(185 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on dynamic-walking control and self-balancing, which are typically implemented using traditional control algorithms.
Yes
The device is described as enabling individuals with hemiplegia to perform ambulatory functions and mobility exercises, and clinical studies demonstrated that patients' functional ambulation abilities and overall balance can be improved, indicating a therapeutic effect.
No
The device description and intended use clearly state that the Atalante exoskeleton is designed to assist individuals with hemiplegia due to CVA in performing ambulatory functions and mobility exercises in rehabilitation. It is a walking system that helps improve functional ambulation and overall balance. There is no mention of it being used to diagnose a medical condition or disease.
No
The device description explicitly states it is a "fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Atalante Exoskeleton Function: The Atalante exoskeleton is a physical device that provides support and assistance for mobility and rehabilitation. It interacts with the patient's body externally to facilitate movement.
- Lack of Specimen Analysis: The provided description does not mention the device analyzing any biological specimens from the patient. Its function is purely mechanical and related to physical support and movement.
Therefore, based on the provided information, the Atalante exoskeleton falls under the category of a physical rehabilitation device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation under the supervision of a trained operator. The operator must complete a training program prior to use of the device.
The Atalante system is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand-up position.
The device is not intended for sports or stair climbing.
Product codes (comma separated list FDA assigned to the subject device)
PHL
Device Description
The Atalante is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante is self-balancing and includes dynamic-walking control. Dynamic-walking allows the Atalante to consume significantly less power and have a more natural gait.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs and the trunk
Indicated Patient Age Range
adolescents of 18 years and older and adults
Intended User / Care Setting
trained operator / rehabilitation institutions
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two clinical studies with a total of 43 patients with cerebrovascular accident (CVA) were undertaken. All the subjects that completed the study were able to complete the performance outcome measures. The findings are supported by real world evidence of use by over 250 patients. There were altogether five adverse events in both clinical studies, none of them serious. The two clinical studies demonstrated that patients with CVA due to stroke can use the Atalante exoskeleton safely and effectively. Furthermore, the clinical studies indicated that the patient`s functional ambulation abilities and overall balance can be improved by using the Atalante exoskeleton at an early stage of the rehabilitation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
December 29, 2022
Wandercraft SAS % Andre Kindsvater Senior Consultant Emergo Global Consulting. LLC 2500 Bee Cave Road Building 1 Suite 300 Austin, Texas 78746
Re: K221859
Trade/Device Name: Atalante Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: June 22, 2022 Received: June 27, 2022
Dear Andre Kindsvater:
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.
1
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 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 (QS) 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 medical devices and radiation-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.
Heather L. Dean -S
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221859
Device Name Atalante
Indications for Use (Describe)
The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation under the supervision of a trained operator. The operator must complete a training program prior to use of the device.
The Atalante system is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand-up position.
The device is 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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510(k) Summary Atalante
1. Submission Sponsor
Wandercraft SAS 88 rue de Rivoli 75004 Paris France
Contact: Matthieu Masselin Title: Chief Executive Officer
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com
Contact: André Kindsvater Title: Senior Consultant RA & QA
3. Date Prepared
June 22nd, 2022
4. Device Identification
| Trade/Proprietary Name: | Atalante |
|---|---|
| Common/Usual Name: | Powered Exoskeleton |
| Classification Name: | Powered lower extremity exoskeleton |
| Regulation Number: | 890.3480 |
| Product Code: | PHL |
| Class: | II |
| Classification Panel: | Neurological and Physical Medicine Devices (OHT5) |
5. Legally Marketed Predicate Devices
| Primary Predicate | Reference Device | |
|---|---|---|
| Device name | Indego® | EksoTM (v.1.1) and |
| Ekso GTTM (v.1.2) | ||
| 510(K) number | K173530 | K143690 |
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| Regulation Number | 21 CFR 890.3480 | 21 CFR 890.3480 |
|---|---|---|
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton |
| Product code | PHL | PHL |
| Review Panel: | Neurology | Neurology |
| Manufacturer | Parker Hannifin Corp | Ekso Bionics Inc. |
6. Indication for Use Statement
The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator must complete a training program prior to use of the device.
The Atalante system is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand-up position.
The device is not intended for sports or stair climbing.
7. Device Description
The Atalante is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante is self-balancing and includes dynamic-walking control. Dynamic-walking allows the Atalante to consume significantly less power and have a more natural gait.
