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SPI® CONTACT Platform Ø 4.0 mm is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPT® Dental 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 design of the SPI CONTACT System has been modified to add an additional implant, with a platform diameter of 4.0 mm, giving further enhanced flexibility.

This document is a 510(k) summary for a medical device modification, specifically for the "SPI® CONTACT Platform Ø 4.0 mm" dental implant.

Based on the provided text, there is no acceptance criteria or study data present that describes device performance against specific metrics.

Here's why and what information is missing:

1. Table of acceptance criteria and reported device performance: This document is a premarket notification for a device modification, focusing on substantial equivalence to a predicate device. It does not contain a study demonstrating performance against specific acceptance criteria.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set: All of these elements are typically part of a detailed study report that would be submitted to demonstrate the safety and effectiveness of a device, especially for novel devices or significant modifications that impact performance. This 510(k) summary explicitly states that the device "incorporates the same basic design, incorporates the same materials, and is packaged using the same materials and processes" as the predicate. This suggests that extensive new performance studies were not deemed necessary for this specific submission, as the modification is to add an additional implant with a different platform diameter, implying that the fundamental performance characteristics are expected to be similar to the already cleared predicate.

Key points from the document indicating why this information is absent:

• "Special 510(k): Device Modification": This indicates a specific type of submission for modifications to devices already on the market. These often rely heavily on demonstrating that the change does not adversely affect safety or effectiveness, often by showing substantial equivalence to the original device.
• "EQUIVALENCE TO MARKETED PRODUCT" section: This section explicitly states the similarities to the unmodified predicate devices, including "has the same intended use," "uses the same operating principle," "incorporates the same basic design," and "incorporates the same materials."
• Conclusion: "In summary, the Thommen SPI® CONTACT Platform Ø 4.0 mm described in this submission is, in our opinion, substantially equivalent to the predicate devices." The FDA's letter (K072933) confirms this substantial equivalence determination.

Therefore, this document does not contain the information requested about acceptance criteria or specific study results because the regulatory pathway chosen (510(k) for a device modification based on substantial equivalence) did not require the submission of new clinical performance data to demonstrate the device meets new acceptance criteria. The approval is based on its similarity to an already approved predicate device.

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