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The Teeth in an Hour - ARK Implant System is indicated for the treatment of totally edentulous jaws for placement of implant fixtures with immediate load function to restore the patient's chewing function. The following prerequisites must be fulfilled:

• adequate amount of jaw bone
• the quality of jaw bone must be judged as adequate
• capability to open the mouth at least 50mm (this is especially important for lower jaws with the opposite jaw)

The Teeth in and Hour – ARK Implant System is a concept bridging the use of existing modeling techniques through a surgical template that transfers pre-determined implant locations to a patient. Existing modeling techniques are performed to create a model of a patient's jaw in order to pre-determine implant location. A surgical template, comprised of acrylic material with cylinders and sleeves embedded, is produced for the purpose of transfering the pre-determined implant locations to the patient. During surgery, the template is held in position in the patient's mouth using anchor pins, which are based upon the modeling, and osteotomies are created using the surgical template, necessary drills, and accessories. Implants are then placed into the jaw using standard technique, and anchor pins are then removed. After the implants are inserted, this concept then allows for pre-produced prosthetic reconstruction to be attached.

This request cannot be fulfilled by the provided document. The document is a 510(k) summary for a dental implant system. It outlines the device description, indications for use, and regulatory classification. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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