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The Thommen SPI® Dental Implant System, TST Surface, is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental Implants can be loaded immediately if they are used for crowns, bridges or overdentures on at least four implants in the mandibular arch or six implants in the maxillary arch.

Contraindications for the use of SPI® CONTACT implant ø 3.5 mm and SPI® ELEMENT implant ø 3.5 mm:
These implants are not suitable for applications in areas where pronounced rotation and/or bending movements are expected to subject the implant to large bending movements.

• Restoration of posterior teeth in the upper or lower jaw -
• Single-tooth restoration of canines and central incisors in the upper jaw -
• Any application involving retentive anchors -

The Thommen SPI® Dental Implant System with TST Surface (the modified design) is a self tapping, root form, endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transgingival portion and treated with the TST implant surface process, in the area intended to contact bone. The modified TST Surface is available on all implants in the SPI® Dental Implant System. The system is constructed of materials that have a long clinical history of proven acceptance and performance.

This 510(k) summary describes a device modification to an existing dental implant system. The core of the submission focuses on demonstrating substantial equivalence to a predicate device, particularly concerning a new surface treatment (TST Surface). As such, a traditional "study" proving acceptance criteria with performance metrics, ground truth, and statistical analysis as one might find for an AI/ML diagnostic device is not applicable here.

Instead, the submission relies on the established safety and effectiveness of the predicate device and demonstrates that the modified device's characteristics (intended use, operating principle, basic design, materials, packaging, sterilization) are substantially equivalent.

Therefore, many of the requested categories (2-9) do not have direct answers in this document because they pertain to a different type of device evaluation.

However, I can extract the closest equivalent information for the acceptance criteria and implied "performance."

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are inferred from the requirements for demonstrating substantial equivalence for a device modification.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not a study assessing device performance on a clinical or imaging dataset. The "test" is the demonstration of substantial equivalence through comparison of device characteristics and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth was established by experts in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication of a test set occurred.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, against which the modified device's characteristics are compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not involve a training set.

9. How the ground truth for the training set was established

Not applicable. This device does not involve a training set.

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