiveness.

HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. The effectiveness of HAL was demonstrated in two clinical studies (see section 5.7 above), the first with 8 subjects and the second with 55 subjects. All subjects were chronic ( > 1 year since trauma) SCI patients with injuries ranging from C2-L5, ASIA D, C, B and ASIA A with Zones of Partial Preservation.

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The effectiveness was measured by collecting data on 10 meter walk tests (10 MWT), 6minute walk tests (6 MWT), and WISCI-II tests, all measured without wearing the HAL device. The endpoints were collected at start of the study (week 0), midpoint (week 6) and upon completion of the study (week 12). The results suggest a statistically significant improvement in the gait related outcome measures collected. In contrast to the predicate device's IFU statement for device worn ambulation, the subject device's IFU statement for gait training required clinical data to support the effectiveness of the gait training intervention (i.e., testing of ambulation while not wearing the exoskeleton). The studies (see section 5.7 above) support the Indications for Use and a decision of substantial equivalence.

	Subject Device(HAL for Medical Use)	Predicate Device(ReWalk K131798)
Device
BodyCoverage	• Worn over legs and around hipsand lower torso.	• Worn over legs and around hipsand lower torso
PatientHeight	150-190 cm	160-190 cm
PatientWeight	40-100 kg	Maximum 100 kg
IntendedEnvironment	• Flat surface of medical facilities(indoor only)• Must be used in combinationwith BWS systems.	• Home use (includes outdoor)• Used with canes (devicecomponent)
IntendedUsers	Medical professionals that havecompleted designated trainingprogram to use the device	Those that have completeddesignated training program(includes medical professionals andnonprofessionals like companions orfamily members)
HardwareandMainComponents	The system consists of threemajor components:• Controller• Main unit• Sensor shoes	The system consists of three majorcomponents:• Remote control communicator• Exoskeleton• Backpack
DeviceVariations	• 8 different size/shape variations:4 leg lengths, 2 waist widths.• Sensor shoes are available insizes of 23, 24, 25, 26, 27, 28,29, 30 cm	• The predicate comes in 2 differentpurpose variations: R(rehabilitation) and P (personal).• The R type has 5 variations fordifferent pelvic band widths. The Rtype has only one pelvic bandwidth.
Device	5 Years	5 Years
Device	Subject Device(HAL for Medical Use)	Predicate Device(ReWalk K131798)
PowerSources	Lithium-ion battery	• Main battery: Lithium ion battery• Auxiliary battery: Lithium polymerbattery
RangeofMotion	• Hips: 120° flexion to -20°extension• Knee: 120° flexion to -6°extension	• Hips: 104° flexion to -34° extension• Knee: 112° flexion to 2° extension
MethodofControl	• Surface electromyographyBioelectrical signals at knee andhip extensor and flexor muscles(CVC mode), Attached controllerused by medical professional,Postural and Shoe sensor cuesfor movement	• Remote control worn on wrist tochange modes; postural cues forstepping
ModesofOperation	• CVC (Cybernic VoluntaryControl)• CAC (Cybernic AutonomousControl)• CIC (Cybernic ImpedanceControl)Can be selected for each joint(right/left hip/knee joints)	• SIT-TO-STAND• STAND• WALK• STAND-TO-SIT• MANUAL• BYPASS
SafetyFeatures	• Limited joint torque and jointvelocity• Mechanical stoppers to preventexcessive joint flexion orextension• System fault for each componentthroughout operation• Task switching conditions thatwill not initiate incorrect taskchanges	• System fault at power up• Main computer failure• Incorrect operational modeselection• Excessive joint flexion/extensionangles• Loss of balance while rising from achair• Misstep or obstacle• Complete loss of power• Loss of communication betweenremote and main computer
FallPreventionMeasures	BWS systems	Crutches
BenchTesting	• Durability of mechanical stopper:applicant test• Durability of ankle part:applicant test• Consecutive Landing:applicant test	• Worst Case Loading of Knee Joint:Sponsor study• Worst Case Loading of Hip Joint:Sponsor study• Structural analysis of frame: FEAanalysis
Device	Subject Device(HAL for Medical Use)	Predicate Device(ReWalk K131798)
	• Software testing: Verification, validation & hazard analysis	validation & hazard analysis
OperatingTemperature	• 50° to 86° F (10° to 30° C)	• 10° to 95° F (-12° to 35° C)
