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The Transitional Tooth Replacement is intended to be used as a temporary restorative application for placement in the bone of the upper arch. The purpose is to provide support for temporary, fixed cosmetic provisional restorations. The implant is intended for patients with congenitally missing teeth, primarily the Upper Lateral Incisors.

The Temporary Tooth Replacement is comprised of dental implant screws and prosthetic components. The system is designed to be used as a temporary restorative application for placement in the bone of the upper arch. The purpose is to provide support for temporary, fixed cosmetic provisional restorations. The implant is intended for patients with congenitally missing teeth, primarily the Upper Lateral Incisors. The system will consist of a screw and a molded pontic tooth that would be secured to the head of the screw using adhesive. The implant screw is removed once the patient reaches maturity and a permanent implant can be placed.

This document is a 510(k) summary for a medical device called "Temporary Tooth Replacement (TTR)". It describes the device, its intended use, and claims substantial equivalence to a predicate device, the Dentatus Monorail Transitional Implant (MTI).

However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory submission focused on demonstrating substantial equivalence to an already marketed device, which generally relies on comparing design, materials, and intended use rather than presenting new performance data against pre-defined criteria.

Therefore, I cannot provide the requested information about acceptance criteria and device performance based on the provided text.

Here is a breakdown of why the requested information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: This document explicitly states it is claiming "Substantial Equivalence" to another legally marketed device. This regulatory pathway typically involves demonstrating that the new device is as safe and effective as a predicate device, often by showing it performs similarly. It does not usually require the establishment and reporting of new, specific acceptance criteria and the results of a study designed to meet those.
2. Sample size used for the test set and the data provenance: No test data or studies are mentioned.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as no ground truth establishment is described.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: This document is about a physical medical device (dental implant), not an AI/ML algorithm. Therefore, "training set" is not relevant here.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) premarket notification for a traditional medical device, not an AI/ML device, and it focuses on substantial equivalence rather than presenting new performance data against acceptance criteria.

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