The intended use of the Pride Mobility Products Corporation Victory XL 130, Four Wheel Scooter / Model # SC713 is to provide mobility to disabled persons having limited walking capabilities.

Device Description

The Victory XL 130, Four Wheel Scooter / Model # SC713 is a Heavy Duty batteryoperated scooter having a Digital Controller, electrical system, Charger, Transaxle / Motor, Batteries, Seating and 2-Piece Frame. The Victory XL 130 Scooter is equipped with electronic regenerative and electromechanical disc brakes, off-board battery charger, removable 12 Volt 55AH batteries, and anti-tip rear wheels.

The scooter has various size foldable Contour seats that are removable. The seat interface is equipped with a clover leaf design allowing for seat rotation and locking at 90° intervals mounted on stationary seat post. The seat is also equipped with sliders for fore-aft adjustment.

The Victory XL 130, Four Wheel Scooter / Model # SC713 is designed with ultimate safety, stability, and performance in mind. The scooter is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "Victory XL 130, Four Wheel Scooter / Model # SC713," indicating substantial equivalence to a predicate device. This type of submission focuses on comparing a new device to an already legally marketed one rather than conducting extensive de novo clinical trials to prove efficacy from scratch. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to compliance with recognized standards and a demonstration of substantial equivalence, not a traditional clinical trial with specific performance metrics for an AI algorithm.

Based on the provided information, here's a breakdown of the requested points, noting where information is not applicable due to the nature of a 510(k) for a mobility scooter:

1. A table of acceptance criteria and the reported device performance

For a mobility scooter undergoing a 510(k) review, the "acceptance criteria" are compliance with relevant safety and performance standards. The "reported device performance" is the demonstration that the device meets these standards.

Acceptance Criteria (Relevant Standards)	Reported Device Performance
RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters)	Device showed compliance through non-clinical testing.
RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems	Device showed compliance through non-clinical testing.
ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility (EMC)	Device showed compliance through non-clinical testing.
IEC 601-1-1 - Medical Electrical Equipment, General Requirements for Safety	Device showed compliance through non-clinical testing.
CAL 117 - Flammability Testing	Device showed compliance through non-clinical testing.
Substantial Equivalence to Predicate Device (K944939)	The device has the same intended use and similar technological characteristics, and differences do not raise new safety or effectiveness concerns.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable in the context of a 510(k) for this type of device. The "test set" here refers to the compliance testing of a physical device sample against specific engineering and safety standards, not a patient dataset. The document does not specify the number of units tested.
Data Provenance: Not applicable. The testing is non-clinical, focusing on product design and manufacturing compliance. No patient data or country of origin for such data is mentioned or relevant.
Retrospective/Prospective: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts & Qualifications: Not applicable. For engineering and safety standard compliance, "ground truth" is established by the specifications within the standards themselves and the expertise of the engineers and technicians conducting the tests. The document does not specify the number or qualifications of personnel involved in the non-clinical testing.

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

Adjudication Method: Not applicable. This concept typically applies to clinical trials where human readers interpret data or images. In non-clinical device testing, the results are objectively measured against defined criteria within the 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 a non-AI, non-diagnostic medical device (a mobility scooter). An MRMC study is completely irrelevant here.

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

Standalone Performance: No. This is a physical mobility device; there is no AI algorithm involved in its operation as described.

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

Type of Ground Truth: For the non-clinical testing, the "ground truth" is derived from the quantitative and qualitative requirements specified in the referenced industry standards (RESNA, ANSI/RESNA, IEC, CAL). The device is tested to demonstrate it meets these pre-defined performance and safety criteria.

8. The sample size for the training set

Training Set Sample Size: Not applicable. There is no AI model or "training set" for this device.

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

Ground Truth for Training Set: Not applicable. There is no AI model or "training set" for this device.

Summary

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K092088

Pride
Mobility Products Corp.

JUL 1 6 2009

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 Victory Fride Mobility Victory Vicel Scooter / Model #SC713

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

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Date Prepared:

6/16/09

Name of Device and Proprietary Name:

Name of Device and Prophetary Name:
Victory XL 130, Four Wheel Scooter / Model # SC713/ Pride Mobility Products Corporation

Common or Usual Name: Four Wheel Power Scooter

Classification Name: Classincation Names
Physical Medicine / Motorized Three - Wheeled Vehicle

Product Code:

INI

Comparison to Predicate Devices:

Comparison to Predicate Devices:
The Victory XL 130, Four Wheel Scooter / Model # SC713 is substantially equivalent
The Victory XL 130, Four Wheel Scooter / Model #SC445, (K9 The Victory XL 130, Four Wheel SC / Model #8C445 (K944939) when comparing,
to the Pride Mobility Celebrity - Life and structure - The performance characteristics to the Pride Mobility Celebrity AL 7 Model #00=10 (1. s reformance characteristics
performance, maneuverability, stability, and structure, similar to achieve the performance, maneuverability, stablily, and drive mechanisms are similar to achieve the and the position of the electioniss and drive moonline on maintain optimum stablity without
same intended use function that enables the user to maintain optimum (130) Four Wh same intended use function that enables me assets to maintain of AL 130, Four Wheel
hindering performance. The major differences between Victory AL 130, Four Wheel hindering performance. The major unferences between between head.
Scooter / Model # SC713 to the Celebrity XL SC445 (K944939) are in the Control Mechanisms.

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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 word. Below the word "Pride" is the text "Mobility Products Corp." 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. Victory XL 130, Four Wheel Scooter / Model # SC713 is to provide mobility to disabled persons having limited walking capabilities.

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 Victory XL 130, Four Wheel Scooter / Model # SC713 has the same intended use and similar technological characteristics as the Celebrity XL SC445 (K944939) 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 Victory XL, Four Wheel Scooter / Model # SC713 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 1 6 2009

Re: K092088

Trade/Device Name: Victory XL 130, Four Wheel Scooter/Model # SC713 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: June 19, 2009 Received: July 9, 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 or any I 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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: Victory XL 130, Four Wheel Scooter / Model # SC713

Indications for Use:

The intended use of the Pride Mobility Products Corporation Victory XL 130, Four The intended use of the hobility to provide mobility to disabled persons having limited walking capabilities.

AND / OR Prescription Use X (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)

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

$10(k) Number K092088

19(k) Number

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).