PerformanceStandards	• Electrical Safety: AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012• Electromagnetic Compatibility: IEC 60601-1-2: 2007• Usability: IEC 60601-1-6: 2010 and IEC 62366: 2014• Battery Safety: IEC 62133: 2012, IEC 60335-1: 2010, IEC 60335-2-29: 2010 and ANSI/UL 1012: 2010• Software: IEC 62304: 2015	• Electrical Safety: IEC 60601-1: 2005• Electromagnetic Compatibility: IEC 60601-1-2: 2007• Battery testing: EMC/EMI certificate• Flammability: ISO 7176-16: 2012
Training	• CYBERDYNE-developed program for medical professionals• The device is intended to be used only in medical facilities for HAL gait training.• Must be used under the supervision of a trained medical professional in accordance with the user assessment and training certification program	• Tier based program• Manufacturer developed program consisting of 4 tiers and 3 levels of tests for users and caregivers or companions
ClinicalStudies	• There are 2 studies conducted on spinal cord injury subjects. The studies cover the indications for use of the device. Both effectiveness and safety are measured in the study and statistical analysis has been performed for results on effectiveness.• The studies were both non-comparative and non-randomized.• All subjects were chronic (> 1 year since trauma) SCI patients with injuries ranging from C2-L5, ASIA D, C, B and ASIA A with Zones of Partial Preservation• The sample size of the studies are 8 and 55 subjects	• There are 3 studies reported, all conducted on spinal cord injury patients.• All studies were non-comparative and non-randomized.• The sample size of the studies are: 7 (6 completed measurements), 24 (20 completed measurements) and 7• The effectiveness is primarily measured by 6 minute walk tests and 10 meter walk tests.• The safety is primarily measured by reporting of no falls, and minor incidents that include blisters, skin tears, bruises, lesions, edema and hematoma.
Device	Subject Device(HAL for Medical Use)	Predicate Device(ReWalk K131798)
	respectively• The effectiveness is primarilymeasured by 10 meter walktests, 6 minute walk tests, andWISCI-II tests, all measuredwithout wearing the HAL device.The results suggest a statisticallysignificant improvement in gaitrelated outcome measures.• The safety of the device isprimarily measured by SAE andAE occurrences. There were noSAE reported. AE's includedreports of minor incidents thatincluded: pain due to pressurefrom device parts that weremanaged by adjusting a betterfit, skin irritation from electrodesand chafed feet due to wrongshoe size.• Long term use of over 12 weeks(60 treatment sessions) has notbeen clinically tested.
Special Controls	Complies with special controls per 21 CFR 890.3480, as applicable	Complies with special controls per 21 CFR 890.3480, as applicable

5.9.1 Comparison of Technological Characteristics

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5.9.2 Similarities and Differences of Technological Characteristics

Similarities are seen in patient height, weight, device lifetime, power sources, performance standards, compliance with special controls. Differences are seen in intended environment, intended users, hardware, device design, modes of operation, safety features, fall prevention measures, and bench testing.

The subject device demonstrates substantial equivalence to the predicate device by implementing mitigations to address design differences, including but not limited to: requiring a Body Weight Support (BWS) system, restricting device use to inside medical facilities, performing additional bench tests to validate exoskeleton design and control systems, and demonstrating conformance to similar recognized consensus standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62133) to support the electrical safety and electromagnetic compatibility of the subject device. The clinical studies provided support a decision of substantial equivalence by demonstrating the subject device can be used as safely as the predicate device; as well as substantiating the claims made in the Indications for Use statement (see section 5.8.2 above for additional information).

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5.10 Conclusions

Based on the above information and comparisons of intended use, indications for use, and technological characteristics, despite the differences described above for which we do not consider to raise different questions of safety and effectiveness, we believe that the subject device is as safe and effective as, and therefore substantially equivalent to, the identified predicate device.

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).