The TRX Vertical Positioner is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:

All positioning benefits associated with the tilt/recline product -
- Comfort As with any individual able-bodied or disabled changes in position are necessary to maintain a state of comfort.
- Repositioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
- Pressure relief Individuals who wish, from time to time, to redistribute pressures from one area of the body to another, can do so by tilting, reclining or vertical positioning. By changing the individual's orientation in space, pressures caused by gravity will shift.
Positioning/Versatility Individuals are able to reach higher elevations, increasing their range of motion and accessibility.

The TRX Vertical Positioner is used to add the vertical positioning function to the tilt, recline, and elevating functions already available in with the TRX Power Positioning System defined in K021264.

Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed. TRX Vertical Positioners are to be installed ONLY by qualified Dealers.

The above indications for use are identical to those of the Levo Mobile LCM defined in K963817 to which we are claiming substantial equivalence.

Device Description

The TRX Vertical Positioner is used to add the vertical positioning function to the tilt, recline. and elevating functions already available in with the TRX Power Positioning System defined in K021264. The Vertical Positioner functions by coordinating the elevating and reclining motion with an anterior tilt motion to change the user from an upright seated position to a vertical position and back again.

The TRX Vertical Positioner is assembled using primarily steel and aluminum, powder coated parts.

The vertical positioning is be activated using TRx switches consisting of either push buttons or togale switches, or through the wheelchair joystick.

Additional safety features include a drive lock-out which prevents the user from driving the power chair while tilted beyond a pre-set limit of 20° from the vertical or elevated beyond 1/2". The system also includes extensions for the existing front anti-tipper wheels to provide additional front stability, and a lockout for the active track suspension in the vertical positioning mode. Electrical components are a maximum of 24 volts with a fuse between the batteries and the relay box and current limiter built into the relay box. Stability of the TRX Vertical Positioner was tested in our facility to ensure that the safety of the power wheelchair was not compromised by the addition of the system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "TRX Vertical Positioner." This document establishes substantial equivalence to a predicate device, the Levo Mobile LCM (K963817), rather than presenting a study to prove acceptance criteria with specific performance metrics.

Therefore, the requested information elements related to detailed study methodologies, sample sizes, expert involvement, and statistical results (such as effect size for MRMC studies or specific performance metrics for standalone algorithms) are not present in this type of regulatory document.

However, based on the information provided, here's what can be extracted and inferred regarding the acceptance criteria and the "study" (in this context, primarily the safety and similarity testing):

1. A table of acceptance criteria and the reported device performance

The document does not provide a quantitative table of acceptance criteria and reported device performance in the manner typically found in a clinical study report. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and by asserting that safety was tested.

Acceptance Criteria (Implicit)	Reported Device Performance/Assertion
Safety: Device does not compromise the safety of the power wheelchair.	"Stability of the TRX Vertical Positioner was tested in our facility to ensure that the safety of the power wheelchair was not compromised by the addition of the system." (Page 1)
Functionality: Provides vertical positioning by coordinating elevating, reclining, and anterior tilt. (Similar to predicate)	"The Vertical Positioner functions by coordinating the elevating and reclining motion with an anterior tilt motion to change the user from an upright seated position to a vertical position and back again." (Page 1) "Both systems combine the anterior tilting and reclining action to achieve a vertical position." (Page 2)
Mechanical Similarity: Uses similar components and materials. (Similar to predicate)	" TRX Vertical Positioner is assembled using primarily steel and aluminum, powder coated parts." (Page 1) "Both products use similar components. Both are fabricated from steel and aluminum and have a generally similar mechanical operation." (Page 2)
Electrical Safety: Meets voltage and safety component standards.	"Electrical components are a maximum of 24 volts with a fuse between the batteries and the relay box and current limiter built into the relay box." (Page 1)
Operational Safety Features: Includes drive lock-outs and stability enhancements.	"Additional safety features include a drive lock-out which prevents the user from driving the power chair while tilted beyond a pre-set limit of 20° from the vertical or elevated beyond 1/2". The system also includes extensions for the existing front anti-tipper wheels to provide additional front stability, and a lockout for the active track suspension in the vertical positioning mode." (Page 1)
Intended Use: Provides safe and reliable powered repositioning on wheelchairs for specified benefits (comfort, repositioning, pressure relief, versatility).	"Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed." (Page 2, 5)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of a clinical trial or AI model validation. The "testing" mentioned ("Stability of the TRX Vertical Positioner was tested in our facility") refers to in-house engineering and functional testing of the device itself.

Sample Size: Not specified. It likely refers to testing performed on a limited number of prototype or production units.
Data Provenance: "in our facility" (Motion Concepts, Canada). These are likely engineering test results, not patient data.
Retrospective or Prospective: Not applicable in the context of this description, as it's not a study involving patient data.

