The Indego® orthotically fits to the lower limbs and the trunk; the device is intended to enable individuals with spinal cord injury at levels T7 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 T4 to T6 to perform ambulatory functions in rehabilitation institutions 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. Unique in design, the Indego consists of five (5) snap-together components (the lumbar/hip section, right and left upper leg sections, and right and left lower leg sections) weighing 26 pounds total. The hip component houses a rechargeable battery pack, central processor, and Bluetooth module, while each upper leg component houses two motors as well as embedded sensors and controllers.

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 Indego by means of postural changes (e.g., to walk forward, the user just leans forward). The technology of the design links the low weight and low profile to battery technology (smaller size), motors (smaller and more powerful), and micro controllers. Visual cues from LED lights on the hip unit and vibratory feedback inform both the therapist and patient 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. Taller torso "wings" 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. Through the use of a Bluetooth connection, the Indego device's mode of operational parameters such as gait speed and step length/height, will be able to be changed or modified in real time. The device can be utilized in multiple indoor and outdoor locations within a rehabilitation setting or personal setting.

AI/ML Overview

The provided text describes the regulatory submission for the Indego exoskeleton device. It details the device, its intended use, and a comparison to a predicate device (ReWalk). The filing includes non-clinical and clinical performance data to demonstrate safety and effectiveness.

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

Criteria	Acceptance Criteria	Reported Device Performance
Primary Safety & Effectiveness Criterion:	Device is both safe and effective for the intended use for patients with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.	The clinical study concluded that the Indego device is safe and effective for its intended use. Adverse events reported were minor (bruising, redness, abrasion, swelling), primarily related to improper fitting or padding, with no unanticipated adverse events. The study demonstrated the ability of subjects to stand up and walk, as detailed in the performance metrics below.
Primary Effectiveness Criterion (Walking Speed):	The average walking speed for persons with SCI using the Indego device with stability aid will be equal to or greater than 0.31 m/s for indoor surfaces.	Walking speed was captured during the study through a Ten Meter Walk Test (10MWT) on indoor surfaces, resulting in speeds of 0.38 m/s ± 0.08 m/s at the completion of the study. This meets the criterion.
Ability to Perform Transitional Motions (TUG Test):	Not explicitly stated as an acceptance criterion with a specific threshold, but the study aimed to measure this ability.	Of the 40 enrolled subjects, 39 were able to complete the Timed Up-and-Go (TUG) Test with minimal contact assistance (FIM score of 4), and one (1) subject was able to complete with moderate contact assistance (FIM score of 3). This indicates successful performance of transitional motions.
Sustained Walking Capacity:	Not explicitly stated as an acceptance criterion.	38 (thirty-eight) subjects were able to complete a single-session walk of 600 meters in length.
Level of Assistance (WISC-II and FIM scores):	Not explicitly stated as an acceptance criterion with specific thresholds, but measured to assess task-specific assistance needed.	The WISC-II scores for all subjects averaged mean scores of 6 ± 1.0 (midpoint) and 7 ± 1.6 (final assessment). FIM scores, as noted above for the TUG test, support that all subjects were capable of managing all tested terrains and scenarios, including indoors/outdoors, various surfaces (tile, concrete, asphalt, grass, carpet), and navigating obstacles (sidewalks, ramps, curb cutouts, elevators, automatic doors, latch doors).
Perceived Exertion (Borg Scale):	Not explicitly stated as an acceptance criterion with a specific threshold.	The averaged results of the Borg Rating of Perceived Exertion for indoor level ground walking at the end of their sessions was 10, which corresponds to an exertion level between "very light exercise" and "light exercise". This suggests the device allows for ambulation with reasonable perceived effort.
Absence of Unanticipated Adverse Events:	Absence of any Unanticipated Adverse Events (UAE).	There were no Unanticipated Adverse Events (UAE) reported.
Non-Clinical Performance Data:	Meet all requirements for design characteristics, non-clinical performance testing, EMC/EMI testing, and electrical safety testing to confirm that the output meets the design inputs and specifications for the device.	Indego device passed Maximum Torque Testing, Cleaning Chemical Compatibility Testing, Component Life Cycle Testing, Durability Testing, Battery Life Cycle Testing, Storage and Transport Testing, Software verification and validation testing, Electrical safety testing (ANSI/AAMI ES60601-1), and Electromagnetic compatibility testing (IEC 60601-1-2).

