(465 days)
The Fit & Brilliant Dental 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. The Fit &Brilliant Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
This medical product is for dental implant that is a surgical component that interfaces with the bone of the jaw to support a dental prosthesis such as a crown, bridge, denture. It is inserted in the jaw to support and maintain the prosthodontic restorative tooth or denture when the tooth is partially or totally lost. It is made of titanium material (ASTM F136 Ti 6Al-4V ELI) that is a widely used in the market. The surface of the produce is treated with powder for CaP, and it is designed to connect with the superstructure that abutment by internal fastening method. This is disposable product sterilized by gamma sterilization method and it prevents re-sterilization or reuse.
The provided document is a 510(k) summary for the "Fit & Brilliant Dental Implant System". This document focuses on demonstrating substantial equivalence to a predicate device (U fit Dental Implant System K132956) based on technological characteristics and performance testing to ensure safety and effectiveness. It is not an AI/ML device, and therefore the requested information regarding AI-specific criteria (like MRMC study, stand-alone algorithm performance, training set details, ground truth for AI) is not applicable or present in this document.
Here's the available information relevant to your request, formatted as closely as possible, and noting where information is not applicable (NA) for this type of device submission.
Acceptance Criteria and Device Performance
The acceptance criteria for this medical device are based on demonstrating substantial equivalence to a predicate device through conformity to recognized standards and comparative characteristics. The "reported device performance" refers to the results of non-clinical studies conducted according to these standards.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Standard/Test) | Reported Device Performance (Conclusion) |
|---|---|---|
| Biocompatibility | ISO 10993-5 Cytotoxicity | Met (Performed) |
| ISO 10993-10 Skin irritation, sensitization | Met (Performed) | |
| Pyrogenicity | USP 29 Biological tests Pyrogen Test | Met (Performed) |
| Endotoxin | USP BET Endotoxin Testing | Met (Performed) |
| Mechanical Strength | ISO 14801: Dynamic Fatigue Testing | Met (Performed) |
| Sterilization | ISO 11737-2: 2009, Sterilization of medical devices | Met (Performed to ensure effective gamma sterilization for the fixture and user steam sterilization for abutments and other components) |
| ISO 17665-1, ISO 17665-2, End-User Sterilization | Met (Performed to ensure effective user steam sterilization for abutments) | |
| Packaging Integrity | ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 | Met (Performed, related to accelerated aging and packaging integrity) |
| Surface Properties | Surface Assessment Evaluation | Met (Performed, ensuring similar surface treatment (RBM) to predicate device for bone integration, and powder for CaP as described in device description) |
| Material Composition | Ti-6Al-4V ELI ASTM F136 | Meets for subject device (Identical to predicate for fixture and most components, some predicate components use Ti-6Al-4V ELI Gr.23) |
| Indications for Use | Identical to predicate device | Met (Explicitly stated as "Identical to the predicate") |
| Technological Characteristics | Similar design, connection, components to predicate | Met (Comparison table shows similar design, connection (2.5 Hex. Indentation and 11° Morse taper), and various abutments and accessories) |
Note: The document states "To demonstrate substantial equivalence, the following studies have been performed on the new device (K190637) in accordance with these standards." and concludes that the "New device (K190637) is substantially equivalent to the predicate device K132956." This implies that the device met the requirements of these standards.
Additional Requested Information:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a separate "test set" in the context of an AI/ML device. For dental implant testing, samples would refer to the number of implants/components tested according to each ISO/ASTM standard. This information (specific number of units tested for fatigue, biocompatibility, etc.) is typically found in the detailed study reports, which are not included in this 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The studies are non-clinical, laboratory-based tests. The manufacturer is F&B Technology Co., Ltd. from Busan, Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This is not an AI/ML device requiring human expert ground truth for classification or diagnosis. The "ground truth" for non-clinical studies is defined by the objective pass/fail criteria of the scientific standards (ISO, ASTM, USP).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to human interpretation of data for ground truth establishment in AI/ML studies, not to objective non-clinical performance testing of a physical medical device.
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 physical dental implant device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of human-labeled data for AI/ML. For this device, the "ground truth" is established by the objective, quantifiable endpoints and criteria defined within the referenced international (ISO) and national (ASTM, USP) standards for medical device performance and safety (e.g., cytotoxicity levels, fatigue limits, sterility assurance levels).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 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.