Search Results

3 i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment.

The 3i TG OSSEOTITE® Wide Implants are trans-gingival implants designed with an internal morse-taper. The wider dimension of the seating surface provides a realistic size proportion of a natural tooth of the posterior area.

The provided document is a 510(k) summary for a medical device, the 3i TG OSSEOTITE® Wide Implants. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets them. It explicitly states under "Performance": "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act."

The purpose of a 510(k) is to show that a new device is "substantially equivalent" to an already legally marketed device – meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that these do not raise new questions of safety and effectiveness. It does not typically involve the presentation of acceptance criteria or a dedicated study to prove performance against those criteria in the same way a PMA (Pre-Market Approval) or a clinical trial for a novel device would.

Based on the document, here's what can be extracted, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not available. The document states "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act." The submission is based on substantial equivalence to predicate devices, not on meeting specific performance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not available. No clinical study or test set data is presented to demonstrate performance against acceptance criteria. The submission relies on demonstrating substantial equivalence to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. No test set or ground truth establishment based on expert consensus for performance evaluation is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring adjudication in the context of performance evaluation 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

• Not applicable. This device is an endosseous dental implant, not an AI-powered diagnostic tool, so an MRMC study is not relevant to its regulatory submission type.

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

• Not applicable. This device is an endosseous dental implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. The submission relies on substantial equivalence, not on establishing ground truth for performance evaluation.

8. The sample size for the training set

• Not applicable. No machine learning algorithm or training set is involved in the submission for this type of device.

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

• Not applicable. No machine learning algorithm or training set is involved.

Summary of the Document's Content:

The document is a 510(k) premarket notification for the "3i TG OSSEOTITE® Wide Implants." Its primary conclusion is that the device is substantially equivalent to legally marketed predicate devices (TG OSSEOTITE® Dental Implants K972444 and OSSEOTITE® IOL Implants K031632). It describes the device as trans-gingival implants designed with an internal morse-taper and a wider seating surface, intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment. The technological characteristics are stated to be similar to the currently available TG OSSEOTITE® Implants. The FDA's letter confirms this substantial equivalence determination, allowing the device to be marketed.

Ask a specific question about this device