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: 40 subjects.
- Data Provenance: The document does not explicitly state the country of origin but implies a prospective clinical study ("The study was performed in compliance with Good Clinical Practices (GCP) with subjects enrolled in an IRB approved study that were consented for participation according to the intended use of the device..."). This suggests a controlled clinical trial setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or diagnostic studies. Instead, the clinical study involved subjects using the device and their performance (walking speed, TUG test, level of assistance, perceived exertion) being measured directly. The "truth" here is the objective measurement of their functional abilities while using the device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of this functional performance study. The data collected (e.g., walking speed, FIM scores, TUG test results) are objective measurements or standardized assessment scores, not subjective interpretations 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study typically applies to diagnostic or screening devices where human readers interpret medical images or data. The Indego is a powered exoskeleton for ambulation; its effectiveness is measured directly through functional performance metrics of the user.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device, by its nature, inherently involves a human-in-the-loop. It is a wearable exoskeleton designed to assist individuals with spinal cord injury in performing ambulatory functions. Therefore, a standalone (algorithm only) performance assessment, independent of human interaction, is not relevant or applicable for this device. The software verification and validation were performed as part of non-clinical testing, but this is distinct from measuring "standalone performance" of a diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is based on objective functional performance data using standardized clinical assessment tools (e.g., Ten Meter Walk Test, Timed Up-and-Go Test, WISC-II, FIM scores, Borg Rating of Perceived Exertion) and direct observation of subjects' abilities while using the device in a controlled clinical study environment.
The sample size for the training set:
- The document does not explicitly mention a "training set" in the machine learning sense for the device's algorithms. The device's internal microprocessors receive signals from integrated sensors and function based on the user's posture and tilt (similar to a Segway). The development of these control algorithms would have involved engineering design, testing, and potentially iterative refinement, but the document does not specify a distinct "training set" of data in the manner of AI/ML models.
How the ground truth for the training set was established:
- Given that a "training set" (as understood in machine learning) is not explicitly described, the method for establishing its "ground truth" is not detailed. The device likely relies on engineering principles and biomechanical models for its control algorithms, validated through non-clinical and clinical testing, rather than an AI model trained on a large dataset with established ground truth labels common in areas like image recognition. The "ground truth" for its functional performance is established through the clinical study mentioned above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2016

Parker Hannifin Corporation % Richard Vincins Vice President QA/RA Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701

Re: K152416

Trade/Device Name: Indego Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: January 27, 2016 Received: January 28, 2016

Dear Mr. Vincins:

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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J.Hoffmann -A

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) K152416

Device Name Indego®

Indications for Use (Describe)

The Indego® orthotically fits to the lower limbs and the trunk; the device is intended to enable individuals with spinal cord injury at levels T7 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 T4 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.

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

Indego®

K152416

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: VPBD/Head, Human Motion and Control

2. Submission Correspondent

Emergo

816 Congress Avenue, Suite 1400

Austin, TX 78701

Office Phone: 512.327.9997

Fax: 512.327.9998

Contact: Richard A. VINCINS, Vice President, QA/RA

Email: project.management@emergogroup.com

3. Date Prepared

26 February 2016

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4. Device Identification

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

5. Legally Marketed Predicate Device

DEN130034/K131798, ReWalk™, Argo Medical Technologies, Inc.

6. Device Description

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7. Indication for Use Statement

8. Substantial Equivalence Discussion

The following table compares the Indego to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices 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 device.

