(368 days)
JDentalCare® implant system is intended for surgical placement in the upper or lower jaw. JDentalCare® implant system is comprised of dental implant fixtures and prosthetic devices. JDentalCare® implant system provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
JDentalCare®implant system is composed by a fixture and an abutment, joined together by a through screw (JDEvolution). In this case the connection is done through an internal hexagon. Abutments and accessories are exclusive for JDentalCare®implant system. JDentalCare®implants are threaded, root-form dental implants, intended to provide a mean for prosthetic attachment in the rehabilitation of partial or total edentulism, in single tooth restorations or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. JDentalCare®implants are machined from grade 4 or grade 5 titanium and tapered. Their surface is treated with a double acid etched treatment. JDentalCare®implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.
This document is a 510(k) Summary for the JDentalCare® Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the way a clinical trial for an AI/CAD system would. Therefore, much of the requested information (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not directly applicable or available from this document.
However, I can extract the acceptance criteria as described for the device's characteristics and the "study" (which are performance tests and validation activities) demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Since this document is a 510(k) summary for a dental implant system (a physical medical device, not an AI/CAD software), the "acceptance criteria" are related to its physical, material, and functional properties being equivalent to legally marketed predicate devices, and demonstrating safety and effectiveness through various tests.
| Acceptance Criteria (Demonstrated Equivalence / Performance) | Reported Device Performance (JDentalCare® Implant System) |
|---|---|
| Intended Use Equivalence | Intended use is substantially equivalent to predicate devices for surgical placement in the upper or lower jaw, prosthetic attachment in single tooth restorations, partially or fully edentulous spans (delayed/immediate loading), and as an abutment for bridgework or overdentures. Immediate function for single/multiple tooth applications with good primary stability and appropriate occlusal loading. |
| Material Composition | Machined from Grade 4 or Grade 5 Titanium (for Ø 3.25mm) for implants; abutments are Titanium (Gr.5). This is equivalent to or the same as predicate devices (e.g., Nobel Active uses Titanium Grade 4, Implant Direct Legacy uses Titanium alloy (Ti6AL-4V ELI) (Grade 5)). |
| Design and Mechanical Features (Shape, Thread, Connection) | Two pieces, tapered screw, internal hexagon with double trapezoidal thread. This is consistent with predicate devices. |
| Dimensions (Diameter, Length) | Implants available in diameters: 3.25, 3.7, 4.3, 5, 6 mm and lengths: 8, 10, 11.5, 13, 15 mm. These dimensions fall within the range or are comparable to the dimensions offered by predicate devices. Abutment heights also consistent with predicate devices. |
| Surface Treatment | Double acid etched treatment (fluoride acid etching, then strong acids sulfuric + hydrochloric acid), followed by cool plasma cleaning. Surface validation tests (SEM, XPS) confirm complete removal of manufacturing materials. |
| Biocompatibility (ISO 10993-1:2010 Part 1) | Tested for Cytotoxicity, Intracutaneous reactivity, Delayed Hypersensitivity, Systemic Toxicity, Bacterial Reverse Mutation. Results: Not Cytotoxic, Satisfying requirements for intracutaneous reactivity, Not sensitizing, Satisfying requirements for systemic toxicity, Not Mutagenic. |
| Mechanical Performance (ISO 14801:2007) | Dynamic fatigue tests performed in compliance with "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "ISO 14801: 2007 - Dynamic fatigue test for endosseous dental implants". The document states tests were performed in compliance, but specific quantitative acceptance criteria or results are not listed in this summary. The implication is that they meet acceptable engineering standards. |
| Sterilization & Packaging Shelf Life (ISO 11137-1, ASTM 1980) | Sterilized with gamma ray sterilization to assure a SAL level of 10⁻⁶. Shelf life is 5 years. Packaging and shelf life were tested and validated according to applicable international standards. The packaging type (plastic vial + blister) and method of sterilization (Gamma Radiation) are consistent with predicate devices. Abutments are noted as not sterile, consistent with one predicate, while another predicate's abutments are sterile. This difference is considered in the context of substantial equivalence. |
| Packaging | Plastic vial + blister, sterile. Consistent with predicate devices. |
2. Sample Size for Test Set and Data Provenance
This document does not describe a clinical study in the format of an AI/CAD device. Instead, "tests" refer to laboratory-based performance testing of the physical implant device and its materials. Therefore, there are no "test sets" of patient data in the conventional sense.
- Sample Size for Test Set: Not applicable. Tests involve physical samples of the implant devices and materials. The number of samples for each mechanical or biocompatibility test is not specified in this summary but would be standard for such device testing.
- Data Provenance: Not applicable for patient data. The tests are laboratory-based, performed on manufactured devices.
3. Number of Experts and their Qualifications for Ground Truth
Not applicable. Ground truth for a physical medical device like a dental implant is established through validated laboratory tests against engineering standards and material specifications, not through expert clinical consensus on patient data.
4. Adjudication Method
Not applicable. No clinical expert adjudication is mentioned or relevant for the types of tests described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical dental implant, not an AI/CAD system, so an MRMC study is not relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical dental implant, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device, which refers to its performance and safety, is established through:
- Compliance with international standards (e.g., ISO 10993-1 for biocompatibility, ISO 14801 for mechanical fatigue).
- Material specifications (e.g., ASTM F67 for Titanium Grade 4, ASTM F136 for Titanium-6Aluminum-4Vanadium ELI Alloy).
- Laboratory test results (e.g., cytotoxicity, fatigue strength, surface analysis).
- Comparison to predicate devices with an established history of safe and effective use.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/CAD system that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.