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The indications for use of the APEX Manual Wheelchair are to provide mobility to persons limited to a sitting position.

The Motion Composites APEX Manual Wheelchair is manually operated, user propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position. The Apex wheelchairs are traditional rigid wheelchairs. They are made of aluminum alloy or carbon fiber. The frame which utilizes a standard geometry that creates a cantilever like rigid assembly. Upon the outside of this framework, and to the rear, are assembled two aluminum axle plates. Wheels of varying size and type are connected to the carbon fiber camber tube via stainless steel axles. On the front end of the frame are assembled two aluminum caster mount. Caster forks are mounted to these mounts via steel axles. A variety of caster wheels and tires are then connected to the fork based on user preference.

The Motion Composites APEX Manual Wheelchair is a mechanical wheelchair, which is a Class I device. As such, it does not require a demonstration of clinical efficacy through extensive human studies. The primary acceptance criteria for this device are related to its mechanical performance and compliance with recognized standards for manual wheelchairs to ensure safety and basic functionality.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document refers to "the APEX Manual Wheelchairs" as having been tested, suggesting that multiple units or configurations were likely tested for each standard. However, specific numbers are not provided.
• Data Provenance: The testing was performed on the APEX Manual Wheelchair itself. The location of the testing facility or specific country of origin for the data is not specified, but the applicant (Motion Composites) is based in Quebec, Canada. The studies are prospective in the sense that the APEX device was specifically subjected to these tests to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• This type of information (experts establishing ground truth for a test set) is typically relevant for interpretational or diagnostic AI/software devices.
• For a mechanical device like a wheelchair, "ground truth" is established by adherence to engineering standards and objective measurements. The "experts" would be the engineers and technicians performing the tests and the bodies (e.g., ISO) that set the standards. Their qualifications would be in mechanical engineering, quality assurance, and adherence to testing protocols for medical devices. The document does not specify the number or specific qualifications of these individuals, as it's implied by compliance with the standards.

4. Adjudication Method for the Test Set:

• Adjudication methods like 2+1 or 3+1 consensus are not applicable to the type of testing described (mechanical performance against standards). The results of these tests are objective measurements (e.g., whether a brake holds a certain force, whether a frame withstands a certain impact). The "adjudication" is inherent in whether the measured values fall within the parameters defined by the ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study assesses the performance of human readers (e.g., radiologists) with and without AI assistance, typically for diagnostic tasks. Given that the APEX Manual Wheelchair is a mechanical mobility device, such a study design is entirely irrelevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:

• No, a standalone (algorithm only) study was not done. This concept applies to AI/software as a medical device (SaMD) where the algorithm performs a task independently. The APEX is a physical mechanical device; its "performance" is its physical function and durability, not an algorithm's output.

7. The Type of Ground Truth Used:

• The "ground truth" for the APEX Manual Wheelchair's performance is defined by the international standards (ISO 7176 series) for wheelchairs and by the safety and performance requirements outlined in FDA guidance documents for manual wheelchairs. These standards provide objective metrics and test methods against which the device's physical and functional properties are measured. Essentially, the "ground truth" is compliance with these established engineering and safety benchmarks.

8. The Sample Size for the Training Set:

• Not applicable. The APEX Manual Wheelchair is a mechanical device, not an AI/machine learning model that requires a "training set" of data. Its design and manufacturing process are based on engineering principles and materials science, not data-driven learning.

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

• Not applicable. As the concept of a "training set" does not apply to this device, neither does the method for establishing its ground truth.

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The indications for use of the Helio A7 and Move Manual Wheelchairs is to provide mobility to persons limited to a sitting position.

The Motion Composites Helio A7 and Move Manual Wheelchairs are manually operated, user propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position.

Both are traditional folding cross-brace wheelchairs. They are made of an aluminum frame which utilizes one cross brace system that, when opened, nestles inside of the frame onto 4 hooks to create a box like rigid assembly. Upon the outside of this framework, and to the rear, are assembled two aluminum axle plates. Wheels of varying size and type are connected to the stainless steel axle receivers via stainless steel axles.

On the front end of the frame are assembled two aluminum caster housings. Caster forks are mounted to these housings via steel axles. A variety of caster wheels and tires are then connected to the fork based on user preference.

