The intended use of the X8 power wheelchair is to provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair.

Device Description

The Extreme 4x4- X8 is a battery powered, electric motor driven device with the intended function of providing mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. It is a four-wheel drive format wheelchair as its basic configuration with direct drive motors on all four wheels. The wheelchair frame is a non-folding type. The frame of the unit is of welded steel construction. The wheelchair consists of the following basic components: frame w/four motors, joystick, seat, armrests, and footrests.

AI/ML Overview

The provided text is a 510(k) summary for a power wheelchair (Extreme 4x4-X8). This document primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison table and general declarations, rather than presenting a detailed study with acceptance criteria and performance data in the typical sense of a clinical or performance study for an AI/software medical device.

Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC study, standalone performance) are not applicable to this type of submission. The device is a physical power wheelchair, not an AI/software device.

However, I can extract the closest information available from the text regarding "acceptance criteria" (interpreted as performance specifications for the device) and "device performance" (as reported in the comparison to the predicate).

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical power wheelchair, "acceptance criteria" are implied by the performance characteristics of the predicate device (K000796, Extreme 4x4-X4) which the new device (Extreme 4x4-X8) aims to meet or exceed. The "reported device performance" refers to the specifications of the Extreme 4x4-X8.

Performance Metric	Acceptance Criteria (Predicate Device K000796)	Reported Device Performance (Extreme 4x4-X8)
Type	Wheelchair, Power	Wheelchair, Power
Intended Use	To provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair	To provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair
Where Used	Designed to operate indoors and over a variety of outdoor surfaces including soft/rough terrain with inclines up to 1 in 14	Designed to operate indoors and over a variety of outdoor surfaces including soft/rough terrain with inclines up to 1 in 14
Design	Compact, rigid	Compact, with front frame articulation
Construction	Steel frame	Steel frame
Overall length	43.3"	45.25"
Overall width	28"	28"
Wheel Size	4 x Ø14"	4 x Ø14"
Rolling Base Weight (No Seat, No Batteries)	159 lbs.	145 lbs.
Range	19 miles	25 miles
Maximum Speed	5 mph	6.5 mph
Maximum Weight Capacity	400 lbs	400 lbs
Controller	Dynamic DX-PMB2 electronic control and joystick	Dynamic DX2-PMA70L electronic control and joystick
Motors	Four 24V, 4 pole direct drive motors/gearbox	Four 24V, 4 pole direct drive gear in line motors/gearbox
Suspension	None	None
Batteries	Two 73 Amp/hour	Two 73 Amp/hour
Seat Width	16"-24"	16"-24"
Seating	Upholstery meets California 117 specifications for fire retardancy	Upholstery meets California 117 specifications for fire retardancy
Footrest	1 piece rigid footplate, flip up footplates and others	1 or 2 piece, fixed or flip up, angle and height adjustable rigid footplates, and others
Armrest	Height adjustable, removable	Height adjustable, removable
Safety Features	Electromagnetic brake engaged when chair is stationary. When electromagnetic brakes are disengaged, chair cannot be driven.	Electromagnetic brake engaged when chair is stationary. When electromagnetic brakes are disengaged, chair cannot be driven. Drive is inhibited with some seat positioning functions.

Study Proving Device Meets Acceptance Criteria:

The document describes the submission as a "510(k) Premarket Notification" for the Extreme 4x4-X8 power wheelchair. The "study" proving the device meets the acceptance criteria is implicitly the comparison to the legally marketed predicate device (Extreme 4x4-X4, K000796), as presented in the "Device Comparison Table" and the "Substantial Equivalence" section. The claim is that the X8 has the "same intended function and use as the X4" with "minor modifications" that improve performance (e.g., articulated frame, higher speed/torque motors, latest electronic software/hardware). The FDA's letter states they "determined the device is substantially equivalent...to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" in the context of a 510(k) pathway for this type of device.

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

Not applicable. This submission is for a physical medical device (power wheelchair), and the provided document does not detail a clinical "test set" or data provenance in the way one would for an AI/software device. The comparison is based on engineering specifications and design features.

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. There is no "ground truth" derived from expert consensus mentioned for a test set in this document.

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

Not applicable. There is no adjudication method mentioned.

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 not an AI/software device, and no MRMC study was performed or is relevant.

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

Not applicable. This is not an AI/software device.

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

Not applicable. The "ground truth" equivalent in this context is the safety and effectiveness profile of the predicate device, established through its prior marketing clearance and compliance with performance standards typical for power wheelchairs. The new device demonstrates substantial equivalency to this established baseline.

8. The sample size for the training set

Not applicable. This is not an AI/software device, and there is no concept of a "training set" in the provided documentation.

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

Not applicable. (See point 8).

Summary

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K090350

Image /page/0/Picture/1 description: The image shows a logo with a spiral design on the left and the words "Innovation In Motion" on the right. The spiral design has small lines radiating outward, resembling a sun. The text is in a simple, sans-serif font, with "Innovation" on the top line and "In Motion" on the bottom line.

