The Merits Model R series Positioning System for Powered Wheelchair is intended for people using a powered wheelchair and requiring positional change. Its intended function and use is to aid in the pressure relief to persons confined to a powered wheelchair, by way of tilt and reclining seat back.

Device Description

The R Series Positioning System for Powered Wheelchair is designed for use with power wheelchairs. The R Series Positioning System for Powered Wheelchair use the Merits Model P323 Power Wheelchair as the base unit for the tilting and reclining System. The Positioning System and base unit is to be sold together. Model P323 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 60amp controller. The user interface is a joystick. P323 is powered by two 12 VDC 64ah batteries. The batteries are charged by 5A off-board charger connect with 3-pin Microphone Connector to charging socket on joystick. The approximate driving range on fully charged batteries is up to 38km (24mi). The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (including motor, gear, brake), batteries and front and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the wheelchair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick. The intended function of the R Series Positioning System for Powered Wheelchair is to aid in the pressure relief of persons confined to a wheelchair, by providing a method of tilting the seat and reclining the seat back. The R series Positioning System consists of tilt, recline and shear reduction power seat modules. The tilting and reclining systems are separate modules and are independent of each other. As such, they will be offered as either a complete tilt/recline system, or as a separate tilt system or reclining system depending upon the user' needs. The tilting and reclining systems are actuated by 24V DC motorized linear actuator. The tilt system include one motorized linear actuator (Manufacturer: Moteck / Model: FD-24-A4-323) causes the seat frame to shift forward. This enhances stability since the center of gravity is kept substantially in plane while the user is tiliting. The recline system include one motorized linear actuator (Manufacturer: Moteck / Model: FD-24-A4-278) change the position of the backrest with respect to the seat pan. The shear reduction module works with recline function to reduce the shear movement between the user and the backress The reclining system also includes a movable leg rest feature. There two basic models included in the R Series Positioning System. They are Model R153(tilt) and R154(tilt +reclining). The upholstery of the device complies with EN 1021-1/-2:2006: Furniture: Assessment of the ignitability of upholstered furniture: Ignition annuce: Smouldering cigarette/ Match flame equivalent. The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Merits Model R Series Positioning System for Powered Wheelchair. This submission focuses on establishing substantial equivalence to a predicate device through non-clinical testing, rather than a clinical study evaluating the device's performance against specific clinical acceptance criteria in a human population.

Therefore, many of the requested categories related to clinical study design, such as "sample size used for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set details," are not applicable in this context. The information provided pertains to engineering and safety performance testing.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard & Section)	Reported Device Performance
ISO 7176-1:1999 (Determination of Static Stability)	Device meets specifications.
ISO 7176-2:2001 (Determination of Dynamic Stability of electric wheelchairs)	Device meets specifications.
ISO 7176-3:2003 (Determination of effectiveness of brakes)	Device meets specifications.
ISO 7176-4:2008 (Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range)	Device meets specifications.
ISO 7176-5:2008 (Determination of overall dimensions, mass and maneuvering space)	Device meets specifications.
ISO 7176-6:2001 (Determination of maximum speed, acceleration and deceleration of electric wheelchairs)	Device meets specifications.
ISO 7176-8:2009 (Requirements and test methods for static, impact and fatigue strengths)	Device meets specifications.
ISO 7176-9:2009 (Climatic tests for wheelchairs)	Device meets specifications.
ISO 7176-10:2008 (Determination of obstacle-climbing ability of electrically power wheelchairs)	Device meets specifications.
ISO 7176-11:1992 (Test dummies)	Device meets specifications.
ISO 7176-13:1989 (Determination of coefficient of friction of test surfaces)	Device meets specifications.
ISO 7176-14:2008 (Power and Control Systems for Electric Powered Wheelchairs and Scooters-Requirements and Test methods)	Device meets specifications.
ISO 7176-15:1996 (Requirements for Information Disclosure, Documentation and Labeling)	Device meets specifications.
ISO 7176-21:2009 (Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters and Battery Chargers)	Device meets specifications.
IEC 60601-1:1988 (Medical electrical equipment Part 1: General requirements for safety)	Device meets specifications.
IEC 60601-1-2:2007 (Electromagnetic Compatibility - Requirements and Tests)	Device meets specifications.
ISO 14971:2007 (Medical devices -- Application of risk management to medical devices)	Device meets specifications.
EN 1021-1:2006 (Furniture Assessment of the ignitability of upholstered furniture : Ignition source: Smouldering cigarette)	Device complies.
EN 1021-2:2006 (Furniture Assessment of the ignitability of upholstered furniture : Ignition source: Match flame equivalent)	Device complies.

