The Indego® orthotically fits to the lower limbs and the trunk; the device is intended to enable individuals with spinal cord injury at levels T3 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels C7 to L5 to perform ambulatory functions in rehabilitations in accordance with the user assessment and training certification program. Finally, the Indego® is also intended to enable individuals with hemiplegia (with motor function of 4/5 in at least one upper extremity) due to cerebrovascular accident (CVA) to perform ambulatory functions in rehabilitations in accordance with the user assessment and training certification program. The Indego is not intended for sports or stair climbing.

Device Description

Parker Hannifin's Indego® device is a wearable powered exoskeleton that actively assists individuals to stand and walk; these are patients with walking impairments resulting from lower extremity weakness or paralysis. The Indego consists of snap-together components weighing 26 pounds total. The hip component houses a rechargeable battery pack, central processor, and Bluetooth radio, while each upper leg component houses two motors as well as embedded sensors and controllers.

In the original operational mode of the device, called Motion+, on-board microprocessors receive signals from integrated sensors which provide information on the user's posture and tilt. This allows the device to function in a manner similar to the Segway personal mobility device, which is controlled by the user's tilt. A user similarly controls the motions of the Indego by means of postural changes (e.g., to walk forward, the user just leans forward). Alternatively, the device can be placed in a second operating mode, referred to as Therapy+, in which the device responds to the motion of users who are able to initiate stepping on their own. When operating in Therapy+, the user walks normally while the system detects step initiation and assists the user. Therapy+ may be used only in a clinical setting under clinical supervision. The technology of the design links the low profile to advanced battery technology (smaller size), motors (smaller and more powerful), and micro controllers (state-of-the art). Visual cues from the LED lights on the hip and vibratory feedback inform both the patient and therapist or trained support person of the status and mode of operation.

The Indego controls are self-contained, with crutches or a walker used solely for stability. Users can perform sit-to-stand and stand-to-sit transitions and walk along even or uneven terrain up to about five degree (5°) grades. Tall hip wings and a tall torso pad are provided to support users who may need additional trunk support while walking. A physical therapist can configure, operate, and monitor the device during therapy and training to make adjustments as needed. This is achieved through the support of a wireless application that will run on mobile/wifi connected smart devices such as an iPod or iPhone. The patient and physical therapist will be able to work in concert to actions of transitioning from sitting to standing to walking, stop walking, and return from standing to sitting. The untethered, free-roaming design of the device allows it to be utilized in multiple indoor and outdoor locations within a rehabilitation or personal setting.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Indego® powered lower extremity exoskeleton. It details the device's indications for use, its description, and its comparison to predicate devices, along with non-clinical and clinical performance data.

However, the document does not contain typical "acceptance criteria" and "reported device performance" in the format of a table with specific metrics for an AI/ML powered device. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and clinical studies for a physical medical device (an exoskeleton).

Therefore, I cannot directly provide a table of acceptance criteria and reported device performance as if it were an AI/ML algorithm being validated. The performance metrics discussed are for the physical functionality and safety of the exoskeleton, not for an algorithmic output.

Similarly, the information requested regarding "sample size for the test set," "data provenance (e.g. country of origin of the data, retrospective or prospective)," "number of experts used to establish the ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established" are all highly relevant to the clinical validation of AI/ML algorithms. This document does not describe an AI/ML algorithm for which these questions would apply in the traditional sense. The "software verification and validation testing per FDA Guidance and IEC 62304" mentioned in section 9 refers to software for controlling the physical device, not an AI for diagnostic or prognostic purposes.

Based on the provided text, here's what can be extracted and inferred regarding the closest relevant information, keeping in mind the context of a physical exoskeleton, not an AI/ML algorithm:

No direct "acceptance criteria" table for an AI/ML device can be constructed as this document is for a physical medical device (exoskeleton) and does not describe an AI/ML algorithm's performance.

The document does describe various non-clinical and clinical tests to demonstrate the safety and effectiveness of the Indego® exoskeleton. The "acceptance criteria" would be implied by the "PASS" status for non-clinical tests and the positive outcomes of the clinical studies.

