The ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the swing phase of gait, the ODFS electrically stimulates muscles in the leg and ankle of partially paralyzed individuals to provide flexion of the foot and may thus improve the individual's gait. Additional benefits of Functional Electrical Stimulation (FES) may include muscle re-education, prevention/retardation of disuse atrophy, maintained or increased joint range of motion, and increased local blood flow.

The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury.

Device Description

The ODFS Dropped Foot Stimulator (ODFSIII Version 6.2) is an external functional neuromuscular stimulator. The ODFS Dropped Foot Stimulator electrically stimulates the common peroneal nerve which may produce contraction of the appropriate muscles that cause dorsiflexion of the ankle in individuals who have lost the ability to do so following neurological injury.

The device is comprised of a small belt-worn, single-channel, foot-switch controlled stimulator used with skin-surface stimulating electrodes. The surface electrodes are typically placed over the common peroneal nerve as it passes near the head of the fibula and the motor point of the tibialis anterior in the lower leg. The heel switch allows the delivery of stimulation to be triggered according to the gait of the user.

AI/ML Overview

The provided 510(k) summary for the ODFS Dropped Foot Stimulator does not contain sufficient information to comprehensively describe acceptance criteria and the study that proves the device meets those criteria, as it primarily focuses on substantial equivalence to predicate devices and general performance testing.

Here's an attempt to extract and describe the available information based on your request, highlighting what is not explicitly stated in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Not explicitly stated as such, inferred from testing)	Reported Device Performance
Output and operational characteristics	Meet product specifications (inferred)	All units tested met product specifications.
Electrical Safety (IEC 60601-1)	Compliance with standard	Testing included IEC 60601-1 (with amendments).
Electrical Safety (IEC 60601-2-10)	Compliance with standard (if applicable)	Testing included IEC 60601-2-10 (as applicable).
Electromagnetic Compatibility (ISO 60601-1-2)	Compliance with standard (if applicable)	Testing included ISO 60601-1-2 (as applicable).
Waveform	Biphasic (Symmetrical and Balanced Asymmetrical)	Biphasic (Symmetrical and Balanced Asymmetrical)
Pulse Width	7 (±4) to 365 (±20) µsec (patient selectable)	7 (±4) to 365 (±20) µsec (patient selectable)
Frequency	40 (±4) Hz	40 (±4) Hz

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document states "All units tested met product specifications," implying a smaller, internal testing sample rather than a clinical trial test set.
Data Provenance: Not specified. The device sponsor is based in the United Kingdom, so the testing likely occurred there, but this is not explicitly stated. The document does not indicate if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as the submission describes device performance testing against specifications, not a clinical study involving experts establishing ground truth for clinical outcomes.

4. Adjudication Method for the Test Set

This information is not provided as the submission does not detail a clinical study with a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No. The document does not mention an MRMC study or any clinical study comparing human readers with and without AI assistance. The device is a stimulator, not an imaging analysis tool.
Effect size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is an external functional neuromuscular stimulator, not an algorithm for diagnostic purposes. The performance assessment describes the device's ability to meet its technical specifications. There is no "algorithm only" performance reported in the context of diagnostic accuracy. The performance described relates to the device's physical outputs (waveform, pulse width, frequency).

7. Type of Ground Truth Used

For the reported performance ("All units tested met product specifications"), the "ground truth" was the pre-defined product specifications for electrical output and operational characteristics. This is a technical ground truth, not a clinical one.

8. Sample Size for the Training Set

This information is not applicable/provided. The device is a hardware product with electrical specifications, not an AI or machine learning algorithm that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the reasons stated above. The "ground truth" for the device's technical specifications would have been established during the design and engineering phases, based on established physiological needs for functional electrical stimulation and electrical engineering principles.

Summary

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K050991

JUL 1 5 2005

510(k) Summary For The ODFS Dropped Foot Stimulator

1. SPONSOR

Department of Medical Physics and Biomedical Engineering Salisbury Heath Care NHS Trust Salisbury District Hospital Salisbury Wiltshire SP2 8BJ United Kingdom

Tina E. Lechman, NDI Medical Contact Person: 216-378-9106 ext. 101 Telephone:

April 15, 2005 Date Prepared:

NDI Medical (US Agent) One Chagrin Highlands 2000 Auburn Drive, Suite 320 Cleveland, OH 44122 Telephone: 216-378-9106 Fax: 216-378-9116

Device Name 2.

Trade/Proprietary Name:	The ODFS Dropped Foot Stimulator
Common/Usual Name:	External Functional Neuromuscular Stimulator (FES)
Classification Name:	External Functional Neuromuscular Stimulator (FES)Powered Muscle Stimulator (NMES)
Classification Code:	Class II
Product Codes:	GZI and IPF

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3. PREDICATE DEVICES

Predicate Name	Company	K Number
EMPI Focus Model 795	EMPI	K951951
WalkAide	NeuroMotion	K974514

DEVICE DESCRIPTION 4.

