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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.

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.

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.

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.

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