Here's an attempt to adapt the requested information based on the provided text, while acknowledging its original context:

1. Table of Acceptance Criteria and Reported Device Performance (Adapted for Exoskeleton Functionality):

Acceptance Criteria Category (Implied)	Specific Performance Metric (Where Available)	Reported Device Performance / Status
Non-Clinical Performance	Maximum Torque Testing (Knees & Hips)	PASS (met defined specifications)
	Cleaning Chemical Compatibility Testing	PASS (integrity over 5 years)
	Component Life Cycle Testing	PASS (safe performance between servicing)
	Durability Testing	PASS (meets IEC 60601-1 factors of safety)
	Battery Life Cycle Testing	PASS (met specifications for charge, capacity, life)
	Storage and Transport Testing	PASS (protected during shipping, met ISTA standards)
Software Performance	Software Verification and Validation Testing	Conformance to FDA Guidance & IEC 62304
Electrical Safety	Electrical Safety Testing	Passed ANSI/AAMI ES60601-1:2005/(R)2012
Electromagnetic Compatibility (EMC)	EMC Testing	Passed IEC 60601-1-2:2014
Clinical Performance (Safety & Effectiveness)	Adverse Events (Trial-related)	2 Reported (non-serious); Issue for one resolved with software update
	Serious Adverse Events (Trial-related)	0 Reported
	Gait Deviations (CVA study)	21 of 30 subjects had fewer reported gait deviations at end of Session 6 vs. Session 1
	Step Length (CVA study)	Equal step length reported in 26 of 108 sessions that began unequal
	STEPS taken in Indego (CVA study)	Increased 38% from Session 2 to Session 6
	Time walking in Indego (CVA study)	Increased 18% (average)
	10-Meter Walk Test (CVA study)	23 of 30 subjects improved times in Session 6
	Functional Ambulation Classification (FAC)	Average FAC score of 5 (walking independently on level surfaces), no change observed
	Subjects successfully learned to use Indego	All subjects in pilot studies learned within first session
	Improvements in gait parameters (Pilot Studies)	Demonstrated in pilot studies

2. Sample Size and Data Provenance for Test Set:

Test Set (Clinical Trials):
- Main Multisite Clinical Trial: 30 subjects
- Single-Site Pilot Study 1: 3 subjects
- Single-Site Pilot Study 2: 3 subjects
- Engineering Study: 6 subjects (ongoing)
- Total unique subjects across all clinical studies: 42 individuals with CVA.
Data Provenance: The documents mention "eight clinical sites" for the main multisite trial but do not specify countries of origin other than "Shepherd Center (Atlanta, GA)" for the engineering study. The studies appear to be prospective clinical trials evaluating the device in use.

3. Number of Experts and Qualifications for Ground Truth:

This section is not directly applicable in the AI/ML sense of establishing a "ground truth" for input data. The "ground truth" for the exoskeleton is the direct, observable performance of the device and the physiological responses of the users.
Clinical data collection and assessments involved "physical therapists" and "specially trained companion(s)" who supervised and assessed the users. Their specific qualifications (e.g., years of experience, board certification) are not detailed but are implied by their roles in a clinical setting.
The "IRB approved" and "Good Clinical Practice (GCP) compliant" nature of the studies indicates adherence to ethical and scientific standards in clinical research.

4. Adjudication Method for the Test Set:

Not applicable in the context of AI/ML ground truth adjudication. Clinical trial data collection involves various assessments by clinicians. The document does not describe a formal multi-reader adjudication process for qualitative assessments but rather direct measurement and observation of physical outcomes by trained personnel.

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

No, a MRMC study (typical for diagnostic or prognostic AI) was not done.
The clinical studies focus on the device's ability to facilitate ambulatory functions and improve gait parameters in individuals with neurological impairments (SCI, CVA). There is no comparison of human readers with vs. without AI assistance. The "assistance" itself is the physical exoskeleton.

6. Standalone Performance (Algorithm Only):

Not applicable. The "device" is a physical exoskeleton designed for human-in-the-loop operation. Its performance is measured in conjunction with a user, not as a standalone algorithm. The "software" component controls the physical device's functions.

