The Innovative Neurotronics WalkAide System 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. The WalkAide System consists of the WalkAide Patient Kit and the WalkAide Clinician Kit . The WalkAide Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System comprises the accessories that a clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.) will use to set up a patient's WalkAide.

AI/ML Overview

The provided 510(k) summary for the Innovative Neurotronics, Inc. WalkAide System does not contain the detailed information requested regarding specific acceptance criteria, a study proving performance against those criteria, or the ground truth establishment process.

The document states that "Applicable performance and safety testing was performed to verify technological and functional characteristics including any design modification," and that "Any design modifications do not raise any safety or effectiveness issues." However, it does not elaborate on what these performance and safety tests entailed, the acceptance criteria used, or the results of such tests.

Therefore, I cannot populate the table or answer most of the specific questions. Based on the provided text, here is what can be inferred or explicitly stated:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	"substantially equivalent to the parent Walk-Aide"
Not specified	"Applicable performance and safety testing was performed to verify technological and functional characteristics"

Here are the answers to the specific questions, based on the provided text:

A table of acceptance criteria and the reported device performance
- As shown in the table above, the document does not specify quantitative acceptance criteria or detailed reported device performance. It only states that the device is "substantially equivalent" to predicate devices and that "applicable performance and safety testing was performed."
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This information is not provided in the 510(k) summary.
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 510(k) summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided in the 510(k) summary.
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 is not applicable as the WalkAide is an FES device, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable in the context of an FES device. The device itself is the "algorithm" delivering stimulation, but the performance is measured on the patient's gait, not against a diagnostic benchmark. The document does not describe standalone performance testing beyond the general statement of "technological and functional characteristics."
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document does not specify the type of ground truth. Given the nature of an FES device, "ground truth" would likely relate to objective measures of gait improvement or physiological effects, but this is not detailed.
The sample size for the training set
- This information is not provided in the 510(k) summary. The WalkAide is a medical device, not a machine learning algorithm that typically requires a "training set" in the computational sense. The "training" for such a device would refer to clinical use and patient adaptation.
How the ground truth for the training set was established
- This information is not provided. As noted above, the concept of a "training set" and "ground truth for training" in the machine learning context does not directly apply here without further explanation within the document.

Summary

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K052329

510(k) Summary for the Innovative Neurotronics, Inc. WalkAide System

SPONSOR 1.

Innovative Neurotronics, Inc. Two Bethesda Metro Center, Suite 1200 Bethesda, Maryland

Contact Person:	Fayyaz Memon – Director of Quality and Manufacturing
Telephone:	1-888-884-6462 ext. 1005

August 25, 2005 Date Prepared:

DEVICE NAME 2.

Proprietary Name:	WalkAide
Common/Usual Name:	External Neuromuscular Functional Stimulator
Classification Names:	External Neuromuscular Functional Stimulator
Classification Number:	21 CFR 882.5810
Product Code:	GZI

PREDICATE DEVICES 3.

Neuromotion WalkAide System-K974514

INTENDED USE 4.

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DEVICE DESCRIPTION ડ.

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The intended use and technological characteristics such as pulse shape, pulse width, pulse intensity, stimulation trigger mechanism, and other characteristics of the proposed WalkAide are either identical or substantially equivalent to the parent WalkAide devices.

Applicable performance and safety testing was performed to verify technological and functional characteristics including any design modification. Any design modifications do not raise any safety or effectiveness issues.

CONCLUSIONS 7.

Based on the information provided in this premarket notification, Innovative Neurotronics believes that the proposed WalkAide is substantially equivalent to the parent Walk-Aide.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Fayyaz Memon Director of Quality and Manufacturing Innovative Neurotronics, Inc. Two Bethesda Metro Center, Suite 1200 Bethesda, Maryland 20814

Re: K052329

Trade/Device Name: Walk Aide External Dunctional Neuromuscular Stimulator Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: August 25, 2005 Received: August 25, 2005

Dear Mr. Memon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Fayyaz Memon

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter with a finding of substantial equivalence of your device of your device to a legally promatics notineted 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Signature

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number : _ _ (1)53337

Device Name: Innovative Neurotronics, Inc., WalkAide External Functional Neuromuscular Stimulator

Indications for Use:

The Innovative Neurotronics WalkAide External Functional Neuromuscular Stimulator (WalkAide System) 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 System 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K052329

Page viii

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).