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

Sample Size: The document does not specify the number of units tested. This type of non-clinical testing typically involves a limited number of production units or prototypes.
Data Provenance: The testing was conducted by Merits Health Products Co., LTD. (Taiwan) according to international standards (ISO, IEC, EN). The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance.

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

This question is not applicable. For non-clinical performance and safety testing against international standards, "ground truth" is not established by clinical experts but by adherence to the specific test methodologies and criteria outlined in each standard. The expertise lies in the engineers and technicians performing and verifying the tests in accordance with these standards.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or symptoms. For this type of device testing, the results are objectively measured against the quantitative or qualitative pass/fail criteria of each standard.

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 question is not applicable. The device is a powered wheelchair positioning system, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is not relevant.

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

This question is not applicable. The device is a mechanical and electrical system, not an algorithm, and is designed for human interaction (the user and caregivers).

7. The type of ground truth used

The "ground truth" in this context is the established performance and safety requirements defined by the international ISO, IEC, and EN standards listed in the document. These standards specify objective test methods and acceptance criteria for various aspects of wheelchair performance, safety, and functionality (e.g., static stability, brake effectiveness, electromagnetic compatibility, material ignitability).

8. The sample size for the training set

This question is not applicable. The device is not based on machine learning or AI that would require a "training set."

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

This question is not applicable for the reasons mentioned in point 8.

Summary

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510(k) SUMMARY

Merits Health Products Co., LTD. 510(k) Premarket Notification

Submitter:

Merits Health Products Co., LTD. No.18, Jingke Rd., Nantun Dist. Taichung City 40852, Taiwan (R.O.C.)

Contact Person:

Steve Chao Merits Health Products Co., LTD. No.18, Jingke Rd., Nantun Dist., Taichung City 40852, Taiwan (R.O.C.) Phone: +886-4-23594985 ext.200 Fax: +886-4-23503962

Date Prepared:

November 30, 2011

Proprietary Name:

Merits Model R Series Positioning System for Powered Wheelchair

Common name:

Power Positioning System

Classification name:

Powered Wheelchair

Comparison to Predicate Devices:

The Merits R Series Positioning System is substantially equivalent to the Motion Concepts TRx-CG power Positioning System (#K021264). R Series Positioning System has the same intended uses and similar indications, technological characteristics and principles of operation.

Device Description

MAY - 8 2012

. .

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brakes released, the wheelchair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The intended function of the R Series Positioning System for Powered Wheelchair is to aid in the pressure relief of persons confined to a wheelchair, by providing a method of tilting the seat and reclining the seat back.

The R series Positioning System consists of tilt, recline and shear reduction power seat modules. The tilting and reclining systems are separate modules and are independent of each other. As such, they will be offered as either a complete tilt/recline system, or as a separate tilt system or reclining system depending upon the user' needs.

The tilting and reclining systems are actuated by 24V DC motorized linear actuator. The tilt system include one motorized linear actuator (Manufacturer: Moteck / Model: FD-24-A4-323) causes the seat frame to shift forward. This enhances stability since the center of gravity is kept substantially in plane while the user is tiliting.

The recline system include one motorized linear actuator (Manufacturer: Moteck / Model: FD-24-A4-278) change the position of the backrest with respect to the seat pan. The shear reduction module works with recline function to reduce the shear movement between the user and the backress The reclining system also includes a movable leg rest feature.

There two basic models included in the R Series Positioning System. They are Model R153(tilt) and R154(tilt +reclining).

The upholstery of the device complies with EN 1021-1/-2:2006: Furniture: Assessment of the ignitability of upholstered furniture: Ignition annuce: Smouldering cigarette/ Match flame equivalent.

