The intended use of the Quantum Blast is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Device Description

The Pride Quantum Blast model rear-wheeled drive powered wheelchairs are battery powered, motor driven devices. A P&G Remote Plus joystick and 100 amp controller is used to operate the Quantum Blast. The Quantum Blast is powered by two 12 VDC, Group 24 batteries and has a range of up to 25 miles on a full charge. The base of the chair is made of welded steel construction. The Quantum Blast comes standard with a Versa Seat. Optional seating material meets California 117 standards for fire retardancy.

AI/ML Overview

This K011993 submission for the Quantum Blast powered wheelchair is for a medical device that does not involve AI/ML. The provided document details the substantial equivalence of the Quantum Blast to a predicate device (Jazzy SC-900) based on non-clinical performance standards and intended use. There are no acceptance criteria, device performance metrics, or studies involving AI/ML described in the document.

Therefore, I cannot provide the information requested in the prompt, as it pertains to AI/ML device performance and studies, which are not relevant to this submission.

Specific answers to the prompt questions, based on the provided document:

A table of acceptance criteria and the reported device performance: Not applicable. This submission concerns a physical medical device, not an AI/ML system. The document lists ANSI/RESNA standards for stability, brakes, dimensions, obstacle climbing, and EMC, but doesn't provide specific quantitative acceptance criteria or reported performance values against those criteria within this summary. It states the non-clinical testing was performed.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set for an AI/ML model is mentioned. The testing refers to physical product testing according to ANSI/RESNA standards.
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): Not applicable. No ground truth for an AI/ML system is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable. No training set for an AI/ML model is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary

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K011993

JUL 1 3 2001

Exhibit 3

510 (K) Summary : Pride Mobility Products, Inc. 510 (K) Premarket Notification Quantum Blast

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Pride Mobility Products, Inc. 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 883-4102

Contact Person: Gene Kulon Official Correspondent Date Prepared: 05-16-01

Name of Device and Name / Address of Sponsor:

Quantum Blast

Pride Mobility Products, Inc. 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 883-4102

Common or Usual Name: Four Wheel Power Base Unit

Classification Name: Power Wheel Chair

Comparison to Predicate Devices:

The product, which is substantially equivalent to the Quantum Blast, is the SC900 (Jazzy) (K945936) they both are Joystick controlled, with onboard batteries and battery charger. All safety features are equivalent.

Device Description:

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construction. The Quantum Blast comes standard with a Versa Seat. Optional seating material meets California 117 standards for fire retardancy.

Intended Use:

The intended use of the Quantum Blast is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Discussion of non-clinical tests performed for determinations of substantial equivalence are as follows:

ANSI/RESNA WC/01 1990 Determination of Static Stability Testing ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes ANSI/RESNA WC/05 1990 Determination of overall Dimensions, Mass, and Turning Space ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters.

Discussion of Clinical Tests Performed:

N/A

Conclusions:

The Quantum Blast has the same intended use and similar technological characteristics as the Jazzy SC-900. 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 Quantum Blast device is substantially equivalent to the predicate device. All software used on the Quantum Blast is Y2K Compliant.

Discussion of Clinical Tests Performed:

N/A

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, representing the department's focus on health and human well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2001

Mr. Gene R. Kulon Regulatory Compliance Officer Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pennsylvania 18643

Re: K011993

Trade/Device Name: Quantum Blast, Powered Wheelchair Regulation Number: 890.3860 Regulatory Class: II Product Code: ITI Dated: June 22, 2001 Received: June 26, 2001

Dear Mr. Kulon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gene R. Kulon

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Hyk Rhodes

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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EXHIBIT 2

Page _ 1 of 1

510(k) Number (if known): K- O / / 9 93

Quantum Blast, Powered Wheelchair Device Name:

Indications for Use:

The intended use of the Quantum Blast is to provide mobility for persons limited to a seated position that are capable of operating a powered wheelchair.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hyet Riode

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

510(k) Number K011993

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96) *

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).