8. Substantial Equivalence Discussion
The following table compares the Atalante to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
Table 5A - Comparison of Characteristics preliminary
| Subject Device | Predicate | Reference Device | |
|---|---|---|---|
| FEATURE | Atalante | Indego® | Ekso |
| Ekso™ (v.1.1) and | |||
| Ekso GT™ (v.1.2) | |||
| 510(k) Number | K221859 | K173530 | K143690 |
| Manufacturer | Wandercraft SAS | Parker Hannifin Corp. | Ekso Bionics Inc. |
| Product Code | PHL | PHL | PHL |
| Regulation | 890.3480 | 890.3480 | 890.3480 |
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton | Powered Exoskeleton |
| Subject Device | Predicate | Reference Device | |
| FEATURE | Atalante | Indego® | Ekso |
| Ekso™ (v.1.1) and | |||
| Ekso GT™ (v.1.2) | |||
| Indications for Use | The Atalante exoskeleton is | ||
| intended to enable | |||
| individuals with hemiplegia | |||
| due to cerebrovascular | |||
| accident (CVA) to perform | |||
| ambulatory functions and | |||
| mobility exercises, hands- | |||
| free, in rehabilitation | |||
| institutions under the | |||
| supervision of a trained | |||
| operator. | |||
| The operator must | |||
| complete a training program | |||
| prior to use of the device. | |||
| The Atalante system is | |||
| intended to be used on | |||
| adolescents of 18 years | |||
| and older and adults able to | |||
| tolerate a stand-up position. | |||
| The device is not intended | |||
| for sports or stair climbing. | The Indego® orthotically fits | ||
| to the lower limbs and the | |||
| trunk; the device is intended | |||
| to enable individuals with | |||
| spinal cord injury at levels | |||
| T3 to L5 to perform | |||
| ambulatory functions with | |||
| supervision of a specially | |||
| trained companion in | |||
| accordance with the user | |||
| assessment and training | |||
| certification program. The | |||
| device is also intended to | |||
| enable individuals with | |||
| spinal cord injury at levels | |||
| C7 to L5 to perform | |||
| ambulatory functions in | |||
| rehabilitation institutions in | |||
| accordance with the user | |||
| assessment and training | |||
| certification program. | |||
| Finally, the Indego® is also | |||
| intended to enable | |||
| individuals with hemiplegia | |||
| (with motor function of 4/5 | |||
| in least one upper | |||
| extremity) due to | |||
| cerebrovascular accident | |||
| (CVA) 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. | 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, | |||
| and 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. | |||
| Subject Device | Predicate | Reference Device | |
| FEATURE | Atalante | Indego® | Ekso |
| Ekso™ (v.1.1) and | |||
| Ekso GT™ (v.1.2) | |||
| Population | Adolescents of 18 years | ||
| and older, and adults | Adults over age of 18 | Adults over age of 18 | |
| Environment | Rehabilitation centers | CVA population cleared | |
| only for use in | |||
| Rehabilitation centers | Rehabilitation centers | ||
| Body Coverage | Worn over legs and upper | ||
| body with rigid torso | Worn over legs and around | ||
| hips with lower torso | Worn over legs and upper | ||
| body with rigid torso | |||
| Size of Components | Adjustable upper leg, lower | ||
| leg. Non adjustable hip | |||
| width; | Modular Small, Medium and | ||
| Large upper leg, lower leg | |||
| and hip components; | Adjustable upper leg, lower | ||
| leg, and hip width; | |||
| Mobility Aid | None | Walker, Crutches, Cane | Walker, Crutches, Cane |
| User Mobility | Sit, stand, walk, turn, | ||
| exercise (weight shift, | |||
| squat), repositioning | Sit, stand, walk, and turn | Sit, stand, walk, exercises | |
| (weight shift) and turn | |||
| Walking Speed | ~2km/hr | ~2 km/hr | ~2 km/hr |
| Type of Surface | Smooth | Smooth, cement, carpet | Smooth, cement,carpet |
| Range of Motion | Hip: 90° flexion, | ||
| 5° extension; | |||
| 17° abduction, | |||
| 10° adduction; | |||
| 10° medial rotation, | |||
| 20° lateral rotation | Hips: 110° flexion | ||
| to 30° extension | Hips: 135° flexion | ||
| to 20° extension | |||
| Knee: 110° flexion | |||
| to -5° extension | |||
| (flexum). | Knees: 110° flexion | ||
| to 10° extension | |||
| Ankle: 0 dorsiflexion, | |||
| 9° plantar flexion, | |||
| 18° pronation and | |||
| supination | Ankles: 0° dorsiflexion | ||
| to 25° plantar extension | |||
| Rechargeable | |||
| Battery | Rechargeable lithium-ion | ||
| battery 46.8 V, 9 Ah | Rechargeable lithium ion. | ||
| 33.3 V, 36A peak current, | |||
| 12A continuous current. | Rechargeable lithium | ||
| ion batteries 48.1V, | |||
| 30A peak current, | |||
| Usage duration: 2 hours of | |||
| continuous usage per | |||
| charge | 159Wh fully charged; | ||
| Usage duration: 1.5 hours | |||
| of continuous usage per | |||
| charge | 1 hour of continuous | ||
| usage per charge | |||
| Battery Charge | |||
| Time | 4 hours | 4 hours | 1 hour |
