(39 days)
The Aquilla Modular Wheelchair is intended to provide mobility for occupants who are unable to walk or have difficulty in walking without assistance.
The Aquilla Modular Wheelchair is manually operated, and can be configured for propulsion by an attendant or an occupant. The range of sizes and build configurations are suitable for male or female sizes from junior to adult. The Aquilla Modular Wheelchair consists of typical components found on most manual wheelchairs. The chairs feature a backrest, folding seat frame, footrest, rear wheels and front castors. Accessories include occupant-positioning belts, and optional features which allow a chair to be changed simply to meet the changing environmental and health requirements of the occupant. Aquilla is suitable for use both indoors and outdoors on surfaces that are intended typically for public access. This type of wheelchair is not suitable for soft and undulating terrain or for climbing obstacles. Aquilla can be easily folded for compact storage, and armrests and footrests can be removed to reduce the weight for lifting. Aquilla is labeled to indicate important aspects of use, including warnings and cautions.
The provided text describes the 510(k) premarket notification for the Aquilla Modular Wheelchair, which is a mechanical wheelchair. The information focuses on its substantial equivalence to a predicate device and its compliance with relevant ISO standards.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Set by ISO Standard) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7176-1 (Wheelchairs – Determination of static stability) | Met |
| ISO 7176-3 (Wheelchairs – Determination of effectiveness of brakes) | Met |
| ISO 7176-5 (Wheelchairs – Determination of dimensions, mass and manoeuvring space) | Met |
| ISO 7176-7 (Wheelchairs – Method for measurement of seating and wheel dimensions) | Met |
| ISO 7176-8 (Wheelchairs – Requirements and test methods for static, impact and fatigue strengths) | Met |
| ISO 7176-15 (Wheelchairs – Requirements for information disclosure, documentation and labelling) | Met |
| ISO 7176-16 (Wheelchairs – Resistance to ignition of upholstered parts) | Met |
| ISO 7176-19 (Wheelchairs – Requirements for wheelchairs for use as seats in motor vehicles) | Met |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the tests. It only states that the "Aquilla wheelchair has been tested to and met the following ISO requirements." The provenance of the data is not explicitly stated beyond the fact that the manufacturer, Remploy Mobility, is located in the United Kingdom. It is implied to be prospective testing carried out for regulatory submission.
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)
This is not applicable as the device is a mechanical wheelchair and its performance is evaluated against ISO standards through physical testing, not against expert interpretation of medical images or data. No experts for ground truth establishment were mentioned or would be relevant in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The device undergoes objective physical tests according to ISO standards, which do not involve subjective adjudication methods like those used in clinical or imaging studies.
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. The device is a mechanical wheelchair, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a mechanical wheelchair, not an algorithm. Performance is assessed through physical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is defined by the objective pass/fail criteria established within each of the specified ISO 7176 standards. This involves physical measurements, strength tests, stability tests, and other performance metrics, not expert consensus or medical outcomes.
8. The sample size for the training set
This is not applicable. The Aquilla Modular Wheelchair is a physical device, and its development and testing do not involve a "training set" in the context of machine learning or AI models. Its performance is validated against established engineering and safety standards.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 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).