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The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The Magicore II System consists of dental implants, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore II implant is treated with SLA (sand-blasted, large-grit, acid-etched). The Fixture diameters are 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm and threaded lengths are 7, 8, 9, 10, 11, 12, 13mm in this system. The contained various abutments and screws in the system are Short Abutment, Magic Multi Abutment, Magic Multi Cylinder, Magic Multi Abutment ST, Abutment Screw, Healing Cap, Magicore Angled Abutment.

This document is a 510(k) summary for the Magicore II System, an endosseous dental implant system. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone clinical study on device performance. Therefore, many of the requested details regarding clinical study design, expert adjudication, MRMC studies, and ground truth establishment are not present in this document, as they are not typically required for a 510(k) submission for this type of device.

The acceptance criteria provided here are primarily based on non-clinical performance testing (fatigue testing) and comparison to predicate devices in terms of material, design, indications for use, and manufacturing processes, rather than a clinical trial demonstrating specific performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are aligned with demonstrating substantial equivalence to its predicate devices through non-clinical testing and comparison of characteristics. The primary performance metric mentioned is fatigue strength.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: This document does not describe a clinical "test set" in the sense of patient data. The "test set" here refers to the physical devices undergoing non-clinical laboratory testing. The sample sizes for these specific non-clinical tests (e.g., how many implants were used for fatigue testing) are not specified in this summary document.
• Data Provenance: The data provenance is primarily from non-clinical laboratory testing (e.g., fatigue, sterilization, biocompatibility tests). Some test results are "leveraged" from previous 510(k) clearances (K152520, K162099, K140806, K173120), implying the data originated from other studies performed by the manufacturer or their affiliates. The country of origin for the data is implicitly where the manufacturer (InnoBioSurg Co., Ltd. - Republic of Korea) and referenced test labs are located. The data is retrospective in the sense that results from previously cleared devices are referenced.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. This submission relies on non-clinical engineering and materials testing standards (e.g., ISO, ASTM, USP) rather than a test set requiring expert clinical ground truth establishment.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not applicable. As there is no clinical test set requiring subjective interpretation by experts, no adjudication method is mentioned or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs. Without AI Assistance

• Not applicable. This device is a dental implant system, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Ground Truth Type: For the non-clinical tests, the "ground truth" is defined by established international and national standards (e.g., ISO 14801 for fatigue limits, ISO 10993 for biocompatibility thresholds). The device's performance is compared against these engineering and material science standards.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that would require training data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, no training set for an algorithm is involved.

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