The "TRS-2000 Power Tilt / Power Recline Seating System" is an aftermarket Power Seating System utilizing the various wheelchair manufacturers base frames and Accelerated Rehab Designs Seat Frame Assembly. The TR-2000 Power Tilt / Power Recline Seating System replaces the existing wheelchair manufacturers seat frame and attaches to the wheelchair base frame allowing for the Tilting and Reclining action of the system upon activation of the Low-Amp Toggle Switch or any alternative low-amp switch that the client may choose to operate. The TRS-2000 System is modular in design and may be added to an existing Power Tilt System, or be a stand alone power recline system.

The TRS-2000 System is appropriate for individuals who require chances in position without the help of an attendant. Power recline systems are utilized by individuals with a variety of physical disabilities. Some of the indications for use include:

The reduction of sitting pressure, may prevent Decubitus Ulcers
Gravity Assisted Positioning
Increased Sitting Stability
Assistance in feeding, Improved Swallowing
Increased Respiratory Function
Decrease Muscle Tone
Comfort Adjustments

Device Description

THE ACCELERATED REHAB DESIGNS "TRS-2000 POWER TILT / POWER RECLINE SEATING SYSTEM IS A " CENTER OF GRAVITY "DESIGN, AFTERMARKET POWER TILT IN SPACE / POWER RECLINE SYSTEM (3" RAISED PIVOT POINT) THAT UTILIZES THE ACCELERATED REHAB DESIGNS SEAT FRAME ASSEMBLY.

THE SYSTEM CONSISTS OF STEEL AND ALUMINUM BRACKETS AND MOUNTING HARDWARE. THE TRS-2000 SYSTEM UTILIZES A LINEAR ACTUATORS MANUFACTURED BY LINAK CORPORATION, AND HAS A LOAD CAPACITY OF 750 POUNDS. THE LINAK ACTUATORS HAVE AN INTERNAL SAFETY NUT ATTACHED TO THE BALL SPINDLE IN THE CASE OF ACTUATOR FAILURE. THIS SAFETY NUT WILL NOT ALLOW THE SEATING SYSTEM TO TILT BACKWARD OR RECLINE BACK ANY FARTHER THAN THE FULL STROKE OF THE ACTUATOR. THIS ELIMINATES THE POSSIBILITY OF THE CLIENT TIPPING OVER BACKWARD DUE TO ACTUATOR FAILURE. THE WHEELCHAIR SEAT FRAME IS ATTACHED TO THE WHEELCHAIR BASE FRAME VIA THE TRS-2000 SYSTEM MOUNTING HARDWARE BRACKETS AND HARDWARE.

THE TRS-2000 SYSTEM IS ACTIVATED BY A DUAL DIRECTION "LOW-AMP" TOGGLE SWITCH. INCLUDED IN THE WIRING HARNESS IS A DUAL MOTOR LOW-AMP SWITCH INTERFACE BOX THAT WILL ACCEPT MOST INDUSTRY WIDE LOW-AMP SINGLE SWITCHES UTILIZING AN 1/8TH INCH MALE PHONO JACK LEAD.

AS THE TOGGLE SWITCH IS ACTIVATED IN ONE DIRECTION, THE SEATING SYSTEM WILL BEGIN TO TILT. AS THE SYSTEM IS TILTING, THE SEATING SYSTEM IS ALSO MOVING FORWARD MAINTAINING THE CENTER OF GRAVITY OF THE CLIENT ON THE WHEELCHAIRS BASE FRAME. THIS ALLOWS FOR USE OF SHORTER BASE FRAMES FOR A WIDER RANGE OF INDIVIDUALS. THE HEAVIER, TALLER CLIENT CAN HAVE THE SAME ACCESS AND PERFORMANCE AS THE SMALLER, LIGHTER CLIENT. ONCE THE POWER TILT SYSTEM PASSES 20 DEGREES OF TILT, THE WHEELCHAIRS DRIVE CONTROLS ARE DISABLED. ACTIVATING THE SWITCH IN THE SAME DIRECTION ONCE AGAIN WILL RETURN THE TILT SYSTEM TO THE FORWARD POSITION. ONCE THE TILT SYSTEM IS RETURNED TO THE FORWARD POSITION, THE DRIVE CONTROLS ARE ENABLED.

