The Quickie P190 R (or S525) is a medium duty, conventional, rear wheel drive, and rigid frame power wheelchair. The Quickie P190R Power Wheelchair consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As a motorized wheelchair, it also controller, a joystick, a motor, brakes, a drive wheel and 2 batteries. Like most power wheelchairs, the joystick is the user interface. It transfers intentions to command the chair. When the control is activated, or moved out of the center position, the motor brake is energized and released, allowing the chair to move in the direction of the activation. When the activation device (joystick or afternate input device) is released, the chair slows to a stop and the motor brake is automatically re-engaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device. If the chair loses power, the motor brake is automatically engaged and the chair comes to a stop. To prevent the rider from becoming stranded, the chair may be pushed. The chair incorporates a "free wheel" device motor lock disengagement option. This option allows the drive train to be manually disengaged, enabling the chair to be more easily pushed by an assistant. It should be noted that the chair would not have electronic brakes when in the "free wheel" mode. However, the manual wheel locks (also optional) will still function if engaged.

AI/ML Overview

This 510(k) premarket notification for the Sunrise Medical S-525 Power Wheelchair is primarily focused on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and adherence to recognized performance standards. Itdoes not describe a study involving an AI/Machine Learning device or a diagnostic/screening medical device in the way typically expected by your request. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.

However, I will extract and present the information available that aligns with your request, interpreting "acceptance criteria" as the standards the device was tested against and "device performance" as its successful adherence to those standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Tested Against)	Reported Device Performance
ISO 7176 Wheelchair Standards:	Device tested to these standards
- Static Stability	Implied successful performance
- Dynamic Stability	Implied successful performance
- Effectiveness of Brakes	Implied successful performance
- Energy consumption	Implied successful performance
- Overall Dimensions	Implied successful performance
- Maximum Speed	Implied successful performance
- Acceleration and retardation	Implied successful performance
- Static Impact	Implied successful performance
- Fatigue Strength	Implied successful performance
- Climatic Test	Implied successful performance
- Obstacle Climbing Ability	Implied successful performance
- Testing of Power and Control System	Implied successful performance
- EMC Testing	Implied successful performance
ANSI/RESNA Wheelchair Standards:	Device tested to these standards
- Static Stability	Implied successful performance
- Dynamic Stability	Implied successful performance
- Effectiveness of Brakes	Implied successful performance
- Energy consumption	Implied successful performance
- Overall Dimensions	Implied successful performance
- Maximum Speed	Implied successful performance
- Acceleration and retardation	Implied successful performance
- Static Impact	Implied successful performance
- Fatigue Strength	Implied successful performance
- Climatic Test	Implied successful performance
- Obstacle Climbing Ability	Implied successful performance
- Testing of Power and Control System	Implied successful performance
- EMC Testing	Implied successful performance
Proposed Addition to ANSI/RESNA W/C 14 Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters Version 1.5 Dated 1/11/94	Device tested to this proposed standard
ISO EMC Draft Standard 7176-14 Rifled Draft ISO EMC Group Proposal Electromagnetic Compatibility Addition Dated 4/3/95 Regarding Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters	Device tested to this proposed standard

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: This document does not specify a separate "test set" in the context of device performance data generation for a diagnostic/screening algorithm. The testing described refers to the physical device itself. It's implied that at least one S-525 Power Wheelchair was tested against the listed standards.
Data Provenance: The testing was conducted internally by Sunrise Medical. The country of origin of the data is the United States, as Sunrise Medical is a US-based company, and the submission is to the FDA. The testing conducted is for prospective validation of the device's adherence to safety and performance standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable. The "ground truth" for a physical product like a power wheelchair is defined by its engineering specifications and its adherence to the published performance standards. There is no mention of human experts establishing ground truth for a diagnostic output.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data, typically in diagnostic studies. Here, the device's performance is objectively measured against technical 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

This section is not applicable. This document describes a physical medical device (power wheelchair), not an AI/ML-driven diagnostic tool that would involve human readers.

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

This section is not applicable. The S-525 Power Wheelchair is a physical product operated by a user, not an algorithm. The performance described is of the complete physical device.

7. The type of ground truth used

The ground truth for the S-525 Power Wheelchair's performance is established by conformance to internationally recognized and national engineering/performance standards (ISO 7176 and ANSI/RESNA). This is an objective, measurable "ground truth" based on predefined specifications and safety thresholds. It is not expert consensus, pathology, or outcomes data in the context of a diagnostic test.

8. The sample size for the training set

This section is not applicable. This device is a physical product, not an AI/ML system that requires a "training set."

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

This section is not applicable, as there is no training set for this type of device.

Summary

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6 1998 NOV

K981462

510(k) SUMMARY OF SAFETY AND EFFICACY 13.0

Sunrise Medical - Mobility Products Division Submitter: 7477 East Dry Creek Parkway Longmont, CO 80503 Fax (209) 218-4565 Phone (303) 218-4595 Rebecca Andersen

Date: November 5, 1998

Name(s) of the device(s):

S-525 Power Wheelchair

Identification of predicate device(s):

1. Quickie P190 by Sunrise Medical
1. Quickie P120 by Sunrise Medical
1. Sabre by Everest & Jennings
1. Ranger II by Invacare Corporation

Description of the device:

The Quickie P190 R (or S525) is a medium duty, conventional, rear wheel drive, and rigid frame power wheelchair.

