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The BLUEDIAMOND IMPLANT System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.

The BLUEDIAMOND IMPLANT is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be surgically placed in the maxillary or mandibular molar areas. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type.

The Abutment Screw is used for securing the abutment to the endosseous implant. It is made of Ti-6AL-4V ELI.

I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA for a dental implant system. This document is a regulatory submission for a medical device and does not contain information about studies proving that a device meets specific acceptance criteria in the context of an AI/ML-enabled medical device.

The document describes:

• The device (BLUEDIAMOND IMPLANT and Abutment Screw)
• Its intended use (dental restorations)
• Comparison with predicate devices for substantial equivalence (materials, design, sterilization, etc.)
• Non-clinical testing performed (biocompatibility, surface treatment, pyrogen/endotoxin, sterilization, shelf life, performance tests based on ISO standards)
• A statement that no clinical studies were submitted.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance (in the context of an AI/ML device): The document reports performance testing to ISO standards for dental implants (e.g., fatigue testing for mechanical properties) but does not provide acceptance criteria and reported performance in the manner requested for an AI/ML device (e.g., sensitivity, specificity thresholds).
2. Sample size used for the test set and data provenance: Not applicable as no AI/ML study is reported.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of AI/ML. The device's "ground truth" for regulatory purposes relies on engineering and material standards.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document discusses non-clinical performance tests for mechanical properties (e.g., fatigue test according to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant Abutment") to demonstrate substantial equivalence to predicate devices, but this is distinct from the type of performance data requested for an AI/ML-driven device.

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