The intended use of the Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also rrovides a mobility product that transports easily for travel usage.
The intended use of the Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to disabled persons.

Device Description

The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is a compact battery-operated scooter having a digital programmable Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Go Go Elite Traveller V, Three Wheel Scooter is designed for but not limited to Pride Mobility Products Corp. providers / retailers and their consumers, The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is that it can be disassembled into 4 parts: the rear section, the front section, the battery pack, and the seat. This allows for ease of use when traveling or stority the unit.

AI/ML Overview

This document describes the 510(k) summary for the Pride Mobility Products Corporation Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study to prove performance against those criteria.

Therefore, much of the requested information regarding a specific study, acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not available in the provided text. The submission is a non-clinical testing submission for substantial equivalence.

Here's an attempt to extract and infer information based on the provided text, and point out what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from standards)	Reported Device Performance (Implied from "Compliance" and "passed all necessary testing")
Performance	Maneuverability, Stability	Substantially equivalent to predicate device
Structure	Construction (frame), Weight capacity	Differences noted but do not raise new questions of safety/effectiveness
Safety	Electronic regenerative & electromechanical disc brakes, Rear anti-tip wheels	Passed all necessary testing; Substantially equivalent; No new safety questions raised
Electrical Systems	As per RESNA WC Vol. 2 2008 DRAFT	Passed all necessary testing
Electromagnetic Compatibility (EMC)	As per ANSI/RESNA WC Vol. 2-1998 Section 21	Passed all necessary testing
General Safety (Electrical)	As per IEC 601-1-1	Passed all necessary testing
Flammability	As per CAL 117	Passed all necessary testing
Intended Use Function	Maintain optimum stability, not hinder performance	Similar to predicate device, enables intended use function
Portability	Disassembly into 4 parts	Design feature; no formal performance metric stated but implied to meet portability goal

2. Sample Sizes used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated. The testing seems to be based on evaluating the design and performance characteristics of the single device model, the Go Go Elite Traveller V / Model SC40EV, against the standards and the predicate device. It's likely one or a few units were tested to demonstrate compliance.
Data Provenance: Not explicitly stated, but given it's a 510(k) submission from Pride Mobility Products Corporation, it can be inferred that the data comes from internal testing and validation activities of the manufacturer. It is retrospective in the sense that the data was collected prior to the submission for regulatory approval. There is no indication of country of origin of the data beyond the manufacturer's location (Exeter, PA, USA).

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

Number of Experts: Not applicable/not stated. This was a non-clinical device testing submission focusing on compliance with performance standards and comparison to a predicate device, not a diagnostic or AI device requiring expert ground truth for a test set. The "experts" involved would be the engineers and quality assurance personnel performing the tests according to the standards.
Qualifications: Not applicable/not stated.

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

Adjudication Method: Not applicable/not stated. This type of adjudication is typically used in clinical studies for diagnostic accuracy, which is not the nature of this submission. The "adjudication" for this type of submission would be the review by regulatory bodies (FDA) of the presented test results against the specified standards.

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

MRMC Study: No. This is not an AI device or a diagnostic medical device that would involve human "readers." The submission explicitly states "Discussion of Clinical Testing Performed: N/A."

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

Standalone Performance: Not applicable. This is a physical mobility device, not an algorithm.

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

Ground Truth: For this device, "ground truth" would be the objective measurements and adherence to engineering specifications and performance standards (e.g., stability measurements, brake effectiveness, flammability rating, electromagnetic compatibility readings) as defined by the RESNA and IEC standards. The predicate device's established safety and effectiveness also serves as a "ground truth" for comparison.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is not a machine learning or AI device. "Training set" is not relevant here.

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

Ground Truth Establishment for Training Set: Not applicable. As this is not an AI device, there is no "training set" or ground truth to establish for such a purpose.

Summary

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Image /page/0/Picture/0 description: The image contains a handwritten word, "Kogosay". The letters are connected in a cursive style, and the writing appears to be in black ink on a white background. The handwriting is somewhat stylized, with distinct loops and curves forming the letters.

Image /page/0/Picture/1 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.

MAR 1 9 2009

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

Exhibit 1

510(k) Summary Pride Mobility Products Corporation Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter

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:

02-20-09

Name of Device and Proprietary Name:

Go Go Elite Traveller V / Model SCV40EV, Three Wheel Scooter / Pride Mobility Products Corporation

Common or Usual Name:

Three-Wheel Power Scooter

Classification Name:

Physical Medicine / Motorized Three - Wheeled Vehicle

Product Code:

INI

Comparison to Predicate Devices:

The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is substantially equivalent to the Pride Mobility Go Go Mini / Model SC30 (K062160) 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. The differences between The Go Go Mini / Model SC30 (K062160) and the Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, are in the front and rear frame construction, weight capacity, and driving range.

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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, 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

Device Description:

Intended Use:

The intended use of the Pride Mobility Products Corp. Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also rrovides a mobility product that transports easily for travel usage.

Non-Clinical Testing:

Compliance to applicable Testing Standards is as follows:

RESNA 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 Go Go Elite Traveller V Model SC40EV, Three Wheel Scooter has the same intended use and similar technological characteristics as the Go Go Mini / Model SC30 (K062160), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not reaisons new questions of safety or effectiveness. Thus, the Go Go Elite Traveller V, Three Wheel Scooter 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

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or a stylized human figure, representing health and human services.

MAR 1 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090524

Trade Name: Go Go Elite Traveller V/Model SC40EV, Three Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vchicle Regulatory Class: II Product Code: INI Dated: February 20, 2009 Received: February 26, 2009

Dear Mr. Schappert:

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 (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. Thomas Schappert

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 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 Millerson

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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Exhibit 3

Indications for Use

510(k) Number (if known): K

Device Name: Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter

Indications for Use:

The intended use of the Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to disabled persons.

Prescription Use X AND / OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (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)

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

Page 1 of 1

510(k) Number K090524

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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).