The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation under the supervision of a trained physical therapist for the following population with upper extremity motor function at least 4/5 in both arms:

· Individuals with spinal cord injuries at levels T4 to L5

· Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D)
The therapist must complete a training program prior to use of the device.

The device is not intended for sports or stair climbing.

Device Description

The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation institutions, hospitals, or similar institutions under the supervision of a healthcare professional (HCP) such as a trained physical therapist. The ExoAtlet-II is indicated for individuals with spinal cord injuries at levels T4-L5 and individuals with spinal cord injuries at levels of C7-T3. All users must have upper extremity motor function of at least 4/5 in both arms. The ExoAtlet-II is intended for multiple users in a clinical setting (i.e., gait lab or rehabilitation center) under supervision. The ExoAtlet-II includes a battery powered exoskeleton, an ExoCrutch, and a Tablet PC.

ExoAtlet-II is designed to be operated with a trained physical therapist who has received preliminary training on the Exoskeleton operation. This therapist will be familiar with the rules of the use and operational documentation. Training is conducted in a designated medical facility that is representative of the indicated environments (e.g., hospital, outpatient physical therapy clinic or similar). The training identifies safe environments of device use and uses all of the safety features found in the subject device. The training manual will be provided with the user manual along with a trainee itinerary and a trainee certification exam. The trainee needs to pass 80% of the exam questions to obtain certification.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ExoAtlet-II device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes general performance characteristics and notes differences from the predicate device that were evaluated for safety and effectiveness through testing.

However, based on the "Comparison of Technological Characteristics" table and the "Summary of Clinical Testing" section, we can infer some key performance aspects and their reported outcomes:

Feature/Metric	Acceptance Criteria (Inferred from Predicate/Safety Evaluation)	Reported Device Performance (ExoAtlet-II)
Indications for Use	Safe and effective for specified SCI populations.	Intended for individuals with spinal cord injuries at T4-L5 and C7-T3 (ASIA D) with 4/5 upper extremity motor function.
Mobility Ability	Sit, Stand, Walk, Turn (predicate)	Sit, Stand, Walk (turning capability not included, evaluated via clinical testing).
Walking Speed	~2 km/hr (predicate)	1.5 km/hr (slightly slower, evaluated via clinical testing, does not pose increased safety risk).
Grade of Inclination	1.15° (predicate)	0-5° (greater inclination, evaluated via clinical testing for safety).
Range of Motion	Hips: 135° flex to 20° ext; Knees: 130° flex to 0° ext; Ankles: 10° flex to 10° ext (predicate)	Hips: 108° flex to 21° ext; Knees: 112° flex to 2° ext; Ankles: 15° flex to 0-15° ext (larger range, evaluated via clinical testing for safety/effectiveness).
Crutch Use	Safe and effective	Evaluated in compliance with ISO 11334-1:2007.
Failsafe Feature	Safely manage failure event	Knees and pelvis become locked (different from predicate, evaluated via clinical testing for safety).
Electrical Safety	Compliance with IEC 60601-1	Complies with IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012.
EMC Compatibility	Compliance with IEC 60601-1-2	Complies with IEC 60601-1-2: 2014.
Software Integrity	Compliance with IEC 62304	Complies with IEC 62304:2006.
Battery Safety/Performance	Safe, functional battery	Tested in compliance with IEC 62133: 2012. 4 hours continuous usage, 4 hours charge time. Evaluated electrical safety, EMC, and clinical testing.
Durability	Expected life comparable to predicate	5 years (longer than predicate's 4 years), evaluated via durability testing.
10 Meter Walk Test	Successful completion	19 of 20 subjects successfully completed.
6-Minute Walk Test (6 MWT)	Successful completion	19 of 20 subjects successfully completed (1 unable due to physical fitness).
User Comfort Survey	Positive user experience	18 of 20 subjects rated comfort 8-10 out of 10; 2 subjects rated 6 out of 10.
Skin Assessment (AEs)	No adverse events related to biocompatibility	None found (abrasions, dry flaky skin, cuts, eschar, rash) before, during, or after use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Study): 20 subjects (n=20)
Data Provenance: The study was described as an "open label, non-randomized clinical study." The document does not specify the country of origin but implies it was internal to ExoAtlet given "ExoAtlet conducted an... clinical study." The study is prospective as it was conducted to assess the safety and effectiveness of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for a test set in the traditional sense of diagnostic accuracy. Instead, the clinical study involved subjects using the device under the supervision of a "trained physical therapist." The therapist's role is to supervise, and their training and certification are mentioned as a requirement for device use. The study monitors objective performance (walk tests) and subjective feedback (comfort surveys, skin assessments) directly from the subjects and observations.

