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The TRx-CG is appropriate for use by any individual who drives a Quickie G-424, S-525, or an S-626 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:

• Comfort As with any individual able-bodied or disabled changes in position are necessary to maintain a state of comfort.
• Positioning -- Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
• Pressure Relief or Reduction Individuals who wish to, from time to time, redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift.

TRx-CG Power Tilt and Recline System

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a power tilt and recline system for wheelchairs, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and indications for use, but no specific performance metrics or study details are provided.

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The TRx-CG system is appropriate for use by any individual who drives an Invacare Storm Power Base wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include: Comfort - As with any individual - able-bodied or disabled - changes in position are necessary to maintain a state of comfort. Positioning - Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. Pressure Relief or Reduction - Individuals, who wish to, from time to time, redistribute pressure from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift. 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-CG Tilt and Recline Systems are to be installed ONLY by qualified Dealers. The above indications for use are identical to those of the Tarsys Tilt and Recline System to which we are claiming substantial equivalence.

TRx-CG Power Tilt and Recline System

This document is a 510(k) clearance letter from the FDA for a medical device called the "TRx-CG Power Tilt and Recline System." It is not a study report or a technical document describing a clinical study. Therefore, the information required to answer your questions about acceptance criteria and study details is not present in the provided text.

The document primarily focuses on:

• Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• Regulatory Classification: The device is classified as Class II.
• Indications for Use: The document clearly states the intended uses of the device.

There is no mention of:

• Acceptance criteria for device performance.
• Any specific study conducted to prove the device meets performance criteria.
• Sample sizes, data provenance, ground truth establishment, expert involvement, or any other details related to a clinical or performance study.

In summary, the provided document does not contain the information requested to populate the table or answer the questions regarding acceptance criteria and study details.

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