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IH Implant System is device made of titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for stage surgical procedures. It is intended for delayed loading.

IH Implant System is device made of titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for stage surgical procedures. It is intended for delayed loading. The system includes IH2 SLA Fixtures, IH Healing Abutments, IH Cement Abutments, and IH Multi-unit Abutments. The fixtures are endosseous threaded implants with a surface treatment of sand blasting and acid etching. The abutments are premanufactured and connect directly to the implant. The materials used are Pure Titanium Grade 4 (ASTMF67-06) and Titanium Alloy (ASTM F 136).

The provided text is a 510(k) Summary for the "IH Implant System." It describes the device and its claimed substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for device performance or a study proving it meets those criteria, nor does it include details like sample sizes for test sets, data provenance, ground truth establishment, or multi-reader multi-case study results.

This document focuses on demonstrating that the new IH Implant System is safe and effective as existing legally marketed dental implant systems. The "Substantial Equivalence Review" section details how various components of the IH Implant System are similar to previously cleared devices.

The "Summary of non-clinical testing" section lists various types of tests performed to support substantial equivalence, such as:

• Endotoxin testing (USP <85> and <161>)
• Biological Evaluation (ISO 10993-1, Cytotoxicity Testing ISO 10993-5)
• Fatigue Testing (ISO 14801:2016)
• Gamma sterilization validation (ISO 11137-1 and ISO 11137-2)
• End User Sterilization Validation (ANSI/AAMI ST79, ISO 17665-2, ISO 11737-1, ISO 11737-2, ISO 11138-1 and ISO 11138-3)
• Shelf Life Test (ASTM F1140, ASTM F1929, ASTM F2096, ASTM F1980 and ISO 11607)
• Worst-case MRI review

However, it does not provide the specific acceptance criteria for these tests, nor does it report the quantitative results or performance metrics that would typically be described in the context of an "acceptance criteria and study" table. The document concludes that "The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate devices," implying that the device passed these tests relative to the predicate, but the specific performance data is not disclosed here.

Therefore, I cannot provide the requested table and detailed information based on the provided text. The document is a regulatory submission for substantial equivalence, not a clinical or performance study report with specific acceptance criteria and detailed device performance outcomes.

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