The intended use of the Pride Mobility Products Corporation Go Go Mini three wheel scooter, is to provide mobility to persons having limited walking capability, or simply to those who wish to ride a scooter for transportation purposes.

Device Description

The Go Go Mini is a compact battery-operated three-wheel scooter having a programmable 45-amp "S" Drive Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic regenerative disc brakes, and rear anti-tip wheels. The Go Go Mini is designed for, but not limited to Pride Mobility Products Corp. providers / refailers and their consumers. The Go Go Mini is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Go Go Mini 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 storing the unit.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Go Go Mini Power Wheelchair" (also referred to as "Go Go Mini / Three-wheel Power Scooter"). It does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically described for AI/ML-based medical devices or diagnostic tools.

Instead, this document details the substantial equivalence of the Go Go Mini to a predicate device (Pride Mobility Sunrunner TE-777, K923193) based on non-clinical testing and comparison of technological characteristics.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document explicitly states "Discussion of Clinical Testing Performed: N/A", which confirms that clinical trials (and thus, studies with detailed acceptance criteria, ground truth, expert adjudication, MRMC studies, or standalone performance) were not performed or are not reported in this submission for this device.

Here's what I can extract regarding the non-clinical testing performed, which is analogous to a "study" for this type of device, but without the detailed performance metrics you requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Applicable Testing Standards)	Reported Device Performance
ANSI/RESNA WC/01 Determination of Static Stability	Compliance affirmed
ANSI/RESNA WC/02 Determination of Dynamic Stability	Compliance affirmed
ANSI/RESNA WC/03 Effectiveness of Brakes	Compliance affirmed
ANSI/RESNA WC/05 Overall Dimensions, Mass & Turning Space	Compliance affirmed
ANSI/RESNA WC/08 Test methods for Static, Impact and Fatigue Strengths	Compliance affirmed
ANSI/RESNA WC/09 Climatic Tests	Compliance affirmed
ANSI/RESNA WC/10 Obstacle Climbing	Compliance affirmed
ANSI/RESNA WC/15 Documentation and Labeling	Compliance affirmed
ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility	Compliance affirmed
ANSI/RESNA WC/93 Maximum overall Dimensions	Compliance affirmed
CAL 117 - Flammability Testing	Compliance affirmed

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

Sample size: Not specified. For mechanical device testing against standards, it usually involves testing a specific number of units of the device itself (e.g., one or more prototypes/production units) rather than a "test set" of data in the context of AI.
Data provenance: The testing was non-clinical, meaning it likely involved laboratory or controlled environment testing of the physical device. Country of origin for the data is not specified, but the manufacturer is US-based (Exeter, PA). This would be considered prospective testing of the device.

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

Not applicable. "Ground truth" in the context of device performance against engineering standards is usually established by the specifications of the standard itself and measurements taken by qualified testing technicians and engineers. Expert consensus or clinical adjudication is not typically relevant for this type of device submission.

4. Adjudication method for the test set:

Not applicable. Compliance to standards is typically a pass/fail determination based on measurements and observations compared to the standard's requirements, not through an adjudication process in the clinical sense.

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:

No. This is not an AI/ML device or a diagnostic tool involving human readers. The document 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:

No. This is a physical, battery-operated three-wheel scooter, not an algorithm.

7. The type of ground truth used:

Compliance to established engineering and safety standards (e.g., ANSI/RESNA, CAL 117). The "ground truth" is the specifications and limits defined within these recognized standards.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Not applicable.

Summary

{0}------------------------------------------------

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

Exhibit 1

510(k) Summary

Pride Mobility Products Corporation
Go Go Mini Power Wheelchair

SEP 1 2 2006

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:

07-10-06

Name of Device and Proprietary Name: Go Go Mini / Pride Mobility

Common or Usual Name:

3-Wheel Power Scooter

Classification Name:

Physical Medicine / Motorized Three-Wheeled Vehicle

Product Code:

INI

Comparison to Predicate Devices:

The Go Go Mini is equivalent to the Pride Mobility Sunrunner TE-777 (K923193) when comparing components, 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 Sunrunner TE-977 (K923193) and the Go Go Mini is in the overall size, framework, and Control Mechanisms.

{1}------------------------------------------------

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 letters. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, less bold font. The logo is black and white.

Device Description:

The Go Go Mini is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Go Go Mini 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 storing the unit.

Intended Use:

The intended use of the Pride Mobility Products Corp. Go Go Mini 3-Wheel Scooter, is to provide mobility to persons having limited walking capability, or simply to those who wish to ride a scooter for transportation purposes. .

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 Go Go Mini has the same intended use and similar technological characteristics as the Sunrunner TE-977 (K923193), 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 Go Go Mini is substantially equivalent to the predicate device, has passed all the necessary testing procedures, and is considered to be safe for user operation.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract eagle-like symbol with three lines forming its body and head, representing health, science, and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2006

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

Re: K062160

Trade/Device Name: Go Go Mini / Model SC30 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: August 25, 2006 Received: August 29, 2006

Dear Mr. Schappert:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use balled in the 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). and coosmeties for , market the device, subject to the general controls provisions of the Act. The I ou may, atores organisms of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.

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 n may be sucjoet to back 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 I'DA's issuance of a substantial equivalence determination does not mean r toase of acreased a determination that your device complies with other requirements of the Act that I Dr. Has hitations and regulations administered by other Federal agencies. You must or any I edetar statuter and enginements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI (CFR 807); adoning (21 CFR Part 820); and if applicable, the elcettronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 – Mr. Thomas Schappert

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow yours organ finding of substantial equivalence of your device to a legally promative newice 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 if you desire specific acritorio 10. Jour 240) 276-0120 . Also, please note the regulation entitled, Connact the Oriece of Companies motification" (21CFR Part 807.97). You may obtain Whisoranding of Yerelettee to preniestion in the Act from the Division of Small other general micronal and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Barbara Buettm

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): KO62160

Device Name: Go Go Mini / Three wheel Power Scooter

Indications for Use:

The intended use of the Pride Mobility Products Corporation Go Go Mini three The Intended use of the Provide mobility to persons having limited walking wheel sooker, it to provise who wish to ride a scooter for transportation purposes.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ 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)

Pauline Knichum

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

Page 1 of 1

510(k) Number K062166

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).