Manufacturer	Parker Hannifin	Argo Medical	Significant Differences
	Corporation	Technologies, Inc.
Trade Name	Indego®	ReWalk™
510(k) Number	K152416	DEN130034/K131798	N/A
Product Code	PHL	PHL	Same
Regulation Number	890.3480	890.3480	Same
Regulation Name	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 T7 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 T4 to T6 toperform ambulatoryfunctions in rehabilitation	The Argo ReWalk™orthotically fits to thelower limbs and part of theupper body and isintended to enableindividuals with spinal cordinjury at levels T7 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 T4 to T6 toperform ambulatory	Same
Manufacturer	Parker HannifinCorporation	Argo MedicalTechnologies, Inc.	Significant Differences
Trade Name	Indego®	ReWalkTM
	institutions in accordancewith the user assessmentand training certificationprogram. The Indego isnot intended for sports orstair climbing.	functions in rehabilitationinstitutions in accordancewith the user assessmentand training certificationprogram. The Indego isnot intended for sports orstair climbing.
Body Coverage	Worn over legs andaround hips and lowertorso	Worn over legs andupper body withbackpack	Similar; thecomponents are wornaround the legs andtorso with the controlunit of Indegointegrated into the hipsegment whereas theReWalk has a separatebackpack control unit.No additional safetyor efficacy concern asthe componentconfiguration is similarfor the legs, hip, andtorso of the patient.
Size ofComponents	Modular Small,Medium, and Largeupper leg, lower leg,and hip components;control unit integratedin hip unit	Adjustable upper leg,lower leg, and multiplesize pelvic bands; with abackpack control unit	Similar; both unitshave an upper leg,lower leg, and hipcomponent withReWalk having anadditional backpackunit. No additionalsafety or efficacyconcerns as thecomponents cover thesame areas of thepatient including thelegs, hip, and torso.
Mobility Aid	Crutches or walkers	Crutches	Similar; both devicesutilize crutches as astability/mobility aid.
Manufacturer	Parker HannifinCorporation	Argo MedicalTechnologies, Inc.	Significant Differences
Trade Name	Indego®	ReWalk™	No additional safetyor efficacy concernsare presented byproviding the addedmobility aid option forthe Indego patients toutilize.
Ability of UserMobility	Sit, stand, walk, andturn	Sit, stand, walk, andturn	Same
Walking Speed	~2 km/hr	~2 km/hr	Same
Grade ofInclination	5 degrees	5 degrees	Same
Type of Surface	Smooth, grass, cement,carpet, transitions,thresholds	Smooth, grass, cement,carpet	Similar; Indegoprovides greaterground clearancewhich is user-selectable. Noadditional safety orefficacy concerns asclinical data supportsambulation over awide range ofsurfaces.
Patient population	Adults over age of 18with Spinal Cord Injury(SCI) from T4 to L5	Adults over age of 18with Spinal Cord Injury(SCI) from T4 to L5	Same
Height of Patient	61" to 75" (1.55 m to1.91 m)	63" to 75" (1.60 m to1.90 m)	Similar; the Indegocan accommodate ashorter height with adifference of twoinches (5 cm) anddoes not present anyadditional safety orefficacy concern.
Weight of Patient	Up to 250 lbs (113 kg)	Up to 220 lbs (100 kg)	Similar; the Indegocan accommodate a
Manufacturer	Parker HannifinCorporation	Argo MedicalTechnologies, Inc.	Significant Differences
Trade Name	Indego®	ReWalk™	heavier weight; thisdoes not add anysafety or efficacyconcerns as theverification andvalidation testingsupports therequirements.