The Quickie P190R Power Wheelchair consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As a motorized wheelchair, it also controller, a joystick, a motor, brakes, a drive wheel and 2 batteries.

Like most power wheelchairs, the joystick is the user interface. It transfers intentions to command the chair. When the control is activated, or moved out of the center position, the motor brake is energized and released, allowing the chair to move in the direction of the activation. When the activation device (joystick or afternate input device) is released, the chair slows to a stop and the motor brake is automatically re-engaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device.

If the chair loses power, the motor brake is automatically engaged and the chair comes to a stop. To prevent the rider from becoming stranded, the chair may be pushed. The chair incorporates a "free wheel" device motor lock disengagement option. This option allows the drive train to be manually disengaged, enabling the chair to be more easily pushed by an assistant. It should be noted that the chair would not have electronic brakes when in the "free wheel" mode. However, the manual wheel locks (also optional) will still function if engaged.

Intended use:

Sunrise powered wheelchairs empower physically challenged persons by providing a means of mobility.

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Comparison of device characteristics to predicate(s):

This device has similar technological characteristics as the predicated devices. They all use steel and aluminum in their frame and components, and standard foams and covers for the slings and backs. Microprocessors are typically used with a programmable controller, and the rider controls the chair using a joystick or other equivalent command mode. Motors use permanent magnets, employing 24 volt D.C., with rechargeable deep cycle batteries for an energy source. The operating speeds and maneuverability are substantially equivalent, and recommended for indoor or moderate outdoor use. The standard accessories and components are common to all power wheel chair lines.

Testing:

This device has been tested to both ISO7176 and ANSURESNA Wheelchair Standards. They include:

Static Stability Dynamic Stability Effectiveness of Brakes Energy consumption Overall Dimensions Maximum Speed acceleration and retardation Static Impact Fatigue Strength Climatic Test Obstacle Climbing Ability Testing of Power and Control System EMC Testing
We have also tested to the Proposed:

Addition to ANSURESNA W/C 14 Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters Version 1.5 Dated 1/11/94

ISO EMC Draft Standard 7176-14 Rifled Draft ISO EMC Group Proposal Electromagnetic Compatibility Addition Dated 4/3/95 Regarding Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters.

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Safety:

An analysis of complaints against Sunrise power chairs was completed and charted. This analysis was supported by a literature search, which was conducted by a third party to determine the number of complaints, MDR's and recalls that have been reported to the FDA concerning wheelchairs in general. This information was summarized, and presented in a Management Review report dated 2/20/97. Subsequent complaints against Sunrise are presented in a chart entitled "Total Sunrise Medical Power Product Complaints". The data and charts are included as The analysis demonstrated common issues across all manufacturer product Attachment 13 - A. lines, and varying levels approximately comparable to relative market share. Sunrise has concluded that there are no use issues exclusive to Sunrise chairs at this time.

Efficacy

Articles are being provided on the use and efficacy of power wheelchairs.

"Power Wheelchair Comparison", Ian Denison, 14th International Seating 1) Symposium Proceedings, pp. 113 - 116, February 1998.
1. "Front, Back or in the Middle: Understanding Mid-Wheel Drive", Mark Greig, Sunrise Horizons, Vol 1, Number 4, pp. 6 - 7, February 1998.
1. "Dynamic Wheelchair Stability: Reliability of an Ordinal Scale", R. L. Kirby, D. A. MacLeod, R. E. Duggan, et. al., Proceedings of RESNA '97, pp. 237-239.
1. "When Wheelchairs Tip backwards Beyond Their Stability Limits", R. L. Kirby, M. DiPersio, and D. A. MacLeod, Proceedings of RESNA '96, pp. 180 - 182.
1. "Effect on Wheelchair Stability and Maneuverability of Varying the Position of the rear Antitip Device: A Theoretical Model", R. L. Kirby, A. V. Thoren, B. D. Ashton, and S. A. Ackroyd-Stolarz, Proceedings of RESNA '93, pp. 313 - 315.

510(k) number: K981462

Conclusion:

The Quickie S-525 (a.k.a. P190R) Power Wheelchair is substantially equivalent to the predicated devices listed in this 510(k); the technology and construction of the S - 525 does not raise any new issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 NOV

Ms. Rebecca Andersen Vice President, Quality and Regulatory Affairs Sunrise Medical, Inc. Mobility Products Division 7477A East Dry Creek Parkway Longmont, Colorado 80503

Re: K981462 S-525 Power Wheelchair Trade Name: Requlatory Class: II Product Code: ITI Dated: August 7, 1998 Received: August 10, 1998

Dear Ms. Andersen:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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 requlations.

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Page 2 - Ms. Rebecca Andersen

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 requlation (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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Sunrise powered wheelchairs empower physically challenged persons by providing a means of mobility.

510(k) number: K981462

Device name: S-525

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (per 21 CFR801.109)

ਲ Over-the-counter use

Acolly

n Sian-Off General Restorative Devices 16981462

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).