(259 days)
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.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Met? |
|---|---|---|
| Fatigue Strength | ISO 14801:2016 for worst-case scenario. | "Fatigue Testing according to ISO 14801:2016 was performed on the subject device under the worst-case scenario and its result is strong enough to achieve their intended use." (Implies criteria met) |
| Sterilization Validation | ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, ISO 11138-1 (End User), ISO 11137-1 and ISO 11137-2 (Provided Sterile) | End User Sterilization Validation Test Report provided. Tests for devices provided sterile (Fixtures) were leveraged from predicate K152520, indicating they meet the standards. |
| LAL Information/Testing | USP | Leveraged from predicate K162099, indicating compliance. |
| Shelf Life Testing | ASTM F1980 on Healing Abutments | Leveraged from predicate K152520, indicating compliance. |
| Biocompatibility | ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010, ISO 10993-11:2006 (Fixtures) and ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 (Abutments) | Biocompatibility testing was leveraged from predicates K140806, K152520, K162099 (fixtures) and K152520, K173120 (abutments), indicating compliance with the standards for the respective components. |
| Material Composition | Ti-6Al-4V Eli (Conforming to ASTM Standard F-136) for fixtures and abutments. | Stated as the material for both subject and predicate devices, demonstrating equivalence. |
| Dimensional Tolerance | Within ± 1% range for Fixtures and Abutments. | Not explicitly stated as "met" in a test report summary, but the discussions of "differences" being within acceptable limits for substantial equivalence implies this. "The differences ... doesn't affect device's fundamental functions and safety." |
| Intended Use | To replace missing teeth to restore chewing function, for single/multiple-unit restorations, cement | "The Magicore II System has same device characteristics with the Primary predicate devices, Magicore system (K152520) such as... intended use..." and all comparative tables confirm identical or highly similar stated intended uses. |
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.
§ 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.