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

IH2 SLA Fixture is dental implant made of titanium metal intended to be 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 SLA (Sandblasted, Large grit and Acid etched) treated. IH2 SLA Fixture has a various diameters 3.7 to 5.1 mm (3.7, 4.2, 4.6 and 5.1mm) and lengths 8.5 to 15mm (8.5, 10, 11.5, 13 and 15mm).

IH Prosthetic System is device made of titanium alloy, CCM alloy and POM intended for use as an aid in prosthetic restoration. It consists of Abutments (Healing Abutment, Solid Abutment, Cement Abutment, Angled Abutment, Temporary Abutment, Multi-unit Abutment and FreeMilling Abutment), Solid Protect Cap, Abutment Screws, Healing Cap, Cylinders (CCM Cylinder, Temporary Cylinder, Plastic Cylinder) and Cylinder Screws. Its surfaces are partially TiN coated or uncoated. IH Prosthetic System is supplied non-sterile and should be sterilized before use. It has a various diameters, gingival heights, heights and angles.

The provided text describes information for a 510(k) premarket notification for the "IH Implant System" by Sewon Medix Inc. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with reported performance metrics.

Therefore, many of the requested elements for a study proving device acceptance against specific criteria are not explicitly present in the provided text. The document details bench testing, specifically fatigue testing and biocompatibility, to show equivalence.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this 510(k) pertains to demonstrating that the new device is as safe and effective as a legally marketed predicate device. For the non-clinical testing performed, the acceptance criteria are generally "in compliance with" or "similar to" established standards and predicate device characteristics, rather than specific performance thresholds.

Table 1: Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence)

Study Details (as far as available in the text)

1. Sample size used for the test set and the data provenance:

   • The document does not specify a "test set" in the context of a clinical study or human performance evaluation.
   • For biocompatibility and fatigue testing, the sample sizes are not explicitly stated. These are typically bench tests performed on a representative number of devices.
   • Data provenance: For Fatigue Testing, it was "conducted according to... ISO 14801:2007 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario." For Biocompatibility, it states "Testing including biocompatibility has been performed to demonstrate that the devices comply with the applicable international and US regulations." The text does not provide country of origin or whether it was retrospective/prospective data, as these are non-clinical lab tests.

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

   • Not applicable. This document describes non-clinical bench testing for substantial equivalence, not a study requiring human expert ground truth.

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

   • Not applicable. This is not a study requiring adjudication of expert interpretations.

4. 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:

   • Not applicable. This is not an AI-assisted device or an MRMC study.

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

   • Not applicable. This is a physical dental implant system, not an algorithm.

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

   • Not applicable in the sense of clinical ground truth. For non-clinical tests (biocompatibility, fatigue, surface roughness), the "ground truth" or reference is established by international standards (e.g., ISO 14801, ASTM F67-06), regulatory guidance, and the characteristics of the legally marketed predicate devices.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" as it is a physical medical device, not an AI/machine learning product.

8. How the ground truth for the training set was established:

   • Not applicable for the same reason mentioned above.

In summary: The provided 510(k) focuses on demonstrating substantial equivalence of a physical dental implant system through non-clinical laboratory testing. It does not present a clinical study with human subjects, associated acceptance criteria as performance metrics, or the human-involved "ground truth" and reader performance details common in studies for diagnostic devices or AI algorithms. The "acceptance criteria" here refer to meeting established safety and performance standards via bench testing to show similarity to predicate devices.

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