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This device is a self- tapping titanium threaded screw indicated for intra-bony and inter-radicular transitional application, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge instillations, for full or partial edentulism, an employing minimally invasive surgical intervention.

Representative applications include the following:

• • Temporary (transitional supports for fixed or removable implant-supported prosthesies while conventional implants are integrating.
• • Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes or integrating implants.
• • Introductory system for nervous or apprehensive potential patients, offering a simple methodology for testing out the actual "feel of bone anchored implants, without the major commitment to final restorations; or as an interim system for medical compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication and general well-being, at modest cost levels.

Self-tapping titanium screw, 1.8 mm in width by 13, 15and 18 mm lengths.

This document is a 510(k) premarket notification for the IMTEC Sendax MDI™, a self-tapping titanium screw intended for immediate transitional splinting stability or ongoing fixation of new/existing crown, bridge, and denture installations. The document describes the device, its indications for use, contraindications, complications, and a comparison of its technological characteristics. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide a response that includes the requested information based on the provided text. The document is a regulatory submission for substantial equivalence, not a performance study report.

Specifically, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are presented.
2. Sample size used for the test set and the data provenance: No test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No test set adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No MRMC study is mentioned.
6. If a standalone performance study was done: No standalone performance study is mentioned.
7. The type of ground truth used: No ground truth is described.
8. The sample size for the training set: No training set is mentioned.
9. How the ground truth for the training set was established: No training set ground truth establishment is described.

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