The intended use of the Pride Mobility Products Corporation Jazzy Frontie is to provide mobility to disabled persons having limited walking capabilities. The intended use of the Jazzy Frontie is to provide mobility to those who are limited to a seated position that have the capability of operating a Powered Wheelchair.

Device Description

The Jazzy Frontie is a Powered Wheelchair having a digital controller, electrical 140 outly motors, batteries, seating, and frame. The Jazzy Frontie is equipped with electronic, regenerative disc brakes, off-board battery charger, removable 12 Volt U1 batteries, front anti-tip wheels, and rear caster wheels. The Jazzy Frontie has a depth adjustable fold flat seat that provides fast, simple adjustment for enhanced, personalized comfort that is removable.

AI/ML Overview

The provided text is a 510(k) summary for a powered wheelchair, the Jazzy Frontie. It details the device's description, intended use, and comparison to a predicate device, as well as non-clinical testing performed. However, it explicitly states "N/A" for "Discussion of Clinical Testing Performed."

Therefore, based on the provided document, the following points regarding acceptance criteria and a study proving the device meets them cannot be answered:

A table of acceptance criteria and the reported device performance: Not provided. The document focuses on regulatory compliance through non-clinical testing and substantial equivalence.
Sample size used for the test set and the data provenance: Not applicable as no clinical study was performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was performed.
Adjudication method for the test set: Not applicable as no clinical study was performed.
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 as no clinical study was performed, and the device is a powered wheelchair, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is a powered wheelchair, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no clinical study was performed.
The sample size for the training set: Not applicable as no clinical study that would require a training set was performed.
How the ground truth for the training set was established: Not applicable as no clinical study that would require a training set was performed.

The document primarily relies on non-clinical testing and substantial equivalence to a predicate device (Pride Mobility Jet 1, K001970) to demonstrate safety and effectiveness.

Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing and Substantial Equivalence):

Acceptance Criteria (Implied by Standards Compliance)	Reported Device Performance (Summary)
Safety and Performance Standards:	Compliance Demonstrated Through Testing:
RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters)	"passed all the necessary testing"
RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems	"passed all the necessary testing"
ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility	"passed all the necessary testing"
IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety	"passed all the necessary testing"
CAL 117 - Flammability Testing	"passed all the necessary testing"
Substantial Equivalence to Predicate Device:	"The Jazzy Frontie is substantially equivalent to the Pride Mobility Jet 1 (K001970) when comparing performance, maneuverability, stability, and structure."
Similar intended use	"The Jazzy Frontie Powered Wheelchair has the same intended use."
Similar technological characteristics	"similar technological characteristics as the Jet 1 (K001970)"
No new questions of safety or effectiveness	"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."

Study Proving Acceptance Criteria Met:

The study proving the device meets the acceptance criteria is non-clinical testing in conjunction with a substantial equivalence comparison to a predicate device.

Non-Clinical Testing: The device underwent testing to comply with various standards including:
- RESNA WC Vol.1 2008 DRAFT
- RESNA WC Vol. 2 2008 DRAFT
- ANSI/RESNA WC Vol. 2-1998 Section 21
- IEC 601-1-1
- CAL 117
  The document states the device "passed all the necessary testing."
Substantial Equivalence Study: A comparison was made to the predicate device, Pride Mobility Jet 1 (K001970), demonstrating that the Jazzy Frontie
- Has the same intended use.
- Has similar technological characteristics.
- Does not raise new questions of safety or effectiveness due to any differences in technological characteristics.

In summary, no clinical study was performed or required for the 510(k) clearance of the Jazzy Frontie powered wheelchair. The evidence supporting its safety and effectiveness is based on adherence to recognized non-clinical performance standards and a demonstration of substantial equivalence to an already legally marketed device.

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, 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.

Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990 www.pridemobility.com

K092961

Exhibit 1

510(k) Summary Pride Mobility Products Corporation Jazzy Frontie

Submitter's Name & Address:

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

Contact Person:

Kimberly Blake Official Correspondent

Date Prepared:

9/15/09 .

Name of Device and Proprietary Name:

Name of Beer Pride Mobility Products Corporation

Common or Usual Name:

Powered Wheelchair

Classification Name:

Physical Medicine / Powered Wheelchair

Product Code:

ITI

Comparison to Predicate Devices:

Comparison to Predicate Devices.
The Jazzy Frontie is substantially equivalent to the Pride Mobility Jet 1 (K001970),
The Jazzy Frontie is substantially equivality, and struc The Jazzy Frontie is substantially equivalorite stability, and structure. The when companing performance, maneuvelton of the electronics and drive mechanisms
performance characteristics and the position of the electronics and drive user to maintain performance charactenstics and the position of the one of the user to maintain
are similar to achieve the same intended use function that enables the user to maintain
t and a are similar to domoithout hindering performance.

OCT 23 2009

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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 large, bold 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 font. The logo is black and white.

Device Description:

The Jazzy Frontie has a depth adjustable fold flat seat that provides fast, simple adjustment for enhanced, personalized comfort that is removable.

The Jazzy Frontie 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.

Intended Use:

The intended use of the Pride Mobility Products Corp. Jazzy Frontie is to provide mobility to disabled persons having limited walking capabilities.

Non-Clinical Testing:

Compliance to applicable Testing Standards is as follows:

SESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters)

RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems

ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.

IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety CAL 117 - Flammability Testing

Discussion of Clinical Testing Performed:

N/A

Conclusions:

The Jazzy Frontie Powered Wheelchair has the same intended use and similar technological characteristics as the Jet 1 (K001970), 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 Frontie 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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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Pride Mobility Products Corporation % Ms. Kimberly Blake Official Correspondent 182 Susquehanna Avenue Exeter, Pennsylvania 18643

OCT 2 3 2009

Re: K092961

Trade/Device Name: Jazzy Frontie Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 15, 2009 Received: September 25, 2009

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.

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 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 - Ms. Kimberly Blake

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark N. Milken

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

510(k) Number (if known): K

Device Name: Jazzy Frontie

Indications for Use:

ート - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

The intended use of the Pride Mobility Products Corporation Jazzy Frontie is to The intendou aso of those to a seated position that have the capability of operating a Powered Wheelchair.

AND / OR Prescription Use_ × (Part 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)

Yvonne W. Olney FOR M. MELKERSON
Sign Off

(Dision Sign-Off) (DWision Sign-Only)
Division of Surgical, Orthopedic, Division of Surgices Division of Sarge
and Restorative Devices

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K092961

510(k) Number -

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).