(464 days)
The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population with upper extremity motor function of at least 4/5 in both arms:
- Individuals with hemiplegia due to stroke
- 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 devices are not intended for sports or stair climbing.
The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
The provided text describes the Ekso™ (version 1.1) and Ekso GT™ (version 1.2) powered lower extremity exoskeletons and their substantial equivalence to a predicate device (ReWalk™). The text primarily focuses on comparing the characteristics of the Ekso device with its predicate and detailing clinical studies to support its safety and performance for its stated indications for use.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative, pass/fail format typical of certain medical device pre-market notifications. Instead, it presents a comparison with a predicate device and then details clinical study results to demonstrate safety and performance. The "acceptance criteria" can be inferred from the "Significant Differences" column in Table 1 and the "Results" section of the clinical studies, demonstrating that the device performs comparably or acceptably for its intended use without raising new safety or efficacy concerns.
Inferred Acceptance Criteria & Reported Performance (from comparison and clinical studies):
| Acceptance Criteria (Inferred from Predicate Comparison & Clinical Studies) | Reported Device Performance (Ekso™) |
|---|---|
| Safety: | |
| - No additional safety or efficacy concerns compared to predicate for expanded indications (stroke, higher SCI injury range). | - Clinical data evaluated safety for higher level SCI and stroke patients, limiting use to those with adequate upper extremity motor strength (at least 4/5 in both arms). |
| - Safety during ambulation and sitting/standing transitions. | - Clinical data supports safe use for ambulation and sitting/standing transitions despite larger range of motion. |
| - Failsafe feature allows user to recover during a fault. | - In event of power failure, knees become locked and hips free, allowing user to remain standing and recover. |
| - No serious adverse events (SAEs) such as falls or injuries reported in clinical studies. | - Study 1: No falls reported. 1 subject with blisters, 5 with pain (self-limiting).- Study 2: 1 subject had 2 falls without injury. No injuries reported.- Study 3: No falls or other adverse events reported.- Study 4: No falls or other adverse events reported.- Study 5: No falls or other adverse events reported. |
| Device Characteristics & Performance: | |
| - Similar indications for use but potentially expanded to include stroke patients and a wider range of SCI levels (C7-T3 ASIA D). | - Intended for hemiplegia due to stroke, SCI T4-L5, and SCI C7-T3 (ASIA D), with upper extremity motor function of at least 4/5 in both arms. Deemed "Similar" without additional safety concerns. |
| - Mobility Aid: Support for various mobility aids (walker, crutches, cane). | - Utilizes walker, crutches, cane. Deemed "Similar" with no additional safety or efficacy concerns for added options. |
| - Ability to sit, stand, walk, and turn. | - Can sit, stand, walk, and turn (same as predicate). |
| - Walking Speed: Comparable to predicate. | - ~2 km/hr (same as predicate). |
| - Grade of Inclination: Suitable for intended flat environments. | - 1.15 deg (lower than predicate's 5 deg, but consistent with indoor use, so no additional safety/efficacy concerns). |
| - Type of Surface: Suitable for smooth, cement, carpet. | - Smooth, cement, carpet. Not walking on grass presents no additional safety concerns as intended for indoor use. |
| - Patient Population: Adaptable to intended patient population. | - Adults over 18 with hemiplegia due to stroke, SCI T4-L5, and SCI C7-L5 ASIA D. Evaluated for these differences. |
| - Control Method: Efficient and safe for initiating steps. | - Handheld interface for PT; weight shift to initiate steps. Deemed "Similar" with no additional safety or efficacy concerns. |
| - Range of Motion: Allows for comfortable and functional movement. | - Hips: 135° flexion to 20° extension, Knees: 130° flexion to 0° extension, Ankles: 10° flexion to 10° extension (larger than predicate, supporting sitting/standing transitions and comfort). |
| - Weight: Lighter is preferable (no additional safety/efficacy concerns). | - 50 lbs (23 kg) - lighter than predicate, no safety/efficacy concerns. |
| - Battery: Provides necessary power and operates safely. | - Rechargeable lithium ion batteries (48.1V, 30A peak current, 1 hr continuous usage). Tested per specification, no additional safety/efficacy concerns. |
| - Battery Charge Time: Manageable for clinical use. | - 1 hour (shorter than predicate, allows for swapping, no additional safety/efficacy concerns). |
| - Expected Useable Life: Reasonable for medical device. | - 4 years (shorter than predicate, but within acceptable limits, no additional safety/efficacy concerns). |
| - Training Program and Certification: Ensures safe operation by trained professionals. | - Yes, extensive two-phase training and certification program for therapists (Level 1: basic, Level 2: advanced/independent). |
| - Clinical Effectiveness: Improvement in ambulation parameters (10MWT, 6MWT, FIM scores). | - Study 1 (SCI): Mean 10MWT improved (66s pre to 40s post).- Study 2 (SCI): Mean 10MWT improved (160s pre to 78s post), Mean 6MWT improved (82m pre to 152m post).- Study 3 (Stroke): Mean 10MWT improved (150s pre to 79s post), Mean 6MWT improved (40m pre to 88m post), Mean FIM scores improved (24 pre to 49 post).- Study 4 (Stroke): Mean FIM scores improved (25 pre to 51 post).- Study 5 (Stroke): Mean 10MWT improved (76s pre to 37s post), Mean 6MWT improved (48m pre to 83m post). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists five clinical studies:
- Study 1 - SCI:
- Sample Size: 44 subjects (35 ASIA A-B, 21 ASIA C-D, some overlap likely given the numbers provided - total patients 44 in text).