4. Adjudication Method for the Test Set

Not applicable. The clinical study described is a performance and safety study involving a device for rehabilitation, not a diagnostic study requiring adjudication of expert interpretations for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, but a powered exoskeleton for rehabilitation. Therefore, an MRMC study and effects on human reader performance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The ExoAtlet-II is a physical device intended to be used by individuals under the supervision of a trained physical therapist. It is inherently a "human-in-the-loop" device by design and intended use. There is no mention of a standalone algorithm performance test.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The clinical study assessed the device's safety and effectiveness directly through:

Performance metrics: Successful completion of the 10 Meter Walk Test and 6-Minute Walk Test.
User feedback: Comfort ratings via surveys.
Medical observation: Skin assessments for adverse events.
Overall safety and functionality: Absence of new safety issues or ineffectiveness compared to predicates.

These are direct measures of the device's functional performance and user impact, rather than a "ground truth" established through external pathological or expert consensus for a diagnostic task.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI. The training described is for the human therapist who uses the device.

Training for Therapists: Not a "training set" for the device's algorithm, but a program for healthcare professionals. The therapist completes a training program and must pass 80% of an exam for certification.

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

As noted above, there is no AI/ML training set mentioned. The "training set" for therapists involves instructions, operational documentation, and an exam, but this is human training, not algorithm training data.

Summary

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July 16, 2021

ExoAtlet Asia Co. Ltd. Allison Komiyama, PhD Principal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave. Suite B-257 San Diego, California 92110

Re: K201473

Trade/Device Name: ExoAtlet-II Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: June 16, 2021 Received: June 16, 2021

Dear Dr. Komiyama:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "Tushar Bansal -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are evenly spaced, and the overall impression is clean and legible.

For Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201473

Device Name ExoAtlet-II

Indications for Use (Describe)

· Individuals with spinal cord injuries at levels T4 to L5

· Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D)
The therapist must complete a training program prior to use of the device.

The device 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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Image /page/3/Picture/0 description: The image shows the logo for EXOATLET. The logo is in a sans-serif font, with the "EXO" portion in a bright blue color and the "ATLET" portion in black. The letters are all capitalized and have a modern, clean design.

DATE PREPARED

July 16, 2021

MANUFACTURER AND 510(k) OWNER

ExoAtlet Asia Co. Ltd. 4582 S. Ulster Street, Suite 205 Denver, CO 80237 Telephone: Official Contact: Bret Bostock, CEO ExoAtlet US

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. Michelle Rubin-Onur, Ph.D. AcKnowledge Regulatory Strategies, LLC +1 (619) 458-9547 Telephone: Email: akomiyama@acknowledge-rs.com, mrubin@acknowledge-rs.com Website: https://www.acknowledge-rs.com/

DEVICE INFORMATION

Proprietary Name/Trade Name:	ExoAtlet-II
Common Name:	Powered Exoskeleton
Regulation Number:	21 CFR 890.3480
Class:	Class II
Product Code:	PHL
Premarket Review:	Neurology
Review Panel:	Neuromodulation and Physical Medicine Devices (DHT5B)

PREDICATE DEVICE IDENTIFICATION

The ExoAtlet-II is substantially equivalent to the following predicates:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K143690	Ekso™ (version 1.1) and Ekso GT™ (version 1.2) /Ekso Bionics, Inc.	✓

The predicate devices have not been subject to a design related recall.

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Image /page/4/Picture/1 description: The image shows the logo for EXOATLET. The logo is written in a sans-serif font, with the first three letters, "EXO," in blue. The remaining letters, "ATLET," are in gray. The logo is simple and modern.

DEVICE DESCRIPTION

INDICATIONS FOR USE

Individuals with spinal cord injuries at levels T4 to L5
Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D)

The therapist must successfully complete a training program prior to use of the device. The device is not intended for sports or stair climbing.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

ExoAtlet believes that the ExoAtlet-II is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design and dimensions as the devices cleared in K143690. The subject device has the same intended use and similar technological characteristics (i.e., energy source, maximum user weight, and type of surface the device can function on) to the devices cleared in K143690. The ExoAtlet-II has undergone testing to ensure that any differences in technological characteristics (i.e., ability of user mobility, walking speed, grade of inclination, and range of motion) do not affect safety and effectiveness when compared to the predicate devices.

