Search Results

The Straumann RC Temporary Abutments are indicated for use in Straumann RC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.

The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, permanent and temporary abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments. Abutments are placed on dental implants to provide support for dental restorations. Temporary abulments act as a basis for the fabrication of individual temporary restorations and temporary bridges on Straumann Dental Implants.

This looks like a 510(k) summary for a dental device, specifically "Straumann RC Temporary Abutments." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed studies of performance against specific acceptance criteria for a novel AI/software medical device.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment is not present in the provided text.

The document primarily focuses on:

• Identification of the device: Straumann RC Temporary Abutments.
• Identification of a predicate device: RC Temporary Abutments, K070478.
• Intended Use: For temporary restorations of single crowns and bridges for up to six months with Straumann RC Bone Level Dental Implants.
• Technological Characteristics: Stating that the proposed abutments are substantially equivalent to marketed devices, with identical intended use, material composition, basic design, and fundamental operating principles.
• FDA Clearance: The letter from the FDA confirms the device is substantially equivalent to legally marketed predicate devices.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document asserts substantial equivalence to a predicate device based on identical intended use, material, design, and operating principles, rather than reporting specific performance metrics against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not available. No specific test set or study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. This type of information is not relevant for a 510(k) summary of a physical dental abutment.
4. Adjudication method: Not available.
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 device is a physical dental abutment, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device