- Data Provenance: Multi-center, prospective, open-label, non-comparative, non-randomized. Conducted at 6 sites from 5 countries.
- Study 2 - SCI:
- Sample Size: 12 subjects (9 ASIA A, 3 ASIA B).
- Data Provenance: Single center, open-label, non-comparative, non-randomized, prospective.
- Study 3 - Stroke:
- Sample Size: 54 subjects.
- Data Provenance: Single center, exploratory retrospective analysis.
- Study 4 - Stroke:
- Sample Size: 54 subjects.
- Data Provenance: Single center, open-label, non-comparative, non-randomized, prospective.
- Study 5 - Stroke:
- Sample Size: 8 subjects (6 in Arm 1, 2 in Arm 2).
- Data Provenance: Single center, prospective, two-arm study.
The countries of origin for the studies are only explicitly stated for "Study 1 - SCI" (6 sites from 5 countries).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The clinical studies report objective measures (e.g., 10MWT, 6MWT, FIM scores, heart rate, blood pressure) and adverse events, which would typically be recorded by trained clinical staff like physical therapists and physicians. The establishment of "ground truth" in terms of expert consensus on diagnosis or a gold standard interpretation is not applicable here as the studies assess functional outcomes and safety for device use. The document does state that the device is used "under the supervision of a trained physical therapist" and mentions a "certification program" for therapists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. The clinical studies describe objective measurements of functional performance and adverse event reporting. There is no mention of an adjudication process by multiple experts for subjective outcomes or interpretations.
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
No MRMC comparative effectiveness study was done or mentioned. This type of study (MRMC) is typically relevant for diagnostic imaging AI devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The Ekso device is a physical rehabilitation exoskeleton, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Ekso device is an exoskeleton designed for use by patients under the supervision of a trained physical therapist. Its core function involves mechanical assistance for ambulation with human interaction and supervision. Therefore, a "standalone algorithm only" performance study is not applicable or relevant for this type of device. The performance is inherently human-in-the-loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in these studies consists of clinical outcomes data and safety event reporting. This includes:
- Functional performance metrics:
- 10-Meter Walk Test (10MWT) time (seconds)
- 6-Minute Walk Test (6MWT) distance (meters)
- Functional Independence Measure (FIM) scores
- Physiological measurements: Heart rate, blood pressure.
- Adverse events: Blisters, pain, falls (with or without injury).
These are direct measurements of patient response and device safety, not an "expert consensus" on a diagnosis or a "pathology" result.
8. The sample size for the training set
The document does not provide a specific sample size for a "training set" in the context of machine learning or AI. The clinical studies mentioned are for evaluating the device's performance and safety, not for training an algorithm within the device. The "training" described in the document refers to the program for physical therapists to learn how to operate the Ekso device.