ACTIVATION OF THE TOGGLE SWITCH IN THE OPPOSITE DIRECTION WILL ACTIVATE THE POWER REDUCED SHEAR RECLINE SYSTEM. ONCE THE RECLINE ANGLE REACHES 120 DEGREES. THE WHEELCHAIR DRIVE CONTROLS ARE DISABLED. ACTIVATION OF THE SWITCH AGAIN WILL RETURN THE RECLINE TO THE UPRIGHT POSITION.UPON RETURNING TO AN ANGLE LESS THAN 120 DEGREES THE DRIVE CONTROLS ARE ONCE AGAIN ENABLED.

THE REDUCED SHEAR POWER RECLINE SYSTEM HAS A MERCURY SWITCH INCLUDED. THIS SWITCH LIMITS THE AMOUNT OF TILT AVAILABLE WHEN RECLINED. THE GREATER THE RECLINE ANGLE, THE LESS THE AVAILABLE AMOUNT OF TILT REMAINING.

THE TRS-2000 SYSTEM HAS A STANDARD TILT RANGE OF ZERO TO 50 DEGREES. CUSTOM ANGLES ARE AVAILABLE. THE POWER RECLINING BACK ASSEMBLY HAS A RECLINE RANGE FROM 90 to 155 DEGREES.

THE ACCELERATED REHAB DESIGNS TRS-2000 POWER TILT/ POWER RECLINE SYSTEM HAS NO SOFTWARE BASED COMPONENTS.

AI/ML Overview

The provided document describes the Accelerated Rehab Designs "TRS-2000 Power Tilt / Power Recline Seating System," which is an aftermarket power tilt-in-space/power recline system. The detailed description about testing and performance is related to the physical stability of the power tilt/recline system under various conditions, rather than a diagnostic AI device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device (including details like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this device. This medical device is a mechanical system, not an AI-powered diagnostic tool.

The testing described in the document focuses on the physical stability of the wheelchair system.

Here's the relevant information based on the provided text, structured to align with the prompt's request for "acceptance criteria and reported device performance" for this specific mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Back Pressure Required to Lift Front Casters)
Stability at Zero Degrees Posterior Tilt (Back Upright): The device should maintain stability and not tip backward easily when the seat is not tilted and the back is upright. (Implied criterion: High back pressure required to lift front casters.)	300 Pounds on a flat level surface 217 Pounds on a 9 percent grade
Stability at 50 Degrees Posterior Tilt (Back Upright): The device should maintain stability even at the maximum tilt angle when the back is upright. (Implied criterion: Adequate back pressure required to lift front casters.)	129 Pounds on a flat level surface 65 Pounds on a 9 percent grade
Stability at Zero Degrees Posterior Tilt (Back at 175 Degrees Recline): The device should maintain stability when the seat is not tilted and the back is significantly reclined. (Implied criterion: Adequate back pressure required to lift front casters.)	178 Pounds on a flat level surface 106 Pounds on a 9 percent grade
Internal Safety Nut Functionality: In case of actuator failure, the safety nut must prevent the seating system from tilting or reclining further than its full stroke, eliminating the possibility of the client tipping over backward.	Stated as a design feature and safety mechanism, no specific quantified test results are provided in the excerpt, but its presence implies it meets this safety objective.
Max Load Capacity: The LINAK actuators should support a specified load.	750 pounds (System utilizes linear actuators with this capacity)
Tilt Range: The system should achieve a standard tilt range.	Standard tilt range of zero to 50 degrees.
Recline Range: The system should achieve a standard recline range.	Recline range from 90 to 155 degrees.

