The EvoWalk 1.0 System is intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stoke, damage to pathways to the spinal cord). The EvoWalk 1.0 System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the flexion or extension; thus, it also may improve the individual's gait.

Device Description

The EvoWalk 1.0 system is a wearable non-invasive functional electrical stimulation (FES) device intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion in adult individuals with muscle weakness related to upper motor neuron diseaselinjury (e.g., stroke, damage to pathways in the spinal cord), thus providing treatment for foot drop. EvoWalk 1.0 can be used in a healthcare facility and home settings.

The EvoWalk 1.0 system consists of the EvoWalk device with an elastic band and built-in rechargeable lithium polymer battery, and the accessories including the EvoWalk mobile application, micro USB type charge cable with charge port, lead cables (one single channel and one dual channel), eight sets of electrodes for each channel, instructions for use (IFU), and a carrying case.

AI/ML Overview

The provided text describes the EvoWalk 1.0 System, an external functional neuromuscular stimulator, and its submission for FDA 510(k) clearance. However, it does not include specific acceptance criteria and detailed study results to demonstrate the device meets those criteria in a format that allows for a direct population of the requested table. The document primarily focuses on establishing substantial equivalence to a predicate device (Bioness L300 Go System) through a comparison of technological characteristics and a summary of nonclinical tests performed.

Therefore, I cannot directly extract and provide the exact acceptance criteria and reported device performance from the given text in a tabular format, nor can I provide information on sample sizes for test and training sets, data provenance, expert ground truth establishment, or clinical study details as requested. The document explicitly states "Summary of Nonclinical Tests Submitted," indicating that only nonclinical (bench and software) tests were submitted, not clinical studies involving human performance metrics against specific acceptance criteria.

The information that can be extracted relates to the nonclinical testing performed to demonstrate safety and effectiveness and substantial equivalence.

Here's a breakdown of what is available and what is missing from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the provided document. The document lists the general nonclinical tests performed but does not provide specific quantitative acceptance criteria or the numerical performance results of the EvoWalk 1.0 System against such criteria.

2. Sample size used for the test set and the data provenance:

Sample size for the test set: Not specified. The document mentions "nonclinical testing" and "bench testing" but does not detail sample sizes for any specific components or tests.
Data provenance: Not applicable as no clinical test set data is described. The tests are nonclinical (bench and software validation).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The document describes nonclinical tests and software validation, which do not typically involve expert review for ground truth in the same way clinical image analysis or diagnostic AI studies would.

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

Not applicable. This relates to clinical studies involving human observers, which are not detailed in this 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:

No, an MRMC comparative effectiveness study was not done according to the provided text. The document focuses on the device's technical performance and substantial equivalence to a predicate, not how human readers improve with AI assistance.

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

Yes, implicitly, for specific functionalities. The document mentions "Motion analysis to validate the gait event detection algorithm" and "Software validation according to IEC 62304." These are standalone algorithm performance evaluations without human-in-the-loop. However, specific performance metrics are not provided. The device itself is a functional electrical stimulator, and its core function is to deliver stimulation based on algorithms detecting gait events.

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

For the nonclinical tests, the ground truth would be based on engineering specifications, established standards (e.g., IEC 60601 series for electrical safety, EMC, and neuromuscular stimulators), and internal verification protocols. For the "gait event detection algorithm," the ground truth would likely be established through sensor data from controlled movements where gait events are precisely known or measured independently. No specific external expert consensus, pathology, or outcomes data are mentioned for ground truth.

8. The sample size for the training set:

Not specified. The document does not discuss a training set for the device's algorithms, implying that the algorithm might be rule-based or trained using internal data without explicit mention of size.

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

Not specified, as no training set is explicitly discussed.

