The intended use of the Pride Mobility Products Corp. Jazzy 600 Power Wheelchair is to provide mobility to persons limited to a seated position, that have the capability of operating a powered wheelchair.

Device Description

The Jazzy 600 is a battery-operated power wheelchair featuring Mid-Wheel Drive technology, rear casters, front anti-tip casters, and a standard 75 amp Pride Flight controller. The Jazzy 600 is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.

The Jazzy 600 Power Wheelchair consists of the same basic components found on the Jazzy (K945936), such as a rigid steel frame, upholstered seat, amrests, football drive wheels, rear caster wheels and front anti-tip devices. As a motorized wheelshair substantially equivalent to the Jazzy (K945936) it also offers 2 motors for operational purposes, electronic regenerative disc brakes, suspension, onboard hattery charger, a fully programmable controller, and requires two batteries. Accessories include lap bett, rear basket, cane or crutch holder, oxygen holder, walker holder, flag holder, cup holder, saddle bag, and dust cover.

The Jazzy 600 is designed with ultimate safety, stability, and performance in mind. It features rear casters, and front anti-tip casters which allow for surface contact all times and prevents pitching on sloped terrain.

AI/ML Overview

The provided document is a 510(k) premarket notification for a powered wheelchair, the Jazzy 600. It focuses on demonstrating substantial equivalence to a predicate device and includes information on non-clinical testing. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a clinical study for an AI/algorithm-based medical device would.

Therefore, I cannot fulfill your request for the specific acceptance criteria and study details as they are not present in the provided text. The document refers to "Non-Clinical Testing" which details compliance to various ANSI/RESNA WC standards. These are likely performance and safety standards for wheelchairs, not clinical efficacy metrics for an AI.

Here's a breakdown of why each numbered point of your request cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present. The document lists "Compliance to applicable Testing Standards" for non-clinical aspects like static stability, dynamic stability, brakes, dimensions, etc., but it doesn't provide specific numerical acceptance criteria or performance metrics in a table format. For example, it lists "ANSI/RESNA WC/01 Determination of Static Stability" but doesn't state what the acceptable static stability angle is or what the Jazzy 600 achieved.
Sample sized used for the test set and the data provenance: Not applicable. The testing described is non-clinical, likely involving physical prototypes and testing equipment, not human subjects or data sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/algorithm performance is not relevant here.
Adjudication method for the test set: Not applicable.
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 powered wheelchair; it does not involve human readers or AI assistance in data interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical powered wheelchair.
The type of ground truth used: Not applicable. The "ground truth" for a physical device like a wheelchair is compliance with engineering and safety standards, determined by physical measurements and tests.
The sample size for the training set: Not applicable. This device is not an AI/algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The provided document describes the non-clinical testing performed for the Jazzy 600 Powered Wheelchair to demonstrate substantial equivalence to a predicate device for its physical and mechanical performance and safety. It is not a document describing the validation of an AI or algorithm.

The non-clinical testing focuses on compliance with the following ANSI/RESNA WC standards:

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/05 Overall Dimensions, Mass & Turning Space
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 Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
ANSI/RESNA WC/93 Maximum overall Dimensions
CAL 117 - Flammability Testing

The conclusion states that the Jazzy 600 "has passed all the necessary testing procedures and is considered to be safe for user operation." This implies that the device met the requirements of these standards, but the document does not further elaborate on specific numerical acceptance criteria or performance results within these standards.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that form the body, wings, and tail. The text is in a simple, sans-serif font and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pride Mobility Products Corporation % Mr. Thomas Schappert Official Correspondent 182 Susquehanna Avenue Exeter, Pennsylvania 18643

JAN 25 2011

Re: K042612

Trade/Device Name: Jazzy 600 Powered Wheelchair Regulation Number: 21 CFR 890. 3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 30, 2004 Received: October 1, 2004

Dear Mr. Schappert:

This letter corrects our substantially equivalent letter of October 6, 2004

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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Thomas Schappert

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Milkeran

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit 3

Indications for Use

Page __ 1 of of 1 _

510(k) Number (if known): K042612

Device Name: Jazzy 600 Powered Wheelchair

Indications For Use:

The intended use of the Pride Mobility Products Corp. Jazzy 600 Powered Wheelchair is to provide mobility to persons limited to a seated position.

Prescription Use × (Per 21 CFR 801 Subpart D)

X Over-The Counter Use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Yong-Hyun Song

(Division Sign-Off) Division of Surgical, Ofthopedic, and Restorative Devices

510(k) Number K042612

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Image /page/3/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, stylized font, with a horizontal line running through the middle of the letters. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, less bold font. The logo is black and white.

OCT 6 - 2004

esearch & Development 330 Philadelphia Avenus est Pittston, PA 18843 570-855-5574 FAX 655-2990 www.pridemobility.com

Exhibit 1 092612

510(k) Summary Pride Mobility Products Corporation Jazzy 600 Power Wheelchair

Submitter's Name & Address:

Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 655-2990

Contact Person:

Thomas Schappert Official Correspondent

Date Prepared:

09-10-04

Name of Device and Proprietary Name: Jazzy 600 / Pride Mobility

Common or Usual Name: Powered Wheelchair Base Unit

Classification Name:

Physical Medicine / Wheelchair, Powered

Product Code:

ITI

Comparison to Predicate Devices:

The Jazzy 600 is substantially equivalent to the Pride Mobility Jazzy (K945936) when comparing performance, maneuverability, stability, dimensions, and geometry. The performance characteristics and the position of the drive mechanisms are similar to achieve the same intended use function that enables the user to maintain optimum stability without hindering performance. Both utilize our patented Mid-Wheel Drive technology, rear casters, and front anti-tip devices for added stability and maneuverability. Key changes between the Jazzy (K945936) and the Jazzy 600 are the replacement of the front anti-tip wheels with front anti-tip casters that have nylon spheres that resist wheel hang-ups. The Jazzy 600 also has side mounted, users accessible freewheel release levers, and front battery access.

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Device Description:

Intended Use:

Non-Clinical Testing:

Compliance to 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/05 Overall Dimensions, Mass & Turning Space 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 Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility. ANSI/RESNA WC/93 Maximum overall Dimensions CAL 117 - Flammability Testing

Discussion of Clinical Testing Performed: N/A

Conclusions:

The Jazzy 600 has the same intended use and similar technological characteristics as the Jazzy (K945936), moreover, the non-clinical testing and the predicate companisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Jazzy 600 is substantially equivalent to the predicate device (Jazzy). The Jazzy 600 has passed all the necessary testing procedures and is considered to be safe for user operation.

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).