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

Sample Size: The document does not specify a "sample size" in the conventional sense of a clinical study. The testing appears to have been conducted on one configuration of the TRS-2000 Power Tilt / Power Recline System with specific seating dimensions (Seat Width = 18", Seat Depth = 18", Back Height = 24") and a weight load of 270 pounds. It's likely a single physical unit of the device was tested under these conditions.
Data Provenance: The testing was conducted by Accelerated Rehab Designs internally. The document describes this as "Testing at Accelerated Rehab Designs." The country of origin is implicitly the USA, where the company is located. The study is retrospective in the sense that the data are presented after the tests were performed.

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

Not Applicable. This is a mechanical device stability test, not a diagnostic task requiring expert ground truth for interpretation.

4. Adjudication method for the test set:

Not Applicable. As a mechanical device stability test, there is no "adjudication method" in the sense of expert consensus on diagnostic outcomes. The "ground truth" (if one can call it that) is the objective physical measurement of pressure required to tip the device.

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:

Not Applicable. This is not an AI diagnostic device, and no MRMC study was conducted.

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

Not Applicable. This is not an algorithm or AI device.

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

The "ground truth" for this testing is the objective physical measurement of the "Back Pressure Required to Lift Front Casters Off the Ground" under specified conditions (tilt angles, recline angles, flat surface vs. 9 percent grade). It is based on a direct physical test, not expert consensus or pathology.

8. The sample size for the training set:

Not Applicable. This is a mechanical device, not an AI system that requires a training set.

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

Not Applicable. No training set was used.

Summary

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K012281

AUG - 1 2001

"510K SUMMARY"

SUBMITER:

Accelerated Rehab Designs, Inc. 32025 Industrial Park Drive Pinehurst, Texas 77362 Phone: (281)356-1950 Fax: (281)356-1903 Email: ard@ev1.net

CONTACT: DATE:

Randall Potter 07/19/2001

NAME OF DEVICE:

TRS-2000 Power Tilt / Power Recline Seating System

TRS-2000 Power Tilt / Power Recline Seating

TRADE NAME:

COMMON NAME:

CLASSIFICATION NAME:

Power Tilt / Power Recliner

Power Tilt / Recline Seating System,

Physical Medicine / Wheelchair, Powered

PRODUCT CODE:

REGULATION No:

TYPE:

Traditional

890.3860

ITI

System

SUBSTANCIAL EQUIVALENCE:

Motion Concepts:	TRX-CG Center of Gravity Shifting Power Tilt
K981837
Medical Industries of America	Optima 2000
K011053
Invacare Corporation.	Tilt/Recliner for Power Wheelchairs, Model 2G
K991119

EACH OF THESE 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 POWER WHEELCHAIR, BY PROVIDING A METHOD OF TILTING THE SEAT OR RECLINING THE BACK. 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.

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DESCRIPTION:

THE ACCELERATED REHAB DESIGNS "TRS-2000 POWER TILT / POWER RECLINE SEATING SYSTEM IS A " CENTER OF GRAVITY "DESIGN, AFTERMARKET POWER TILT IN SPACE / POWER RECLINE SYSTEM

(3" RAISED PIVOT POINT) THAT UTILIZES THE ACCELERATED REHAB DESIGNS SEAT FRAME ASSEMBLY.

LISTED BELOW ARE SOME OF THE WHEELCHAIR BASE FRAMES COMPATABLE FOR INSTALLATION OF THE TRS-2000 SYSTEM: (BUT NOT LIMITED TO)

WHEELCHAIR BASE FRAME MODEL

SYSTEM MODEL NO:

