The ODFS® Pace is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. By detecting the swing phase of gait through a foot switch signal, appropriate electrical stimulation of the leg and ankle muscles may improve gait by flexing the foot of persons who have lost or impaired function. There may be additional benefits from FES such as muscle re-education, prevention/retardation of disuse atrophy, increased or maintained range of joint motion and increase in local blood flow.

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

Device Description

The ODFS® Pace is an external functional neuromuscular stimulator. It consists of a small, body worn, single channel stimulator which is triggered by a wired footswitch worn in the shoe. Electrical pulses are generated by the device in order to stimulate muscles in the lower limb. Triggering with a footswitch permits the stimulation to be varied according to the gait of the user. Stimulation produces contraction of the appropriate muscles to cause dorsiflexion of the ankle in individuals who have impaired or absent ability to pick up their foot during walking as a result of a neurological injury. This partial paralysis affecting the foot is commonly known as 'drop foot' or 'dropped foot'.

The electrical stimulation is delivered via self adhesive skin surface electrodes. The electrodes may be flexibly placed according to the optimum response of the patient but typically are located over the common peroneal nerve as it passes near the head of the fibula.

For individuals presenting with weakness and/or spasticity a muscle stimulation exercise program can be delivered by the ODFS® Pace. In this case the footswitch trigger is not used and the ODFS® Pace functions as a powered muscle stimulator. A clinician would determine the need for this application which can enabled from a setup option in the ODFS® Pace. (Default is to have the exercise disabled)

AI/ML Overview

The provided text describes a 510(k) submission for the ODFS® Pace, an external functional neuromuscular stimulator. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria based on studies and then proving the device meets those criteria.

Therefore, many of the requested details about acceptance criteria, study design, expert ground truth, and comparative effectiveness are not applicable or available within this type of regulatory document. This document primarily focuses on technical specifications and regulatory compliance.

Here's the information that can be extracted or deduced, along with explanations for the missing information:

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

The document does not explicitly state "acceptance criteria" in the way a clinical study or performance study would. Instead, it demonstrates compliance with technical specifications and relevant standards. The "device performance" in this context refers to its ability to meet these technical specifications and legal requirements.

Acceptance Criteria (Implied)	Reported Device Performance
Functional and output specifications met	Production units pass functional testing of stimulator controls, settings and indicators, stimulus output and timing, footswitch operation, and power consumption. Parameters measured under conditions specified in FDA Guidance Document for Powered Muscle Stimulator 510(k)s.
Compliance with ISO 60601-1-1:2006 (Basic Safety & Essential Performance)	Passed applicable requirements
Compliance with ISO 60601-1-2:2007 (EMC)	Passed applicable requirements
Compliance with ISO 60601-2-10:2001 (Safety of Nerve & Muscle Stimulators)	Passed applicable requirements
Substantial equivalence to predicate devices for FES indications	ODFS® Pace has identical indications for use as an FES device as ODFS III v6.2 and corresponds to FES functions of EMPI Focus Model 795.
Substantial equivalence to predicate devices for NMS/NMES indications	The exercise function of ODFS® Pace corresponds to and is substantially equivalent to the NMS/NMES indications of the EMPI Focus Model 795.

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 Test Set: Not applicable. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to existing devices and technical performance testing, not a clinical trial with a "test set" of patients in the way an AI/diagnostic device might have. The "production units" mentioned for functional testing don't represent a patient-based test set.
Data Provenance: Not applicable for a typical clinical test set. The technical testing was conducted by Odstock Medical Ltd., which is based in the United Kingdom.

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):

Not applicable. No "ground truth" established by experts for a test set of patient data is mentioned or required for this type of 510(k) submission for a physical medical device like an FES stimulator. The "truth" is established by compliance with engineering specifications and recognized electrical safety standards.

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

Not applicable. As there is no clinical "test set" of patient cases requiring ground truth establishment, no adjudication method is relevant.

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:

Not applicable. The ODFS® Pace is an external functional neuromuscular stimulator, not an AI-powered diagnostic or decision support system that would involve "human readers" or AI assistance in interpretation. It directly delivers electrical stimulation.

