The intended use of the Pride Mobility Products Corporation device is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

Device Description

The Jazzy Elite 6 is a Powered Wheelchair having a digital controller, electrical system, motors, batteries, seating, and frame. The Jazzy Elite 6 is equipped with electronic regenerative disc brakes, 3A off-board battery charger, removable 12 volt batteries, drive wheels, and front and rear caster wheels.

The Jazzy Elite 6 is designed with ultimate safety, stability, and performance in mind. The Powered Wheelchair is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.

AI/ML Overview

The provided document describes the Jazzy Elite 6 Powered Wheelchair and its substantial equivalence to a predicate device, the Jazzy Frontie (K092961). The information focuses on non-clinical testing and comparison rather than a study involving human readers or a standalone algorithm.

Here's a breakdown based on your request, highlighting what is and isn't available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Compliance to applicable Testing Standards:	Jazzy Elite 6 passed all necessary testing. (No specific numerical performance metrics are provided in this document beyond compliance.)
- RESNA WC Vol.1 2009 - Requirements and Test Methods for Wheelchairs (Including Scooters)	Compliant
- RESNA WC Vol. 2 2009 - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems	Compliant
- ANSI/RESNA WC Vol. 2-2008 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.	Compliant
- CAL 117 - Flammability Testing	Compliant
- ISO 10993 - Biocompatibility Testing	Compliant
Substantial Equivalence to Predicate Device (Jazzy Frontie K092961) in terms of:	Determined to be substantially equivalent.
- Performance	Similar
- Maneuverability	Similar
- Stability	Similar
- Structure	Similar
- Position of electronics and drive mechanisms	Similar to achieve the same intended use function that enables the user to maintain optimum stability without hindering performance.
- Intended Use	Same
- Technological Characteristics	Similar; differences do not raise any new questions of safety or effectiveness.

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

This document describes non-clinical testing of a powered wheelchair, not a test set for an AI/algorithm-based device. Therefore, the concept of "sample size for the test set" and "data provenance" in the context of clinical data is not applicable. The testing involves physical tests on the device itself.

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

This information is not applicable as the document describes physical testing and compliance with engineering standards, not a study requiring expert-established ground truth for an algorithm.

4. Adjudication method for the test set:

This information is not applicable for the reasons stated above.

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:

This is not applicable. The device is a powered wheelchair, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

This is not applicable. The device itself is a physical product (a powered wheelchair), not a standalone algorithm.

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

The "ground truth" for the Jazzy Elite 6 is established through compliance with recognized industry standards and regulatory requirements (e.g., RESNA, ANSI/RESNA, CAL 117, ISO 10993). This involves objective measurements and evaluations against specified criteria for safety, performance, and functionality of the physical device. It is not based on expert consensus for a diagnostic outcome or pathology.

8. The sample size for the training set:

This is not applicable as the document does not describe the development or testing of an AI algorithm that would require a training set.

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

This is not applicable for the reasons stated above.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is referred to as "Non-Clinical Testing" and the "Comparison to Predicate Devices."

The document states:

"Compliance to applicable Testing Standards is as follows (See 7F for FDA-3654 forms):" followed by a list of RESNA, ANSI/RESNA, CAL 117, and ISO 10993 standards.
"The Jazzy Elite 6 Powered Wheelchair has the same intended use and similar technological characteristics as the Jazzy Frontie (K092961), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Jazzy Elite 6 is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation."

In essence, the "study" is a series of engineering and safety tests conducted on the physical device to ensure compliance with established standards, and a direct comparison of its design and performance against a previously cleared predicate device (Jazzy Frontie K092961). The specific details of these tests (e.g., how many units tested, exact results for each parameter within the standards) are not provided in this summary but are referenced as having been performed and demonstrating compliance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, italicized font, with a registered trademark symbol next to the "e". Below the word "Pride" is the text "Mobility Products Corp." in a smaller, non-italicized font.

APR 1 8 2012

AGE 10 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990

KII3489

Exhibit 1 510(k) Summary Pride Mobility Products Corporation Jazzv Elite 6

Submitter's Name & Address:

Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 655-1470

Contact Person:

Kimberly Blake

Date Prepared: 11/18/2011

Name of Device and Proprietary Name: Jazzy Elite 6

Common or Usual Name: Powered Wheelchair

Classification Name:

Physical Medicine / Powered Wheelchair

Product Code:

ITI

Comparison to Predicate Devices:

The Jazzy Elite 6 is substantially equivalent to the Pride Mobility Jazzy Frontie (K092961), when comparing performance, maneuverability, stability, and structure, The performance characteristics and the position of the electronics and drive mechanisms are similar to achieve the same intended use function that enables the user to maintain optimum stability without hindering performance. Refer to Exhibit 7 for verification and validation activities.

The major differences between the Jazzy Elite 6 and the Jazzy Frontie (K092961) are in the front wheels. The Jazzy Frontie (K092961) has four (4) wheels on the ground while the Jazzy Elite 6 has six (6) wheels on the ground:

Jazzy Frontie (K092961) utilizes 3" front anti-tip wheels (off of the ground) . versus the Jazzy Elite 6 which utilizes 5" front caster wheels (on the ground).

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Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, sans-serif font, with the "i" dotted with a registered trademark symbol. Below "Pride" is the text "Mobility Products Corp." in a smaller, sans-serif font. The logo is black and white.

KIT3488 AGE 2 OF 2 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990

Device Description:

Intended Use:

The intended use of the Pride Mobility Products Corporation device is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

Non-Clinical Testing:

Compliance to applicable Testing Standards is as follows (See 7F for FDA-3654 forms): RESNA WC Vol.1 2009 - Requirements and Test Methods for Wheelchairs (Including Scooters) RESNA WC Vol. 2 2009 - Additional Requirements for Wheelchairs (Including Scooters)

with Electrical Systems ANSI/RESNA WC Vol. 2-2008 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.

CAL 117 - Flammability Testing

ISO 10993 -Biocompatibility Testing

Discussion of Clinical Testing Performed:

N/A

Conclusions:

The Jazzy Elite 6 Powered Wheelchair has the same intended use and similar technological characteristics as the Jazzy Frontie (K092961), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Jazzy Elite 6 is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

APR 1 8 2012

Pride Mobility Product Corporation % Ms. Kimberly Blake Assistant Manger, Regulatory QA-Regulatory Compliance 182 Susquehanna Avenue Exeter. Pennsylvania 18643

Re: K113488

Trade/Device Name: Jazzy Elite 6 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 19, 2012 Received: March 19, 2012

Dear Ms. Blake:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Kimberly Blake

device-related adverse events) (21 CFR 803); 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.

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,

Eunel Keith

´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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Image /page/4/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, sans-serif font, with the letters slightly overlapping. Below "Pride" is the text "Mobility Products Corp." in a smaller, sans-serif font. The logo is black and white.

182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990

Exhibit 3

Indications for Use

510(k) Number (if known): K

Device Name: Jazzy Elite 6

Indications for Use: The intended use of the Pride Mobility Products Corporation device is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND / OR

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)

(Div) Rick -Off Sigh Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113488

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).