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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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