K Number

Device Name

Manufacturer

MUSMATE LTD

Date Cleared

2008-02-04

(52 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Foot raising paresis.

Device Description

The Musmate uses six out of eight components, depending on whether it is for a single leg or both legs.

A shoulder harness for a single leg (left or right) which holds the elastic assembly in place and is available in two mirror-image designs (for the left leg and for the right leg), four sizes, and a range of colours. It is made from polypropylene webbing and plastic components. There are adjusters to alter the length of the harness to suit the individual. It has a length-adjusting strap which controls the height of the foot lift. This has a triangle on one end which connects to the upper hook on the elastic cord assembly, and a square ring grip which the person pulls on to adjust. The strap passes through a ladderloc control which prevents the strap moving in use. The shoulder harness has two front release clips which connect to the waist belt (or which can be clipped together if the belt is not used);
An optional waist belt made from polypropylene webbing. This features two adjusters so that it is adjustable in length to suit each person and clips for attaching to the shoulder harness. This is available in three lengths and a range of colours;
A shoulder harness for both legs. This is made from polypropylene webbing. Its function is to hold the elastic assembly in place and it is available in one design, four sizes, and a range of colours. This features triglide adjusters to alter the length of the harness to suit the individual. There is a steel ring on the rear which brings the different parts together. It has a length-adjusting strap which controls the height of the foot lift. This has a triangle on one end which connects to the upper hook on the elastic cord assembly, and a square ring grip which the person pulls on to adjust. The strap passes through a ladderloc control which prevents the strap moving in use. The shoulder harness has two front release clips which connect to the waist belt (or which can be clipped together if the belt is not used);
Optional polypropylene webbing waist half-belts for the shoulder harness for both legs which help balance the harness if the loads applied are different on each leg. Two are used out of the four supplied (there are two short and two long). These feature an adjuster so that it is adjustable in length to suit each person. There are two front release clips which connect to the shoulder harness. These are available in six lengths and a range of colours;
An optional foam shoulder pad which can be used to cushion the load of the shoulder harness until the muscles become accustomed to the additional effort. This is made from leatherette with a foam insert and hook and loop fastenings. It is available in two sizes and a range of colours;
An elastic cord assembly. This is made from 8mm shock cord, which has a rubber core and polypropylene sheathing. It has a nylon peg adjuster which can be used to adjust the elastic cord for length to optimise the support offered by the Musmate. There is a hook at the top for connecting to the shoulder harness, and one at the bottom for connecting to either the shoe harness or shoelace connector as required. The cord is only available in black, and the nylon adjuster and hooks are available in black and white;
A shoe harness made from shoe soling which wraps under and over the shoe. This is secured with hook and loop fittings. There is a polypropylene strap which is sewn onto this which goes around the back of the shoe to hold it in place. This is adjustable in length with a triglide adjuster. This also has a front-release clip for ease of removal, and a short length of elastic tape for tensioning the harness on the shoe. There is a triangle on top of the shoe which is used to connect to the elastic cord assembly. The position of the triangle which connects to the elastic cord assembly can be adjusted to suit the person's requirements;
A shoelace connector which goes round either shoelaces or a sandal strap for a discreet but secure fit. This is made from polypropylene webbing with a plastic triangle and a front release clip.

The Musmate works in the following manner. When you place your foot on the ground during the gait cycle, you stretch the elastic cord. Then, when you lift your leg to walk forward, the shoulder harness acts as an anchor, the tension on the cord is reduced by the lifting of the leg and so contracts. This lifts your foot up. The length of the elastic cord is adjustable so that the amount of support is altered to best meet your needs. A shorter cord has a stronger action, because it has to be stretched further to reach the ground and also because more of the elastic cord is doubled over by the adjusting nylon peg. The height of the foot lift is adjustable by changing the length of the length-adjusting strap on the shoulder harness. A shorter strap will lead to a higher lift because the effective end of the elastic cord assembly is raised higher up.

The person using the Musmate puts the shoulder harness, shoulder pad (if used), and waist belt on first. They then attach the desired shoe harness or shoelace connector onto their shoes and then connect the two with the elastic cord assembly. They stand up and then adjust the tension in the elastic cord to their satisfaction.

AI/ML Overview

The provided text describes the Musmate Walking Aid and its comparison to a predicate device, the Foot-Up. Here's an analysis of the acceptance criteria and study details based solely on the provided input:

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

The document does not explicitly state formal "acceptance criteria" for the Musmate device in terms of specific performance thresholds that must be met for clearance. Instead, the study aims to demonstrate "substantial equivalence" to a predicate device and highlight clinical benefit.

However, based on the clinical test data presented, we can infer a primary performance metric: walking speed improvement.

