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

Device Description

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.

AI/ML Overview

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.

Summary

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K042535

Ulrich Alber GmbH + Co. KG
Vor dem Weißen Stein 21
72461 Albstact
Tel.: 07432-2006-0
Fax: 07432-2006-299

510(k) summary

DOVENTUAG

Identification of Legally Marketed Devices:

Ranger RWD
1. Applicant:	Invacare Corp.
2. Manufacturer:	Invacare Corp.
3. Device Name:	Ranger RWD
4. 510(k)-Number	K993413
5. Decision Date:	12/15/1999

Trax

1. Applicant:	Permobil A.B.
2. Manufacturer:	Permobil A.B.
3. Device Name:	Trax
4. 510(k)-Number	K993413
5. Decision Date:	12/18/2000

D. Description of the device

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.

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Obstacles up to a height of 120 mm can be negotiated with the aid of a curb climber included in the accessories.

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:

Image /page/1/Figure/9 description: 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.

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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 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.

E. Intendend use statement

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

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F. Technological Characteristics summary

The Adventure is substantially equivalent to Invacare´s Ranger RWD, cleared on 12-15-1999 as K993413.

The Adventure is also substantially equivalent to Permobil´s Trax, cleared on 12-18-2000 as K993413.

Both substantially equivalent wheelchairs had to be tested on the same international standards for wheelchairs and both are listed by the FDA.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 - 2004

Ulrich Alber GMBH c/o Mr. Stefan Preiss TUV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112

Re: K042535 Trade/Device Name: Adventure A10 Regulation Number: 21CFR 890. 3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 14, 2004 Received: September 20, 2004

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, diererere, mains of the Act include requirements for annual registration, listing of general controls profice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device is onaceaned (tional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or carry with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Stefan Preiss

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Melkerson

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K042535

Device Name: Adventure A10

Indications For Use:

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

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A Melhum

al. Restorative. and Neurological Devices

Page 1 of

510(k) Number K042535

Regulation Number and Section

§ 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).