7. Type of Ground Truth Used:

The "ground truth" is derived from directly observable functional performance and physiological measurements during use of the physical device by human subjects. This includes:
- Functional Outcomes: Ability to sit, stand, walk, turn; walking speed (10MWT); Functional Ambulation Classification (FAC) scores.
- Physiological/Gait Parameters: Gait deviations, step length, stride length.
- Safety Data: Incidence of adverse events.
- Expert Observation/Assessment: Assessments by physical therapists and trained companions.

8. Sample Size for the Training Set:

Not applicable as this is not an AI/ML algorithm in the context typically discussed for "training sets." The device undergoes extensive non-clinical testing and clinical evaluation.
The document implies iterative design and testing for the physical device and its control software. For instance, the improvement in stand-to-sit transition after an adverse event suggests design modification based on observational data, akin to development cycles rather than a distinct "training set" for an AI model.

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

Not applicable for the same reasons as #8. The "training" here refers to device development and improvement, not algorithmic learning. System functionality and safety are established through engineering design principles, non-clinical validation (e.g., torque, durability, battery life tests), and iterative clinical testing.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

January 31, 2018

Parker-Hannifin Corporation % Audrey Swearingen Director Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Road, Bldg 1, Suite 300 Austin, Texas 78746

Re: K173530

Trade/Device Name: Indego® Regulation Number: 21 CFR 890.3480 Regulation Name: Powered lower extremity exoskeleton Regulatory Class: Class II Product Code: PHL Dated: November 14, 2017 Received: November 15, 2017

Dear Audrey Swearingen:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

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) K173530

Device Name Indego®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Indego®

K173530

1. Submission Sponsor

Parker Hannifin Corporation Human Motion and Control 1390 E. Highland Road Macedonia, Ohio, 44056 USA Phone number: 216.896.2044 Contact: Achilleas Dorotheou Title: VP/Head, Human Motion and Control

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Rd., Building 1, Suite 300 Austin, TX 78746 Cell Phone: 512.818.3811 Office Phone: 512.327.9997 Fax: 512.327.9998 Contact: Audrey Swearingen, Director Regulatory Affairs Email: project.management@emergogroup.com

3. Date Prepared

January 8, 2018

4. Device Identification

Trade/Proprietary Name:	Indego®
Common/Usual Name:	Powered Exoskeleton
Classification Name:	Powered Exoskeleton
Regulation Number:	890.3480
Product Code:	PHL
Device Class:	Class II
Classification Panel:	Neurology

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5. Legally Marketed Predicate Devices

K152416/K171334, Indego®, Parker Hannifin Corporation

K161443, Ekso™, Ekso Bionics

6. Device Description

7. Indication for Use Statement

The Indego® orthotically fits to the lower limbs and the trunk; the device is intended to enable individuals with spinal cord injury at levels T3 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels C7 to L5 to perform ambulatory functions in rehabilitation in accordance with the user assessment and training certification program. Finally, the Indego® is also intended to enable individuals with hemiplegia (with motor function

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of 4/5 in at least one upper extremity) due to cerebrovascular accident (CVA) to perform ambulatory functions in rehabilitation in accordance with the user assessment and training certification program. The Indego is not intended for sports or stair climbing.

8. Substantial Equivalence Discussion

The following table comparesthe Indego to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance. The comparison of the devices in Table 5A below provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate devices.

