The Invacare Storm Series, Invacare Power 9000 Series, Power Tiger power wheelchairs with gyroscope control are battery powered, motorized mobility vehicles. Their intended function and use is to provide mobility and transportation to physically challenged persons that may be restricted to a seated position. The various models differ somewhat in design, drive mechanisms, styling, aesthetics and mechanical components. The primary difference between the Power 9000 Series and the Storm Series wheelchairs is in the wheelchair frame style. Where the Power 9000 is a cross brace type folding frame wheelchair, the Storm is a rigid frame non-folding type wheelchair. Additionally, the Power 9000 Series wheelchairs are a basic, economical, more traditional type wheelchair whereas the Storm Series wheelchairs, are designed to have a more sporty, aesthetic appeal. The gyroscope control feature is an angular rate sensor that measures power wheelchair speed and turning (rotational velocity), and compensates by changing wheel speed to correct for differences. The intended function of this feature is provide a more accurate response to wheelchair joystick user commands, thereby providing a more consistent response of the wheelchair drive wheels.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Invacare power wheelchairs with gyroscope control. However, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

The document is a regulatory submission for a physical medical device (power wheelchairs) and focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than an AI/ML system's performance metrics.

Therefore, for aspects related to AI/ML device performance, such as sample sizes for test/training sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, the information is not available in the provided text.

The document does mention performance data in the context of adhering to industry standards for power wheelchairs.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Applicability of RESNA Standard ANSI/RESNA WC/14 (1991)	"The Invacare Models Storm, Power 9000 and Power Tiger with Gyroscope Control meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991)"
Applicability of ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs"	"and ISO Standard ISO 7176: 1993 (E) 'ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs'"

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document states the device meets the standards but does not detail the specific testing methodologies (like sample size, test set characteristics, or data provenance) used to demonstrate compliance.

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)

Not applicable/Not provided. This is relevant for AI/ML ground truth establishment. For a physical device demonstrating compliance with engineering standards, "ground truth" in this sense isn't derived from expert consensus on medical images or outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. Similar to point 3, this is an AI/ML specific concept for resolving disagreements in ground truth labeling.

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/Not provided. This type of study is specifically for evaluating the impact of AI assistance on human performance, which is not relevant for this physical device submission.

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

Not applicable/Not provided. This refers to the performance of an algorithm without human intervention, which is not applicable to a power wheelchair with gyroscope control in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided in the AI/ML sense. The "ground truth" here is compliance with established engineering and performance standards for wheelchairs (RESNA and ISO).

8. The sample size for the training set

Not applicable/Not provided. This is relevant for AI/ML model training.

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

Not applicable/Not provided. This is relevant for AI/ML model training.

Summary

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510(k) SUMMARY

INVACARE CORPORATION'S 510(k) PREMARKET NOTIFICATION STORM SERIES, POWER 9000 SERIES AND POWER TIGER POWER WHEELCHAIRS WITH GYROSCOPE CONTROL

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

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

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

Date Prepared: October 7, 1999

Name of Device and Name/Address of Sponsor: Storm Series, Power 9000 Series and Power Tiger power wheelchairs with gvroscope control

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

Common or Usual Name Power Wheelchair

Classification Name Wheelchair, Powered

Predicate Devices

Products which are substantially equivalent to the Models Storm, Power 9000 and Power Tiger with gyroscope control are; the Invacare Storm Power wheelchair (K940051), the Invacare Power 9000 Power Wheelchair (K900565) and the Invacare Power Tiger Power Wheelchair (K930676).

Intended Use

The intended use of the Storm Series, Power 9000 Series and Power Tiger power wheelchairs with gyroscope control is to provide mobility to persons limited to a seated position.

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Technological Characteristics and Substantial Equivalence Device Description

The various models differ somewhat in design, drive mechanisms, styling, aesthetics and mechanical components. The primary difference between the Power 9000 Series and the Storm Series wheelchairs is in the wheelchair frame style. Where the Power 9000 is a cross brace type folding frame wheelchair, the Storm is a rigid frame non-folding type wheelchair. Additionally, the Power 9000 Series wheelchairs are a basic, economical, more traditional type wheelchair whereas the Storm Series wheelchairs, are designed to have a more sporty, aesthetic appeal.

The gyroscope control feature is an angular rate sensor that measures power wheelchair speed and turning (rotational velocity), and compensates by changing wheel speed to correct for differences. The intended function of this feature is provide a more accurate response to wheelchair joystick user commands, thereby providing a more consistent response of the wheelchair drive wheels.

Substantial Equivalence

Products which are substantially equivalent to the Models Storm. Power 9000 and Power Tiger with gyroscope control Invacare Storm Power wheelchair (K940051), the Invacare Power 9000 Power Wheelchair (K900565) and the Invacare Power Tiger Power Wheelchair (K930676).

PERFORMANCE DATA

The Invacare Models Storm, Power 9000 and Power Tiger with Gyroscope Control meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs

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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 features a stylized representation of a human figure in profile, with three overlapping faces suggesting a sense of community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 1 2 1999

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

Re: K993413

Trade Name: Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control Regulatory Class: II Product Code: ITI Dated: October 7, 1999 Received: October 12, 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 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 yours,

Nil R.P. Ogden

James E. Dillard III
for

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): TBD

Device Name: Invacare Power Wheelchairs with Gyroscope Controller

Its intended use is to provide mobility to persons limited to a sitting position, that Indications For Use: have the capability of operating a powered wheelchair.

NRO for

(Division Sign-Off) Division of General Restorative Devices K 993413 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

Image /page/4/Picture/9 description: The image shows the text "Over-The-Counter Use" in bold font. To the right of the text is a symbol that looks like an X with a line underneath it. The text and symbol are in black and are set against a white background. The image appears to be a label or sign indicating that the product is available for over-the-counter use.

(Optional Format 1-2-96)

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).