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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.

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