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The Orthodontic Temporary Anchorage Implant Screws are intended to provide a fixed anchorage point for the attachment of intraoral orthodontic appliances to facilitate the orthodontic movement of teeth. They are intended for temporary use and should be removed after orthodontic treatment has been completed. The screws are intended for single use only.

The Orthodontic Temporary Anchorage Implant Screws are available in three sizes, 6mm, 8mm and 10mm. The head of the screw allows insertion by either a screwdriver type instrument mated with a slot head or a socket driver type instrument matched with the dual socket design. The neck is long enough, with a .022 hole, to engage auxiliaries and short enough to maintain a low profile. The screws are intended for immediate loading and are highly polished to prevent osseointegration. The screws are made from the same materials, 100% biocompatible titanium ASTM F136, as most of the predicate devices and are sold as non-sterile with instructions to use steam sterilization methods or other accepted techniques used by the orthodontist.

This 510(k) summary describes a medical device submission for orthodontic temporary anchorage implant screws and does not include information about acceptance criteria or a study proving device performance against such criteria. The document focuses on establishing substantial equivalence to previously cleared predicate devices.

Therefore, I cannot provide the requested information. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Information on experts used to establish ground truth or adjudication methods.
4. Details of an MRMC comparative effectiveness study or related effect sizes.
5. Results of a standalone algorithm performance study.
6. The type of ground truth used (expert consensus, pathology, etc.).
7. Sample size for a training set.
8. How ground truth for a training set was established.

The 510(k) submission process is primarily about demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical studies if technological characteristics and intended use are similar. In this case, the manufacturer asserts substantial equivalence based on material, design, and function compared to existing devices.

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