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Tomas-pins are temporary, enossal anchorage point for attachment of orthodontic appliances.
To provide a fixed anchorage point for attachments of orthodontic appliances.

tomas-pin micro screws (orthodontic micro implant) are anchorage elements made of grade 5 titanium (3.7165), according to ASTM (American Society for Testing and Materials). They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The tomaspin is constructed as follows: The screw features hex type slots. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed on the tomas-pin with light cured adhesive should completely/fully enclose the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-on. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head.

The thread of the tomas-pin SD is self-drilling. The tomas-pin SD is inserted and screwed into the bone by either manual or mechanical method.

The shoulder connection between the thread and soft tissue sleeve serves as a stop to prevent the tomas-pin from sinking into the soft tissue. The soft tissue sleeve between the thread and retention head helps to prevent irritation between the gingiva and the tomas-pin, therefore.

The provided document is a 510(k) premarket notification summary for the Dentaurum tomas-pin (Temporary Orthodontic Micro Anchorage System). This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria and supporting data for a new device.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a device performance study.

Instead, it relies on a comparison of the tomas-pin device to predicate devices based on:

• Intended Use: The tomas-pin has the same intended use as the predicate devices: "To provide 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."
• Material: The tomas-pin is made of Titanium Grade 5 (ASTM), which is similar to the Titanium and Titanium Alloy (ASTM F 136-98) used in the predicate devices.
• Design and Characteristics: The submission states that the tomas-pin has similar dimensions and characteristics to the predicate devices.
• Potential Adverse Effects: These are identified as identical to those of the predicate devices.

The conclusion drawn is that the tomas-pin is "substantially equivalent in design, material, intended use and function" to the listed predicate devices. There is no performance study described in this document to assess specific acceptance criteria for a new device's efficacy or accuracy.

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