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

Not applicable. This device is a hardware stimulator and does not describe a standalone "algorithm" in the context of AI or image analysis. Its function is directly related to hardware performance and user-controlled settings.

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

The "ground truth" in this context is primarily defined by the technical specifications for electrical output, waveform properties, frequency, pulse width, and compliance with international safety and performance standards (ISO 60601 series). There is no "patient ground truth" required for this type of submission.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that would require a "training set" of data.

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

Not applicable, as there is no training set.

Summary

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K10211.5

Image /page/0/Picture/1 description: The image shows a logo with the letters "OML" in a bold, sans-serif font. The letters are white and are set against a dark, textured background. The logo is contained within a rounded rectangle with a thick border. The overall appearance of the logo is somewhat distressed or vintage due to the texture and shading.

LEADING REHABILITATION

THROUGH TECHNOLOGY

Odstock Medical Limited

National Clinical FES Centre MAR 3 0 2011 Salisbury District Hospital Salisbury Wilitshire SP2 8BJ വന

Tel +44 (0) 1722 439541 Fax +44 (0) 1722 425263 steven.crook@odstockmedical.com www.odstockmedical.com

510(k) Summary For the

ODFS® Pace

[Section 5 of the Submission]

5.1 Sponsor/Owner

Odstock Medical Limited Laing Building Salisbury District Hospital Salisbury Wiltshire SP2 8BJ United Kingdom

Odstock Medical Ltd is a Registered Establishment, number: 3005344585

Contact person:	Steven Crook, Quality and Regulatory Manager
Telephone:	0044 1722 439541
Fax:	0044 1722 425263
Email:	steven.crook@odstockmedical.com

21 July 2010, with revisions 11&14 March 2011 Date prepared

US Agent

Boston Brace International20 Ledin DriveAvon, MA 02322 USA	Phone: 800-262-2235Fax: 800-634-5048
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Barry Bull (Chairman) • Malcom Cassells (Director) • Philip Casson (CEO) • Ian Swain (Director)

Odstock Medical Limited (Company No: 5532620) is part of Salisbury NHS Foundation Trust

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510(k) Summary for the ODFS® PACE Dropped Foot Stimulator

5.2 DEVICE NAME

Trade/Proprietary Name:	ODFS®-Pace
Common/Usual Name:	External Functional Neuromuscular Stimulator (FES)
Classification Name:	External Functional Neuromuscular Stimulator (FES)Powered Muscle Stimulator (NMES)
Classification No.	21 CFR 882.5810
Classification Code:	Class II
Product Codes:	GZI and IPF

5.3 Predicate Devices

Predicate Device	K number	Comment
EMPI Focus Model 795	K951951	EMPI
ODFS III V6.2	K020991	Odstock Medical Ltd (transferred from
		Salisbury District Hospital)

5.4. Device Description

5.5 Intended Use

Odstock Medical Ltd 510(k) Summary, v4, ODFS® PACE

Page 2 of 4, Section 5

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prevention/retardation of disuse atrophy, increased or maintained range of joint motion and increase in local blood flow.

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

5.6 Technological Characteristics and Substantial Equivalence

The technological characteristics of the ODFS® Pace and predicate devices are tabulated below. All the devices are battery powered and deliver electrical stimulation pulses of similar waveform, pulsewidth and frequency. The ODFS® Pace is a development of the ODFS III v6.2 and therefore has identical indications for use as an FES device. These indications correspond to the FES functions of the EMPI device. The exercise function of the ODFS® Pace corresponds to and is substantially equivalent to the NMS/NMES indications of the EMPI device.

