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The SFI-Bar® is intended to be used with the implant manufacturer's implant (Table 1) to provide support for fixation of overdentures.

The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar@ consists of an implant adapter (abutinent) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.

Here's a breakdown of the acceptance criteria and study information for the SFI-Bar® based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a separate "test set" and its sample size in the context of clinical data for the SFI-Bar®. The performance evaluation relies on non-clinical test data.

Data Provenance: The testing was conducted as part of a 510(k) submission, originating from Switzerland (Cendres + Métaux SA, Biel/Bienne, Switzerland). The data is retrospective in the sense that it's an evaluation against established performance metrics and comparison to predicate devices, rather than a prospective clinical trial.

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

This information is not provided as the ground truth for this device's performance evaluation was based on engineering and performance testing rather than expert-derived clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation did not involve human interpretation or adjudication processes like those in clinical image analysis studies. The adjudication for performance was based on meeting technical specifications from engineering tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the nature of the SFI-Bar®.

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

This concept is not applicable to the SFI-Bar®. The device is a physical dental abutment, not an algorithm. The performance evaluation was of the physical device's mechanical properties and function.

7. The Type of Ground Truth Used

The ground truth for evaluating the SFI-Bar®'s performance was based on:

• Engineering specifications and standards: Adherence to established mechanical properties (e.g., torque, application, functional requirements).
• Performance characteristics of predicate devices: The SFI-Bar® was compared for substantial equivalence to legally marketed predicate devices, meaning their established safe and effective performance served as a benchmark.

8. The Sample Size for the Training Set

This information is not applicable. The SFI-Bar® is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as there is no "training set" for this device.

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