Search Results

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

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.

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

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.

Ask a specific question about this device

Ask a specific question about this device

The "E-2000 Power Tilt Seating System" is an elevating system utilizing the wheelchair manufactures existing tubular seating system with armrests, front rigging, back assembly, and optional accessories.

The Elevating Seat System attaches to the wheelchair base frame and seat frame. By activation of the supplied switch, the system will elevate up to eight (8) inches from its lowest position.

The E-2000 Power Elevating Seat System allows the customer the availability to reach items that in the past, were unreachable to them due to their physical limitations. In the home, the overhead kitchen cabinets are now accessible. In the workplace, the availability of reaching the upper drawers of file cabinets without help from others. Having the ability to interact with fellow students on their level, within the school setting. Some of the customers that may benefit from the use of the E-2000 System are customers with a diagnosis of , but not limited to:

• Muscular Dystrophy (MD) .
• . Multiple Sclerosis (MS)
• Spinal Cord Injury (SCI) .
• Amyotrophic Lateral Sclerosis (ALS) ◆

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 Mechanical Application Designs, Inc Liftmaster System in which we are claiming substantial equivalence.

THE ACCELERATED REHAB DESIGNS, INC "E-2000 POWER ELEVATING SEAT SYSTEM" CONSISTS OF A MOTION SYSTEM, BALL DRIVE TOWER ACTUATOR WITH A LOAD CAPACITY OF 500 POUNDS. THE SYSTEM BRACKETS AND MOUNTING HARDWARE MATERIALS ARE DESIGNED AND MANUFACTURED FROM ALUMINUM AND STEEL. THE E-2000 SYSTEM HAS A BEGINNING SEAT TO FLOOR HEIGHT OF 18 % INCHES, AND WILL ELEVATE 8 INCHES TO AN UPPER LIMIT OF 26 % INCHES. CUSTOM SEAT TO FLOOR HEIGHTS WILL BE AVAILABLE UPON REQUEST WITH A MAXIMUM ELEVATION OF 28 1/2" INCHES.

THE E-2000 ELEVATING SEAT SYSTEM HAS A WEIGHT LIMIT OF 250 POUNDS, OR THE WHEELCHAIR MANUFACTURES BASE FRAME WEIGHT LIMIT. WHICH EVER IS LOWER. ACCELERATED REHAB DESIGNS WILL NOT EXCEED THE WHEELCHAIR MANUFACTURES BASE FRAME LIMIT.

THE E-2000 SYSTEM IS DESIGNED TO BE DRIVEN IN THE LOWERED POSITION. THERE ARE CERTAIN CIRCUMSTANCES THAT MAY ARRISE THAT A CUSTOMER NEEDS TO DRIVE IN THE ELEVATED POSITION. THIS MAY BE AT WORK, HOME, OR IN THE SCHOOL SETTING. THE WHEELCHAIRS ELECTRONICS ARE TO BE PROGRAMMED TO A VERY SLOW DRIVING SPEED WHILE IN THE ELEVATED POSITION. IF IT IS FELT BY THE REHAB PROFESSIONAL THAT A CUSTOMER SHOULD NOT DRIVE WHILE ELEVATED, A MAGNETIC SWITCH DRIVE LOCKOUT IS INSTALLED. ONCE THE CUSTOMER BEGINS TO ELEVATE, THE WHEELCHAIRS DRIVE CONTROLS ARE DISABLED. ONCE BACK IN THE LOWER POSITION, THE CHAIR MAY BE DRIVEN AGAIN.

BY DESIGN, THE E-2000 SYSTEM WILL ALLOW CUSTOM SEATING SYSTEMS TO BE MOUNTED. THE SYSTEM IS ACTIVATED BY THE USE OF A LOW-AMP DUAL DIRECTION TOGGLE SWITCH.

This document [K992828](https://510k.innolitics.com/search/K992828) describes a 510(k) premarket notification for a medical device: the "E-2000 Power Elevating Seat System". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and studies.