Feature	ODFS® Pace	ODFS III v6.2	EMPI Focus 795
Waveform	Biphasic (symmetricaland balancedasymmetrical)	Biphasic (symmetricaland balancedasymmetrical)	Biphasic (symmetricaland balancedasymmetrical)
Pulsewidth	$0μs - 360μs (±10%)$according to patientselection (3.6 μs steps)	$7μs - 365μs (±10%)$according to patientselection	$300μs$
Frequency	Default is 40Hz.20 - 60 Hz in 5Hz stepsavailable	40Hz ± 10%	25, 30, 35, 45,50,80Hz
Indications for use	The ODFS® Pace isintended to provideankle dorsiflexion inindividuals who have adropped foot as aconsequence of uppermotor neuron injury. Bydetecting the swingphase of gait through afoot switch signal,appropriate electricalstimulation of the legand ankle muscles mayimprove gait by flexingthe foot of persons whohave lost or impairedfunction. There may beadditional benefits fromFES such as muscle re-education,prevention/retardation ofdisuse atrophy,increased or maintainedrange of joint motionand increase in local	To provide ankledorsiflexion inindividuals who have adropped foot as aconsequence of uppermotor neuron injury. Bydetecting the swingphase of gait through afoot switch signal,appropriate electricalstimulation of the legand ankle muscles mayimprove gait by flexingthe foot of persons whohave lost or impairedfunction. There may beadditional benefits fromFES such as muscle re-education,prevention/retardation ofdisuse atrophy,increased or maintainedrange of joint motionand increase in localblood flow.	TENS deviceSymptomatic relief andmanagement of chronicintractable pain.Adjunctive treatment forpost-surgical and posttrauma acute painAs a NMS/NMESdevice: relaxation ofmuscle spasm;prevention or retardationof disuse atrophy;increasing local bloodcirculation; musclereduction; immediatepost surgical stimulationof the calf muscles toprevent venousthrombosis; maintainingor increasing range ofmotion.As a FES device:Stimulating muscles in

5.6 Technological Characteristics and Substantial Equivalence - Table

Odstock Medical Ltd

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510(k) Summary for the ODFS® PACE Dropped Foot Stimulator

	blood flow.As a NMS/NMESdevice: relaxation ofmuscle spasm;prevention or retardationof disuse atrophy;increasing local bloodcirculation; muscle re-education; maintainingor increasing range ofmotion.		the leg and ankle ofpartially paralysedpatients to provideflexion of the foot andthus improve thepatients gait.
Accessories	Heel switch	Heel switch	Heel switch, handswitch
Electrode size & shape	5cm x 5cm	Scm x 5cm	5.1cm4

5.7 Performance testing

The ODFS® Pace system has been subjected to testing to verify that the device meets its functional and output specifications. Production units pass functional testing of stimulator controls, settings and indicators, stimulus output and timing, footswitch operation, and power consumption.

Parameters measured under the conditions specified in FDA Guidance Document for Powered Muscle Stimulator 510(k)s are included in the ODFS® Pace 510(k) submission.

In addition to functional and operational performance testing the ODFS® Pace passed the applicable requirements of the following standards:

ISO 60601-1-1:2006 Medical Electrical Equipment General requirements for . basic safety and essential performance.
I ISO 60601-1-2:2007 Medical Electrical Equipment – General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility - Requirements and tests
. ISO 60601-2-10:2001 Medical electrical equipment. Particular requirements for the safety of nerve and muscle stimulators

Based on the information provided above the ODFS® Pace is substantially equivalent to legally marketed predicate devices.

	--X--
--	-------	--

Version	Comment	Author
3->4	Amend indications for use and add regulation number for classification name.	1 S.Crook 14/3/11

Odstock Medical Ltd 510(k) Summary, v4, ODFS® PACE

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol consists of three curved lines that converge at the bottom.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Odstock Medical, Ltd. c/o Dr. Steven Crook Quality and Regulatory Manager Salisbury District Hopital Salisbury, Wilitshire United Kingdom, SP2 8BJ

MAR 3 0 2011

Re: K102115

Trade/Device Name: ODFS® Pace Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: January 21, 2011 Received: January 26, 2011

Dear Dr. Crook:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

signature

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K102115 510(k) Number (if known)

Device Name: ODFS® Pace

Indications for use: The ODFS® Pace is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. By detecting the swing phase of gait through a foot switch signal, appropriate electrical stimulation of the leg and ankle muscles may improve gait by flexing the foot of persons who have lost or impaired function. There may be additional benefits from FES such as muscle re-education, prevention/retardation of disuse atrophy, increased or maintained range of joint motion and increase in local blood flow.

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

Prescription use X (Part CFR 801 Subpart D) and/or

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

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

of CDRH, Office of Device Evaluation, (ODE)

(Division Sign-O Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K102115

Odstock Medical Ltd Indications statement v4, ODFS® PACE

[section 4]

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).