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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.

The Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 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, prosthetic parts and related surgical instruments. The Bone Level D 3.0 to 6.0 mm implants use the same platforms and abutment connections like the Bone Level implants (K111003) for the diameter 4.1. 4.8. and 6.0 mm implants, and therefore the abutments and prosthetic parts of the Bone Level implants are used. The diameter 3.0 mm implants use the same connection concept in a narrower version. The submission includes:

• Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0
• Diameter 4.1 and 4.8 mm Implants with Length of: 6.5 mm; Platform B2
• Diameter 6.0 mm Implants with Length of: 6.5, 8, 10, and 12 mm; Platform B2
• Straight abutments (Straight, Temporary, Ball, Locator); B0 platform, Length 10.4 14.9 mm, Diameter 3.6 - 4.0 mm
• Healing abutments, closure screws; B0 platform, Height 0.5 7.1 mm, Diameter 2.8 3.9bmm

The provided text describes a 510(k) Pre-market Notification for the Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. Therefore, it does not involve a study with acceptance criteria and reported device performance in the typical sense of a diagnostic or AI-driven device.

Here's an analysis of the provided information based on your requested criteria, highlighting what is present and what is not:

Acceptance Criteria and Study for Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm

This 510(k) submission primarily relies on non-clinical testing to demonstrate the substantial equivalence of the Biodenta Dental Implant System to previously marketed predicate devices. The "acceptance criteria" here are defined by the performance in these non-clinical tests, ensuring the device meets safety and effectiveness standards comparable to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information (primarily relevant for AI/diagnostic studies):

• 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented. The testing pertains to physical device properties.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established for this type of device submission. Performance is based on engineering tests.
• 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 a medical device (dental implant), not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/diagnostic device. The "truth" for this device is its adherence to mechanical performance standards and material specifications, demonstrated through laboratory testing.
• 8. The sample size for the training set: Not applicable. There is no "training set" for a physical dental implant.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of Approach:

The Biodenta Dental Implant System's 510(k) submission demonstrates substantial equivalence primarily through non-clinical test data. This involved:

• Fatigue testing: Conducted according to FDA guidance for root-form endosseous dental implants and abutments. This test assessed the mechanical strength under worst-case scenarios, proving it is sufficient for the intended clinical application.
• Surface area analysis: Compared the implant surface area of the new device to predicate devices, finding it to be almost identical or higher, which is deemed sufficient.

The submission explicitly states: "Non-clinical test data was used to support the decision of safety and effectiveness." No clinical testing was presented in this summary to support the substantial equivalence. The "acceptance criteria" were met by successfully passing these specified non-clinical performance benchmarks.

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Biodenta bone level tapered 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.

The Biodenta Dental Implant System - Bone Level Tapered 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 and related surgical instruments. The Bone Level Tapered implants use the same platforms and abutment connections like the Bone Level implants (K111003), and therefore the abutments and prosthetic parts of the Bone Level implants are used with the Bone Level Tapered implants.

The System includes dental implants with the following dimensions:

• Diameter 3.5 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B1
• Diameter 4.1 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B2
• Diameter 4.8 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B2
• Diameter 6.0 mm Implants with Length of: 8, 10, and 12 mm; Platform B2

The provided document is a 510(k) summary for the Biodenta Dental Implant System - Bone Level Tapered. It details the device's indications for use, description, and a comparison to predicate devices, focusing on demonstrating substantial equivalence.

However, the document does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML algorithm or a human-in-the-loop study. The "Non-clinical Testing Data" section only mentions fatigue testing according to FDA guidance and ISO 14801 for mechanical strength. This is a physical device (dental implant), not a software or AI/ML device that would typically have acceptance criteria presented in the requested format.

Therefore, I cannot provide the requested table and study details. The information requested (sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth) is only relevant for studies validating AI/ML-based medical devices, which is not the subject of this 510(k) submission.

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