9. How the ground truth for the training set was established
Since there is no "training set" in the context of machine learning described for the device itself, this question is not applicable. The "ground truth" for the therapist training is established through competency demonstration as assessed by the "Ekso Bionics Clinical Training Team" against defined operational and safety criteria.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2016
Ekso Bionics. Inc. Thomas Looby President and Chief Commercial Officer 1414 Harbour Way South, Suite 1201 Richmond. CA 94804
Re: K143690
Trade/Device Name: Ekso™ (version 1.1) and Ekso GTTM (version 1.2) Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: March 2, 2016 Received: March 2, 2016
Dear Mr. Looby:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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
Carlos L. Peña. PhD, MS for 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) K143690
Device Name
EksoTM (version 1.1) and Ekso GTTM (version 1.2)
Indications for Use (Describe)
The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population with upper extremity motor function of at least 4/5 in both arms:
· Individuals with hemiplegia due to stroke
· 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 devices are not intended for sports or stair climbing.
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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| Device name | Ekso™ |
|---|---|
| Submitters name & contact info | Ekso Bionics® Inc.1414 Harbour Way SouthSuite 1201Richmond, CA 94804 |
| Contact Details:Thomas LoobyCEO | |
| Tel: +1 937-838-0842Email: tom@eksobionics.com | |
| Tel: +1 (510) 984-1761Fax: +1 (510) 927-2647 | |
| Preparation Date | March 31, 2016 |
| Device Name & Classification | Trade Name: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Common Name: ExoskeletonClassification Name: Powered ExoskeletonDevice Classification: Class II, 21 CFR 890.3480Product Code: PHL |
| Indications for Use | The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population with upper extremity motor function of at least 4/5 in both arms:Individuals with hemiplegia due to strokeIndividuals with spinal cord injuries at levels T4 to L5Individuals 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 devices are not intended for sports or stair climbing. |
| Device Description | The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker. |
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| Predicate Device | Manufacturer | 510(k) | Date |
|---|---|---|---|
| Argo Medical Technologies | K131798 | 6/26/2014 |
Table 1- Comparison of Characteristics
| Manufacturer | Ekso Bionics®, Inc. | Argo MedicalTechnologies, Inc. | SignificantDifferences |
|---|---|---|---|
| Trade Name | Ekso™ (version 1.1)and Ekso GT™(version 1.2) | ReWalk™ | |
| 510(k) Number | K143690 | 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 Ekso™ (version1.1) and Ekso GT™(version 1.2) areintended to performambulatory functionsin rehabilitationinstitutions under thesupervision of atrained physicaltherapist for thefollowing populationwith upper extremitymotor function of atleast 4/5 in botharms:Individuals withhemiplegia due tostroke, Individualswith spinal cordinjuries at levels T4 toL5, and Individualswith spinal cordinjuries at levels of C7to T3 (ASIA D). Thetherapist mustcomplete a trainingprogram prior to useof the device. Thedevices are notintended for sports orstair climbing. | The ARGO ReWalk™orthotically fits to thelower limbs and partof the upper body andis intended to enableindividuals with spinalcord injury at levelsT7 to L5 to performambulatory functionswith supervision of aspecially trainedcompanion inaccordance with theuser assessment andtraining certificationprogram. The deviceis also intended toenable individualswith spinal cord injuryat levels T4 to T6 toperform ambulatoryfunctions inrehabilitationinstitutions inaccordance with theuser assessment andtraining certificationprogram. TheReWalk™ is notintended for sports orstair climbing. | Similar; the Ekso isintended for strokeand for a higher SCIinjury range for ASIAD. No additionalsafety or efficacyconcerns arepresented by theadditional indications. |
| Manufacturer | Ekso Bionics®, Inc. | Argo MedicalTechnologies, Inc. | SignificantDifferences |
| Trade Name | Ekso™ (version 1.1)and Ekso GT™(version 1.2) | ReWalk™ | |
| Body Coverage | Worn over legs andupper body with rigidtorso | Worn over legs andupper body withbackpack | Similar; theEkso provides a rigidback frame whereasthe predicate has aseparate backpack.No additional safetyor efficacy concern asthe componentconfiguration issimilar for the legs,hip, and torso of thepatient. |