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Manufacturer	Parker HannifinCorporation	Parker HannifinCorporation	Ekso Bionics
Trade Name	Indego®Subject Device	Indego®Primary Predicate	Ekso™Secondary Predicate	Differences
510(k) Number	K173530	K152416/K171334	K161443	N/A
Product Code	PHL	PHL	PHL	Same
Regulation Number	890.3480	890.3480	890.3480	Same
Regulation Name	Powered Exoskeleton	Powered Exoskeleton	Powered Exoskeleton	Same
Indications for Use	The Indego® orthoticallyfits to the lower limbs andthe trunk; the device isintended to enableindividuals with spinal cordinjury at levels T3 to L5 toperform ambulatoryfunctions with supervisionof a specially trainedcompanion in accordancewith the user assessmentand training certificationprogram. The device isalso intended to enableindividuals with spinal cordinjury at levels C7 to L5 toperform ambulatoryfunctions in rehabilitationinstitutions in accordancewith the user assessmentand training certificationprogram. Finally, theIndego® is also intended toenable individuals withhemiplegia (with motorfunction of 4/5 in least oneupper extremity) due to	The Indego® orthoticallyfits to the lower limbs andthe trunk; the device isintended to enableindividuals with spinal cordinjury at levels T3 to L5 toperform ambulatoryfunctions with supervisionof a specially trainedcompanion in accordancewith the user assessmentand training certificationprogram. The device isalso intended to enableindividuals with spinal cordinjury at levels C7 to L5 toperform ambulatoryfunctions in rehabilitationinstitutions in accordancewith the user assessmentand training certificationprogram. The Indego is notintended for sports or stairclimbing.	The Ekso™ (version 1.1)and Ekso GT™ (version 1.2)are intended to performambulatory functions inrehabilitationinstitutions under thesupervision of a trainedphysical therapist for thefollowing population:• Individuals withhemiplegia due to stroke(upper extremity motorfunction of at least 4/5 inat leastone arm)• Individuals with spinalcord injuries at levels T4 toL5 (upper extremity motorfunction of at least 4/5 inboth arms)• Individuals with spinalcord injuries at levels of C7to T3 (ASIA D with upperextremity motor functionof at least 4/5 inboth arms).The therapist mustcomplete a training	Comparable.The intended use ofenabling individuals withSCI to perform ambulatoryfunctions undersupervision are the sameamong the subject andpredicate devices. Theexpanded indications ofuse of the Indego inindividuals with hemiplegiadue to CVA are shared withthe Ekso device. Theexpanded indications foruse of the Indego are alsosupported by the clinicalstudy data provided, anddo not raise any newquestions for safety andeffectiveness.
Manufacturer	Parker HannifinCorporation	Parker HannifinCorporation	Ekso Bionics	Differences
Trade Name	Indego®Subject Device	Indego®Primary Predicate	Ekso ™Secondary Predicate	Differences
	cerebrovascular accident(CVA) to performambulatory functions inrehabilitation institutionsin accordance with the userassessment and trainingcertification program. TheIndego is not intended forsports or stair climbing.		program prior to use of thedevice. The devices are notintended for sports or stairclimbing.
Body Coverage	Worn over legs and aroundhips and lower torso	Worn over legs and aroundhips and lower torso	Worn over legs and upperbody with rigid torso	Same as the Indegopredicate; Similar to theEkso - the components ofthe Indego are wornaround the legs and torsowith the control unitintegrated into the hippiece. Ekso has separatebackpack control units.This does not raise any newsafety or efficacy questionsas the componentconfiguration is similar.
Size of Components	Modular Small, Mediumand Large upper leg, lowerleg and hip components;control unitintegrated inhip unit	Modular Small, Mediumand Large upper leg, lowerleg and hip components;control unit integrated inhip unit	Adjustable upper leg, lowerleg and hip width; controlunit integrated into rigidtorso piece	Same as the Indegopredicate; Similar to theEkso - all three units haveupper leg, lower leg andhip component. Ekso hasrigid torso piece. This doesnot raise any new safety orefficacy questions as thecomponents cover mostlythe same areas of thepatient.
Manufacturer	Parker HannifinCorporation	Parker HannifinCorporation	Ekso Bionics	Differences
Trade Name	Indego®	Indego®	Ekso ™
	Subject Device	Primary Predicate	Secondary Predicate
Mobility Aid	Walker, cane or crutches	Walker, cane or crutches	Walker, cane or crutches	Same
Ability of User Mobility	Sit, stand, walk and turn	Sit, stand, walk and turn	Sit, stand, walk and turn	Same
Walking Speed	~2 km/hr	~2 km/hr	~2 km/hr	Same
Type of Surface	Smooth, grass, cement,carpet, transitions,thresholds	Smooth, grass, cement,carpet, transitions,thresholds	Smooth, cement, carpet	Same as the Indegopredicate; Similar to theEkso - Indego providesmore ground clearancethan Ekso. There are nonew safety or efficacyconcerns as the clinicaldata supports walking overa wide range of surfaces.
