The Fusion is an indoor/outdoor scooter that is battery operated. Fusic standard technology seating, thumb operated throttle, digital controller rarger, motor, brake, transaxle, frame material and till we have used for years on our - - Saver units. The Fusion frame separates for transport and has removable batteries anc تحتوب Accessories include a front light and a basket.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Fusion" (later referred to as PaceSaver Fusion), a 3-wheel power scooter.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail threshold format for performance metrics. Instead, it refers to compliance with applicable Testing Standards. The reported device performance is that the Fusion "passed the necessary testing to recognized consensus standards."

Acceptance Criteria (Standards Met)	Reported Device Performance
ANSI/RESNA WC/01 Determination of Static Stability	Passed necessary testing
ANSI/RESNA WC/02 Determination of Dynamic Stability	Passed necessary testing
ANSI/RESNA WC/03 Effectiveness of Brakes	Passed necessary testing
ANSI/RESNA WC/04 Determination of Energy Consumption - Theoretical Range	Passed necessary testing
ANSI/RESNA WC/05 Overall Dimensions, Mass, and Turning Space	Passed necessary testing
ANSI/RESNA WC/06 Determination of Maximum Speed, Acceleration, and Retardation of Electric Wheelchairs	Passed necessary testing
ANSI/RESNA WC/08 Test Methods for Static, Impact, and Fatigue Strengths	Passed necessary testing
ANSI/RESNA WC/09 Climatic Tests	Passed necessary testing
ANSI/RESNA WC/10 Obstacle Climbing	Passed necessary testing
ANSI/RESNA WC/15 Documentation and Labeling	Passed necessary testing
ANSI/RESNA WC/93 Maximum Overall Dimensions	Passed necessary testing

The document implies that meeting these standards constitutes the acceptance criteria.

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

Sample Size: The document does not specify a separate "test set" or its sample size. The testing refers to the device (Fusion) itself being subjected to the standards listed. It does not involve a cohort of subjects or data collection in the way a clinical study would.
Data Provenance: Not applicable in the traditional sense of retrospective or prospective human clinical data. The data provenance would be from the engineering and product testing performed on the device by Burke, Inc.

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

Not applicable. The ground truth for the device's performance is established by its compliance with the specified ANSI/RESNA standards, which define objective measurement methods and pass/fail criteria. It does not rely on expert consensus for interpreting results.

4. Adjudication Method for the Test Set:

Not applicable. There's no mention of an adjudication process as there would be in a study involving human interpretation. The testing is based on objective measurements against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical testing is not appropriate and not required for the proposed device. Clinical testing was not performed." Therefore, there is no effect size of human reader improvement with or without AI assistance as AI is not part of this device.

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

Not applicable. This device is a physical power scooter, not an algorithm or a software-as-a-medical-device (SaMD). There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used:

The ground truth used is compliance with recognized consensus standards (ANSI/RESNA WC series). These standards provide objective criteria and methodologies for evaluating the mechanical and performance characteristics of power wheelchairs and scooters.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this is not an AI/ML device requiring training data. The testing involves the physical device itself.

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

Not applicable, as there is no training set for this device.

Summary

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K0619/2

Fusion 510(k) Summary

AUG 0 1 2006

Submitter's Name & Address:	Burke, Inc.1800 Merriam LaneKansas City, KS 66105Phone: 913-722-5653Fax: 913-722-2614
Contact Person:	DuWayne E KramerOfficial Corresponde--
Date Prepared:	06-22-06
Name of Device and Proprietary Name:	Fusion
Common or Usual Name:	3 Wheel Power Scooter
Class:	II
Classification Name:	Vehicle, Motorized 3-Wheeled
Product Code:	INI

Device Description:

Comparison to Predicate Devices:

The Fusion is substantially equivalent to our PaceSaver Little Junior (K.S.25 122) and PaceSaver Espree Scooter (K965123) when comparing maneuverability, performance and technological characteristics. While the frame material s the same, Fusion's key change is in the frame design. PaceSaver Fusion uses 3 primary wheels similar to the predicate device design. However, while the predicate devices يڪ اس fixed-in-place anti-tip wheels for tip-over safety, the Fusion uses two caster wheels on spring-loaded trailing arms. Fusion's patent-pending frame design provides the indoor manesterability of our small scooter with the traction and stability of our larger standard scooters.

Intended Use:

Motorized five-wheeled battery powered scooter intended for medical purposes by disabled persons and other non-medical purposes.

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Non-Clinical Testing:

Compliance with applicable Testing Standards is as follows:

ANSI/RESNA WC/01 Determination of Static Stability ANSI/RESNA WC/02 Determination of Dynamic Stability ANSI/RESNA WC/03 Effectiveness of Brakes ANSI/RESNA WC/04 Determination of Energy Consumption - Theoretical Range ANSI/RESNA WC/05 Overall Dimensions, Mass, and Turning Space ANSI/RESNA WC/06 Determination of Maximum Speed, Acceleration, and Retardation of Electric Wheelchairs ANSI/RESNA WC/08 Test Methods for Static, Impact, and Fatigue Strengths ANSI/RESNA WC/09 Climatic Tests ANSI/RESNA WC/10 Obstacle Climbing ANSI/RESNA WC/15 Documentation and Labeling ANSI/RESNA WC/93 Maximum Overall Dimensions

Discussion of Clinical Testing Performed:

Clinical testing is not appropriate and not required for the proposed device. Clinical testing was not performed.

Conclusions:

The PaceSaver Fusion has the same intended use and substantially equivalent technological, physical, and operational characteristics as the predicate devices PaceSaver Little Jr. (K925122) and PaceSaver Espree Scooter (K965123). Moreover, the non-clinical testing and comparison to predicate devices demonstrates that the differences do not cause any questions as to the safety or effectiveness of the proposed device. The Fusion has passed the necessary testing to recognized consensus standards and is considered to be safe for user operation.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of a human figure with three lines extending above it, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG () 1 2006

Burke, Inc. % Mr. DuWayne E. Kramer, Jr. President 1800 Merriam Lane Kansas City, Kansas 66106

Re: K061912

Trade/Device Name: PaceSaver Fusion Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: June 30, 2006 Received: July 6, 2006

Dear Mr. Kramer:

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 mav, 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 Cor.trols) 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 (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. DuWayne E. Kramer, Jr.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hubert Leuner wo

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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To: Elmar Einberg
Re.: K061912 Fusion

Indications for Use

510(k) Number (if known): K061912

Device Name: PaceSaver Fusion

Indications For Use:

Motorized five-wheeled battery powered scooter intended for medical purposes by disabled persons and other non-medical purposes.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

Huler Leener

Division of General, Restorative, and Neurological Devices

Page 1 of _

510(k) Number K061912

4 - 2

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).