Summary of Nonclinical Tests Mentioned:

The document primarily relies on nonclinical testing to support the safety and effectiveness and substantial equivalence of the EvoWalk 1.0 System. The tests performed include:

Technological Characteristics of Powered Muscle Stimulation Stimulation Output Waveforms
Motion analysis to validate the gait event detection algorithm
Electrical Safety according to IEC 60601-1; IEC 60601-1-11
Muscle and Nerve Stimulators according to IEC 60601-2-10
Electromagnetic compatibility according to IEC 60601-1-2
Software validation according to IEC 62304

The document concludes that "Evolution Devices believes the EvoWalk 1.0 system is substantially equivalent to the Bioness L300 GO system (K173682), and does not raise any new issues or concerns of safety or effectiveness. The evidence presented in the bench testing and non-clinical testing is sufficient to support the safety and effectiveness of the device."

In essence, the provided text details the regulatory context (510(k) summary) and the types of nonclinical tests conducted to support substantial equivalence, but it does not contain the detailed quantitative results and specific acceptance criteria that would be found in a full clinical study report or a detailed test report.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 28, 2023

Evolution Devices, Inc. Pierluigi Mantovani CEO 1111 Broadway FL 3. Oakland, California 94607

Re: K230997

Trade/Device Name: EvoWalk 1.0 System Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: December 5, 2023 Received: December 18, 2023

Dear Pierluigi Mantovani:

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 (the 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 available 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}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

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

Sincerely,

Lauren E. Woodard -S

for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices

{2}------------------------------------------------

OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K230997

Device Name EvoWalk 1.0 System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	☑
----------------------------------------------	-----------------------------------------

Over-The-Counter Use (21 CFR 801 Subpart C)	☐
---------------------------------------------	-----------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

Evolution Devices, Inc. EvoWalk 1.0 System

510(k) Summary: EvoWalk 1.0 System

Company Name: Evolution Devices, Inc.

Contact Person: Pierluigi Mantovani Chief Executive Officer Evolution Devices, Inc. 1111 Broadway FL 3, Oakland CA 94607 United States Phone Number: 6619930685 Email: pierluigi@evolutiondevices.com

Date Prepared: November 15, 2023

Trade Name: EvoWalk 1.0 System

Classification: Name: External functional neuromuscular stimulator Product Code: GZI Regulation Number: 21 CFR 882.5810 External functional neuromuscular stimulator Class: II Classification Panel: Neurology

Predicate devices: Company: Bioness Inc. Device: L300 Go System (K173682)

Purpose of the traditional 510(k): This Traditional 510(k) is submitted to clear a new device, the EvoWalk 1.0 System.

Device description:

Indications for use:

The EvoWalk 1.0 system is intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron

{5}------------------------------------------------

disease/injury (e.g., stroke, damage to pathways to the spinal cord). The EvoWalk 1.0 system electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the floxion or extension; thus, it also may improve the individual's gait.

Substantial Equivalence:

Table 1. Predicate Comparison Chart

Trade Name	EvoWalk 1.0 System(K230997)	L300 Go System(K173682)
Manufacturer	Evolution Devices Inc.	Bioness Inc.
510(k) Number	K230997	K173682
Product Code	GZI	GZI & IPF
Indication forUse	The EvoWalk 1.0 system is intended toprovide ankle dorsiflexion in adult individualswith foot drop and/or to assist knee flexion orextension in adult individuals with muscleweakness related to upper motor neurondisease/injury (e.g., stroke, damage topathways to the spinal cord). The EvoWalk1.0 system electrically stimulates muscles inthe affected leg to provide ankle dorsiflexionof the foot and/or knee flexion or extension;thus, it also may improve the individual's gait.	The L300 Go System is intended to provide ankledorsiflexion in adult and pediatric individuals withfoot drop and/or to assist knee flexion orextension in adult individuals with muscleweakness related to upper motor neurondisease/injury (e.g., stroke, damage to pathwaysto the spinal cord). The L300 Go Systemelectrically stimulates muscles in the affected legto provide ankle dorsiflexion of the foot and/orknee flexion or extension; thus, it also mayimprove the individual's gait.The L300 Go System may also:• Facilitate muscle re-education• Prevent/retard disuse atrophy• Maintain or increase joint range of motion• Increase local blood flow
Number ofOutput Modes	Biphasic Symmetric Mode only	2 modes: Biphasic Asymmetric and Symmetric
Number ofPrograms	• Gait• Tuning• Standby	• Gait• Training/Exercise• Clinician mode
RegulatedCurrent orRegulatedVoltage	Current	Current
Power Source	Rechargeable, Li-Ion, Prismatic, 3.7 V, 700mAh	Control Unit: Li Coin Cell, CR2032, 3 V, 240 mAhEPG: Rechargeable, Li-Ion, Prismatic, 3.7 V,1000 mAhFoot Sensor: Li Coin Cell, CR2032, 3 V, 240 mAh
Microprocessor-Controlled	Yes	Yes