| Size of Components | Adjustable upper leg,lower leg, and hipwidth; control unitintegrated into thetorso | Adjustable upper leg,lower leg, andmultiple size pelvicbands; with abackpack control unit | Same |
| Mobility Aid | Walker, Crutches,Cane | Crutches | Similar; both devicesutilize crutches as astability/mobility aid.No additional safetyor efficacy concernsare presented byproviding the addedmobility aid optionsfor the Ekso. |
| Ability of UserMobility | Sit, stand, walk, andturn | Sit, stand, walk, andturn | Same |
| Walking Speed | ~2 km/hr | ~2 km/hr | Same |
| Grade of Inclination | 1.15 deg | 5 deg | Similar; the Ekso isintended for flatenvironmentswhereas thepredicate is intendedfor communityambulation. Noadditional safetyor efficacy concernsare presented by thelower grade. |
| Manufacturer | Ekso Bionics®, Inc. | Argo MedicalTechnologies, Inc. | SignificantDifferences |
| Trade Name | Ekso™ (version 1.1)and Ekso GT™(version 1.2) | ReWalk™ | |
| Type of Surface | Smooth, cement,carpet | Smooth, grass,cement, carpet | Similar; the Ekso isintended for indoorenvironments and thepredicate is intendedfor communityambulation. TheEkso not walking ongrass presents noadditional safety orefficacy concerns. |
| Patient Population | Adults over age of 18with hemiplegia dueto stroke, Spinal CordInjury (SCI) from T4to L5, and SCI fromC7 to L5 ASIA D | Adults over age of 18with Spinal CordInjury (SCI) from T4to L5 | Different; the Ekso isintended for strokeand for a higher SCIinjury range for ASIAD. Safety concernassociated withhigher level SCI andstroke was evaluatedthrough clinical dataand indications foruse that limit use ofthe device to patientswith adequate upperextremity motorstrength in eachmuscle group of atleast 4/5 in both arms |
| Height of Patient | ~62" to 74" (1.58 m to1.88 m) | 63" to 75" (1.60 m to1.90 m) | Similar; the Ekso canfit one inch shorterand one inch lessheight and does notpresent anyadditional safety orefficacy concern. |
| Weight of Patient | Up to 220 lbs (100kg) | Up to 220 lbs (100kg) | Same |
| Control Method | Handheld interfacefor PT: weight shift toinitiate steps | Remote control wornon the wrist to changemodes; postural cuesfor stepping | Similar; both devicesrequire selection ofactions by thecontroller. Eksoinitiates each stepseparately based onweight shift. Noadditional safety orefficacy concerns arepresented by theEkso method. |
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| Manufacturer | Ekso Bionics®, Inc. | Argo MedicalTechnologies, Inc. | SignificantDifferences |
|---|---|---|---|
| Trade Name | Ekso™ (version 1.1)and Ekso GT™(version 1.2) | ReWalk™ | |
| Range of Motion | Hips: 135° flexion to20° extensionKnees: 130° flexion to0° extensionAnkles: 10° flexion to10° extension | Hips: 104° flexion to34° extensionKnees: 112° flexion to2° extensionAnkles: none | Similar; there is alarger range of motionfor the Ekso to alloweasier sit-to standtransitions andgreater comfortduring walking. Noadditional safety orefficacy concerns asclinical data supportsthe safe use of thedevice for ambulationand sitting/standingtransitions. |
| Weight | 50 lbs (23 kg) | 66 lbs. (30 kg) with 5lbs.(2.3 kg) backpack | Different; Ekso is lessweight than thepredicate device; thelessened weight ofthe device does notadd any concern forsafety or efficacy. |
| Rechargeable Battery | Rechargeable lithiumion batteries 48.1V,30A peak current, 1hour of continuoususage per charge | Rechargeable lithiumion primary withlithium polymersecondary.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 Charge Time | 1 hour | Minimum of 4 hours | Similar; the Eksobatteries can berecharged whileanother set is in use.No additional safetyor efficacy concernsare presented byEkso's shortercharge. |
| Expected UseableLife | 4 years | 5 years | Similar; the Ekso isexpected to have a 4year useable life. Noadditional safety orefficacy concerns arepresented by Ekso'sshorter life. |
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| Manufacturer | Ekso Bionics®, Inc. | Argo MedicalTechnologies, Inc. | SignificantDifferences |
|---|---|---|---|
| Trade Name | Ekso™ (version 1.1)and Ekso GT™(version 1.2) | ReWalk™ | |
| Training Program | Yes | Yes | Same |
| Certification Program | Yes | Yes | Same |
| User Feedback | Provides visualfeedback on thehandheld controllerand auditoryfeedback | Provides vibratoryfeedback frombackpack and LEDindicators on user'swrist controller | Similar; both devicesuse visual and otherfeedback. Noadditional safety orefficacy concernsfrom the auditoryfeedback on theEkso. |
| Fall Detection andMitigation | None | None | Same |
