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Endosseous dental implant angled abutments are premanufactured prosthetic components directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation. They can be used in singled and multi-unit restorations where angled correction is required.

BTI Endosseous dental implant angled abutments consist of 15 degree angled abutments. The artificial tooth abutments are designed to fit and function on the internal and external BTI conexion implants.

They can be used in singled and multi-unit restorations where angled correction is required.

The angled abutments differ from the BTI predicate abutments in that the abutments are angled. The angled abutments provide for more flexibility in the implant placement and restoration process.

The provided text is a 510(k) summary for a medical device (Endosseous dental implant angled abutments). It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested sections about study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness are not applicable or not present in this type of submission.

Here's a breakdown of the information that can be extracted based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable.
This 510(k) summary for Endosseous dental implant angled abutments does not present specific quantitative acceptance criteria or performance metrics derived from a study designed to meet such criteria. Instead, it claims "substantial equivalence" in material, design, and function to existing predicate devices.

The basis for clearance is that the device is "as safe and effective as the predicate devices" based on this substantial equivalence claim, rather than a direct performance study against defined thresholds.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable.
No specific test set or data from a performance study is described in this 510(k) summary. The submission relies on demonstrating substantial equivalence to already cleared devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable.
Since no specific test set or performance evaluation is described, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not Applicable.
Since no specific test set or performance evaluation is described, there's no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No.
An MRMC comparative effectiveness study was not done. The submission is a 510(k) for substantial equivalence of a physical dental implant component, not an AI or diagnostic device that would typically involve a reader study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable.
This device is a physical dental implant component, not an algorithm or AI system. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

Not Applicable.
Since no specific performance study is discussed, there is no mention of a ground truth being established (e.g., pathology, expert consensus, outcomes data). The "truth" in this context is the comparison to the performance and safety profiles of the predicate devices.

8. The Sample Size for the Training Set

Not Applicable.
This submission pertains to a physical medical device (dental implant abutment), not a machine learning or AI model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable.
As there is no training set mentioned, the establishment of ground truth for it is not applicable.

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