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The Thommen SPI® ONETIME Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® ONETIME implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.

The two-stage HA-Ti Dental Implant acquired from HATI Dental AG by Thommen Medical AG has been modified to make it a one-piece one-stage transgingival implant and will be marketed as the SP1® ONETIME Dental Implant. Other components of the HA-Ti Dental Implant System have not been modified and are suitable for use with the modified implant, and will be sold under the SP10 Dental Implant System name.

The Thommen SP1® ONETIME Dental Implant is a one-stage root form endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transqingival portion and sandblasted and acid-etched in the area designed to contact bone. The implant is offered in three lengths (8 mm, 11 mm, 14 mm, not including the 2.9 mm transgingiyal portion), with two diameters (4.2 mm, 5.0 mm) for each length. It is constructed of materials that have a long clinical history of proven acceptance and performance,

The provided 510(k) summary for the Thommen SPI® ONETIME Dental Implant does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be described for a diagnostic AI device.

This document is a premarket notification for a Class III medical device (an endosseous dental implant), and the regulatory review process for such devices focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies designed with AI in mind.

Here's why the requested information cannot be fully provided based on the input:

• Dental Implants vs. AI/Diagnostic Devices: The document concerns a physical implant, not a software algorithm or an AI-powered diagnostic tool. The "acceptance criteria" and "device performance" in this context refer to material properties, sterilization methods, and intended use as defined by the FDA's substantial equivalence pathway, not metrics like sensitivity, specificity, or AUC as seen in AI studies.
• Substantial Equivalence: The primary goal of this 510(k) submission is to demonstrate that the SPI® ONETIME Dental Implant is substantially equivalent to a legally marketed predicate device (Thommen Medical AG HA-Ti Dental Implant). This means showing it has the same intended use, operating principle, basic design, materials, packaging, and sterilization processes. Performance is inferred through the predicate device's established safety and effectiveness, and through material conformity to standards like ASTM F67 and ISO 5832-2.
• Lack of AI-Specific Information: All the points you've requested (sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training/test sets) are specific to the evaluation of AI/ML-based medical devices or diagnostic tools. These concepts are not applicable to the 510(k) submission for a physical dental implant.

Therefore, I cannot populate the table or answer the questions as they pertain to AI device evaluation. The document describes a traditional medical device submission.

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