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Thommen SP1® Dental Implant Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.

Thommen SP1® Dental Implant Abutments are endosseous dental implant abutments made of commercially pure grade titanium and intended for cemented restorations. They may be used for cemented single crowns or bridges.

This document is a 510(k) premarket notification for a medical device, specifically dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving performance against acceptance criteria.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not available in the provided text.

The document primarily provides administrative information, device classification, predicate device information, intended use, and a statement of equivalence to marketed products.

Here's a breakdown of why each requested point cannot be fulfilled based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: This document does not establish new performance criteria or report performance data. It relies on the equivalence to devices that would have already met such criteria.
• 2. Sample sized used for the test set and the data provenance: No new performance study or test set is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant in an equivalence submission of this type.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no new test set is described.
• 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: This is a physical medical device (dental abutment), not an AI-powered diagnostic or assistive tool. MRMC studies are completely irrelevant.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable as this is not a machine learning/AI device.
• 9. How the ground truth for the training set was established: Not applicable.

Summary from the document:

This document is a 510(k) submission for Thommen SPI® Dental Implant Abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices: the HA-Ti Dental Implant System (K901927) and SPI Easy Dental Implant Abutment (K023645).

The basis for equivalence is stated as:

• Same intended use
• Same operating principle
• Same basic design
• Same materials (commercially pure grade titanium)
• Same packaging materials and processes

The device is intended for use in conjunction with SPI System dental implants to support crowns, bridges, or overdentures in the maxillary and/or mandibular arch. No new performance studies or data are presented to establish acceptance criteria for the device itself; rather, its compliance is inferred through its similarity to already approved devices.

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