{6}------------------------------------------------

Max OutputCurrent(± 10%)	Thigh Channel:102.4 mA @ 500Ohm load	Lower Leg Channel:102.4 mA @ 500 Ohmload	Thigh FSC: 100mA @ 500Ohm load	L300 Lower Leg FSC: 100mA @ 500 Ohm load
Max AverageCurrent Density[mARMS/cm²][Over smallestelectrode]	Thigh Channel:rectangularelectrodes0.26 mArms/cm²(500 Ω, Irms=13.0mA, electrode areaof 50 cm²)	Lower Leg Channel:Square electrodes0.56 mArms/cm²(500 Ω, Irms=13.0 mA,electrode area of 25cm²)round electrodes1.37 mArms/cm²(Area 10.2 cm²)	Thigh EPG:0.18 mArms/cm²(500 Ω, Irms=13.0mA, electrode area of74cm²)	Lower Leg EPG:small cuff, gel electrodes1.27 mArms/cm²(500 Ω, Irms=13.0 mA,electrode area of 10.2cm²)
Max AveragePower Density,(mW/cm²)	Thigh Channel:rectangularelectrodesA = 10.1x5.0 cm =50 cm²1.7 mW/cm² @ 500Ω	Lower Leg Channel:square electrodesA = 5x5 cm = 25 cm²3.4 mW/cm² @ 500 Ωround electrodesA =10.2cm²8.3 mW/cm² @ 500 Ω	Thigh EPG:1.1 mW/cm²(500 Ω, Irms=13.0mA, electrode area of74 cm²)	Lower Leg EPG: small cuff,gel electrodes8.3 mW/cm²(500 Ω, Irms=13.0mA, electrode area of 10.2cm²)regular cuff, gel electrodes5.3 mW/cm²(500 Ω, Irms=13.0mA, electrode area of 15.9cm²)
StimulationChannels	2 channels		Thigh EPG: 1	Lower Leg EPG: 2(functioning as a singlechannel with separately-adjustable medial / lateralstimulation intensity)
Electrodes usedin the system	Hydrogel Electrodes:Square Electrodes:Male Snap connector;Surface area 25.0 cm²Rectangular Electrodes:Male Snap connector;Surface area 50.0 cm²Round Electrode:Male Snap connector;Surface area: 10.2cm²		Lower Leg FSC:• 2 Hydro-Gel electrodes assembled onelectrode bases, or• 2 non-woven cloth electrodes assembledon electrode bases, or• 2 non-woven cloth electrodes attached withsnaps (also called "QuickFit" electrodes), or• 3 non-woven cloth electrodes attached withsnaps (segmented electrodes [also called"steering" electrodes], using common anodeto allow separate adjustment of medial andlateral stimulation)Thigh FSC:• 2 single, non-woven cloth electrodesattached with snaps

