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The HGIII Ultra wide Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The HGIII Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The HGIII Ultra wide Fixture System is intended to be used in the molar region.

The HGIII Ultra wide Fixture System is dental implant made of titanium metal intended to be used in the molar region and surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is RBM, Resorbable Blast Media, treated. HGIII Ultra wide Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has RBM surface.

This 510(k) premarket notification describes a dental implant system (HGIII Ultra wide Fixture System) and its substantial equivalence to a predicate device. This type of submission generally does not include studies demonstrating device performance against specific acceptance criteria in the way an AI/ML device would. Instead, substantial equivalence is established through comparison of design, materials, intended use, and performance characteristics (often non-clinical, such as fatigue testing) to a legally marketed predicate device.

Therefore, many of the requested elements for an AI/ML device study are not directly applicable or available in this document. I will extract the information that is present and indicate where certain information would not be found in this type of submission.

1. A table of acceptance criteria and the reported device performance

This document does not present "acceptance criteria" in the context of clinical performance metrics (like sensitivity, specificity, AUC) that an AI/ML device would need to meet. Instead, it establishes substantial equivalence based on a comparison of characteristics to a predicate device. The performance characteristics are primarily mechanical/material.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not discuss a "test set" in the context of clinical data for performance evaluation. The primary "test" mentioned is non-clinical fatigue testing.

• Sample Size for Test Set: Not applicable for clinical performance. For fatigue testing, it's mentioned as "the worst case scenario of the GSIII Fixture(or HGIII Fixture) and an angled abutment". The exact number of samples for this test is not specified in the summary.
• Data Provenance: Not applicable for clinical performance. The fatigue testing is likely laboratory-based, performed by the manufacturer, HiOSSEN Inc. (Fairless Hills, PA, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission does not involve human readers establishing ground truth for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no multi-reader adjudication for a test set.

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

No MRMC study was done. This is a submission for a dental implant, not an AI/ML device intended to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not an AI/ML device, so standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a physical device like a dental implant, "ground truth" relates to material properties, mechanical integrity, and biocompatibility.

• For material properties and dimensions: Standardized measurements and material certifications (e.g., Pure Titanium Grade 4 (ASTMF67-06)).
• For functional performance: Non-clinical bench testing (e.g., fatigue testing) against established industry standards and guidance documents ("Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment").
• For biocompatibility: Biocompatibility tests performed to comply with applicable International and US regulations.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device, so there is no training set or ground truth established for it in that context.

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