(107 days)
The NB Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. NB Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
An endosseous dental implant is a device made of a material such as Pure titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. The NB Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is 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). The Scan Healing Abutments are designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined marking for identification when taking an abutment level impression or an intraoral scan/digital impression. Identification information is captured in the intraoral scan or model scan.
Here's a breakdown of the acceptance criteria and study information for the NB Implant System, based on the provided text. It's important to note that this document is a 510(k) summary for a dental implant system, which primarily relies on substantial equivalence to predicate devices and existing testing, rather than a de novo AI/software device that would have explicit AI performance acceptance criteria.
Therefore, the "acceptance criteria" here are related to demonstrating substantial equivalence for a medical device (dental implant), focusing on material safety, sterilization, and mechanical characteristics, rather than specific performance metrics for an AI algorithm. The study described is primarily non-clinical testing to support this equivalence.
Device Name: NB Implant System
Regulation Number: 21 CFR 872.3640 (Endosseous Dental Implant)
Product Code: DZE, NHA
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a physical dental implant system, the "acceptance criteria" are focused on demonstrating a device that is as safe and effective as a legally marketed predicate. Performance is demonstrated through non-clinical testing and comparison to predicates.
| Acceptance Criteria Category | Specific Criteria (from text, implied or explicit) | Reported Device Performance / Justification |
|---|---|---|
| Biocompatibility | TI CP4 (ASTM F67) and Ti-6Al-4V Eli (ASTM F136) materials are biocompatible. | Demonstrated by reference to previous ARUM DENTISTRY submission (K213506) using the same materials and manufacturing processes. |
| Sterilization Efficacy | Achieve sterility assurance level (SAL) of 10⁻⁶ for gamma-sterilized components (fixtures). | Sterilization validating testing performed according to ISO 11137-1 and ISO 11137-2, substantiating a 25 kGy dose using method VDmax25 (referenced from K213506). |
| Endotoxin Content | Acceptable levels of Bacterial Endotoxin Units (EU) for sterile components. | LAL endotoxin testing performed according to AAMI / ANSI ST72:2011/(R)2016 (referenced from K213506). |
| End-User Sterilization (Abutments) | Non-sterile abutments can be effectively sterilized by end-users. | End User Sterilization Validation Test Report on Abutments according to ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1 (referenced in K21350). |
| Shelf-Life | Device maintains safety and effectiveness for its proposed shelf-life. | Accelerated aging method in accordance with ASTM F1980 used; test results validated 5 years Shelf-Life. |
| Mechanical Equivalence (Fixture Design) | New external thread design does not negatively impact safety/effectiveness compared to predicate, despite dimensional difference (longer cutting-edge). | Stated that "this function of the cutting-edge is self-tapping by creating a screw path. Therefore, this difference doesn't impact substantial equivalence." Implies mechanical testing or analysis showed no worse performance, but specific data not provided in summary. "No need to perform any non-clinical testing for the subject device since the subject device and predicate device are substantially equivalent in indications, fundamental technology, material and design." However, it then states: "Although the dimensions are slightly different, it doesn't impact product's safety and effectiveness because the predicate device is the worst case based on the product's dimensional comparison analysis provided." This suggests a comparative analysis was done to deem the predicate the "worst case" for certain mechanical properties. |
| Mechanical Equivalence (Abutment Dimensions) | Slightly different abutment dimensions (cuff ranges) do not affect safety/effectiveness. | Stated that "this dimensional difference doesn't affect device safety and effectiveness. To support cuffs, K182448 were added." (This implies the range expansion is covered by reference to another device). |
| MRI Safety | Devices are safe for use in an MRI environment. | Non-Clinical worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque per FDA guidance (e.g., Terry O. Woods et al., 2019 publication). |
| Functional Equivalence | NB Implant System Fixture (new thread) and Scan Healing Abutment (new scanning feature) function comparably to predicate devices for their intended use. | Fixture design is "substantially equivalent... such as diameters, length, intended use, material, functions, general shape (Design), structure and applied production method" to primary predicate (K213506). Scan Healing Abutment has "same indication for use, principle of operation, functions, diameter and material to the predicate K213506," and its scanning feature is "equivalent to the reference predicate K173374." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the non-clinical tests (biocompatibility, sterilization, shelf-life, MRI). It refers to the tests being performed "in accordance with" relevant ISO and ASTM standards, which would dictate minimum sample sizes for each specific test type.
- Data Provenance: All data referenced appears to be from non-clinical (laboratory/bench) testing. The document heavily relies on previously submitted data (K213506, K173374, K182448) from ARUM DENTISTRY Co., Ltd. and other manufacturers. The company's address is in Daejeon, Republic of Korea, suggesting the testing was likely conducted in Korea or by contract labs following international standards. The data is retrospective in the sense that it relies on previously generated and accepted data for predicate devices and earlier versions/components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a submission for a physical medical device (dental implant), not an AI/software device that requires expert-established ground truth for a test set of images or clinical data. The ground truth for device safety and performance relies on physical measurements, material properties, and established laboratory testing protocols (e.g., ISO, ASTM standards).
4. Adjudication Method for the Test Set
Not applicable. No human adjudication of results is described, as the studies are non-clinical tests (e.g., sterilization reports, material testing).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation or diagnostic devices, not for physical dental implants.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental implant system, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness is established through:
- Standardized Non-Clinical Testing: Adherence to established international standards (ISO, ASTM) for biocompatibility, sterilization, shelf-life, and material properties.
- Predicate Device Data: The safety and effectiveness of previously cleared, substantially equivalent predicate devices.
- Scientific Rationale/Literature: For MRI safety, peer-reviewed literature and scientific rationale are cited.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See #8)
§ 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.