Therefore, the provided text does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Here's why and what kind of information is present instead:

• 510(k)s vs. PMAs/Clinical Studies: A 510(k) submission primarily compares a new device to a "predicate" device already on the market, arguing that they are "substantially equivalent" in terms of intended use, technological characteristics, and safety/effectiveness. It generally does not require new clinical studies with predetermined acceptance criteria to prove efficacy and safety in the same way a Premarket Approval (PMA) application would for a novel device.
• Focus of this document: The document focuses on:
  • Device Description: What the E-2000 Power Elevating Seat System is, its components, load capacity, elevation range, and design features.
  • Intended Use: How the device is meant to be used (on power and manual wheelchairs to elevate users).
  • Technological Characteristics Comparison: How it compares to the predicate device (Mechanical Application Designs, Inc: Liftmaster K972563) regarding mounting, installation, and versatility.
  • Indications for Use: Specific scenarios and patient populations that might benefit (e.g., Muscular Dystrophy, Multiple Sclerosis).
  • Substantial Equivalence Claim: The central argument that the E-2000 is substantially equivalent to the Liftmaster system.

Therefore, I cannot populate the requested table or provide answers to the specific questions because the document is a 510(k) summary, which does not typically include the detailed study design and results as requested.

The crucial piece of information missing for your request is a dedicated clinical study report with performance metrics, statistical analyses, and predetermined acceptance criteria.

Ask a specific question about this device

The "T-2000 Power Tilt System" is an aftermarket Power Tilt in Space Seating System utilizing the wheelchair manufactures base frame and seat frame. The T-2000 Power Tilt Seating System attaches between the base frame and seat frame of the wheelchair, allowing for the tilting 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 T-2000 system has no software based components. The T-2000 system is appropriate for individuals who require chances in position without the help of an attendant. Power tilt 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

THE ACCELERATED REHAB DESIGNS "T-2000 POWER TILT SEATING SYSTEM" IS A CENTER OF GRAVITY DESIGN. AFTERMARKET POWER TILT IN SPACE SYSTEM THAT UTILIZES THE WHEELCHAIR MANUFACTURES EXISTING TUBULAR SEAT FRAME, ARMRESTS, FRONT RIGGING, BACK ASSEMBLY AND OPTTONAL ACCESSORIES. THE SYSTEM CONSISTS OF STEEL AND ALUMINUM BRACKETS AND MOUNTING HARDWARE. THE T-2000 SYSTEM UTILIZES A LINEAR ACTUATOR MANUFACTURED BY LINAK CORPORATION, AND HAS A LOAD CAPACITY OF 750 POUNDS. THE LINAK ACTUATOR HAS AN INTERNAL SAFETY NUT ATTACHED TO THE BALL SPINDLE IN THE CASE OF ACTUATOR FATURE. THIS SAFETY NUT WILL NOT ALLOW THE SEATING SYSTEM TO TILT BACKWARD 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 T-2000 SYSTEM MOUNTING HARDWARE BRACKETS AND HARDWARE. THE T-2000 SYSTEM IS ACTIVATED BY A DUAL DIRECTION "LOW-AMP" TOGGLE SWITCH. INCLUDED IN THE WIRING HARNESS IS A LOW-AMP SWITCH INTERFACE BOX THAT WILL ACCEPT MOST INDUSTRY WIDE LOW-AMP SINGLE AND DUAL SWITCHES UTILIZING AN 1/8™ INCH MALE PHONO JACK LEAD. AS THE TOGGLE SWITCH IS ACTIVATED. 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. THE T-2000 HAS A STANDARD TILT RANGE OF ZERO TO 50 DEGREES. CUSTOM ANGLES ARE AVAILABLE. THERE IS A MINI-MICRO SWITCH ATTACHED TO THE SYSTEMS MOUNTING HARDWARE THAT RESTRICTS THE CLIENT FROM DRIVING BEYOND 20 DEGREES OF TILT.

This document is a 510(k) summary for the "T-2000 Power Tilt Seating System." It outlines the device description, intended use, and substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory submission for market clearance based on substantial equivalence, not on the performance testing against specific acceptance criteria.

Ask a specific question about this device