(184 days)
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
| Acceptance Criteria (Performance Standard) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7176-1:1999 (Static Stability) | Compliant |
| ISO 7176-3:2012 (Effectiveness of Brakes) | Compliant |
| ISO 7176-5:2008 (Overall Dimensions, Mass, Maneuvering Space) | Compliant |
| ISO 7176-7:1998 (Seating and Wheel Dimensions) | Compliant |
| ISO-7176-8:1998 (Static Impact and Fatigue Strength) | Compliant |
| ISO 7176-15 (Information Disclosure, Documentation, Labeling) | Compliant |
| Cal 117 (Flammability for upholstery) | Compliant |
| FDA 1995 Guidance (Mechanical & Powered Wheelchairs) | Met or Addressed |
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.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).