The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

The Merits R Series Positioning System is substantially equivalent to the Motion Concepts TRx-CG power Positioning System (#K021264). Both products are battery power, motorized, seating systems designed for use with powered wheelchairs. Performance characteristics and drive mechanisms are similar and all have the same intended function and use which is to aid in the pressure relief of persons confined to a powered wheelchair, by providing a method of tilting the seat and reclining the seat back. Additional, they are all constructed from the same basic materials, have the same basic operational principles and all use DC batteries as their source of power.

Although there are some minor differences between R Series Positioning System and its predicate device, they raise no new issues of safety or effectiveness. Performance data demonstrate that the R Series Positioning System is safe. The non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do no raise any new questions of safety or effectiveness.

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Intended Use

The Merits Model R series Positioning System for Powered Wheelchair is intended for people using a powered wheelchair and requiring positional change.

Its intended function and use is to aid in the pressure relief to persons confined to a powered wheelchair, by way of tilt and reclining seat back.

Discussion of Non-clinical Tests Performed for Determinations of Substantial equivalence are as follows:

ISO 7176-1:1999	Determination of Static Stability
ISO 7176-2:2001	Determination of Dynamic Stability of electric wheelchairs
ISO 7176-3:2003	Determination of effectiveness of brakes
ISO 7176-4:2008	Energy consumption of electric wheelchairs and scooters fordetermination of theoretical distance range
ISO 7176-5:2008	Determination of overall dimensions, mass and maneuveringspace
ISO 7176-6:2001	Determination of maximum speed, acceleration anddeceleration of electric wheelchairs
ISO 7176-8:2009	Requirements and test methods for static, impact and fatiguestrengths
ISO 7176-9:2009	Climatic tests for wheelchairs
ISO 7176-10:2008	Determination of obstacle-climbing ability of electrically powerwheelchairs
ISO 7176-11:1992	Test dummies
ISO 7176-13:1989	Determination of coefficient of friction of test surfaces
ISO 7176-14:2008	Power and Control Systems for Electric Powered Wheelchairsand Scooters-Requirements and Test methods.
ISO 7176-15:1996	Requirements for Information Disclosure, Documentation andLabeling
ISO 7176-21:2009	Requirements and Test Methods for ElectromagneticCompatibility of Electrically Powered Wheelchairs andScooters and Battery Chargers.
IEC 60601-1:1988	Medical electrical equipment Part 1: General requirements forsafety
IEC 60601-1-2:2007	Electromagnetic Compatibility - Requirements and Tests
ISO 14971:2007	Medical devices -- Application of risk management to medicaldevices
EN 1021-1:2006	Furniture Assessment of the ignitability of upholsteredfurniture : Ignition source: Smouldering cigarette
EN 1021-2:2006	Furniture Assessment of the ignitability of upholsteredfurniture : Ignition source: Match flame equivalent

The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.

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Conclusions

According to comparison table, the differences on weight capacity, function of elevate, recline and dimension of width do not deleteriously affect the safety and effectiveness of the device.

So based on the design, performance specifications and testing and intended use, the Merits R Series Positioning System for Powered Wheelchair is substantially equivalent to the currently marketed device Motion Concepts TRx-CG power Positioning System (#K021264).

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Merits Health Products Co., Ltd. % Mr. Steve Chao Manager No. 18 Jingke Road, Nantun District Taichung City, 40852 Taiwan (R.O.C)

MAY - 8 2012

Re: K113577

Trade/Device Name: Merits Health Products R Series Positioning System for Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 29, 2012 Received: March 29, 2012

Dear Mr. Chao:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 comply 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

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Page 2 - Mr. Steve Chao

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Erine Keith

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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INDICATIONS FOR USE STATEMENT

510(k) File Number:

Device Name: Merits Health Products R Series Positioning System for Powered Wheelchair

Indications For Use: The Merits Model R series Positioning System for Powered Wheelchair is intended for people using a powered wheelchair and requiring positional change. Its intended function and use is to aid in the pressure relief to persons confined to a powered wheelchair, by way of tilt and reclining seat back.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) (Division Sign-cical, Orthopedic, and Restorative Devices

510(k) Number K113577

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).