(15 days)
A wheelchair can be provided as a result of medical indication where walking is no longer possible or the ability to walk is severely restricted through:
- paralysis ●
- . loss of a limb or limbs
- . defects/deformation of a limb or limbs
- . contractures of the joints
- . other illnesses
The intended use of the wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair
The Adventure A10 wheelchair is a lightweight wheelchair with full spring suspension and extremely good outdoor driving characteristics which can also be used indoors without any problems, due to its maneuverability.
All components are made of non-corrosive materials or have an anti-corrosive surface.
The housing for electronic components and all plug connections fulfill the IPX4 degree of protection. The permitted operating temperature lies between -25°C and +50°C.
In addition to the comfort offered on normal asphalted streets, roads and paths, the A10 also offers a high degree of driving comfort on cobbled streets and, in particular, on field and forest paths and on level meadows. This is realized through its chassis with full spring suspension, longitudinal steering wheels and individual wheel suspension elements. Spring travel is 52 mm.
Obstacles up to a height of 120 mm can be negotiated with the aid of a curb climber included in the accessories.
The tires are designed to achieve good rolling characteristics and noise-free operation on smooth surfaces, both indoors and outdoors. The integrated cleat tread provides the required traction in off-road use.
The tilt supports secure the vehicle against tilting backwards when negotiating obstacles and slopes. The Adventure can be raised on the drive wheels with the integrated jack-up mechanism to facilitate their removable and refitting.
The Adventure can be rapidly and simply dismantled into 8 individual components without tools or aids, thanks to the modular construction. Contact is established automatically during this with the drives and battery packs.
The modular construction of the Adventure means it can also be transported easily in smaller vehicles. Defective components can be replaced quickly in the event of a breakdown, meaning that long periods of disuse are avoided and there is no longer any need to send the entire wheelchair in for repairs.
The logical lightweight construction means that the max, empty weight is 96.7 kg (without accessories). The weight of individual removable components is derived as follows:
The image shows an exploded view of a wheelchair and its components. The seat unit weighs 14.3 kg, the chassis weighs 26.2 kg, and each wheel weighs 11.2 kg. The steering wheel weighs 2.3 kg each, and each battery pack weighs 14.6 kg.
The max. permissible occupant weight is 140 kg. The permissible overall weight is 255 kq. Slopes and gradients up to 18% and sloping ground up to 12% can be safely traversed, thanks to the optimally positioned center of gravity of the Adventure.
The compact dimensions of the Adventure, with an overall length of 1100 - 1300 mm (depending on the setting of the seat angle and leg supports), a max. width of 680 mm and a turning radius of 950mm enable its easily handling, even indoors. An option exists for switching the control on the control panel to indoor mode, enabling better control of the vehicle in confined spaces.
The removable seat is available in standard and function seat versions. The standard seat is equipped with washable, non-removable seat padding and has limited adjustment functions.
The function seat version is available with standard or comfort padding, each of which is removable and washable.
In contrast to the standard seat, the function seat has continuous adjusting options for both the back and leg supports. The seat width, depth and back height can also be varied.
The armrests are removable or can be simply pivoted to the rear (to facilitate movement of the occupant).
The Adventure is equipped with a parking brake which can be actuated by the driver. The Adventure can be pushed by an accompanying person when the parking brake is released and the system deactivated.
The various driving parameters which can be adapted to suit the occupant's disability can be edited directly on the control panel without an additional external programming unit.
The provided document is a 510(k) summary for a powered wheelchair, the "Adventure A10". This type of document is for medical device regulatory submissions and typically focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, rather than presenting detailed studies on acceptance criteria and performance metrics in the way one might find for a diagnostic AI device.
Therefore, the requested information regarding acceptance criteria, study details (sample sizes, data provenance, expert consensus, MRMC studies, standalone performance, training sets), and ground truth establishment is not available in the provided text.
The document details the physical characteristics, maneuverability, and component breakdown of the Adventure A10 wheelchair, and identifies two predicate devices (Invacare Ranger RWD and Permobil Trax) that it is substantially equivalent to. It also includes the FDA's clearance letter.
Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and associated studies. The 510(k) summary for a wheelchair does not contain the kind of performance study data you've requested for an AI/diagnostic device.
However, I can extract information related to the device description and intended use:
Device Description (Adventure A10 Wheelchair):
- Type: Lightweight powered wheelchair with full spring suspension.
- Outdoor/Indoor Use: Extremely good outdoor driving characteristics, but also maneuverable indoors.
- Materials: Non-corrosive materials or anti-corrosive surface.
- Electronic Protection: IPX4 degree of protection for electronic components and plug connections.
- Operating Temperature: -25°C to +50°C.
- Suspension: Chassis with full spring suspension, longitudinal steering wheels, individual wheel suspension. Spring travel: 52 mm. Offers comfort on various surfaces (asphalt, cobbled, field/forest paths, meadows).
- Obstacle Negotiation: Can negotiate obstacles up to 120 mm with a curb climber.
- Tires: Designed for good rolling characteristics and noise-free operation on smooth surfaces (indoor/outdoor), integrated cleat tread for off-road traction.
- Tilt Supports: Secure against backward tilting on obstacles and slopes.
- Maintenance: Integrated jack-up mechanism to raise drive wheels for easy removal/refitting.
- Dismantling: Rapidly and simply dismantles into 8 individual components without tools (modular construction). Automatic contact established with drives and battery packs.
- Transport: Modular construction allows transport in smaller vehicles.
- Repair: Defective components can be replaced quickly to avoid long disuse.
- Weight (empty): Max. 96.7 kg (without accessories).
- Seat unit: 14.3 kg
- Chassis: 26.2 kg
- Wheel: 11.2 kg each
- Steering wheel: 2.3 kg each
- Battery pack: 14.6 kg each
- Max. Permissible Occupant Weight: 140 kg.
- Permissible Overall Weight: 255 kg.
- Slopes/Gradients: Can safely traverse slopes/gradients up to 18%, and sloping ground up to 12% (due to optimally positioned center of gravity).
- Dimensions: Overall length 1100-1300 mm, max. width 680 mm, turning radius 950 mm.
- Control Panel: Option for indoor mode for better control in confined spaces. Various driving parameters can be adapted to occupant's disability and edited directly on the control panel.
- Seat:
- Removable, available in standard and function seat versions.
- Standard seat: Washable, non-removable padding, limited adjustment.
- Function seat: Standard or comfort padding (removable, washable), continuous adjusting options for back and leg supports, variable seat width, depth, and back height.
- Armrests: Removable or pivotable to the rear.
- Brakes: Parking brake actuated by driver. Can be pushed by accompanying person when parking brake is released and system deactivated.
Intended Use Statement (and Indications for Use):
- To provide mobility to persons limited to a sitting position who have the capability of operating a powered wheelchair.
- Medical Indications for provision of a wheelchair include:
- Paralysis
- Loss of a limb or limbs
- Defects/deformation of a limb or limbs
- Contractures of the joints
- Other illnesses where walking is no longer possible or severely restricted.
This information describes the device itself and its purpose, but not performance metrics or acceptance criteria as typically defined for a diagnostic study.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).