| Training Program | Yes | Yes | Yes |
| Subject Device | Predicate | Reference Device | |
| FEATURE | Atalante | Indego® | Ekso |
| Ekso™ (v.1.1) and | |||
| Ekso GT™ (v.1.2) | |||
| Certification | |||
| Program | Yes | Yes | Yes |
| User Feedback | Provides visual feedback on | ||
| the handheld controller and | |||
| physio interface, and | |||
| auditory feedback. | Provides vibratory feedback | ||
| and LED indicators on top | |||
| of hip unit, visible to wearer | Provides visual feedback on | ||
| the handheld controller and | |||
| auditory feedback | |||
| Fall Detection and | |||
| Mitigation | Must be used in | ||
| combination with safety rail | Detects forward, backward | ||
| and sideways falling as it is | |||
| happening; the device | |||
| makes adjustments during | |||
| the course of the fall to | |||
| position the user for | |||
| minimal risk of injury or | |||
| allow the user to attempt to | |||
| recover unassisted | None | ||
| Failsafe Feature | None | In the event of power failure | |
| knees become locked and | |||
| hips free (similar to typical | |||
| passive leg braces) | In event of power failure– | ||
| knees become locked and | |||
| hips free (similar to typical | |||
| passive leg braces) | |||
| Electrical Testing | ANSI AAMI ES60601- | ||
| 1:2005/(R)2012 And | |||
| A1:2012. | ANSI/AAMI ES60601- | ||
| 1:2005/(R)2012 | IEC 60601-1:2005 | ||
| with US deviations | |||
| Electromagnetic | |||
| Compatibility | |||
| Testing | IEC 60601-1-2:2014 | IEC 60601-1-2: 2014 | IEC 60601-1-2: 2007 |
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9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of Atalante and to show substantial equivalence to the predicate device, Wandercraft SAS completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Atalante passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate devices:
- Cytotoxicity testing per ISO 10993-5: Passed
- . Irritation and Sensitization testing per ISO 10993-10: Passed
- Electrical safety testing per ANSI/AAMI ES60601-1: Passed
- Electromagnetic Interreference (EMI) testing per IEC 60601-1-2: Passed
- Software verification and validation per IEC 62304 and FDA Guidance – the current version has been fully validated and there are only two minor unresolved anomalies which do not affect the safety or performance of the device
- System (Device) Verification and Validation: Passed
- Electronics Sub-system Verification: Passed
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- . Mechanics Sub-system Verification: Passed
- Cycling Testing: Passed
- Thermal Testing: Passed
- Useful Life Testing – supports 5 years
- Transportation Testing per ASTM D4169 demonstrates package integrity is maintained: Passed ●
10. Clinical Performance Data
Two clinical studies with a total of 43 patients with cerebrovascular accident (CVA) were undertaken. All the subjects that completed the study were able to complete the performance outcome measures. The findings are supported by real world evidence of use by over 250 patients.
There were altogether five adverse events in both clinical studies, none of them serious.
The two clinical studies demonstrated that patients with CVA due to stroke can use the Atalante exoskeleton safely and effectively. Furthermore, the clinical studies indicated that the patient`s functional ambulation abilities and overall balance can be improved by using the Atalante exoskeleton at an early stage of the rehabilitation.
11. Training
Prior to the first use of Atalante, to ensure safe and effective operation of the device, the operator must complete a certification training. To optimize the integration of the clinical setting, such training is then followed by frequent visits by Wandercraft Customer Care to further support the operator with the exoskeleton. The training program is offered for as many operators as agreed in the contract signed with the customer.
Training is composed by a theoretical part including presentation and description of the whole system and its mode of operations and a hands-on practice. This latter will be performed both in pairs – with an operator in the role of "operator" and another operator in the role of a "patient" – and in individual sessions. The double role allows the operators to understand the device from both the operator's and patient's perspectives.
An operator is considered certified, i.e., with proven competence to safely operate Atalante alone with the patient, only after fulfilling all eligibility requirements and pass the certification evaluation.
12. Statement of Substantial Equivalence
The Atalante has the same intended use as the Indego® predicate and Ekso™ (v.1.1)/Ekso GT™ (v.1.2) reference devices, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the Atalante is as safe and effective as the predicate device. Therefore, the Atalante is substantially equivalent to the predicate device.