Control Method	Uses postural cues totrigger all transitions	Remote control worn onthe wrist to changemodes; postural cuesfor stepping	Similar; themovement activationis preceded by theuser setting the modeon the control units.No additional safetyor efficacy concernsbecause the posturalcues are triggers forthe movementactivation of thedevice.
Range of Motion	Hip: 110° flexion to 30°extensionKnees: 110° flexion to10° extension	Hip: 104° flexion to 34°extensionKnees: 112° flexion to 2°extension	Similar; there is alarger range of motionfor the Indego deviceto allow easier sit-to-stand transitions. Noadditional safety orefficacy concerns asclinical data supportsthe safe use of thedevice for ambulationand sitting/standingtransitions.
Manufacturer	Parker HannifinCorporation	Argo MedicalTechnologies, Inc.	Significant Differences
Trade Name	Indego®	ReWalk™
Weight	26 lbs. (12 kg)	66 lbs. (30 kg) with 5 lbs.(2.3 kg) backpack	Different; Indego isless weight of thepredicate device; thelessened weight of thedevice does not addany concern for safetyor efficacy as can bemanaged by anindividual.
RechargeableBattery	Rechargeable lithiumion. 33.3V, 36A peakcurrent, 12A continuouscurrent. 159Wh fullycharged; 1.5 hours ofcontinuous walking percharge	Rechargeable lithiumion primary with lithiumpolymer secondary.25.9V, 30A peakcurrent, 10.4Acontinuous current; 2hours of continuouswalking per charge	Similar; the batterytypes are slightlydifferent, but providethe necessary powerfor the operation ofthe device. Noadditional safety orefficacy concern asthe battery power hasbeen tested perspecification.
Battery ChargeTime	Maximum of 4 hours	Minimum of 4 hours	Similar; the predicatetakes a minimum of 4hours and a maximumof 7 hours to becharged. Noadditional safety orefficacy concern assimilar charging time.
Expected UseableLife	5 years	5 years	Same
Training Program	Yes	Yes	Same
CertificationProgram	Yes	Yes	Same
User Feedback	Provides vibratoryfeedback and LEDindicators on top of hip	Provides vibratoryfeedback from backpackand LED indicators on	Similar; both devicesprovide vibratoryfeedback and the LED
Manufacturer	Parker HannifinCorporation	Argo MedicalTechnologies, Inc.	Significant Differences
Trade Name	Indego®unit, visible to thewearer	ReWalk™user's wrist controller	indicators tocommunicateinformation to theuser and do notincrease any safety orefficacy concerns.
Fall Detection andMitigation	Detects forward,backward, and sidewaysfalling as it is happening;the device makesadjustments during thecourse of the fall toposition the user forminimal risk of injury	None	Different; there are noadditional safetyconcerns or efficacy asthe fall detectionmethods will helpreduce the risk ofinjury to the user.
Failsafe Feature	In event of power failure– knees become lockedand hips free (similar totypical passive legbraces)	In the event of a powerfailure the ReWalkcollapses slowlywhether user is in safecondition for sitting ornot	Similar; the Indegouser is allowed toremain standing in theevent of amalfunction. Noadditional safety orefficacy concerns asthe failsafe featuresallow the user torecover during a faultwith the device.
OperatingTemperature	32°F to 88°F (0°C to31°C)	-13°F to 105°F (-25°C to40°C)	Similar; the operatingtemperature is similarthat would beexpected in a typicalsetting for the use ofthe device.
OperatingHumidity	30% to 75% RH	Not available	Not applicable
Electrical SafetyTesting	Passed ANSI/AAMIES60601-1:2005/(R)2012	Passed IEC 60601-1:2005	Similar; the Indegopassed the currentlyrecognized electricalsafety standard.
Manufacturer	Parker HannifinCorporation	Argo MedicalTechnologies, Inc.	Significant Differences
Trade Name	Indego®	ReWalk™
ElectromagneticCompatibilityTesting	Passed IEC 60601-1-2:2007	Passed IEC 60601-1-2:2007	Same

