The Invacare Corporation Model Top End Terminator SS is a manually operated, self propelled, manual, mechanical wheelchair. It's intended function and use is to provide mobility to persons who may be restricted to a sitting position. The product consists basically of a metal frame, larger rear wheels with handrims for propelling the chair, and smaller front pivoting casters for steering and turning. The product is designed to be a lightweight, user adaptable, everyday wheelchair, for both indoor and outdoor use. It is a rigid, or, non-folding type wheelchair, which has a more sporty appearance than the traditional type of manual wheelchairs. The Top End Terminator SS Wheelchair incorporates a one piece frame. The frame is constructed from 1'' and 1 1/8 " diameter chrome-moly steel tubing, that is brazed together. The wheelchair upholstery is a vinyl material which meets the requirements of EN 1021:1 standard for flame retardancy. The Top End Terminator SS also includes a front and rear suspension feature. This feature which mounts to the front and rear of the wheelchair, is designed to absorb minor bumps and shocks encountered during everyday use, thus providing added comfort to the wheelchair user.

AI/ML Overview

The provided text describes a 510(k) submission for the Invacare Corporation's Model Top End Terminator SS Manual Wheelchair. The primary purpose of this submission is to demonstrate substantial equivalence to predicate devices, rather than to present a de novo study with acceptance criteria and performance data for a novel device.

Therefore, the text does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a new device.

The only relevant performance information provided is:

Acceptance Criteria/Performance Standard: The device "meets the applicable performance requirements specified in: Rehabilitation Engineering Society of North America (RESNA) Standard . ANSI/RESNA WC/Vol.1-1998 'Requirements and Test Methods for Wheelchairs (Including Scooters)'."

Essentially, the "study" demonstrating this involves testing the wheelchair against the parameters outlined in the RESNA standard. However, the document does not provide the specific numerical acceptance criteria from the RESNA standard itself, nor does it present the detailed results of the Invacare device's performance against those criteria. It merely states that the device meets them.

Without this specific information from the RESNA standard and the detailed test results, a table of acceptance criteria and reported device performance cannot be fully constructed as requested.

Here's what can be extracted and inferred from the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from RESNA ANSI/RESNA WC/Vol.1-1998)	Reported Device Performance
Specific parameters of the RESNA standard (e.g., static stability, dynamic stability, braking efficiency, structural integrity, durability, etc.)	Meets the applicable requirements of the RESNA standard.

Note: The specific numerical thresholds and performance metrics are not detailed in the provided document, only the general statement that the device meets the standard.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. Typically, performance testing for devices like wheelchairs involves a limited number of units (often a few prototypes or production samples) subjected to standardized tests rather than a large "test set" in the sense of patient data.
Data Provenance: Not explicitly stated, but the testing would be conducted in a laboratory or testing facility to comply with the RESNA standard. It is prospective testing of the device itself, not retrospective or prospective patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of device performance testing against an engineering standard. The "ground truth" here is the standard itself, developed by a professional society (RESNA). The experts involved would be the engineers and technicians conducting the tests and interpreting the RESNA standard. Their qualifications are not mentioned.

4. Adjudication method for the test set:

Not applicable. Performance against an engineering standard is typically objectively measured and assessed against defined pass/fail criteria, not adjudicated through multi-expert consensus.

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:

Not applicable. This is a manual wheelchair, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed.

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

Not applicable. The device itself (the wheelchair) is the "standalone" entity being tested for its mechanical performance. There is no AI algorithm involved.

7. The type of ground truth used:

Engineering Standard: The ground truth for performance is established by the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol.1-1998 "Requirements and Test Methods for Wheelchairs (Including Scooters)." This standard defines the objective, measurable criteria a wheelchair must meet.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device. There is no "training set."

9. How the ground truth for the training set was established:

Not applicable.

Summary

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3 1999 FEB

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510(k) SUMMARY

K99015-7

Invacare Corporation's Model Top End Terminator SS Manual Wheelchair

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

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

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

January 18, 1999 Date Prepared:

Name of Device and Name/Address of Sponsor

Model Top End Terminator SS Manual Wheelchair Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Manual Wheelchair Common or Usual Name:

Wheelchair, Mechanical 89IOR Classification Name:

Predicate Devices

Invacare Top End Terminator SS is substantially equivalent to the Model "Top End Terminator" Manual Wheelchair (K922535 7/24/92) and the Quickie Designs Model "Quickie Suspension Wheelchair Series Model XTR" Manual Wheelchairs (K982989 10/5/98).

Intended Use: The intended use of the Model Top End Terminator SS Manual Wheelchair is to provide mobility to persons limited to a sitting position.

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Technological Characteristics and Substantial Equivalence

Device Description The Invacare Corporation Model Top End Terminator SS is a manually operated, self propelled, manual, mechanical wheelchair. It's intended function and use is to provide mobility to persons who may be restricted to a sitting position.

The product consists basically of a metal frame, larger rear wheels with handrims for propelling the chair, and smaller front pivoting casters for steering and turning. The product is designed to be a lightweight, user adaptable, everyday wheelchair, for both indoor and outdoor use. It is a rigid, or, non-folding type wheelchair, which has a more sporty appearance than the traditional type of manual wheelchairs.

The Top End Terminator SS Wheelchair incorporates a one piece frame. The frame is constructed from 1'' and 1 1/8 " diameter chrome-moly steel tubing, that is brazed together. The wheelchair upholstery is a vinyl material which meets the requirements of EN 1021:1 standard for flame retardancy.

The Top End Terminator SS also includes a front and rear suspension feature. This feature which mounts to the front and rear of the wheelchair, is designed to absorb minor bumps and shocks encountered during everyday use, thus providing added comfort to the wheelchair user.

Substantial Equivalence The Invacare Top End Terminator SS is substantially equivalent to the Model "Top End Terminator" Manual Wheelchair (K922535 7/24/92) and the Quickie Designs Model "Quickie Suspension Wheelchair Series Model XTR" Manual Wheelchairs (K982989 10/5/98).

Performance Data

The Invacare Top End Terminator SS Manual Wheelchair meets the applicable performance requirements specified in:

Rehabilitation Engineering Society of North America (RESNA) Standard . ANSI/RESNA WC/Vol.1-1998 "Requirements and Test Methods for Wheelchairs (Including Scooters).

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble a person's head and torso.

3 1099 FEB

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K990157 Re: Top End Terminator SS Manual Wheelchair Trade Name: Requlatory Class: I Product Code: IOR Dated: January 18, 1999 Received: January 19, 1999

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 The general controls provisions of the Act 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. ਕਿ 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 regulation (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

Sincerely yours,

Neil R.P. Osher for

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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510(k) Number (if known): TBD

Device Name: Top End Terminator SS Manual Wheelchair

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

NRRO

(Division Sign-Off)

(Division of General Restorative Devices 190157 510(k) Number -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use &

(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).