{7}------------------------------------------------

ClinicianControl/Programming	Clinician uses the EvoWalk 1.0 companionapplication to set stimulation energy andtemporal parameters related to the functionalstimulation performance for dorsiflexioncontrol and/or knee weakness control	Clinician uses the Clinician Programmer (CAPP)to set stimulation energy and temporalparameters related to the functional stimulationperformance for dorsiflexion control and/or kneeweakness control
ClinicianProgrammer(CAPP)Platform	Mobile Application (iOS and Android)	Tablet PC
User Control	Wearable unit:Users can press the button to power on,power off, enter pairing mode and togglebetween standby mode (pause all stimulation)and active mode.Mobile application:From the app the user can set stimulationparameters, review usage data, togglebetween standby mode (pause allstimulation), active mode, and tune thestimulation intensity before and duringambulation.	Using hand-held Control Unit, the mobileapplication (MAPP), or the EPG-based interface,the user can:• Turn system On/Off (via EPG only) andStart/Stop stimulation• Select Gait/Training program• Fine-tune stimulation intensity aroundworking point set by the clinician• Test L300 Lower Leg EPG & Thigh EPG
Stimulationtrigger source(when used forgait)	In gait mode, stimulation is triggered bythe inertial measurement unit motion sensorembedded in the stimulator printed circuitboard	In gait mode, stimulation is triggered by:(1) the motion sensor embedded in the EPG;or(2) Foot Sensor that detects Heel On & HeelContact events during gait and transmitsthem wirelessly to the lower and thighEPGs.
Communicationmethod	EvoWalk 1.0 system - mobile user interfaceapplication:wireless Bluetooth (Low Energy)communication protocol	Control Unit – Lower Leg /Thigh EPG: wirelessBluetooth (Low Energy) communication protocolGait Sensor - Lower Leg/Thigh EPG: wirelessBluetooth (Low Energy) communication protocolClinician Programmer - EPG: wireless Bluetooth(Low Energy) communication protocolMAPP - Lower Leg /Thigh EPG: wirelessBluetooth (Low Energy) communicationprotocol
Maximum PhaseCharge, (µC)@500 Ω	Lower leg:$200μs * 102mA = 20μC$Thigh:$200μs * 102mA = 20μC$	Not Reported

The indication for use is the same for EvoWalk 1.0 System and Bioness L300 Go System except EvoWalk 1.0 system is for adults only and Bioness L300 Go System is for pediatrics and adults. Additionally, EvoWalk 1.0 System is not indicated for muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, or increase local blood flow. Both devices are worn on the user's leg, use hydrogel electrodes, have two channels of stimulation, use an embedded sensor to control stimulation, and both devices have a user interface through a mobile application. The EvoWalk 1.0 system eliminates some optional features of the Bioness L300 Go System including the separate thigh cuff, heel sensor, semi-rigid cuff, cloth electrode option, and dedicated remote control. Both systems control the stimulation in the gait program by reading the embedded motion sensor and applying algorithms and user-specified parameters such that the stimulation activates at a specific time within each gait cycle.

{8}------------------------------------------------

Summary of Nonclinical Tests Submitted

The EvoWalk 1.0 system has been verified and validated successfully for its intended use through a combination of original bench testing and verification and validation of all software and firmware. Based on the result of the nonclinical testing, Evolution Devices, Inc. concludes that the device is substantially equivalent to the predicate Bioness L300 Go System. The tests listed have been conducted to demonstrate that the EvoWalk 1.0 system performs as intended and is substantially equivalent to the predicate device.

Technological Characteristics of Powered Muscle Stimulation Stimulation Output Waveforms ●
Motion analysis to validate the gait event detection algorithm ●
Electrical Safety according to IEC 60601-1; IEC 60601-1-11 ●
Muscle and Nerve Stimulators according to IEC 60601-2-10 ●
Electromagnetic compatibility according to IEC 60601-1-2 ●
Software validation according to IEC 62304 ●

Conclusion:

Evolution Devices believes the EvoWalk 1.0 system is substantially equivalent to the Bioness L300 GO system (K173682), and does not raise any new issues or concerns of safety or effectiveness. The evidence presented in the bench testing and non-clinical testing is sufficient to support the safety and effectiveness of the device.

The testing ensures that the device is safe for the intended use and will not cause harm to the user or interfere with other medical equipment or electronic devices. The software verification and validation testing ensure that the software used in the device operates as intended and is free of defects or errors.

In conclusion, the non-clinical evidence and testing considered for the bench testing 510k FDA submission for the EvoWalk 1.0 system supports the safety and effectiveness of the device.

Regulation Number and Section

§ 882.5810 External functional neuromuscular stimulator.

(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).