| Failsafe Feature | In event of powerfailure- kneesbecome locked andhips free (similar totypical passive legbraces) | In the event of apower failure theReWalk collapsesslowly whether user isin safe condition forsitting or not | Similar; the Ekso useris allowed to remainstanding in the eventof a malfunction. Noadditional safety orefficacy concerns asthe failsafe featuresallow the user torecover during a faultwith the Ekso. |
| OperatingTemperature | 10° to 95°F (-12° to -35° C) | -13°F to 105°F (-25°Cto 40°C) | Similar; the operatingtemperature is similarthat would beexpected in a typicalsetting for the use ofthe device. |
| Operating Humidity | Not available | Not available | Same |
| Electrical SafetyTesting | IEC 60601-1:2005with US deviations | IEC 60601-1:2005 | Same |
| ElectromagneticCompatibility Testing | Passed IEC 60601-1-2: 2007 | Passed IEC 60601-1-2: 2007 | Same |
Table 2 - Performance Testing
| Technical Area | Tests Completed |
|---|---|
| Electrical Safety andElectromagneticCompatibility | IEC 60601-1:2005, IEC 60601-1-2:2007, low battery testing, IEC62133, IEC 61960 parts 7.4 and 7.5, UN 38.3, UN Manual(ST/SG/AC. 10/11/Rev.5/Amend.1), battery life cycle testing |
| Durability | Worst case loading of knee and hip joints beyond service life,worst case loading of structure beyond service life, ankle spring |
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| durability, component strength testing | |
|---|---|
| Thermal | IEC 60601-1:2005 (ISO 7176 not required; batteries on the Eksoare mounted to the aluminum Torso frame, enclosed in analuminum case, and not near any flammable material. The testingconducted per IEC 60601 -1 in terms of flame retardantevaluations is sufficient to support the device functionality in termsof flame retardant materials.) |
| Software | Verification, Validation, and hazard analysis |
| Bench Testing | IEC 60601-1:2005 sec. 15.3 (IP22 not required) |
Table 3 - Clinical Information
| Study | Description |
|---|---|
| Study 1 - SCI | Multi-center, prospective, open-label, non-comparative, non-randomized, prospective study of patients with spinal cord injury, at 6 sites from 5 countriesDuration of Intervention 27 visits over 12-13 weeks. 44 subjects total 35 ASIA A-B with injury levels from C7 to L2 21 ASIA C-D with injury levels from C1 to L2 32% female mean age of 39.9 years (range 19 to 65) mean time since injury 1146 days (range of 71 to 6790) Results Mean 10MWT pre and post-training were 66 (N=18) and 40 (N=7) seconds, respectively. Mean heart rates increased slightly from the pre-training measure to the mid-training measure while mean blood pressures remained stable. One (1) subject experienced a blister on the left shoulder under the backpack strap. Five (5) patients reported pain in the hands, lower back, or ribs. No falls were reported. All issues were self-limiting and resolved without medical attention. |
| Study 2 - SCI | Single center, open-label, non-comparative, non-randomized, prospective study of patients with spinal cord injury.Duration of Intervention: 24 sessions over 12 weeks |
| 12 subjects total 9 ASIA A with injury levels C7 to L1 3 ASIA B with injury levels T3 to T9 42% female mean age of 35 (range 19 to 56) mean time sine injury 7.6 years (range 1 to 24) | |
| Results Mean 10MWT pre and post-training were 160 (N=12) and 78 (N=17) seconds, respectively Mean 6MWT pre and post-training were 82 and 152 meters, respectively One (1) subject had 2 falls without injury. No injuries were reported | |
| Study 3 - Stroke | Single center, exploratory retrospective analysis of patients with hemiplegia due to stroke |
| Duration of Intervention Mean of 10 sessions (range 2 to 27) | |
| 54 subjects total used the Ekso GT Mean time since injury 12.2 days (range of 0 to 107 days) 36 ischemic, 18 hemorrhagic 7 moderate, 47 severe | |
| Results Mean 10MWT pre and post-training were 150 and 79 seconds, respectively Mean 6MWT pre and post-training were 40 and 88 meters, respectively Mean FIM scores pre and post-training were 24 and 49, respectively There were no falls or other adverse events reported | |
| Study 4 - Stroke | Single center, open-label, non-comparative, non-randomized, prospective study of patients with hemiplegia due to stroke |
| Duration of Intervention Mean of 3 sessions (range 1 to 9) | |
| 54 subjects total Mean time since injury 25.1 days (range of 5 to 146 days) 41 ischemic, 13 hemorrhagic 4 moderate, 50 severe | |
| Results Mean FIM scores pre and post-training were 25 and 51, respectively. Mean blood pressure before and after session 1 was 131/80 and 128/81, respectively. Mean heart rate before and after session 1 was 79 and 85, respectively. There were no falls or other adverse events reported |
24 sessions over 12 weeks.