Control Method	Uses postural cues anduser motion to trigger alltransitions	Uses postural cues totrigger all transitions	Handheld interface for PT;weight shift to initiatesteps	Similar to the Indegopredicate and Ekso -movement is activated byuser. The subject Indego isactivated by either posturalcues or user motiondepending on the profilemode. No new safety orefficacy questions areraised.
Range of Motion	Hip: 110° flexion to 30°extensionKnees: 110° flexion to 10°extension	Hip: 110° flexion to 30°extensionKnees: 110° flexion to 10°extension	Hips: 135° flexion to 20°extensionKnees: 130° flexion to 0°extensionAnkles: 10° flexion to 10°extension	Same as the Indegopredicate; Similar to theEkso - Does not raise newsafety or efficacyquestions as Indego'sclinical data supports safeuse of the device forwalking and sitting/standing transitions.
Manufacturer	Parker HannifinCorporation	Parker HannifinCorporation	Ekso Bionics	Differences
Trade Name	Indego®Subject Device	Indego®Primary Predicate	Ekso ™Secondary Predicate
Rechargeable Battery	Rechargeable lithium ion.33.3 V, 36A peak current,12A continuous current.159Wh fully charged; 1.5hours of continuouswalking fully charged	Rechargeable lithiumion.33.3 V, 36A peak current,12A continuous current.159Wh fully charged; 1.5hours of continuouswalking fully charged	Rechargeable lithium ionbatteries 48.1V, 30A peakcurrent, 1 hour ofcontinuous usage percharge	Same as the Indegopredicate; Similar to theEkso - All haverechargeable lithiumbatteries, but the Ekso is aslightly different type. Allprovide the powernecessary for use of thedevice.
Battery Charge Time	Maximum of 4 hours	Maximum of 4 hours	1 hour	Same as the Indegopredicate; Similar to theEkso - the charge timedifference does notpresent any new questionsof safety or efficacy.
Training and CertificationProgram (Clinical Use)	Yes; a thorough trainingprogram that providescertification is required forclinicians before usingIndego with patients	Yes; a thorough trainingprogram that providescertification is required forclinicians before usingIndego with patients	Yes	Same
Training and CertificationProgram (Personal Use)	Yes; a comprehensivetraining program requirespersonal users to achieveMinimal Assist or less (FIMScore of 4 or higher) for allIndego skills includingdonning and doffing, walkinginside and outside andwalking over ramps withtheir support persons beforebeing cleared to use Indegoin the home and community	Yes; a comprehensivetraining program requirespersonal users to achieveMinimal Assist or less (FIMScore of 4 or higher) for allIndego skills includingdonning and doffing, walkinginside and outside andwalking over ramps withtheir support persons beforebeing cleared to use Indegoin the home and community	No	Same as the Indegopredicate; different fromthe Ekso-the Ekso is notapproved for personal use.
Manufacturer	Parker HannifinCorporation	Parker HannifinCorporation	Ekso Bionics
Trade Name	Indego®Subject Device	Indego®Primary Predicate	Ekso™Secondary Predicate	Differences
User Feedback	Provides vibratoryfeedback and LEDindicators on top of hipunit, visible to wearer	Provides vibratoryfeedback and LEDindicators on top of hipunit, visible to wearer	Provides visual feedback onthe handheld controllerand auditory feedback	Same as the Indegopredicate; Similar to theEkso - the Ekso offers visualand auditory feedbackwhile Indego providesvibratory and visual cues.This difference issupported by clinical andusability data.
Fall Detection andMitigation	Detects forward, backwardand sideways falling as it ishappening; the devicemakes adjustments duringthe course of the fall toposition the user forminimal risk of injury orallow the user to attemptto recover unassisted	Detects forward, backwardand sideways falling as it ishappening; the devicemakes adjustments duringthe course of the fall toposition the user forminimal risk of injury	None	Similar to the Indegopredicate; Different fromthe Ekso - there are noadditional safety concernsas Indego methods helpreduce risk of injury to theuser.
Failsafe Feature	In the event of powerfailure knees becomelocked and hips free(similar to typical passiveleg braces)	In the event of powerfailure knees becomelocked and hips free(similar to typical passiveleg braces)	In the event of powerfailure knees becomelocked and hips free(similar to typical passiveleg braces)	Same
Electrical Safety Testing	Passed ANSI/AAMIES60601-1:2005/(R)2012	Passed ANSI/AAMIES60601-1:2005/(R)2012	IEC 60601-1:2005 with USdeviations	Same; the Indego passedthe currently recognizedelectrical safety standard.
ElectromagneticCompatibility Testing	Passed IEC 60601-1-2:2014	Passed IEC 60601-1-2:2014	Passed IEC 60601-1-2:2007	Both the subject Indegoand predicate Indego arecompatible with the latestversion of IEC 60601-1-2:2014. Data for Eksoindicates compatibility withIEC 60601-1-2:2007. No
Manufacturer	Parker HannifinCorporation	Parker HannifinCorporation	Ekso Bionics	Differences
Trade Name	Indego®Subject Device	Indego®Primary Predicate	Ekso™Secondary Predicate	new concerns of safety oreffectiveness.

