The Kuschall Design K3/K4 series of manual wheelchairs are lightweight wheelchairs that provide mobility to persons limited to a sitting position. They consist of a rigid, mechanical, aluminum frame and a coated nylon upholstery that meets EN1021-1; Assessment of the Ignitability of Upholstered Furniture. They have larger rear wheels with handrims for pushing and steering. They have smaller front casters for turning and maneuverability. Different front casters are available. The K3 has 3 wheels, 2 large rear wheels and 1 front caster. The K4 has 4 wheels, 2 large rear wheels and 2 front casters.

The Kuschall Design K3/K4 series is available in various seat width's, depths, and heights and has an adjustable seat angle and tip stability. The camber is also adjustable to various increments.

They are sporty looking chairs with a more high performance feel that the standard version wheelchair. They are intended for the more active user.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Kuschall Design K3/K4 series of manual wheelchairs. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for a novel device with specific acceptance criteria in the manner one might find for a software algorithm or a diagnostic tool.

Therefore, many of the requested categories related to algorithm performance, expert ground truth, and training data are not applicable to this submission. The "acceptance criteria" here refer to compliance with established performance standards for manual wheelchairs, and the "study" is the testing conducted against these standards.

Here's the information extracted and adapted to the prompt:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Requirement)	Reported Device Performance (Compliance)
DIN EN 12182 (2/96): Manually Propelled Wheelchair Requirements and Test Methods	Met all requirements of DIN EN 12182
DIN ISO 7176 Part 8 (1992): Wheelchairs Part 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths	Met all requirements of DIN ISO 7176 Part 8
EN 1021-1: Furniture Assessment of the Ignitability of Upholstered Furniture	Met all requirements of EN 1021-1 (specifically for the coated nylon upholstery)

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

The document does not explicitly state the number of wheelchairs tested (sample size) for each standard.
The testing was conducted by TUV Product Service, an organization typically external to the manufacturer. The data provenance is implied to be from physical testing of the device, which is prospective in nature for the purpose of this submission. The country of origin of the testing is not specified, but TUV Product Service operates internationally.

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

This is not applicable. The "ground truth" for a physical device like a wheelchair is compliance with engineering and safety standards, directly measured by testing procedures rather than expert interpretation of data. The "experts" would be the engineers and technicians at TUV Product Service responsible for conducting the tests, whose qualifications are in performing and interpreting standard-based device testing.

4. Adjudication Method for the Test Set

This is not applicable. As machine performance is not being evaluated, there's no need for adjudication of expert opinions. Device performance is determined by passing or failing specified tests within the standards.

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 submission is for a physical medical device (manual wheelchair), not a diagnostic or AI-powered software. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This is not applicable. No algorithm is being evaluated. The submission is for a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by adherence to established international and European performance standards and test methods (DIN EN 12182, DIN ISO 7176 Part 8, EN 1021-1). This is essentially a form of engineering compliance and safety testing data.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product and does not involve a "training set" in the context of machine learning or algorithms. The design and manufacturing process would involve extensive engineering and design validation, but not a "training set" as defined for AI.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as #8.

Summary

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982336

510(k) SUMMARY

AUG 21 1998

Invacare Corporation Kuschall Design AG K3/K4 series of manual wheelchairs

Submitter's Name, Address, Telephone Number, Contact Person and, Date Prepared.

Invacare Corporation One Invacare Way PO Box 4028 Elyria, Ohio 44036 Phone: (440) 329-6595 Facsimile: (440) 365-4558

Edward A. Kroll Contact Person: Director, TQM and Regulatory Affairs

June 26, 1998 Date Prepared:

Name of Device and Name/Address of Sponsor

Kuschall Design K3/K4 series of manual wheelchairs

Invacare Corporation One Invacare Way Elyria, Ohio 44036-2028 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Name and Address of Manufacturer

Kuschall Design AG Ringstrasse 15 4123 Allschwill Switzerland Phone: 011-41-61-61-5666 Facsimile: 011-41-61-481-5240

Common or Usual Name

Manual Wheelchair

Classification Name

Wheelchair, Mechanical

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Predicate Devices

The Kuschall Design K3/K4 series of manual wheelchairs are substantially equivalent to The Invacare Action Pro T Manual Wheelchairs (K914553, 10/9/91).

Intended Use

The intended use of Kuschall Design K3/K4 series of manual wheelchairs is to provide mobility to persons limited to a sitting position.

Technological Characteristics and Substantial Equivalence

A. Device Description

The Kuschall Design K3/K4 series is available in various seat width's, depths, and heights and has an adjustable seat angle and tip stability. The camber is also adjustable to various increments.

They are sporty looking chairs with a more high performance feel that the standard version wheelchair. They are intended for the more active user.

B. Substantial Equivalence

The Kuschall Design K3/K4 series of manual wheelchairs are substantially equivalent to the Action Pro and Pro T Manual Wheelchairs (K914553, 10/9/91).

Each of these products are lightweight manual wheelchairs with the intended use of providing mobility to a person limited to a seated position. They are rigid frames with foldable backs and adjustable seat angle, tip stability and camber.

PERFORMANCE DATA

The Kuschall Design K3/K4 series was tested by TUV Product Service to the following standards and met all the requirements:

· DIN EN 12182 (2/96) Manually Propelled Wheelchair Requirements and Test Methods
DIN ISO 7176 Part 8 (1992) Wheelchairs Part 8: Requirements and Test . Methods for Static, Impact and Fatigue Strengths
EN 1021-1 Furniture Assessment of the Ignitability of Upholstered Furniture .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 21 1998

Mr. Edward A. Kroll Director, TQM and Regulatory Affairs Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125

K982336 Re: Kuschall Design K3/K4 Series of Manual Wheelchairs Regulatory Class: I Product Code: IOR Dated: June 26, 1998 Received: July 6, 1998

Dear Mr. Kroll:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ್ರಾಮ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Edward A. Kroll

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N. Millikinson

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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70(k) Number (if known): TBD

Device Name: Kuschall Design K3/K4 series of manual wheelchairs

Indications For Use: To provide mobility to persons limited to a seated position.

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

Concurrence of CDRH, Office of De

Mark-N-Mellerson

fon (Division Sign-Oft)
cmin Division of General Restorative Devices
510(k) Number K982336

Prescription Use Per 21 CFR 801.109)

Over-The-Counter Us

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).