Table 1 - 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 device of this 510(k) submission, Parker Hannifin completed a number of tests. The Indego device meets all requirements for design characteristics, non-clinical performance testing, EMC/EMI testing, and electrical safety testing to confirm that the output meets the design inputs and specifications for the device.

The Indego device passed all testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

. Maximum Torque Testing: testing to 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 to 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: performance testing designed to verify the device meets the factor of safety designated by the ANSI/AAMI ES60601-1 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: completed 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

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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

The Indego passed all testing stated above as shown by the acceptable results obtained.

10. Clinical Performance Data

A clinical study was performed with the investigational product, Indego, for assessing the mobility of persons with Spinal Cord Injury (SCI) while using the device. The study was conducted to evaluate the Indego device for safety and effectiveness in allowing persons with SCI who are non-ambulatory to poorly ambulatory to stand up and walk under a variety of conditions. The study was performed in compliance with Good Clinical Practices (GCP) with subjects enrolled in an IRB approved study that were consented for participation according to the intended use of the device, defined inclusion criteria, and defined exclusion criteria; with the purpose of meeting the study objectives.

The study objectives were defined as the following:

. Demonstrate that the Indego device is both safe and effective for the intended use for patients with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.
. Demonstrate that the average walking speed for persons with SCI using the Indego device with stability aid will be equal to or greater than 0.31 m/s for indoor surfaces.

The clinical study was planned for 40 (forty) subjects to be enrolled, which was met. The subjects were then required to complete a series of 27 (twenty-seven) study sessions that included introduction, evaluation, training with the device, assessment from each session, and outcome measurements. The statistical plan was descriptive in nature to test the hypothesis that the Indego system will consistently enable legged mobility for the intended population of non-ambulatory or poorly ambulatory patients. Interviews and assessments were conducted throughout the total number of sessions with outcome measurements recorded midway through and at the completion of the study.

The outcomes measurements for the clinical study are summarized as follows:

. The Timed Up-and-Go (TUG) Test measured the ability of the subject to perform transitional motions beyond just walking, i.e. standing up, sitting down, and turning. Of the enrolled subjects 39 (thirty nine) were able to complete with minimal contact assistance (FIM score of 4) and one (1) subject was able to complete with moderate contact assistance (FIM score of 3).
. Walking speed was captured during the study through a Ten Meter Walk Test (10MWT) on indoor surfaces resulting in speeds of 0.38 m/s ± 0.08 m/s at the completion of the study. In addition as a test of sustained walking for individuals with SCJ, 38 (thirty eight) subjects were able to complete a single-session walk of 600 meters in length.

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. Level of assistance was measured according to WISC-II and FIM scores during the study to provide a view of task-specific level of assistance needed while performing movements using the Indego device. The WISC-II scores for all subjects averaged mean scores of 6 ± 1.0 and 7 ± 1.6 respectively for the midpoint assessment and final assessment during the study. The FIM scores as noted previously support that all subjects were capable of managing all tested terrains and scenarios presented, which included using the device indoors and outdoors; on smooth tile, concrete, asphalt, grass and carpet; and navigating sidewalks, ramps, curb cutouts, elevators, automatic doors, and latch doors.
. Study participants were requested to complete multiple questionnaires during the study trial including a Borg Rating of Perceived Exertion to capture the effort subjects felt to achieve basic level-ground walking. The averaged results of the assessment for indoor level ground walking at the end of their sessions was 10, which corresponds to an exertion level between "very light exercise" and "light exercise".
Adverse Events (AE) reported during the study included minor instances of bruising, redness, abrasion, and swelling. The causes attributed to these reported incidents were generally related to improper fitting or improper padding. In one case of abrasion raised by a subject was related to a padding malfunction. There were no Unanticipated Adverse Events (UAE).

The clinical study concluded that the Indego device is safe and effective for its intended use and the outcomes of the study met the stated objectives. The clinical trial supports the indication for use for enabling ambulatory function in individuals with T4 to L5 level SCI in an institutional setting and individuals with T7 to L5 SCI in a personal use setting.

