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Dental implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. Dental implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

The proposed devices, Dental Implant Systems, are integrated systems of endosseous dental implants, which are intended to support prosthetic devices.

The systems are mainly available in two models which are Tissue Level (TL) and Bone Level (BL), each model consists of the following components: (1) Dental Implants, (2) Abutments, (3) Occlusal Screws and (4) Healing Caps. Each component is available in various configuration. In addition, the systems also consist of various specific surgical instruments.

Abutment models for TL dental implants include: Coping, Solid abutment, Retentive anchor abutment, Screw-retained abutment, Cementable abutment, Angled abutment.

Abutment models for BL dental implants include: Healing Abutment, Anatomic abutment, Meso abutment, Cementable abutment, Multi-base abutment.

The provided text is a 510(k) premarket notification for a Medical Device, specifically a "Dental Implant System." This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a study of device performance against pre-defined acceptance criteria in the context of clinical or AI-based performance metrics.

Therefore, the document does not contain the information requested for acceptance criteria and a study that proves the device meets those criteria, especially in relation to AI/algorithm performance. It is a regulatory submission demonstrating mechanical, material, and safety equivalence.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/Algorithm Component: There is no mention of any AI, machine learning, or algorithm being part of this "Dental Implant System." The device is a physical dental implant.
• Focus on Substantial Equivalence: The entire document is geared towards proving that the proposed device is "substantially equivalent" to a legally marketed predicate device (STRAUMANN DENTAL IMPLANT SYSTEM). This is a regulatory pathway, not a clinical trial to demonstrate new performance metrics against acceptance criteria for a novel AI.
• No Clinical Study: Section 7 explicitly states: "No clinical study is included in this submission." This means there is no data from human subjects or a clinical setting to evaluate performance.
• Non-Clinical Test Conclusion: Section 6 details non-clinical tests. These tests are primarily for material properties, sterility, biocompatibility, and mechanical durability (e.g., dynamic fatigue test). These are engineering and material science tests, not performance studies for a diagnostic or AI-driven medical device.

Therefore, it is impossible to complete the requested table or answer the specific questions about acceptance criteria, ground truth, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of this 510(k) submission for a physical dental implant.

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