Search Results

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

Representative applications include the following:

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

Self-capping citanium threaded screw, 1.8mm in width by 14,17,19,&22mm lengchs

The provided text is a premarket notification summary (510(k)) for a dental implant, not a study describing acceptance criteria and device performance in the way typically seen for diagnostic or AI-driven medical devices. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance metrics against specific acceptance criteria.

Therefore, many of the requested categories (e.g., specific acceptance criteria, sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of document.

However, I can provide available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a "test set" in the context of typical device performance evaluations. The clinical data is based on a "twenty year prospective clinical study." The exact number of patients or implants is not provided.
• Data Provenance: The study "commencing in 1976 by Sendax & associates" suggests the data is prospective and collected over a long period. The country of origin is not explicitly stated but "Sendax MDIC Management, Inc." and "New York, N.Y." might imply US-based data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided. The study appears to be a clinical outcome study, not one requiring expert consensus for a ground truth label in the diagnostic sense.

4. Adjudication method for the test set:

• Not applicable as the study type does not involve a "test set" requiring adjudication in this manner.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a dental implant, not an AI-driven diagnostic tool. No MRMC study was performed, and human readers are not involved in its "performance."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is a physical medical device (dental implant), not an algorithm.

7. The type of ground truth used:

• The "ground truth" implicitly refers to the clinical outcomes of the dental implants, specifically their "survival" over 20 years, confirming safety and efficacy.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model. The clinical data constitutes the "study data" rather than a "training set."

9. How the ground truth for the training set was established:

• Not applicable. The ground truth (clinical survival) was established through direct observation and follow-up in the "twenty year prospective clinical study."

Ask a specific question about this device