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The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient s chewing function

The Luna Dental Implant System is a device of pure titanium(ASTM F67) and titanium alloy(ASTM F136) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw. The fixture's surface is S.L.A(Sand-Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System fixture and healing abutment are supplied with gamma sterilization.

Fixtures consisted of mount type and mount free type. Abutments consisted of simple abutment, hex and non-hex duo abutment, hex and non-hex angled abutment (15° & 25°), hex and non-hex contour abutment, hex and non-hex temporary abutment screw abutment with titanium cylinder, ball abutment with socket assembly, healing abutment, screw abutment screw, and abutment screw. Fixture dimension is 3.7mm x 8.5-15mm and 4.2mm - 5.7mm x 7.0mm - 15mm and Abutment diameter is 4.0mm ~ 6.0mm

The Luna Dental Implant System, an endosseous dental implant, established substantial equivalence by comparing its performance to predicate devices (Dentium Implantium K041368 and Implantium Prosthetics K052957). The device, made of pure titanium and titanium alloy, is designed for surgical placement in the jaw to support prosthetic devices and restore chewing function.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance testing conducted to demonstrate compliance with ISO standards and confirm performance characteristics. The specific quantitative acceptance criteria or thresholds for these tests are not explicitly stated. Instead, the document generally asserts that the device met the established specifications necessary for consistent performance.

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

The document does not specify the sample sizes used for any of the performance tests (biocompatibility or mechanical/physical). It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective). However, the submission is from a South Korean company (SHINHUNG MST Co., Ltd in the Republic of Korea), suggesting that the testing and data likely originated in South Korea. The nature of the tests (bench testing and biocompatibility) suggests they are laboratory-based and controlled studies, rather than clinical trials with human subjects.

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

This section is not applicable to the provided document. The performance tests described (biocompatibility, mechanical bench testing) do not involve expert interpretation or subjective assessment of a test set in a clinical context to establish 'ground truth' in the way a diagnostic AI device would. The "ground truth" for these tests would be objective measurements against established engineering and biological standards.

4. Adjudication Method for the Test Set:

This section is not applicable as the testing described does not involve methods requiring expert adjudication for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The Luna Dental Implant System is a physical medical device, not a diagnostic AI tool, so this type of study is not relevant.

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

This section is not applicable. The Luna Dental Implant System is a physical dental implant, not an algorithm or AI system. Its performance is evaluated through bench testing and biocompatibility assessments, not through algorithmic performance.

7. The Type of Ground Truth Used:

The ground truth for the Luna Dental Implant System's performance testing is based on:

• Established ISO Standards: For biocompatibility (ISO 7405) and presumably for mechanical/physical properties, the 'ground truth' refers to compliance with the specific criteria and methodologies outlined in these international standards.
• Material Specifications: The chemical composition and physical properties of titanium and titanium alloy (ASTM F67 and ASTM F136) are known and serve as a baseline for material quality.
• Engineering Specifications: For mechanical tests, the 'ground truth' is determined by meeting predefined engineering specifications for strength, fatigue, torque, accuracy, etc., which are derived from industry standards and clinical requirements for dental implants.

8. The Sample Size for the Training Set:

This section is not applicable. The Luna Dental Implant System is a physical device being evaluated through performance testing, not a machine learning model that requires a training set.

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

This section is not applicable as there is no training set for a physical medical device like the Luna Dental Implant System.

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