11. Training

Training is a critical and required component of appropriate utilization and progression to higher degrees of proficiency for Indego usage. Patients and their caregivers must undergo training developed by the manufacturer to learn and demonstrate proper use of the Indego device. The sponsor has proposed the following training program, which is a tier-based system (Table 2), with the following skills identified for basic (home/limited community) and advanced (community) skills for both the User and Support Person (Tables 3, 4, 5). Prior to moving to another level of proficiency, the Indego User needs to demonstrate sufficient proficiency utilizing a scoring metric as summarized in Table 7. It should be noted that the Indego device is currently indicated for usage only with supervisions of a specially trained companion in accordance with the user assessment and training certification program.

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Indego Competency Levels
	Rehabilitation Use	Personal Use
		Level 1 (Home/Limited Community)	Level 2 (Community)
Location	Institution (inside and outside, level and un-level surfaces)	Home (inside and outside, level and un-level surfaces)Activities of daily livingLimited community ambulation	Community AmbulationMust pass all Level 1 skills prior to advancing to Level 2
Supervision	Indego specialist	Support Person	Support Person
User training	Learn basic or advanced skills	Learn Basic and Limited community skills	Focus on obtaining longer walking distances and faster gait speeds
Support person training	N/A	Learn basic and limited community skills	Learn community skills
Prerequisites	Meets all inclusion criteriaSCI T4 and below	User meets all inclusion criteriaSCI T7 and belowIndego user and support person pass all Level 1 skills on competency checklist	Indego user and Support Person pass all Level 2 skills on competency checklist

Table 2 – Indego Competency Levels

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	Table 3 – Level 1 User and Support Person: Home/Limited Community Skills Report Card Score Sheet

Skill	Score	Pass or Fail
General knowledge of the device
Putting on/taking off the device
Assessing skin, pressure and appropriate fit
Safe operation of the device (basic skills)
Walking Level Inside
Walking-Stop-Walking
Turning Left/Right/180
Walking Level Outside*
Wall Rest in Standing
Use of hand held controller
Safety during unique situations
Emergency Sit Procedure
Proper care and storage of the device
Verbalized understanding of approved skills

*Skills that are suggested, but not mandatory to take device home at Level 1

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Skill	Score	Device Used(RW or FC)	Pass or Fail
Indoor ramps
Outdoor ramps
Manual Doors
Automatic Doors
Irregular outdoor surfaces (ie grass,cracked pavement, sidewalks, stony path)
Activities of Daily Living (ADL's)(Household, Kitchen, etc)
Verbalize understanding of approvedskills

Table 4 – Level 2 User: Community Skills Report Card Score Sheet

Table 5: Level 2 Support Person: Community Skills Report Card Score Sheet

Skill	Score	Device Used(RW or FC)	Pass or Fail
Elevators
Curb cut out
Walking Speed of 0.4 m/s or greaterduring 10MWT
*Car transfers
Walks 600 m distance
*Cross 2 way street
Verbalized understanding of approvedskills

*Skills that are suggested, but not mandatory to take device home at Level 2

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Table 6 – Scoring Key for Behavior Skills for Level 1 and Level 2

Score	Description of Score Assignment
1	Pass User and Support Person Safely Perform Skill
0	Fail User and Support Person Did NOT Safely Perform Skill
NS	No Score User and Support Person Did NOT perform the skill at all

Table 7: FIM Scoring Criteria – for Indego device

FIM Scoring Criteria:
No Helper Required
Score	Description
7	Complete Independence
6	Modified Independence (patient requires use of a device, but no physical assistance)
Helper (Modified Dependence)
Score	Description
5	Supervision or Setup
4	Minimal Contact Assistance (patient can perform 75% or more of task)
3	Moderate Assistance (patient can perform 50% to 74% of task)
Helper (Complete Dependence)
Score	Description
2	Maximal Assistance (patient can perform 25% to 49% of tasks)
1	Total assistance (patient can perform less than 25% of the task or requires more than one person to assist)
0	Activity does not occur

12. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or

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the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).

The Indego, as designed and manufactured, meets the Specified in 21 CFR 890.3480, and is determined to be substantially equivalent to the referenced 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).