(484 days)
The J2A SLA 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, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.
The J2A SLA Dental Implant System is internal hexagon type dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with SLA (sandblasted, Large- grit, Acid-etched).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SEM surface analysis | Not explicitly stated, but implies meeting surface characteristics for SLA treated implants | Conducted |
| EDS Surface chemistry analysis | Not explicitly stated, but implies meeting chemical composition for SLA treated implants | Conducted |
| Cytotoxicity test (ISO 10993-5) | Non-cytotoxic | Conducted (implies non-cytotoxic) |
| Skin sensitization test (ISO 10993-10) | Non-sensitizing | Conducted (implies non-sensitizing) |
| Intracutaneous reactivity test (ISO 10993-10) | Non-reactive | Conducted (implies non-reactive) |
| Sterilization validation test (ISO 11137-1 & -2) | Sterilized according to standards | Conducted (implies meeting sterilization standards) |
| Shelf life validation test: visual inspection | Pass visual inspection (no degradation) | Conducted (implies pass visual inspection) |
| Shelf life validation test: label | Maintain label integrity | Conducted (implies label integrity maintained) |
| Shelf life validation test: seal inspections (ASTM F88) | Maintain seal integrity | Conducted (implies seal integrity maintained) |
| Shelf life validation test: dye penetration (ISO 11607-1 & -2) | No dye penetration, maintaining sterile barrier integrity | Conducted (implies no dye penetration) |
| Shelf life validation test: microbial challenge (ISO 11737-2) | Maintain sterility | Conducted (implies sterility maintained) |
| Endotoxin testing (USP ) | Below 0.5 EU/mL | Conducted (referenced USP 39 for the 0.5 EU/mL limit) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes for each non-clinical test conducted (e.g., number of implants tested for SEM, cytotoxicity, etc.). The study is a retrospective comparison to a predicate device (J2A Dental Implant System, J2C Dental Implant System, K150060) and aims to demonstrate substantial equivalence to this already marketed device. The data provenance would be from internal testing conducted by KJ Meditech Co., Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not describe an expert-based ground truth establishment for the non-clinical tests. These tests (e.g., SEM analysis, cytotoxicity, sterilization validation) inherently have objective, measurable endpoints determined by established scientific methods and standards, rather than expert interpretation of images or clinical outcomes.
4. Adjudication method for the test set
Not applicable, as the tests are objective and do not involve human interpretation or adjudication for ground truth.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device (dental implant). This submission focuses on the safety and performance of the physical implant itself, not on an AI-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not performed, nor is it applicable. This device is a physical dental implant, not a software algorithm.
7. The type of ground truth used
The ground truth for the non-clinical tests is established by objective measurements and adherence to international standards (e.g., ISO, ASTM, USP). For instance:
- Pathology/Histology (indirectly): Cytotoxicity and intracutaneous reactivity tests assess biological responses at a cellular and tissue level, often involving microscopic examination by trained professionals, but the 'truth' is defined by the biological reaction severity against established criteria.
- Physical/Chemical Standards: SEM, EDS, and physical integrity tests (seal, dye penetration) are based on direct physical and chemical measurements against defined specifications.
- Microbiological Standards: Sterilization and microbial challenge tests are based on established microbiological methods to confirm the absence or reduction of microorganisms.
- Analytical Standards: Endotoxin testing follows a defined analytical method to quantify endotoxin levels against a specified limit.
8. The sample size for the training set
Not applicable. This submission is for a physical medical device (dental implant), not a machine learning or AI-based system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As a physical medical device, there is no "training set" or need to establish ground truth in the context of machine learning.
§ 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.