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Super Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

The Super Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.6 and 1.8 mm in screw diameter and 6, 8, 10, 12mm in length. It is made of Titanium 6AI-4V alloy(ASTM F 136-98). The surface of the screw is non-treated and that of head is TiN coated. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. It is supplied non-sterile and must be sterilized prior to use by Steam heat sterilization.

The provided document for K062156, Osstem Implant Co., Ltd.'s "Super Orthodontic Screw," does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria.

This 510(k) submission is a "premarket notification" that focuses on demonstrating "substantial equivalence" to predicate devices. It relies on a comparison of characteristics (material, design, use concept) and general safety, performance, and product validations, rather than specific performance metrics and dedicated studies with acceptance criteria as typically found in more recent device submissions or clinical trial reports.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, or ground truth for a performance study from this document.

However, I can extract the general claims made about the device's validation:

General Claims Regarding Validation:

"Super Orthodontic Screw has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations. An extensive review of literature pertaining to the safety and biocompatibility of Super Orthodontic Screw has been conducted. Appropriate safeguards have been incorporated in the design of Super Orthodontic Screw."

Without further documentation beyond this 510(k) summary, it's impossible to fulfill the request for detailed acceptance criteria and study information. This submission primarily serves to establish substantial equivalence based on general design, materials, and intended use, rather than presenting a detailed performance study against specific acceptance criteria.

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