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Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. They are intended for delayed loading.

The Biodenta Dental Implant System - Bone Level Tapered D3.0 and L6.5 mm is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, prosthetic parts and related surgical instruments. The Bone Level Tapered D3.0 and L6.5 mm implants use the same platforms and abutment connections like the Bone Level D 3.0 to 6.0 (K123512). Therefore the abutments and prosthetic parts which are compatible to the Bone Level D 3.0 to 6.0 (K123512) are also compatible to the predicate device.

The submission includes:

• Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0
• Diameter 4.1, 4.8, and 6,0 mm Implants with Length of: 6.5 mm; Platform B2

The provided text describes a 510(k) summary for the Biodenta Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable in this context, as the submission relies on non-clinical testing and comparison to predicate devices, not on a clinical performance study with acceptance criteria.

However, I can extract the non-clinical testing data that was used to support the safety and effectiveness for equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The device should have sufficient mechanical strength for the intended clinical application and its surface area/bone to implant contact area should be sufficient compared to predicate devices.
• Reported Device Performance:
  • Dynamic Fatigue Testing: The subject device (Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm) was found to be "identical" to the predicate device (Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm, K123512) and thus has "sufficient mechanical strength for the intended clinical application."
  • Surface Area and Bone to Implant Contact Area: The Biodenta implant's surface area and bone to implant contact area were calculated to be "larger than the predicate device's surface area and bone to implant contact area." Therefore, the surface area and bone to implant contact area are "considered to be sufficient."

2. Sample size used for the test set and the data provenance: Not applicable. The testing described is non-clinical (dynamic fatigue, CT scan modeling).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical tests is based on established engineering standards (e.g., ISO 14801:2007) and calculations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is not an AI/medical imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests:
* Dynamic fatigue testing: Conformance with ISO 14801:2007 standard.
* Surface area and bone to implant contact area: Calculated from 3D models generated from CT scans, compared against predicate devices.

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable.

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