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EXOATLET

	Subject Device	Predicate Device
	ExoAtlet Asia Co. Ltd.	Ekso Bionics, Inc.	Statement of
			Equivalence
	ExoAtlet-II	Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
	K201473	K143690
Indications for	The ExoAtlet-II is intended to perform ambulatory functions in	The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended	Different to the
Use	rehabilitation institutions under the supervision of a trained	to perform ambulatory functions in rehabilitation institutions	predicate. The subject
	physical therapist for the following population with upper	under the supervision of a trained physical therapist for the	device is not intended to
	extremity motor function at least 4/5 in both arms:	following population with upper extremity motor function of at	be used by individuals
	Individuals with spinal cord injuries at	least 4/5 in both arms:	with hemiplegia whereas
	levels T4 to L5	● Individuals with hemiplegia due to stroke	the predicate device is.
	Individuals with spinal cord injuries at	● Individuals with spinal cord injuries at levels T4 to	Both the subject and
	levels of C7 to T3 (ASIA D)	L5	predicate device includea training program prior
	The therapist must successfully complete a training program	● Individuals with spinal cord injuries at levels ofC7 to T3 (ASIA D).	to use of the device.
	prior to use of the device. The device is not intended for sports	The therapist must complete a training program prior to use of	Both devices are not
	or stair climbing.	the device. The devices are not intended for sports or stair	intended for sports or
		climbing.	stair climbing.
Product Codes /	PHL / 21 CFR 890.3480	PHL / 21 CFR 890.3480	Identical to the
Regulation			predicate. No impact on
Number			safety or effectiveness.
Regulation	Powered lower extremity exoskeleton	Powered lower extremity exoskeleton	Identical to the
Description			predicate. No impact on
			safety and effectiveness.
Technical Characteristics
Components	ExoskeletonExoCrutchTablet PC	● Exoskeleton● Mobile application	Different to the
			predicate device. Clinical
			evidence demonstratesthat there is no impact
			on safety and
			effectiveness.
Exoskeleton	25 kg	23 kg	Different to the
Weight			predicate device.
			Performance and clinical
			testing demonstrate that
			there is no impact on
			safety and effectiveness.
Body Coverage	Worn over legs and upper body with rigid torso	Worn over legs and upper body with rigid torso	Identical to the
			predicate device. No
			impact on safety and
			effectiveness.
Size of	Adjustable upper leg, lower leg, and hip width	Adjustable upper leg, lower leg, and hip width , control unit	Identical to the
Components		integrated into the torso	predicate device. No
			impact on safety and
			effectiveness.
Ability of UserMobility
	SitStandWalk	SitStandWalkTurn	Different from thepredicate device. TheExoAtlet-II does notturn. Effectiveness of thesit, stand, and walkfunctions wereevaluated throughclinical testing.
Mobility Aid	Crutch, Walker	Crutch, Walker	Identical to thepredicate device. Noimpact on safety andeffectiveness.
Energy Source	Rechargeable lithium batteries 25.55V, 5700mAh, 4 hours ofcontinuous usage per charge	Rechargeable lithium batteries 48.1V, 30A peak current, 1 hour ofcontinuous usage per charge	Different from thepredicate device. Thebattery of the ExoAtlet-IIcan be charged forlonger. Safety concernsregarding battery safetywere evaluated throughelectrical safety andEMC testing.
Maximum UserWeight	100 kg (220 lbs)	100 kg (220 lbs)	Identical to thepredicate device. Noimpact on safety andeffectiveness.
User Height	1.60-1.90 m	1.58-1.88 m	Different to thepredicate device.Performance and clinicaltesting demonstrate thatthere is no impact onsafety and effectiveness.
Walking Speed	1.5 km/hr	~ 2 km/hr	Different from thepredicate device. TheExoAtlet-II speed isslightly slower and doesnot pose an increasedsafety risk; the reducedspeed of the device wasevaluated throughclinical testing.
Grade ofInclination	0-5º	1.15º	Different from thepredicate device. TheExoAtlet-II can handle agreater grade ofinclination. Safetyconcerns regarding theincreased inclinationwas evaluated throughclinical testing.
Type of Surface	Smooth, cement, carpet	Smooth, cement, carpet	Identical to thepredicate device. Noimpact on safety andeffectiveness.
Range of Motion	Hips: 108º flexion to 21º extension Knees: 112º flexion to 2º extension Ankles: 15º flexion to 0-15º extension	Hips: 135º flexion to 20º extension Knees: 130º flexion to 0º extension Ankles: 10º flexion to 10º extension	Different from thepredicate device. TheExoAtlet-II has a largerrange of motion in thehips, knees, and ankles.Safety and effectivenesswere evaluated throughclinical testing.
Fall Detectionand Mitigation	None	None	Identical to thepredicate device. Noimpact on safety andeffectiveness.
Failsafe Feature	Yes, in the event of a failure-knees and pelvis become locked	Yes, in the event of a failure-knees become locked and hips free	Different from thepredicate device. TheExoAtlet-II locks theknees and pelvis. Safetyconcerns regarding thislocking were evaluatedthrough clinical testing.The therapist trainingprogram also educatesthe therapist on what todo under thiscircumstance
Operatingtemperature	0°C to 35°C	-12°C to 40°C	Different from thepredicate device. TheExoAtlet-II can beoperated at atemperature that iswithin the predicate'soperating range. Anypossible effect on devicefunction was evaluatedthrough electrical safetyand EMC testing, as wellas performance testing.
Battery ChargeTime	4 hours	1 hour	Different from thepredicate device. TheExoAtlet-II can remaincharged for longer.Battery safety andeffectiveness wereevaluated throughelectrical safety andEMC testing, and clinicaltesting.
Expected useablelife	5 years	4 years	Different from thepredicate device. TheExoAtlet-II has a slightlylonger shelf life. Thedifference in shelf lifewas evaluated throughdurability testing.
Testing
PerformanceTesting	Software Electrical safety and electromagnetic compatibility Durability Clinical	Software Electrical safety and electromagnetic compatibility Durability Clinical	Identical to thepredicate device. Noimpact on safety andeffectiveness.
Electrical safetyTesting	IEC 60601-1	IEC 60601-1	Identical to thepredicate device. Noimpact on safety andeffectiveness.
EMCCompatibilitytesting	IEC 60601-1-2	IEC 60601-1-2	Identical to thepredicate device. Noimpact on safety andeffectiveness.
Clinical	Yes	Yes	Identical to thepredicate device. Noimpact on safety andeffectiveness.
Training Program	Yes	Yes	Identical to the predicate device. No impact on safety and effectiveness.
Certification Program	Yes	Yes	Identical to the predicate device. No impact on safety and effectiveness.