ARD-TRSSTORM

INVACARE STORM SERIES WHEELCHAIR �
- REAR WHEEL DRIVE s A
- MID-WHEEL DRIVE A
FRONT WHEEL DRIVE INVACARE RANGER-II WHEELCHAIR
.
INVACARE PRONTO WHEELCHAIR .
INVACARE PRONTO-M6 WHEELCHAIR .
QUICKIE P-222 WHEELCHAIR .
QUICKIE P-320 WHEELCHAIR .
. QUICKIE S-424 WHEELCHAIR
QUICKIE S-525 WHEELCHAIR .
QUICKIE S-626 WHEELCHAIR ●
PRIDE JAZZY 1100 WHEELCHAIR ●
PRIDE JAZZY 1120 WHEELCHAIR .
PRIDE JAZZY 1120-2000 WHEELCHAIR .
PRIDE JAZZY 1170 WHEELCHAIR .
PRIDE JAZZY 1400 WHEELCHAIR .
PRIDE JAZZY 1420 WHEELCHAIR .
. PRIDE JAZZY 1470 WHEELCHAIR
E & J LANCER 2000 WHEELCHAIR ●
E & J SOLARA WHEELCHAIR ●
BRUNO PWC2200 WHEELCHAIR ●
BRUNO PWC2300 WHEELCHAIR .
SHOPRIDER 888WA WHEELCHAIR .
SHOPRIDER 888WNL WHEELCHAIR .

ARD-TRSSTORM ARD-TRSSTORM ARD-TRSRANGERII ARD-TRSPRONTO ARD-TRSPRONTOM6 ARD-TRSP222 ARD-TRSP320 ARD-TRSG424 ARD-TRSS525 ARD-TRSS626 ARD-TRSJAZZY ARD-TRSJAZZY ARD-TRSJAZZY ARD-TRSJAZZY ARD-TRSJAZZY ARD-TRSJAZZY ARD-TRSJAZZY ARD-TRSLANCER ARD-TRSSOLARA ARD-TRSPWC2200 ARD-TRSPWC2300 ARD-TRS888WA ARD-TRS888WNL

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THE WHEELCHAIRS BASE FRAME. THIS ALLOWS FOR USE OF SHORTER BASE FRAMES FOR A WIDER RANGE OF INDIVIDUALS. THE HEAVIER, TALLER CLIENT CAN HAVE THE SAME ACCESS AND PERFORMANCE AS THE SMALLER, LIGHTER CLIENT. ONCE THE POWER TILT SYSTEM PASSES 20 DEGREES OF TILT, THE WHEELCHAIRS DRIVE CONTROLS ARE DISABLED. ACTIVATING THE SWITCH IN THE SAME DIRECTION ONCE AGAIN WILL RETURN THE TILT SYSTEM TO THE FORWARD POSITION. ONCE THE TILT SYSTEM IS RETURNED TO THE FORWARD POSITION, THE DRIVE CONTROLS ARE ENABLED.

THE TRS-2000 SYSTEM HAS A STANDARD TILT RANGE OF ZERO TO 50 DEGREES. CUSTOM ANGLES ARE AVAILABLE. THE POWER RECLINING BACK ASSEMBLY HAS A RECLINE RANGE FROM 90 to 155 DEGREES.

THE ACCELERATED REHAB DESIGNS TRS-2000 POWER TILT/ POWER RECLINE SYSTEM HAS NO SOFTWARE BASED COMPONENTS.

INTENDED USE:

THE ACCELERATED REHAB DESIGNS, INC TRS-2000 POWER TILT / POWER RECLINE SEATING SYSTEM IS INTENDED FOR THE CLIENT THAT REQUIRES POSITIONING CHANGES DURING THE COURSE OF THE DAY WITHOUT THE AID OF AN ATTENDANT. THIS COULD BE FOR PRESSURE RELIEF, COMFORT ADJUSTMENTS, AND POSITIONING NEEDS.

