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The CTD Mark I is a mobile, cervical, pneumatic pulling-traction device expressly used to perform traction and mobilization of the cervical muscles and vertebrae. It provides intermittent or continuous traction modes. The CTD Mark I when used as a cervical traction device is for clinical use only by prescription of a licensed physician.

The CTD Mark I is a mobile, cervical, pneumatic pulling-traction device.

The provided document is a 510(k) premarket notification letter from the FDA regarding the CTD Mark I Traction Device. It states that the device has been found substantially equivalent to previously marketed devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device itself.

The letter only confirms the regulatory clearance for the device to be marketed based on its substantial equivalence. It describes the "Indications for Use" for the device, but does not provide any clinical study details.

Therefore, for the information requested in your prompt (Table of acceptance criteria, sample sizes, expert details, adjudication, MRMC studies, standalone performance, ground truth type and establishment), the answer is:

This information is not available in the provided document.

The document is purely a regulatory clearance letter and does not include the technical or clinical study data that would detail the device's performance against specific acceptance criteria.

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