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The BR Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. BR Type Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

The BR Implant System is a dental implant system made of CP Ti Gr 4 / ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The surface of the implants has been treated with R.B.M (Resorbable Blast Media) with acid etch. The BR Type Implant System is offered in the following sizes. Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Abutments, Angled Abutments, Cemented Abutments (Hex, Non-hex), and Solid Abutments) for restorations. Small diameter implants and angled abutments are not recommended for the posterior region. They are made of Titanium Grade 4 / ASTM F67, and provided as non-sterile.

The provided document is a 510(k) summary for a medical device (BR Type Implant System), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of regulatory submission does not typically include detailed study reports with acceptance criteria and device performance metrics in the way a clinical trial or a performance study for a novel AI device would.

The document primarily focuses on demonstrating substantial equivalence through comparisons of design, materials, indications for use, and non-clinical testing to established standards. It does not contain the specific information requested about acceptance criteria, detailed device performance metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment for a machine learning or AI-based device.

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

• No specific acceptance criteria or reported device performance for an AI/ML component: The document discusses non-clinical tests for a dental implant system (e.g., sterilization, fatigue, biocompatibility) against ISO standards, not performance metrics for an AI algorithm.
• No test set sample size, data provenance, or ground truth details: These are not relevant for a physical medical implant's 510(k) submission, which focuses on similarity to an existing device.
• No mention of experts, adjudication, MRMC studies, or standalone performance: These concepts apply to the evaluation of diagnostic or assistive AI systems, not to the premarket notification of a dental implant.
• No training set information: There is no AI/ML component described, so no training set is relevant.

The document lists "Non-Clinical Test data" which refers to standard engineering and biocompatibility tests for a physical implant, such as:

• Sterilization Validation testing (ISO 11137, ISO 11737-1&2 for gamma; ISO 17665-1&2 for steam)
• Surface Characteristics Test Report (Chemical and SEM image analyses)
• Shelf-life and packaging material validation (ISO 11607, ISO 11137, ISO 11737, ASTM F1980, ASTM D882, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096, ASTM F1608)
• Comparative Fatigue testing (ISO 14801:2007)
• Cytotoxicity Test (ISO 10993-5:2009)
• Sensitization test (ISO 10993-10:2010)

These tests "met the criteria of the standard," allowing the device to claim substantial equivalence. However, these are not the type of acceptance criteria and performance metrics used for an AI/ML medical device as implied by your question.

In summary, the provided document does not contain the information required to populate the requested table and answer the specific questions related to the acceptance criteria and study of an AI-powered device.

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