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.

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.

AI/ML Overview

The provided text describes the Atalante exoskeleton and its substantial equivalence submission to the FDA. However, the document does not contain acceptance criteria for device performance in the format of a table, nor does it detail a study specifically designed to prove the device meets such criteria with precise metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on:

Non-Clinical Performance Data: Demonstrating that the device meets internal, national, and international standards for electrical safety, EMC, software validation, mechanical verification, thermal testing, and useful life. This is reported as "Passed" for each test.
Clinical Performance Data: Highlighting two clinical studies and real-world evidence to show safety and effectiveness in improving functional ambulation and overall balance in CVA patients. It states that all subjects completed performance outcome measures successfully and there were no serious adverse events.

Since the request asks for specific information that is not present in the provided text (such as a table of acceptance criteria with reported performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth information for training sets), I will have to state where the information is absent.

Here's the breakdown of the information requested, based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or numerical thresholds for functional improvement) and corresponding reported device performance. It generally states that the device "Passed" various tests or that clinical studies "demonstrated" safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Clinical Studies (Test Set): "Two clinical studies with a total of 43 patients with cerebrovascular accident (CVA) were undertaken."
Data Provenance: Not specified in terms of country of origin or whether the studies were retrospective or prospective. Given they are referred to as "clinical studies," they are typically prospective, but this is not explicitly stated. The mention of "real world evidence of use by over 250 patients" suggests a broader patient base but does not specify its provenance or use as a formal "test set" for performance evaluation in the same way as the 43 patients.

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 evaluated patient outcomes, but there's no mention of specific experts establishing a "ground truth" in the context of diagnostic or interpretive performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

This type of study is not mentioned in the document. The device is a powered exoskeleton, not an AI-assisted diagnostic or interpretive tool where "human readers" would be involved in interpretation. The clinical studies assessed patient functional improvements.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a "Powered Lower Extremity Exoskeleton" intended to be used "under the supervision of a trained operator." Therefore, a "standalone" algorithm-only performance assessment in the context of diagnostic AI is not applicable. The device's performance is intrinsically tied to its use by a patient under operator supervision.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the clinical studies, the "ground truth" or primary outcome measured would be outcomes data related to functional ambulation abilities and overall balance improvement in CVA patients. These improvements are assessed through standard rehabilitation performance outcome measures.

8. The sample size for the training set

The document explicitly mentions clinical studies (test set) and real-world evidence, but does not provide a specific sample size for a "training set" in the context of machine learning model development. This device, as an exoskeleton, may undergo continuous calibration or adaptation, but the concept of a distinct "training set" for an AI model's ground truth, as typically understood in diagnostic AI, is not detailed.

9. How the ground truth for the training set was established

As no specific "training set" for an AI model is detailed, the method for establishing its "ground truth" is not provided. The documentation focuses on engineering validation and clinical outcomes for device performance.

Summary

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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.

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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 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) andEkso 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

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®	EksoEkso™ (v.1.1) andEkso 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®	EksoEkso™ (v.1.1) andEkso GT™ (v.1.2)
Indications for Use	The Atalante exoskeleton isintended to enableindividuals with hemiplegiadue to cerebrovascularaccident (CVA) to performambulatory functions andmobility exercises, hands-free, in rehabilitationinstitutions under thesupervision of a trainedoperator.The operator mustcomplete a training programprior to use of the device.The Atalante system isintended to be used onadolescents of 18 yearsand older and adults able totolerate a stand-up position.The device is not intendedfor sports or stair climbing.	The Indego® orthotically fitsto the lower limbs and thetrunk; the device is intendedto enable individuals withspinal cord injury at levelsT3 to L5 to performambulatory functions withsupervision of a speciallytrained companion inaccordance with the userassessment and trainingcertification program. Thedevice is also intended toenable individuals withspinal cord injury at levelsC7 to L5 to performambulatory functions inrehabilitation institutions inaccordance with the userassessment and trainingcertification program.Finally, the Indego® is alsointended to enableindividuals with hemiplegia(with motor function of 4/5in least one upperextremity) due tocerebrovascular accident(CVA) to performambulatory functions inrehabilitation institutions inaccordance with the userassessment and trainingcertification program. TheIndego is not intended forsports or stair climbing.	The Ekso™ (version 1.1)and Ekso GT™ (version1.2) are intended to performambulatory functions inrehabilitation institutionsunder the supervision of atrained physical therapistfor the following populationwith upper extremity motorfunction of at least 4/5 inboth arms:Individuals with hemiplegiadue to stroke,Individuals with spinal cordinjuries at levels T4 to L5,and Individuals with spinalcord injuries at levels of C7to T3 (ASIA D).The therapist mustcomplete a training programprior to use of the device.The devices are notintended for sports or stairclimbing.
	Subject Device	Predicate	Reference Device
FEATURE	Atalante	Indego®	EksoEkso™ (v.1.1) andEkso GT™ (v.1.2)
Population	Adolescents of 18 yearsand older, and adults	Adults over age of 18	Adults over age of 18
Environment	Rehabilitation centers	CVA population clearedonly for use inRehabilitation centers	Rehabilitation centers
Body Coverage	Worn over legs and upperbody with rigid torso	Worn over legs and aroundhips with lower torso	Worn over legs and upperbody with rigid torso
Size of Components	Adjustable upper leg, lowerleg. Non adjustable hipwidth;	Modular Small, Medium andLarge upper leg, lower legand hip components;	Adjustable upper leg, lowerleg, 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° flexionto 30° extension	Hips: 135° flexionto 20° extension
	Knee: 110° flexionto -5° extension(flexum).	Knees: 110° flexionto 10° extension
	Ankle: 0 dorsiflexion,9° plantar flexion,18° pronation andsupination		Ankles: 0° dorsiflexionto 25° plantar extension
RechargeableBattery	Rechargeable lithium-ionbattery 46.8 V, 9 Ah	Rechargeable lithium ion.33.3 V, 36A peak current,12A continuous current.	Rechargeable lithiumion batteries 48.1V,30A peak current,
	Usage duration: 2 hours ofcontinuous usage percharge	159Wh fully charged;
		Usage duration: 1.5 hoursof continuous usage percharge	1 hour of continuoususage per charge
Battery ChargeTime	4 hours	4 hours	1 hour
Training Program	Yes	Yes	Yes
	Subject Device	Predicate	Reference Device
FEATURE	Atalante	Indego®	EksoEkso™ (v.1.1) andEkso GT™ (v.1.2)
CertificationProgram	Yes	Yes	Yes
User Feedback	Provides visual feedback onthe handheld controller andphysio interface, andauditory feedback.	Provides vibratory feedbackand LED indicators on topof hip unit, visible to wearer	Provides visual feedback onthe handheld controller andauditory feedback
Fall Detection andMitigation	Must be used incombination with safety rail	Detects forward, backwardand sideways falling as it ishappening; the devicemakes adjustments duringthe course of the fall toposition the user forminimal risk of injury orallow the user to attempt torecover unassisted	None
Failsafe Feature	None	In the event of power failureknees become locked andhips free (similar to typicalpassive leg braces)	In event of power failure–knees become locked andhips free (similar to typicalpassive leg braces)
Electrical Testing	ANSI AAMI ES60601-1:2005/(R)2012 AndA1:2012.	ANSI/AAMI ES60601-1:2005/(R)2012	IEC 60601-1:2005with US deviations
ElectromagneticCompatibilityTesting	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.

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).