PO ROX 507 gola, IN 46703 USA h. 260.665.2769 260.665.3047

510(k) Summary Extreme 4x4-X8 Power Wheelchair Innovation In Motion 510(k) Premarket Notification

APR 1 0 2009

C-1

Applicant's Name, Address, Telephone, Fax, and E-mail information:

Innovation In Motion 201 Growth Parkway P0 Box 507 Angola, IN 46703 Phone: 260.665.2769 Fax: 260.665.3047 E-mail: rick@vestil.com

Preparer's Name, Address, Telephone, Fax, Contact Name, E-mail information, and Date Prepared:

Innovation In Motion 201 Growth Parkway P0 Box 507 Angola, IN 46703 Phone: 260.665.2769 Fax: 260.665.3047 Contact Name: Rick Michael Vice President E-mail: rick@vestil.com Date: February 2009

Manufacturer's Name, Address, Telephone, and Fax Information:

Magic International Pty. Ltd. 2/16 Viewtech Place Rowville, Victoria 3178 Australia Phone: 011.613.9755.8100 Fax: 011.613.9755.8111

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Image /page/1/Picture/0 description: The image shows a logo with the words "Innovation In Motion". To the left of the text is a spiral design with three lines extending from the left side. The text is in a simple, sans-serif font. The overall design is clean and modern.

PO BOX 507
Angola, IN 46703 USA
Ph. 260.665.2769
F. 260.665.3047
mobility-usa.com

Device Trade, Common, and Classification names:

Device Name: Extreme 4x4- X8

Common Name: Power Wheelchair

Classification Name: Restorative Devices

Predicate Device:

Extreme 4x4- X4 (K000796)

Device Description:

The frame of the unit is of welded steel construction. The wheelchair consists of the following basic components: frame w/four motors, joystick, seat, armrests, and footrests.

Intended Use:

This device is an electric powered wheelchair for indoor and/or outdoor use, to be used by partially disabled individuals capable of operating a few essential hand controls.

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ాevice Comparison Table:

COMPARISON TABLE WITH MARKETED DEVICE

··

K000796
	X4	X8
Type	Wheelchair, Power	Wheelchair, Power
Intended Use	To provide mobility to persons limited to asitting position, who have the capability ofoperating a power wheelchair	To provide mobility to persons limited to asitting position, who have the capability ofoperating a power wheelchair
Where Used	Designed to operate indoors and over avariety of outdoor surfaces includingsoft/rough terrain with inclines up to 1 in 14	Designed to operate indoors and over avariety of outdoor surfaces includingsoft/rough terrain with inclines up to 1 in 14
Design	Compact, rigid	Compact, with front frame articulation
Construction	Steel frame	Steel frame
Dimensions	Overall length: 43.3"Overall width: 28"	Overall length: 45.25"Overall width: 28"
Wheel Size	4 x Ø14"	4 x Ø14"
Rolling Base Weight(No Seat, NoBatteries)	159 lbs.	145 lbs.
Range	19 miles	25 miles
Maximum Speed	5 mph	6.5 mph
Maximum WeightCapacity	400 lbs	400lbs
Controller	Dynamic DX-PMB2 electronic control andjoystickProgrammable to meet individual needsBattery charge level gauge*Attaches to either side	Dynamic DX2-PMA70L electronic controland joystickProgrammable to meet individual needsBattery charge level gauge*Attaches to either side
Motors	Four 24V, 4 pole direct drive motors/gearbox*Freewheeling lever/motor lock releases andengages front and rear motor brakes	Four 24V, 4 pole direct drive gear in linemotors/gearbox*Freewheeling lever/motor lock releases andengages rear motor brakes
Suspension	None	None
Batteries	Two 73 Amp/hour	Two 73 Amp/hour
Seat Width	16"-24"	16"-24"
Seating	Upholstery meets California 117specifications for fire retardancy	Upholstery meets California 117specifications for fire retardancy
Footrest	1 piece rigid footplate, flip up footplates andothers	1 or 2 piece, fixed or flip up, angle andheight adjustable rigid footplates, and others
Armrest	Height adjustable, removable	Height adjustable, removable
Safety Features	Electromagnetic brake engaged when chairis stationary. When electromagnetic brakesare disengaged, chair cannot be driven	Electromagnetic brake engaged when chairis stationary. When electromagnetic brakesare disengaged, chair cannot be drivenDrive is inhibited with some seat positioningfunctions

・・・..

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Image /page/3/Picture/0 description: The image shows a logo with the words "Innovation In Motion". To the left of the text is a circular design that resembles a sun or a spiral. The text is stacked, with "Innovation" on top and "In Motion" below. The font appears to be handwritten or stylized, giving the logo a unique and informal look.

PO BOX 507 Angola, IN 46703 USA Ph. 260.665.2769 F. 260.665.3047 mobility-usa.com

Substantial Equivalence:

The X8 has the same intended function and use as the X4. The X8 is the next generation of the X4 with minor modifications:

. Articulated frame for improved obstacle climbing and handling
High Speed, high torque high efficiency gear in-line motors .
Latest edition of Dynamic Control electronic software/hardware .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping curved lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vestil Manufacturing Coporation % Innovation in Motion Mr. Rick Michael Vice President 201 Growth Parkway Angola, Indiana 46703

Re: K090350

Trade Name: Extreme 4x4 - X8 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: March 16, 2009 Received: March 20, 2009

Dear Mr. Michael:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that 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 comply 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

APR 1 0 2009

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Page 2 - Mr. Rick Michael

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Wilkerson

Mark N. Melkerson 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):

Device Name: EXTREME 4x4-X8

Indications For Use:

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Prescription Use (Part 21 CFR 301 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milliken

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page : xi

510(k) Number K

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).