3. 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. This device is a mechanical accessory; its "ground truth" is based on engineering specifications, safety standards, and functional equivalence to a predicate device, rather than expert judgment on complex medical interpretations. Safety testing would be evaluated against established engineering parameters and regulatory standards by qualified engineers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no information about expert adjudication as it relates to a "test set" in a diagnostic or interpretive context.

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 a medical device accessory for wheelchairs, not an AI software intended for diagnostic or interpretive tasks requiring human readers.

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

Not applicable. This is a mechanical/electrical device, not an algorithm.

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

The "ground truth" for this device's safety and effectiveness determination is essentially:

Compliance with engineering specifications and safety standards.
Functional equivalence to the legally marketed predicate device (Levo Mobile LCM K963817) with respect to its mechanism of action and intended use.
Internal stability testing results validating the mechanical integrity and safe operation of the system when added to a power wheelchair.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

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

Not applicable.

Summary

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KOZ344

Image /page/0/Picture/1 description: The image shows a logo with a circular design on the upper left and the word "Motion" in bold, larger font below it. To the right and slightly above the word "Motion" is the word "Concepts" in a smaller, slanted font. The logo appears to be for a company or product named "Motion Concepts."

NOV 21 2002

510(k) Summary

Submitter: Motion Concepts

84 Citation Dr. Address: Concord, ON L4K 3C1 Canada
Phone: (905) 695-0134
Contact: David Ciolfe
dciolfe @ motionconcepts.com E-mail:
October 1, 2002 Date Prepared:
Device Trade Name: TRX Vertical Positioner
Common Name: Power Positioning System
Classification Name: Powered Wheelchair
ldentification of Predicate Device: Levo Mobile LCM (K963817)

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Description of Device:

The TRX Vertical Positioner is assembled using primarily steel and aluminum, powder coated parts.

The vertical positioning is be activated using TRx switches consisting of either push buttons or togale switches, or through the wheelchair joystick.

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Statement of Indications for Use:

All positioning benefits associated with the tilt/recline product -.
- Comfort As with any individual able-bodied or disabled changes in position are necessary to maintain a state of comfort.
- Repositioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
- Pressure relief Individuals who wish, from time to time, to redistribute pressures from one area of the body to another, can do so by tilting, reclining or vertical positioning. By changing the individual's orientation in space, pressures caused by gravity will shift.
Positioning/Versatility Individuals are able to reach higher elevations, increasing their . range of motion and accessibility.

Substantial Equivalence Comparison:

1100315 Ontario Limited claims that our product is substantially equivalent to the Mobile LCM as manufactured by Levo. The pre-existing device is classified as Class I as listed in 21 CFR Parts 890.3860. The Levo 510(k) document control number is K963817.

Both the TRx Vertical Positioner and the Levo Mobile LCM systems are devices that are used on power wheelchairs in order to provide the user with the capability to change his/her position from a seated position to a vertical position and back. Both products use similar components. Both are fabricated from steel and aluminum and have a generally similar mechanical operation. Both systems combine the anterior tilting and reclining action to achieve a vertical position.

The following is a comparison of the Mobile LCM and the TRx Vertical Positioner.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or progress. The overall design is simple and professional, reflecting the department's role in public health and human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2.1 2002

Motion Concepts David Ciolfe Operations Manager 84 Citation Drive Concord, Ontario L4K 3C1 Canada

Re: K023426

Trade/Device Name: TRX Vertical Positioner Regulation Number: 890.3860 Regulation Name: Powered Wheelchair (accessory) Regulatory Class: Class II Product Code: ITI Dated: November 4, 2002 Received: November 8, 2002

Dear Mr. Ciolfe:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the

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quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Muriam C. Provost

fel Celia M. Witten, Ph.D., MD 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):__KO23426

Device Name: TRx Vertical Positioner

Statement of Indications for Use:

All positioning benefits associated with the tilt/recline product -●
- Comfort As with any individual able-bodied or disabled changes in position are necessary A to maintain a state of comfort.
- Repositioning - Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
- Pressure relief Individuals who wish, from time to time, to redistribute pressures from one A area of the body to another, can do so by tilting, reclining or vertical positioning. By changing the individual's orientation in space, pressures caused by gravity will shift.
. Positioning/Versatility -- Individuals are able to reach higher elevations, increasing their range of motion and accessibility.

The TRX Vertical Positioner is used to add the vertical position to the tilt, recline, and elevating functions already available in with the TRX Power Positioning System defined in K021264.

The above indications for use are identical to those of the Levo Mobile LCM defined in K963817 to which 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) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Miriam C. Provost

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

510(k) Number K023426

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).