(105 days)
The NB Mini Implant System is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The NB Mini Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The NB Mini Implant System consist of below: Fixture - NB Fixture Mini Abutment - Cover Screw - . Healing Abutment - Scan Healing Abutment - Scan Healing Abutment Screw - Cemented Abutment Mini - . Angled Abutment Mini - Abutment Screw The NB Fixture Mini is made of Ti-6AI-4V Eli (Conforming to ASTM F136) which will be placed in the alveolar bone to replace the function of the missing tooth. The NB Mini Implant System consists of dental implants, abutments 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 fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).
This document is a 510(k) summary for the NB Mini Implant System by Arum Dentistry Co., Ltd. It declares that the device is substantially equivalent to existing predicate devices. Consequently, it does not contain a typical acceptance criteria table with reported device performance as would be found in a study demonstrating novel device performance. Instead, it provides a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, here’s an analysis of the "acceptance criteria" and "study" information:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, this document is a 510(k) summary for substantial equivalence, not a standalone performance study with explicit acceptance criteria. The "acceptance criteria" in this context are implicitly that the subject device's performance is substantially equivalent to legally marketed predicate devices. The "reported device performance" is presented through direct comparison of features and results of non-clinical benchtop tests against these predicate devices.
The table below summarizes the comparative information provided for the NB Fixture Mini (one component of the NB Mini Implant System) against its primary predicate and a reference device. Similar comparative summaries are provided for other components (Cover Screw, Healing Abutment, Scan Healing Abutment, Cemented Abutment Mini, Angled Abutment Mini, and Abutment Screw), all concluding substantial equivalence.
| Feature | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance (Subject Device: NB Fixture Mini) | Primary Predicate (IS-III active System, K190849) | Reference Device (Magicore Narrow System, K220079) |
|---|---|---|---|---|
| Intended Use/ | ||||
| Indications for use | Must be same or highly similar | Same as predicate | Mandibular/maxillary incisor regions of partially edentulous jaws for prosthetic support; immediate loading. | Mandibular central/lateral incisors and maxillary lateral incisors; immediate loading. |
| Material | Ti-6Al-4V Eli (ASTM F136) | Ti-6Al-4V Eli (ASTM F136) | Ti-6Al-4V Eli (ASTM F136) | Ti-6Al-4V Eli (ASTM F136) |
| Anti-Rotational Feature | Internal Hex | Internal Hex | Internal Hex | Internal Hex |
| Range of Diameters (Ø) | Comparable range | 3.2, 3.5 | 3.2 | 3.0, 3.5 |
| Range of Lengths (mm) | Comparable range | 8.5, 10, 11.5, 13.0, 15.0 | 8.5, 10, 11.5, 13.0, 15.0 | 11.0, 13.0, 15.0 |
| Surface treatment | SLA or similar proven safe/effective | SLA | SLA | RBM & SLA |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf-life | 5 Years or comparable | 5 Years | 5 Years | 8 Years |
| Principle of Operation | Root-type fixture, replaces functions of missing teeth | Root-type fixture, replaces functions of missing teeth | Root-type fixture, replaces functions of missing teeth | Root-type fixture, replaces functions of missing teeth |
| Dynamic fatigue testing | Performance substantially equivalent to predicate | Found to be substantially equivalent | (Performed on predicate) | (Performed on reference) |
| Bone to Implant Contact (BIC) analysis | Comparable BIC value to predicate | BIC value compared and confirmed substantial equivalence | (Measured for predicate) | (Not specified for reference here) |
| Surface area analysis | Comparable surface area to predicate | Surface area compared and confirmed substantial equivalence | (Measured for predicate) | (Not specified for reference here) |
| Pullout test | Comparable pullout force value to predicate | Pullout force value compared and confirmed substantial equivalence | (Measured for predicate) | (Not specified for reference here) |
2. Sample size used for the test set and the data provenance
The document refers to a variety of non-clinical testing data for various components of the NB Mini Implant System:
- Mechanical performance testing (Fatigue test): "For each compatible implant line, worst-case constructs were subjected to static compression and compression fatigue testing." No specific numerical sample size is provided.
- Bone to Implant Contact (BIC) analysis: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
- Surface area analysis: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
- Pullout test: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
- Biocompatibility: Demonstrated by reference to ARUM DENTISTRY submission K213506.
- Sterilization validation: Performed according to ISO 11137-1 and ISO 11137-2 (method VDmax25 for 25 kGy dose, referenced from K213506), End User Moist Heat Sterilization Test (ANSI/AAMI ST79, ISO 17665-1, -2, ISO 11737-1, -2 and ISO 11138-1, referenced from K213506), and LAL endotoxin testing (AAMI / ANSI ST72:2011/(R)2016).
- Shelf-Life: Accelerated aging method in accordance with ASTM F1980.
The data provenance is not explicitly stated as country of origin, retrospective or prospective, but all tests are non-clinical, meaning they were performed in a lab setting, likely by the manufacturer or a contract lab. The referenced 510(k) submissions (K213506, K190849, K220079, etc.) indicate these are devices marketed in the US, but the company (Arum Dentistry Co., Ltd.) is from the Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the studies described are non-clinical benchtop tests, not clinical studies involving expert interpretation of patient data to establish ground truth.
4. Adjudication method for the test set
This section is not applicable as the studies described are non-clinical benchtop tests, not clinical studies requiring adjudication of human reader interpretations.
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
This section is not applicable. The device is an endosseous dental implant system, not an AI or software-based diagnostic tool that would typically be evaluated with MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable as the device is a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used
For the non-clinical performance tests:
- Mechanical fatigue: The "ground truth" or reference for evaluating performance is the established mechanical properties and fatigue resistance standards (e.g., ISO 14801), and the performance of the predicate devices.
- Biocompatibility: Demonstrated via material testing and reference to previous submissions, ensuring the material meets established safety standards for biological interaction.
- Sterilization: Ground truth is defined by sterility assurance levels (e.g., SAL of 10^-6) and adherence to recognized standards (ISO 11137, ANSI/AAMI ST79).
- Shelf-Life: Ground truth is established by test methods (ASTM F1980) that predict long-term stability and integrity.
- BIC, Surface Area, Pullout: These are physical measurements compared against predicate device performance, implying the predicate's performance serves as the reference for "substantially equivalent" ground truth.
8. The sample size for the training set
This section is not applicable as the device is a physical medical implant, not an AI or software system that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable as the device is a physical medical implant, not an AI or software system that requires a training set and corresponding ground truth.
§ 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.