Acceptance Criteria (Inferred)	Reported Device Performance (Musmate)
Demonstrate a statistically significant improvement in walking speed.	Initial mean walking speed: 0.44 ms-1
	Walking speed with Musmate (initially fitted): 0.64 ms-1 (T-test 6.194, significance 0.000)
	Walking speed with Musmate (after one month): 0.73 ms-1 (T-test 2.828, significance 0.013)
	Comparison of initial walking speed (without Musmate) and final speed (with Musmate): 0.29 ms-1 difference (T-test 5.795, significance 0.000)
Demonstrate clinical benefit as good as, or better than, existing treatments.	T-test value for Musmate: 3.069 (Probability Value 0.008) – This is compared to Ankle Foot Orthosis (2.035, 1.762) and Functional Electrical Stimulation (3.285). The conclusion states it was "as good as, or better than existing treatments."

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

Sample size for the test set: The "Degrees of Freedom" for the Musmate in Table 5.3 is 15. For a T-test, Degrees of Freedom (df) is typically n-1. Therefore, the sample size (n) for the Musmate clinical test was 16.
Data provenance: The document states "Musmate Ltd is a company registered in England & Wales" and provides UK contact details. It also mentions "The company is not yet registered with the FDA., but will do so once clearance is obtained." This suggests the study was conducted in the United Kingdom.
Retrospective or prospective: The description "When the test started, the mean walking speed..." and "After one month, the walking speed..." indicates a prospective study design.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. The primary metric measured (walking speed) is objective and does not inherently require expert interpretation for ground truth.

4. Adjudication method for the test set

The document does not mention any adjudication method for the test set. Given that walking speed is an objective measurement, a formal adjudication process may not have been deemed necessary.

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

Was an MRMC study done? No, this device is a walking aid, not an imaging device or diagnostic tool that would typically involve "human readers" or AI assistance in a diagnostic context. The study focuses on direct physiological/functional improvement.
Effect size of human readers with AI vs without AI assistance: This is not applicable to the Musmate device.

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

The Musmate is a physical medical device (walking aid), not an algorithm or AI system. Therefore, a "standalone algorithm-only" performance study is not applicable. The device itself is the "standalone" component being tested for its effect on human performance (walking).

7. The type of ground truth used

The ground truth used was objective physiological/functional measurement, specifically mean walking speed (in m/s).

8. The sample size for the training set

The document does not mention a training set. This is a physical device, not a machine learning model, so the concept of a "training set" in the context of AI/ML is not applicable. The clinical study described serves as the evaluation or validation study for the device's performance.

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

As there is no mention of a "training set" for an AI/ML model, this question is not applicable.

Summary

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Walking Made Easier with

Image /page/0/Picture/1 description: The image shows the word "MuSmate" in a bold, sans-serif font. There are three wavy lines underneath the word. The lines appear to be a design element, possibly representing sound waves or water.

Walking Aids

K073521 (pg 1/-)

Musmate Ltd, P.O.Box 3976, Bath BA1 0DF

FEB 4 2008 T UK (0845) 094 4674 UK (0845) 094 4674 F sales(a)musmate.co.uk E

510(k) Summary

5.1 Document Details

The owner of the 510(k) is Musmate Ltd. Musmate Ltd is a company registered in England & Wales, Number 5671724.

The registered office of the company is at 124 High Street, Midsomer Norton, . Somerset BA3 2DA, United Kingdom.
The company operates from the following address: 4 Ford Road, Peasedown St . John, Bath, BA2 8DG, United Kingdom.
The company uses the postal address P.O. Box 3976, Bath, Somerset BA1 0DF, . United Kingdom.
. The company's telephone number is +44-(0)845-094 4674
The company's fax number is +44-(0)845-094 4674 �
The company's e-mail address is musmate@uk2.net. ◆

The official contact person is Dr Andrew James Wynd, who is the company director.

The company is not yet registered with the FDA., but will do so once clearance is obtained.

This summary was prepared on 29th November 2007

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K073521 (pg 2/7)

5.2 Product Details

. Trade name - Musmate
Common name- foot drop brace .
Classification name- Limb Orthosis (21 CFR 890.3475 ) .

The Musmate uses six out of eight components, depending on whether it is for a single leg or both legs.