The provided text is a 510(k) premarket notification for the Motion Composites Helio A7 and Move Manual Wheelchairs. This document focuses on demonstrating substantial equivalence to a predicate device, the Sunrise Medical Quickie 2 Manual Wheelchair (K123975), rather than describing acceptance criteria for a new, unique device needing extensive clinical validation.

Therefore, the typical structure for acceptance criteria and a study proving device performance as commonly understood for AI/diagnostic devices (e.g., sensitivity, specificity, F1-score with defined thresholds and ground truth from experts) does not directly apply to this submission for a mechanical wheelchair.

Instead, the "acceptance criteria" here are compliance with recognized standards and demonstrating similarity to a legally marketed predicate device. The "study" proving performance is a series of engineering tests against these standards.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of physical units tested. However, the testing involves physical prototypes of the Helio A7 and Move Manual Wheelchairs to determine compliance with the listed ISO standards.
• Data Provenance: The tests were conducted on physical prototypes of the devices by the manufacturer (Motion Composites) or an accredited testing facility to ISO standards. This is prospective conformance testing of engineered products.

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

• This is not applicable in the context of mechanical wheelchair testing against engineering standards. The "ground truth" is defined by the objective metrics and test procedures outlined in the ISO standards themselves, rather than expert consensus on a clinical diagnosis. The "experts" would be the engineers and technicians performing the tests and comparing results to the specified limits within the ISO standards.

4. Adjudication method for the test set

• Not applicable in the sense of clinical adjudication. Compliance is determined by whether the physical measurements and performance during the tests fall within the acceptable ranges specified by each ISO standard.

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

• This is not applicable. This is a submission for a mechanical medical device (wheelchair), not an AI-enabled diagnostic or therapeutic device. No MRMC study was conducted.

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

• This is not applicable. The device is a manual wheelchair, operated by a human user. There is no algorithm or standalone performance in the sense of AI. The device function is "dependent solely upon the wheelchair user."

7. The type of ground truth used

• The "ground truth" is adherence to international engineering standards (ISO 7176 series and Cal 117) for wheelchair performance and safety, along with FDA guidance documents for mechanical wheelchairs. These standards define objective, measurable criteria for stability, braking, dimensions, strength, flammability, and other safety/performance aspects.

8. The sample size for the training set

• This is not applicable. There is no "training set" in the context of a mechanical device like a wheelchair. The design and manufacturing process would involve engineering principles and prototypes, but not machine learning training data.

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

• This is not applicable as there is no training set. The design of the wheelchair is based on established engineering principles for mechanical stability, durability, and user interface, aiming to meet the performance criteria outlined in the relevant ISO standards.

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The helio wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position. It is not indicated for the pediatric population.

The helio is a traditional folding cross-brace wheelchair. It is made of lightweight hi-Modulus carbon fiber mixed with epoxy resin similar to what is used on existing products such as K915533. The frame utilizes one patented cross brace system that, when opened, nestles inside of the frame onto 4 hooks to create a box like rigid assembly. Upon the outside of this framework, and to the rear, are assembled two aluminum axle plates. Wheels of varying size and type are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled 2 aluminum caster housings. Caster forks are mounted to these housings via stainless steel axles. A variety of caster wheels and tires are then connected to the forks. Upon the top of the frame is attached a seat sling. Into the rear of the frame assembly 2 back tubes are inserted to the desired height. Backrest upholstery is affixed to the back tubes. Armrests receivers bolt onto the rear of each side frame. Individual swing away armrests are then inserted into the receivers. If flip back armrests are chosen, a receiver is mounted onto the front of each side frame to catch the forward most section of the arm and the rear mounting to allow the arm to rotate backward. Height Adjustable arms fit into a receiver that mounts onto the frame. Wheel locks mount onto the upper side frame and are adjusted so that the brake arm engages with the tire and when in the locked position prevents to the wheel from rotating. Footrests with footplates attach at the front of the chair. There is a plug at the footrest hanger that inserts into an opening at the top front of the wheelchair frame. The footrest hanger is inserted 90 degrees away from the frame and rotates inwards. The latch will engage once the footrest hanger is centered.

The provided document is a 510(k) Pre-market Notification for a manual wheelchair and does not contain information about an AI/ML device or its acceptance criteria from a study.

Therefore, I cannot provide a response to your request, as it pertains to AI/ML device performance and testing, which is not present in the document.

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