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Image /page/7/Picture/0 description: The image shows the logo for EXOATLET. The logo is in a sans-serif font. The letters "EXO" are in blue, while the letters "ATLET" are in black.

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Image /page/8/Picture/1 description: The image shows the word "EXOATLET" in a stylized font. The "EXO" portion of the word is in a light blue color, while the "ATLET" portion is in black. The font is sans-serif and has a modern, minimalist look.

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Image /page/9/Picture/0 description: The image shows the word "EXOATLET" in a stylized font. The "EXO" portion of the word is in a bright blue color, while the "ATLET" portion is in a light gray color. The font is modern and sleek, with sharp angles and clean lines. The logo appears to be for a sports or fitness-related company.

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Image /page/10/Picture/1 description: The image shows the logo for "EXO ATLET". The word "EXO" is in a blue color, while the word "ATLET" is in black. The font is sans-serif and modern. The logo is simple and clean.

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the ExoAtlet-II.

Bench Testing: The elbow crutches provided in the ExoAtlet-II were testing in compliance to:

. ISO 11334-1:2007 Assistive products for walking manipulated by one arm -Requirements and test methods — Part 1: Elbow crutches
Software Verification: The software development and testing were executed in compliance to:
. IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC 62304:2006 Medical device software Software life cycle processes ●

Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to:

IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 Medical electrical equipment -. Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
. IEC 60601-1-6:11 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
CISPR 11: 2015 (Class A, Group 1) Industrial, scientific and medical equipment - Radiofrequency disturbance characteristics - Limits and methods of measurement
. IEC 61000-3-2: 2014 Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
. IEC 61000-3-3: 2013 Amendment 1 - Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public lowvoltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection
IEC 62368-1: 2014 (Second Edition) Audio/video, information and communication technology equipment - Part 1: Safety requirements
IEC 62133: 2012 (Second Edition) Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable application – Part 2: Lithium systems

SUMMARY OF CLINICAL TESTING

ExoAtlet conducted an open label, non-randomized clinical study to assess the safety and effectiveness of the ExoAtlet-II in subjects, 18 years and older, with spinal cord injuries in the T4-L5 or C7-T4 range and type D neurological disorders according to the ASIA scale (n=20).

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Image /page/11/Picture/1 description: The image shows the word "EXOATLET" in a stylized font. The "EXO" portion of the word is in a bright blue color, while the "ATLET" portion is in a dark gray color. The font is sans-serif and appears to be custom-designed, with unique shapes for some of the letters.

19 of the 20 subjects successfully completed the 10 Meter Walk Test and the six-minute walk test (6 MWT). One subject was unable to complete the 6 MWT due to insufficient physical fitness. The surveys found that all of the subjects were able to use the subject device and on a scale from 1-10 (worst to best), 18 of the 20 subjects rated their comfort from eight out of ten to a ten out of ten. Two subjects rated their comfort a six out of ten. Additionally, none of the skin assessments found any adverse events related to biocompatibility such as abrasions, dry flaky skin, cut, eschar, or rash before, during, or after use of the ExoAtlet-II.

CONCLUSION

Based on the testing performed, including clinical testing, software validation, and electrical safety testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed ExoAtlet-II are assessed to be substantially equivalent to the 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).