Table 5A – Comparison of Characteristics

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9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the Indego device and in showing substantial equivalence to the predicate devices, Parker Hannifin completed a number of tests. The Indego device meets all requirements for design characteristics, non-clinical performance testing, and electrical safety/EMC testing to confirm that the output meets the design inputs and specifications for the device.

. Maximum Torque Testing: verify the maximum continuous and peak torques that are applied at the knees and hips measured in Nm against defined specifications: PASS
. Cleaning Chemical Compatibility Testing: verify the integrity of the structural plastics with no significant degradation over five (5) year time period through routine cleaning of the device: PASS
. Component Life Cycle Testing: verification that the device meets the requirements for the major mechanical subsystems to perform safely during the expected use between routine servicing in simulated normal use: PASS
. Durability Testing: verify the device meets the factor of safety designated by the IEC 60601-1 requirements for any mechanical hazards that require the support system maintaining structural integrity and does not decrease over simulated lifetime of use of the device: PASS
. Battery Life Cycle Testing: testing performed for the batteries being cycled through normal use including measuring the full charge amount, capacity of battery, and cycle life over defined periods according to the specification for the battery: PASS
. Storage and Transport Testing: to support that the device is protected and not damaged during normal, routine shipping according to ISTA standards for drop, compression, and vibration: PASS
. Software verification and validation testing per FDA Guidance and IEC 62304: conformance of software development life cycle for the Indego Software System and compliance to the requirements of the FDA guidance document for software contained in a medical device.
. Electrical safety testing per ANSI/AAMI ES60601-1: PASS
. Electromagnetic compatibility testing per IEC 60601-1-2: PASS

10. Clinical Performance Data

Four Indego clinical studies have been performed in individuals with hemiplegia resulting from CVA; two 3-subject single-site pilot studies, an engineering study, and a 30-subject multisite clinical trial. The main goal of the multisite clinical trial was to show that the Indego is a safe gait training tool for individuals with hemiplegia due to CVA. The primary objective of both pilot studies was to evaluate whether the Indego could be used to improve gait parameters in subjects recovering from CVA. Additionally, an engineering study remains open to test Indego with CVA patients.

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10.1 30-Subject Multisite Clinical Trial

Thirty subjects completed all six study sessions (one evaluation and five Indego training sessions) across eight clinical sites. The study was IRB approved, Good Clinical Practice (GCP) complaint and informed consent was received from all participants. Several measures were used to evaluate the quality of gait for each subject. Gait deviations, which assess a person's walking technique and the actual quality of their gait pattern, were recorded independent of the Indego in the Evaluation during Session 1 and both before and after ambulating in the Indego in Sessions 2-6. Twenty-one of 30 subjects had fewer reported gait deviations at the end of Session 6 compared to Session 1.

Data was collected from 150 Indego walking sessions, 108 of which began with unequal step length. After walking in the Indego, equal step length was reported in 26 of these 108 sessions that began with unequal step length. The average number of steps taken in the Indego increased 38% from Session 2 (the first Indego walking session) to Session 6 and the average amount of time spent walking in the Indego increased 18%. The 10MWT was used to capture walking speed independent of the Indego in Sessions 1 and 6. Twenty-three of the 30 subjects who completed the study had improved 10MWT times in Session 6.

