(140 days)
The MiNi Internal Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
- The intended use for the 3.0 mm diameter MiNi implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
- Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
- It is intended for delayed loading.
MiNi Internal Implant System is composed of MiNi Internal Fixtures, abutments, and surgical instruments. The dental fixtures are made of CP Ti Grade 4 designed for use in dental implant surgery. This system is used as two stage surgery, root-form dental implants, associated with abutment systems, which provide the clinician with the screw and cement retained restoration for multi-mount options. The fixtures are available in diameters of 3.0mm, 3.4mm and lengths of 8.0mm, 9.5mm, 11.0mm, 12.5mm, and 14.5mm. The fixtures, abutments, and surgical instruments are produced and packaged separately. The Surface treatment for this device is S.L.A (Sand-blasted, Large grit, Acid-etched). This system includes various abutments, such as Abutment Screw, Cover Screw, Healing Abutment, EZ Post, Angled Abutment, Milling Abutment, Solid Abutment, Temporary Abutment, Impression Coping, Plastic Impression Coping, Guide Pin, Lab Analog, and Meg-Rhein Abutment. These abutments are compatible with MiNi Internal Fixtures.
This document pertains to the 510(k) premarket notification for the "MiNi Internal Implant System" by MegaGen Implant Co., Ltd. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the device itself.
Based on the provided text, the device is an endosseous dental implant, and the 510(k) submission primarily relies on comparing its design, materials, and intended use to a legally marketed predicate device (OsseoSpeed™ Plus, K120414) and a reference predicate device (XPEED AnyRidge Internal Implant System, K140091).
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device's performance in a clinical study in the way one might expect for a standalone AI/medical device. Instead, it relies on demonstrating that the device meets existing standards and is substantially equivalent to predicate devices. The "reported device performance" is primarily in relation to meeting these standards through non-clinical testing.
| Acceptance Criteria (Implicit from testing standards) | Reported Device Performance |
|---|---|
| Sterilization: SAL (Sterility Assurance Level) of 10^-6 (per ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11737-1, ISO 11737-2 for gamma sterilization, and ISO 17665-1, ISO 17665-2 for steam sterilization) | Test results demonstrated that the SAL of 10^-6 was achieved, and all testing requirements were met for both gamma and steam sterilization. |
| Dynamic Fatigue: Meet criteria of ISO 14801:2007 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants), following FDA guidance for "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | The fatigue test was performed on the subject device. The results of the non-clinical testing demonstrate that the results have met the criteria of the standards. (Specific numerical performance metrics for fatigue strength are not provided in this summary, but the general statement indicates compliance). |
| Biocompatibility: Meet requirements for cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity, sub-chronic toxicity, genotoxicity, implantation (based on material and surface properties). | Biocompatibility tests were not conducted on the subject device. The rationale is that the subject device has the same material (CP Ti Grade 4), surface treatment (S.L.A), and manufacturing process as the reference predicate device (K140091), for which these tests were presumably previously conducted and met. |
| Surface Analysis: (to ensure consistency with predicate) | Surface analysis was not conducted on the subject device, using the same rationale as biocompatibility. |
| Residue Analysis: (to ensure consistency with predicate) | Residue analysis was not conducted on the subject device, using the same rationale as biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of a prospective study for the MiNi Internal Implant System. The testing described is non-clinical (sterilization and fatigue).
- Non-Clinical Testing: The sample sizes for the fatigue test and sterilization validation are not explicitly stated in this summary. These tests would involve a specific number of manufactured devices for destructive and non-destructive testing.
- Data Provenance: The manufacturing company, MegaGen Implant Co., Ltd., is located in Gyeongsan-si, Gyeongsangbuk-do, South Korea. The non-clinical testing would have been performed there or at associated testing facilities. This is a retrospective submission based on existing data and comparisons.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert-established ground truth on a test set (e.g., image interpretation). The evaluation is based on non-clinical engineering and material science standards and comparison to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There is no human adjudication process described, as it's not a clinical or interpretive study.
5. 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 a dental implant, not an AI or imaging diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (dental implant), not an algorithm or AI.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Sterilization: The ground truth is the established scientific and regulatory requirement for a Sterility Assurance Level (SAL) of 10^-6, as defined by ISO standards.
- Fatigue Test: The ground truth is the performance criteria outlined in the ISO 14801:2007 standard and the FDA guidance document for endosseous dental implants.
- Biocompatibility, Surface Analysis, Residue Analysis: The "ground truth" for the non-conducted tests is established by the identical material, surface treatment, and manufacturing process to the reference predicate device (K140091), implying that the prior testing of the predicate serves as the ground for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no training set for this type of device submission.
§ 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.