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Biodenta Dental Implant System Multi Use Abutments are intended for terminal or intermediate abutment support for fixed or removable crown, bridgework and to retain overdentures.

The Biodenta Dental Implant System - Multi-Use Abutment is an extension to the Biodenta Dental Implant System Bone Level (K111003), which is an integrated system of endosseous dental implants, abutments and prosthetic parts and related surgical instruments.

The Biodenta Dental Implant System - Multi-Use Abutment includes 0°, 18°, and 30° abutments for screw retained restorations. Each angulation is available with 2, 3, 4, and 5 mm cuff height for both Biodenta Bone Level implant platform types (B1 and B2). The angulated abutments include hexed and non-hexed versions for single unit or multi unit restorations respectively. Abutment diameters are from 4.5 - 5.0 mm.

The system includes a ball attachment abutment with a diameter of 4.5 mm and height of 5.5 mm, and temporary abutments with a diameter of 4.0 mm and height of 12.5 mm, which are to be attached onto the Multi-Use Abutment. Burn out cylinders are provided. The system includes 2 diameters of abutment and 1 diameter of prosthetic screws. Short and long impression posts for open and closed tray impression taking, and a protective cap for the Multi-Use Abutment is included.

The provided 510(k) summary does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically seen for AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, this submission is for a dental implant abutment, and its "acceptance" is based on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing and comparison of design features and intended use.

Here's an breakdown based on the information provided, highlighting what is present and what is absent regarding acceptance criteria and study details:

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

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

• Test Set Sample Size: Not explicitly stated. The "worst case scenario" was tested for fatigue, implying a limited number of test units were subjected to mechanical loading.
• Data Provenance: The testing was conducted internally by Biodenta Swiss AG. This is a non-clinical, in-vitro study (mechanical testing), not a study involving human patient data.

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

• This is not applicable as the "ground truth" for a mechanical strength test is the material's failure point under a specific load, determined by engineering standards and equipment, not human experts.

4. Adjudication method for the test set

• Not applicable. The test results are objective measurements from mechanical testing.

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. This is a submission for a physical medical device (dental implant abutment), not an AI/ML diagnostic software. Therefore, an MRMC study is not relevant or performed.

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

• No. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" in this context is the mechanical load and cycle count at which the device fails, compared against established engineering standards and guidelines for dental implant abutments (specifically, the FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments).

8. The sample size for the training set

• Not applicable. There is no "training set" as this is a physical device and not an AI/ML model.

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

• Not applicable. No training set for an AI/ML model is involved.

Summary of the Study:

The primary study mentioned is fatigue testing conducted according to the "FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff." This is a non-clinical, in-vitro mechanical test. The study design focused on a "worst case scenario" for the Biodenta Dental Implant System - Multi Use-Abutment and implant. The purpose of this testing was to demonstrate that the device possesses sufficient mechanical strength for its intended clinical application, thereby supporting its substantial equivalence to predicate devices. The study did not involve human subjects, AI/ML algorithms, or expert adjudication for its results.

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