TECHNOLOGICAL CHARACTERISTICS:

THE TRS-2000 SYSTEM UTILIZES THE LINAK ACTUATOR WHICH HAS A PROVEN TRACK RECORD OF PERFORMANCE, AND RELIABILITY. THE SYSTEM MOVES FORWARD ON THE TRS-2000 MOUNTING HARDWARE VIA A PAIR OF SELF- CLEANING, MAINTENANCE FREE LINEAR BEARING GUIDES. BY USE OF THESE GUIDES, THERE IS VERY LITTLE RESISTANCE ASSOCIATED WITH THE TILTING OF THE SYSTEM. THE LINEAR BEARINGS ARE MUCH MORE EFFICIENT THAN CAMS, AND OIL LIGHT ROLLER BEARINGS. THIS INCREASES ACTUATOR LIFE, AND REDUCES STRESS AND FATIGUE ON STRUCTURAL COMPONENTS. THE POWER RECLINE SYSTEM ALSO UTILIZES A LINAK POWER ACTUATOR FOR ACCURATE ANGLE ADJUSTMENTS.

THE TILTING AND RECLINING SYSTEMS ARE SEPARATE MODULES AND ARE INDEPENDENT OF EACH OTHER. THIS ALLOWS FOR THE SYSTEMS TO BE OFFERED AS SEPARATE POWER TILT (ONLY), POWER RECLINE (ONLY), OR POWER TILT/POWER RECLINE COMBINATION DEPENDING ON THE NEEDS OF THE CLIENT.

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TESTING:

THERE WAS NO CLINICAL TESTING ASSOCIATED WITH THE TRS-2000 POWER TILT SYSTEM. TESTING AT ACCELERATED REHAB DESIGNS REVEILED THE FOLLOWING RESULTS:

THE FOLLOWING ARE ADDITIONAL FORCES (PRESSURES) REQUIRED BEYOND THE CLIENTS WEIGHT, TO TIP THE TRS-2000 POWER TILT / POWER RECLINE SYSTEM REARWARD ENOUGH TO LIFT THE FRONT CASTERS OFF OF THE FLOOR. THE SEATING DEMINSIONS OF THE SYSTEM TESTED WERE AS FOLLOWS:

SEAT WIDTH = 18"
SEAT DEPTH = 18"
BACK HEIGHT = 24"
V WEIGHT LOAD = 270 POUNDS

SYSTEM LOCATION(DEGREE OF SYSTEM TILT)	BACK PRESSUREREQUIRED TO LIFT FRONTCASTERS OFF THEGROUND ON A FLAT LEVELSURFACE	BACK PRESSUREREQUIRED TO LIFTFRONT CASTERS OFF THEGROUND ON A9 PERCENT GRADE
Zero Degrees of Posterior TiltBack in the upright position	300 Pounds	217Pounds
50 Degrees of Posterior TiltBack in the upright position	129 Pounds	65 Pounds
Zero Degrees of Posterior TiltBack at 175 Degrees	178 Pounds	106 Pounds

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

AUG - 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Randall Potter President Accelerated Rehab Designs, Inc. 32035 Industrial Park Drive Pinehurst, Texas 77362

Re: K012281

Trade/Device Name: TRS-2000 Power Tilt/Power Recline Seating System Regulation Number: 890.3860 Regulatory Class: II Product Code: ITI Dated: July 19, 2001 Received: July 20, 2001

Dear Mr. Potter:

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. Randall Potter

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,

Mahlkeeton

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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510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

K 012281

Device Name:

TRS-2000 POWER TILT / POWER RECLINE SEATING SYSTEM

Indications For Use:

The TRS-2000 System has no software based electronic components.

The reduction of sitting pressure, may prevent Decubitus Ulcers ●
Gravity Assisted Positioning ●
Increased Sitting Stability .
Assistance in feeding, Improved Swallowing ●
Increased Respiratory Function .
Decrease Muscle Tone .
Comfort Adjustments .

Accelerated Rehab Designs makes no claims as to the therapeutic effectiveness of the product(s) listed. Accelerated Rehab Designs recommends that an accredited Rehabilitation Therapist and Supplier evaluate all customers of its products.

The above indications for use are identical to those of the Motion Concepts, Invacare Corporation, and Medical Industries of America Power Tilt / Recline Seating Systems we are claiming substantial equivalence.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

Revised 11/13/1998

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

отчислено в спии

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

510(k) Number K012281

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).