The NeuroMotion WalkAide is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.

Device Description

The WalkAide is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NeuroMotion WalkAide, based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal "acceptance criteria" in terms of specific performance thresholds for clinical or technical metrics for the WalkAide itself. Instead, it focuses on demonstrating substantial equivalence to predicate devices by comparing technical specifications and functional characteristics.

The table below summarizes the comparison to predicate devices, which implicitly serves as the "acceptance criteria" through equivalence:

Feature	Acceptance Criteria (Predicate Devices)	Reported Device Performance (WalkAide)
Stimulation Type	External Functional Neuromuscular Stimulator (Implied by predicates)	External Functional Electrical Stimulator
Constant Current Range	0 - 100mA (Respond III/Select), 0 - 50mA (Verite Model 817)	0 - 95mA
Pulse Duration (μsec.)	300 (Respond III/Select), 500 (+ve: EMPI), 110 (Verite Model 817)	200
Frequency Range (PPS)	1 - 80 (Respond III/Select), 20 - 50 (EMPI), 50 (Verite Model 817)	25
Electrode Size & Shape	Various, including 2.5cm diameter (Respond III/Select), 3cm & 5cm diameter (EMPI), 4.3cm diameter (Verite Model 817)	2.5cm diameter, Round
Stimulation Activation	Foot sensor (capable, for predicates and WalkAide)	Foot sensor (capable), Built-in tilt sensor
General Safety	No new issues regarding safety (Implied by predicates)	Claims no new safety issues
General Effectiveness	No new issues regarding effectiveness (Implied by predicates)	Claims no new effectiveness issues

Study Information

The provided 510(k) summary describes a series of tests rather than a single, comprehensive clinical study. The primary goal of these tests was to establish substantial equivalence to predicate devices, not to prove standalone efficacy against specific clinical endpoints with a large patient cohort.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific sample sizes for users or patients in the "testing" section. The tests listed are technical in nature, focusing on device characteristics. There's no indication of patient data provenance (country of origin, retrospective/prospective). It appears to be device-centric testing rather than patient-centric clinical trials.
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 tests described are technical device evaluations, not those requiring expert interpretation of clinical data against a ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. Given the nature of the tests (e.g., "Stimulation Pulse Characteristics," "Electrode Current Density Spread"), formal clinical adjudication methods like 2+1 or 3+1 would not apply.
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. The WalkAide is an external functional electrical stimulator, not an AI-powered diagnostic or assistive tool for human interpretation. Therefore, the concept of "human readers improve with AI" is not applicable here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes standalone device testing in terms of its technical characteristics, such as pulse parameters, electrode performance, and trigger mechanisms. The "Clinician System Application Program" also suggests testing of the device's software interface for clinicians. However, this is not an "algorithm only" in the modern AI sense, but rather the device functioning as intended in a controlled environment.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the technical tests mentioned (Stimulation Pulse Characteristics, Electrode Current Density Spread, Foot Sensor Characteristics, Stimulation Trigger Source Timing, Clinician System Application Program), the "ground truth" would be established by engineering specifications, direct measurements using calibrated equipment, and functional verification against design requirements. It is not clinical ground truth like pathology or outcomes data.
The sample size for the training set:
This information is not applicable/not provided. The WalkAide, as described, is a functional electrical stimulator and does not appear to employ machine learning or AI models that would require a "training set" in the context of diagnostic or predictive algorithms.
How the ground truth for the training set was established:
This information is not applicable/not provided for the same reason as point 7.

Summary

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

NEUROMotionFEB - 6

K974514

401 11044 - 82 AVENUE EDMONTON, ALBERTA CANADA T6G OT2

PHONE: (403) 433-1700 FAX: (403) 433-2893

info@nevromotion.com

510(K) SUMMARY

GENERAL

SUBMITTOR:

NeuroMotion Inc.

401 11044 - 82 Avenue NW Edmonton, Alberta Canada T6G 0T2

Phone (403) 433-1700 (403) 433-2893 Fax

Contact: Brian Zerb, Director of Quality

DATE PREPARED:

98-01-27

DEVICE:

Proprietary Name -	WalkAide
Common/Usual Name -	External Functional Neuromuscular Stimulator
Classification Name -	External Functional Neuromuscular Stimulator
Classification Code -	Class II

PREDICATE DEVICES:

Medtronic, Inc.	Respond III	K920436
Medtronic, Inc.	Respond Select®	K903434C
Empi, Inc.	Model 2000	K800380A
Verite	Model 817 VERI/DFS™	K813515

510(K) SUMMARY - WALKAIDE - K974514

{1}------------------------------------------------

DEVICE DESCRIPTION:

Users of the WalkAide are people who have lost the ability to voluntarily lift their foot by flexing the ankle, often as a result of damage to the central nervous system such as stroke, spinal cord injury, and traumatic brain injury. This stimulation will not work with people who have damage to the lower motor neurons/peripheral nerves.

INTENDED USE:

The NeuroMotion WalkAide is intended to address the lack of ankle dorsifiexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.

Feature	WalkAide	MarketedDevices
Device Name	WalkAide	Respond III andRespond Select®	EMPIModel 2000	Verite Model817VERI/DFS
Constant CurrentRange (1000 Ohm load)	0 - 95mA	0 - 100mA		0 - 50 mA
Pulse Duration (μsec.)	200	300	+ ve: 500	110
Frequency Range(PPS)	25	1 - 80	20 - 50	50
Electrode Size andShape	2.5cmdiameterRound	Various, includingSnapEase®2.5cm diameter	3cm & 5cmdiameterRound	4.3cm diameterRound

COMPARISON TABLE

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

DISCUSSION OF SUBSTANTIAL EQUIVALENCE:

STIMULATION CHARACTERISTICS

Pulse shape, pulse width, pulse intensity, and pulse repetition frequency are substantially equivalent to the predicate devices.

STIMULATION ACTIVATION TRIGGER MECHANISM

Beside being capable of using a foot sensor to trigger stimulation, the WalkAide mainly utilizes a built-in tilt sensor to trigger stimulation on and off points in an equivalent manner to a foot sensor.

ELECTRODES

The WalkAide electrodes are similar to certain electrodes listed with the predicate devices. They are 2.5cm in diameter, contain an integral snap connector, and are pre-gelled.

TESTING:

The following tests were conducted to aid in the determination of substantial equivalence, and successfully completed:

Stimulation Pulse Characteristics .
Electrode Current Density Spread ●
. Foot Sensor Characteristics
. Stimulation Trigger Source Timing Foot Sensor Tilt Sensor
Clinician System Application Program ●

CONCLUSION:

Based on the information provided above, NeuroMotion believes that the WalkAide is substantially equivalent to the existing legally marketed devices, and does not alter or introduce any issues regarding safety and effectiveness.

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

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 1998

Mr. Brian Zerb · Director of Quality NeuroMotion, Inc. 401 11044-82 Avenue Edmonton, Alberta Canada T6G 0T2

K974514 Re: WalkAide Requlatory Class: II Product Codes: GZI and IPF November 27, 1997 Dated: December 1, 1997 Received:

Dear Mr. Zerb:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and ---------prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. . A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Mr. Brian Zerb

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number: K974514

WalkAide Device Name:

Indications for Use:

The NeuroMotion WalkAide is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gair. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased. local blood flow, muscle re-education, and maintained or increased joint range of motion.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Pcole &

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974514

Prescription Use (Per 21 CFR 801.109) OR

Over the Counter

510(K) NOTIFICATION - WALKAIDE DATE PREPARED: 97-11-27 REVISION DATE: 98-01-27

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).