. A shoulder harness for a single leg (left or right) which holds the elastic assembly in place and is available in two mirror-image designs (for the left leg and for the right leg), four sizes, and a range of colours. It is made from polypropylene webbing and plastic components. There are adjusters to alter the length of the harness to suit the individual. It has a length-adjusting strap which controls the height of the foot lift. This has a triangle on one end which connects to the upper hook on the elastic cord assembly, and a square ring grip which the person pulls on to adjust. The strap passes through a ladderloc control which prevents the strap moving in use. The shoulder harness has two front release clips which connect to the waist belt (or which can be clipped together if the belt is not used);
� An optional waist belt made from polypropylene webbing. This features two adjusters so that it is adjustable in length to suit each person and clips for attaching to the shoulder harness. This is available in three lengths and a range of colours;
A shoulder harness for both legs. This is made from polypropylene webbing. . Its function is to hold the elastic assembly in place and it is available in one design, four sizes, and a range of colours. This features triglide adjusters to alter the length of the harness to suit the individual. There is a steel ring on the rear which brings the different parts together. It has a length-adjusting strap which controls the height of the foot lift. This has a triangle on one end which connects to the upper hook on the elastic cord assembly, and a square ring grip

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

KO7352 (pg 3/7)

which the person pulls on to adjust. The strap passes through a ladderloc control which prevents the strap moving in use. The shoulder harness has two front release clips which connect to the waist belt (or which can be clipped together if the belt is not used);

Optional polypropylene webbing waist half-belts for the shoulder harness for . both legs which help balance the harness if the loads applied are different on each leg. Two are used out of the four supplied (there are two short and two long). These feature an adjuster so that it is adjustable in length to suit each person. There are two front release clips which connect to the shoulder harness. These are available in six lengths and a range of colours;
An optional foam shoulder pad which can be used to cushion the load of the . shoulder harness until the muscles become accustomed to the additional effort. This is made from leatherette with a foam insert and hook and loop fastenings. It is available in two sizes and a range of colours;
An elastic cord assembly. This is made from 8mm shock cord, which has a . rubber core and polypropylene sheathing. It has a nylon peg adjuster which can be used to adjust the elastic cord for length to optimise the support offered by the Musmate. There is a hook at the top for connecting to the shoulder harness, and one at the bottom for connecting to either the shoe harness or shoelace connector as required. The cord is only available in black, and the nylon adjuster and hooks are available in black and white;
A shoe harness made from shoe soling which wraps under and over the shoe. . This is secured with hook and loop fittings. There is a polypropylene strap which is sewn onto this which goes around the back of the shoe to hold it in place. This is adjustable in length with a triglide adjuster. This also has a frontrelease clip for ease of removal, and a short length of elastic tape for tensioning the harness on the shoe. There is a triangle on top of the shoe which is used to

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

K073521 (pg 4/7

connect to the elastic cord assembly. The position of the triangle which connects to the elastic cord assembly can be adjusted to suit the person's requirements;

A shoelace connector which goes round either shoelaces or a sandal strap for a . discreet but secure fit. This is made from polypropylene webbing with a plastic triangle and a front release clip.
The Musmate works in the following manner. When you place your foot on the ground during the gait cycle, you stretch the elastic cord. Then, when you lift your leg to walk forward, the shoulder harness acts as an anchor, the tension on the cord is reduced by the lifting of the leg and so contracts. This lifts your foot up. The length of the elastic cord is adjustable so that the amount of support is altered to best meet your needs. A shorter cord has a stronger action, because it has to be stretched further to reach the ground and also because more of the elastic cord is doubled over by the adjusting nylon peg. The height of the foot lift is adjustable by changing the length of the length-adjusting strap on the shoulder harness. A shorter strap will lead to a higher lift because the effective end of the elastic cord assembly is raised higher up.

5.3 Predicate Device

890.3475 KNP Foot-up orthotic device

5.4 Intended Use Comparison

This is summarised in the following Table.

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Device	Foot-Up	Musmate
Anatomical Sites	Foot	Foot
Function	The Foot-Up is a lightweightdynamic aid for drop foot orrelated disorders which requiredorsal flexion support.	The Musmate is a dynamicaid for drop foot or similardisorders who have a lackof ankle dorsiflexion.
Indications	The Foot-Up is indicated for foot-raising paresis, particularly suitablefor KG 3,4	The Musmate is indicatedfor foot-raising paresis.
Contra-indications	(i) circulatory disorders(ii) neurogenically-specificorganoleptic and skin trophicdisorders in the body area beingtreated (sensory disorders with andwithout skin damage)	Due to the additionaleffort, people with weakbacks (eg from arthritis ofthe spine) should not usethe Musmate. It supportswalking and so those whoare unable to walk 10metres (with aids such aswalking sticks) may notbenefit without appropriateprofessional medicalsupport.
Side-effects	With proper use and proper fitting,so far there have been no reportsof serious general side-effects.Local pressure symptoms andimpaired circulation can beprevented with sufficient certaintyon an individual basis if allowanceis made for any contraindicationsand with non-restrictingconsistently-shaped body fitting.	May cause temporary leg,knee, shoulder, and/ orback pain. There has beenone report of pins andneedles in the feetfollowing use.
Cautions	None	Check shoes regularly forwear and tear. TheMusmate cannot be usedwith some shoes such ashigh heeled or low-cutshoes, or those which haveno heel (eg clogs). TheMusmate may lead toadditional wear and tear orscuffing on clothes andshoes.
Device	Foot-Up	Musmate
Duration of Use	Designed to be worncontinuously to providefoot-raising support	Designed to be worncontinuously to providefoot-raising support
Core Technology	Support provided byelastic strap	Support provided byelastic cord
Anchor Point	For the product on the leftfoot: the left ankleFor the product on theright foot: the right ankle	For the product for the leftfoot: the right shoulderFor the product for theright foot: the left shoulderFor the product for bothfeet: both shoulders
Foot ConnectingComponents	(i) A shoelace connectorwhich has an insert whichlocates between the tongueof the shoe and theshoelaces, with the elasticcloth rising betweenshoelaces to join to theankle.	(i) A shoelace connectorwhich passes roundshoelaces or sandal strapsand has a triangle toconnect to hook on theelastic cord.(ii) A shoe harness whichgoes around the shoe andcan therefore be used onshoes without laces