ട. INTENDED USE

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Feature	ODFS	EMPI Focus Model 795	WalkAide
Waveform	Biphasic(Symmetrical andBalanced Asymmetrical)	Biphasic(Symmetrical andBalanced Asymmetrical)	Not available
Pulse Width	7 (±4) to 365(±20) µsec(patient selectable)	300 µsec	200 µsec
Frequency (Hz)	40 (±4) Hz	25, 30, 35, 45, 50, 80 Hz	25 Hz
Indications for Use	To provide ankledorsiflexion in individualswith dropped foot followingan upper motor neuroninjury. During the swingphase of gait, the ODFSelectrically stimulatesmuscles in the leg and ankleof partially paralyzedindividuals to provideflexion of the foot and maythus improve the individual'sgait. Additional benefits ofFunctional ElectricalStimulation (FES) mayinclude muscle re-education,prevention/retardation ofdisuse atrophy, maintainedor increased joint range ofmotion, and increased localblood flow.	As a TENS device:Symptomatic relief and managementof chronic intractable pain;adjunctive treatment for post-surgical and post-trauma acute painAs a NMS/NMES device:.Relaxation of muscle spasm;prevention or retardation of disuseatrophy; increasing local bloodcirculation; muscle re-education;immediate post-surgical stimulationof the calf muscles to preventvenous thrombosis; maintaining orincreasing range of motion.As a FES device:Stimulating muscles in the leg andankle of partially paralyzed patientsto provide flexion of the foot andthus improve the patient's gait.	To address the lack ofankle dorsiflexion inpatients who havesustained damage to uppermotor neurons orpathways to the spinalcord. During the swingphase of gait, theWalkAide electricallystimulates the appropriatemuscles that cause ankledorsiflexion and may thusimprove the patient's gait.Medical benefits of FESmay includeprevention/retardation ofdisuse atrophy, increasedlocal blood flow, musclere-education, andmaintained or increasedjoint range of motion.
Accessories	Heel switch	Heel switch, Hand switch	Heel switch, Tilt sensor
Electrode Size andShape	5.0 cm x5.0cm square = 25 cm24cm x 6.4 cm oval = 20 cm2	5.1cm2	2.5cm round

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

7. PERFORMANCE TESTING

The ODFS system has been subjected to testing to verify that the device meets its key output specifications. All units tested met product specifications.

Testing included:

Functional verification testing of output and operational characteristics .
IEC 60601-1 (EN 60601-1:1988 with amendments of 1991 & 1995). .
IEC 60601-2-10 (as applicable). ●
ISO 60601-1-2 (as applicable). .

Based on the information provided, the ODFS Dropped Foot System is substantially equivalent to legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Department of Medical Physics and Biomedical Eng. Salisbury Health Care NHS Trust c/o Ms. Tina E. Lechman Clinical Project Manager, US Agent NDI Medical One Chagrin Highlands 2000 Auburn Drive, Suite 320 Cleveland, Ohio 44122

JUL 1 5 2005

Re: K050991

Trade/Device Name: ODFS Dropped Foot Stimulator Regulation Number: 21 CF 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: July 8, 2005 Received: July 11, 2005

Dear Ms. Lechman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarer of the device is substantially equivalent (for the indications felerenced above and nave develomined by marketed predicate devices marketed in interstate for use stated in the enorosure) (3 16gars) in the Medical Device Amendments, or to commerce prior to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, devices mat nave occh rechasined in assere approval of a premarket approval application (PMA). alle Costile Act (110.) that to hovice, subject to the general controls provisions of the Act. The r ou may, mercere, mainer of the Act include requirements for annual registration, listing of general controlly provisions of ractice, 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 If your device is olassined (too as corrols. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of actived that it is mination that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must or any I each statutes and streequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quant) by by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Tina E. Lechman

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manieming your and equivalence of your device to a legally premarket notheadon: "The PDF milling of east will be 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 If you desire specific advice for your accept 2011 276-0120. Also, please note the regulation entitled, program and Colliact the Orition of Compilance and (21CFR Part 807.97). You may obtain Misofanung by reference to premainentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Signature

Miriam C. Provost, Ph.D 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 (if known): K050991

Device Name: ODFS Dropped Foot Stimulator

Indications for Use:

The ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the morradaze with the ODFS electrically stimulates muscles in the leg and ankle of swing prace or grouped individuals to provide flexion of the foot and may thus improve partially paral's gait. Additional benefits of Functional Electrical Stimulation (FES) the marriadal s garrestion, prevention/retardation of disuse atrophy, maintained or increased joint range of motion, and increased local blood flow.

The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

19131011 Sign-Off) Ivision of General, Restorative and Neurological Devices

Page 1 of 1

Number K050921

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).