(387 days)
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.
| Test Category | Specific Test | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO Cytotoxicity | (Implicit: Non-toxic) | Materials are non-toxic to biological tissues. |
| ISO Systemic toxicity | (Implicit: Non-toxic) | Materials are non-toxic to biological tissues. | |
| ISO Pyrogenicity | (Implicit: Non-pyrogenic) | Materials are non-pyrogenic. | |
| ISO Sensitization | (Implicit: Non-sensitizing) | Materials are non-sensitizing to biological tissues. | |
| ISO Intracutaneous reactivity | (Implicit: Non-reactive) | Materials are non-reactive. | |
| ISO Implantation | (Implicit: Biocompatible) | Materials are consistent with intended use. | |
| Mechanical/Physical | ISO Static compressive | (Implicit: Meets specified strength/load limits) | Confirmed performance characteristics. |
| ISO Fatigue | (Implicit: Meets specified fatigue life) | Confirmed performance characteristics. | |
| Torque Force | (Implicit: Meets specified torque requirements) | Confirmed performance characteristics. | |
| Adaptation Accuracy | (Implicit: Meets specified fit/accuracy) | Confirmed performance characteristics. | |
| Rotational shear strength | (Implicit: Meets specified shear strength) | Confirmed performance characteristics. | |
| Loosening torque | (Implicit: Meets specified loosening resistance) | Confirmed performance characteristics. |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that 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, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.