Table 5.1 Functional Indication Comparison

・! : ... -. .

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

K073521 (pg 617)

5.5 Technological Comparison

The following Table 5.2 summarises the technological characteristics of the Musmate and the predicate device, the Foot-Up.

Table 5.2 Technological Comparison of the Foot-Up and Musmate

5.6 Clinical Test Data Summary

When the test started, the mean walking speed of the group was 0.44ms ', which rose to 0.64ms 1 when the Musmate was initially fitted. The T-Test result was 6.194 with a 2tailed significance of 0.000. After one month, the walking speed without the Musmate had increased to a mean 0.57ms1 (T-test 3.371, significance 0.003) and with the Musmate to 0.73ms (T-test 2.828, significance 0.013). Comparison of the initial walking speed without the Musmate and the final speed with it, yielded a difference of 0.29 ms 1 (T-test 5.795, significance 0.000) .

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

Device	MeanDifference(Note 1)	EstimatedStandardError	DegreesofFreedom	T-Test	ProbabilityValue
Ankle FootOrthosis890.3475 IQI	0.10	0.048	11	2.035	0.067
Ankle FootOrthosis890.3475 IQI	5.92	3.360	8	1.762	0.116
FunctionalElectricalStimulation882.5810 GZI(note 2)	0.15	0.046	110	3.285	0.001
Musmate	0.29	0.095	15	3.069	0.008

Table 5.3 The T-Test Values

5.7 Conclusions

The comparison of the clinical factors showed substantial equivalence between the Musmate and the predicate device, the Foot-Up. The technological and design comparison between the Musmate and the predicate device showed that there was substantial equivalence between the Musmate and the Foot-Up. The design differences meant that the Musmate has additional functionality, improved flexibility and overall a lower risk profile than the Foot-Up. Clinical trial data and a literature review demonstrated that the Musmate showed a statistically significant improvement in walking speed and its clinical benefit was as good as, or better than existing treatments. Substantial equivalence is therefore demonstrated.

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Image /page/7/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of an eagle.

4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Musmate LTD % Mr. Andrew James Wynd 4 Ford Rd Peasedown St John Bath. Somerset. United Kingdom BA2 8Dg

Re: K073521

Trade/Device Name: Musmate Walking Aid Regulation Number: 21 CFR 890.3475 Regulation Name: Limb orthosis Regulatory Class: Class I Product Code: OHI Dated: December 7, 2007 Received: December 17, 2007

Dear Mr. Wynd:

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.

We note that your device exceeded the Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 CFR Part 890.9), and therefore required the submission and clearance of a premarket notification prior to commercial distribution in the United States. Future devices of this same type, that meet the exemption criteria and do not exceed the limitations of exemptions found in 21 CFR Part 890.9 will be exempt from the premarket notification requirements of the Act.

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.

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

Page 2 - Mr. Andrew James Wynd

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.

This letter will allow you to begin marketing your device as described in your Section 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), 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 toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Chabae boyem

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

Enclosure

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K073521 (pg 1/1)

4. Indications for Use Statement

510(k) Number (if known): K073521

Device Name: Musmate Walking Aid

Indications for Use

Foot raising paresis.

Table 4.1 Summary of Use by Type Prescription Use Over-The-Counter Use YES_____________________________________________________________________________________________________________________________________________________________________ AND/OR YES_________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Valvare buend

命令 > 1000~20インの第1リンピンのペント 3630%のインデザインと2600%

Division of General, Restorative, and Neurological Devices

510(k) Number K073521

Regulation Number and Section

§ 890.3475 Limb orthosis.

Link to an amendment published at 90 FR 55994, Dec. 4, 2025. (a)
Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.