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The Quest Intersegmental Roller Table uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient.

The Quest Intersegmental Roller Table uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient.

The provided text is a 510(k) clearance letter from the FDA for a device called "Quest Intersegmental Roller Traction Table". This document does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, or ground truth establishment.

The letter primarily:

• Acknowledges receipt of the 510(k) notification.
• States that the device is substantially equivalent to a legally marketed predicate device.
• Grants permission to market the device, subject to general controls and other FDA regulations.
• Identifies the product as a Class II device.
• Provides contact information for regulatory questions.

The "Indications For Use" section describes how the device functions ("uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient") but does not quantify performance or set acceptance criteria.

Therefore, I cannot provide the requested table and study details based on the input document. The document is a regulatory approval letter, not a device performance study report.

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