Functional Ambulation Classification (FAC) scores measure the how independently an individual can walk. The scores range from 1, where assistance of more than 1 person is required, to 6, where the person can walk independently over level and non-level surfaces. FAC scoring criteria is shown in Table 20A below. The average FAC score across subjects was 5, corresponding to walking independently on level surfaces, and no change was observed throughout the course of the study.

There were two trial-related Adverse Events and zero trial-related Serious Adverse Events reported throughout the course of this study. The first adverse event occurred when the subject was attempting to turn in-place in the device. The subject flexed his/her knee to pivot which inadvertently triggered a stand-to-sit transition from the Indego. This caused the subject to lose his/her balance. The subject was stabilized by the physical therapists and assisted in descending to a seat. The subject was not injured. The adverse event was the unintended stand-to-sit transition. Following this event, Parker HMC developed a new sequence of events to initiate a stand-to-sit transition which includes the user or physical therapist deliberately pushing the power button to signal that they are ready to sit. This updated software was distributed to sites participating in the clinical trials beginning in May of 2017. No further events of this type were reported when using the updated software, and the issue is believed to be resolved. The second reported adverse event was a case of knee pain. The patient had a history of osteoarthritis and the physical therapist believed it was aggravated during training.

10.2 Single-Site Pilot Study 1

In the first pilot study the Vanderbilt Exoskeleton – a prototype of the Indego Exoskeleton – was used, as the Indego was not yet commercially hardened. The subjects' time since CVA ranged from 3 to 17 months, spanning the subacute and chronic stages of recovery. Each subject successfully learned to use the Indego within the first session and demonstrated improvement in gait parameters after with PT assistance. Each subject participated in three 2-hour sessions consisting of approximately 45 minutes spent walking in the Indego. Gait Speed, Asymmetry in Step Length, and Stride Length were analyzed. IRB approval was obtained for this study and informed consent was received from each subject. No adverse events were reported.

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10.3 Single-Site Pilot Study 2

In the second pilot study the Indego Exoskeleton was used. The since CVA ranged from 7 to 22 months, meaning all subjects were in the chronic phase of recovery and not experience any spontaneous gait recovery. Each subject successfully learned to use the Indego within the first session and demonstrated improvement in gait parameters. Each subject participated in four 2-hour sessions consist ing of 20-30 minutes walking in the exoskeleton, with time before and after the session to evaluate their gait. During these sessions, subjects used one of two different control methods for the exoskeleton, both of which proved safe and easy to use. Gait Speed and Stride Length were analyzed to determine whether the subjects were experiencing improvements in their gait parameters. Two of the three subjects experienced improvements in their gait parameters. Informed consent was obtained each subject and this study was IRB approved. There were no reported adverse events during the course of this study.

10.4 Engineering Study

Six CVA patients have completed a total of thirty sessions of experimental Indego testing at Shepherd Center (Atlanta, GA). The study is IRB approved and remains open. The study is to trial Indego in individuals with CVA and informed consent has been obtained from each participant thus far. One adverse event, an incidence of heeldiscomfort, has been reported to date.

A total of 42 individuals with CVA have completed over 200 sessions in the combined four studies described above. This is summarized in Table 5B below. All four trials have demonstrated that the Indego is safe and effective when used as a gait training intervention in individuals with hemiplegia due to CVA. No additional safety concerns have been identified.

Trial	Number of Subjects	Number of IndegoSessions per Subject	Total Indego Sessions
30-Subject Multisite Clinical Trial	30	5	150
Single-Site Pilot Study 1	3	3	9
Single-Site Pilot Study 2	3	4	12
Engineering Study	6	Variable	30
Total	42	Variable	201

Table 5B – Summary of IRB Approved Indego CVA Clinical Trials

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device; or the device has the same intended use and different technological characteristics but it can be demonstrated that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicat e device(s) and that the device is substantially equivalent to the predicate device.

Based on the data, the subject Indego is determined to be substantially equivalent to the previously cleared Indego and the Ekso predicate devices.

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).