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Single center, prospective, two-arm study of patients with Study 5 - Stroke hemiplegia due to stroke
Duration of Intervention
- . 6 subjects had between 25 and 27 sessions (Arm 1)
- 2 subjects had 18 sessions (Arm 2) .
8 subjects total
- Mean time since injury 601 days (range of 333 to 1550 . days)
- . 7 ischemic, 1 hemorrhagic
- . All limited household ambulators at recruitment
Results
- . Mean 10MWT pre and post-training were 76 and 37 seconds, respectively
- . Mean 6MWT pre and post-training were 48 and 83 meters, respectively
- . Mean blood pressure before and after session 10 was 126/77 and 130/70, respectively
- Mean Heart rate before and after session 10 was 73 and 78, respectively
- . There were no falls or other adverse events reported.
Training
The Ekso provides various dynamic programming options that enable the physical therapist to customize sessions for patients based on a wide array of clinical presentations. To ensure safe operation, certification training is required before a therapist may use the Ekso.
To optimize the integration of the technology, certification training takes place in two phases. The training program is offered for up to 4 therapists from each facility with each Ekso purchased.
Phase 1 – Initial Training Week
The first phase is a full week of training for each therapist on the basic feature set of the Ekso. During training a therapist will become competent to:
- Screen, evaluate, and measure Patients
- . Setup the Ekso
- . Fit the Ekso to the Patient
- Use the Safety Checklist
- . Select and use the operating mode appropriate for the patient
- . Safely guard and cue patient during operation of the Ekso
- Use the LCD Controller
- . Perform after secession physical checks
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When a therapist is determined to be at Level 1 by the Ekso Bionics Clinical Training Team, it means the therapist has demonstrated the competence to safely operate the Ekso when working with another therapist at Level 1 (or higher).
At Level 1, a therapist does not direct any other staff or team member to aid in operation of the Ekso. Two therapists are required to do the following.
- screening appropriate patients for using the Ekso
- . administering a walking session
- selecting appropriate programming
- . managing emergency situations.
lt is important for therapists at Level 1 to continue using the Ekso after the initial training week to build their skills and be prepared for the second phase of training. It is recommended that they achieve the following prior to beginning phase 2.
- . Perform 3-5 new patient evaluations and screenings for use of the Ekso
- Adjust the Ekso hardware and software for 15 to 20 Ekso walking sessions
- Manage 15 to 20 walking sessions in the Ekso with both new and recurring patients,
- Don and Doff the Ekso for 10 to 15 patient sessions
- Manage Ekso safety features (requires a variable number of sessions)
Phase 2 – Advanced Features
The Ekso Bionics Training Team returns to complete the second phase of training after a period of continued use of the Ekso by therapists at Level 1. Phase two training lasts 2-3 days and incorporates the remaining features of Ekso, and expands the possibilities for clinical use.
To progress from Level 1 to Level 2, a therapist must demonstrate the following mastery safely and independently.
- evaluating and screening appropriate persons for use of the Ekso
- . directing all aspects of Ekso operation to support personnel
- . device operation and selection of appropriate programming for an Ekso walking session
- . managing emergency situations
At Level 2, a therapist independently operates the Ekso with support personnel of his or her choice, and is fully responsible for directing and running all aspects of the Ekso walking session. Level 2 Ekso therapists are also able to delegate appropriate (high level) patients to support personnel that they supervise and train on proper Ekso operation/spotting.
Statement of Substantial Equivalence
Based on safety and performance testing, technological characteristics, and clinical data, the Ekso has been demonstrated to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device.
§ 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).