(80 days)
The EZ Plus Implant Systems are intended to be surgically placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. Large angle abutments (e.g. 25°) on small diameter implants of the EZ Plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strength of the implant.
The EZ Plus Implant system consists of machined titanium, screw-form, root-form endosseous dental implant. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained restoration for multi-mount options. Fixtures, the prosthetics, and the surgical instruments are produced and packaged separately. All included devices in the system are covered by this submission.
This submission describes the EZ Plus Implant System, an endosseous dental implant. The document is a 510(k) summary for premarket notification, indicating a pathway for market clearance based on substantial equivalence to a predicate device, rather than a de novo approval requiring extensive clinical efficacy studies with predefined acceptance criteria.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this type of regulatory submission.
The 510(k) submission primarily focuses on demonstrating that the new device (EZ Plus Implant System) is as safe and effective as a legally marketed predicate device (EXFEEL IMPLANT SYSTEM). This is typically achieved through comparative data on design, materials, sterilization, indications for use, and mechanical testing, rather than clinical performance metrics relative to predefined acceptance criteria in the context of device performance.
Here's the relevant information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The submission does not define specific clinical acceptance criteria for performance metrics (e.g., success rates, failure rates) for the EZ Plus Implant System. Its clearance is based on substantial equivalence to a predicate device.
Instead, the submission includes a comparative table to demonstrate equivalence:
| Content | Subject Device (EZ Plus Implant System) | Predicate Device (ExFeel Implant System) |
|---|---|---|
| 510(K) Number | Not available yet | K052369 |
| Characteristic | EZ Plus Implant System | ExFeel Implant System |
| Manufacturer | MegaGen Co., Ltd. | MegaGen Co., Ltd. |
| Indications for Use | Mandible and Maxilla Endosseous Dental Implant & Accessories | Mandible and Maxilla Endosseous Dental Implant & Accessories |
| Design: | Internal and External Hex | Internal and External Hex |
| Endosseous Implant Material | Commercial pure titanium | Commercial pure titanium |
| Implant Sterile | Yes | Yes |
| Sterilization Method | Gamma | Gamma |
| Implant Diameters | - Internal Type Implant: 3.3, 4.0, 5.0mm |
- External Type Implant: 3.3, 4.0, 5.0mm | 3.5, 4.1, 4.8mm (Internal)
3.30, 3.75, 4.0, 5.0mm (External) |
| Implant Lengths | - Internal Type Implant: 8.0, 10.0, 11.0, 13.0, 15.0, 18.0mm - External Type Implant: 8.0, 10.0, 11.0, 13.0, 15.0, 18.0mm | - Internal Type Implant: 7.0, 8.5, 10.0, 11.5, 13.0mm
- External Type Implant: 8.5, 10.0, 11.5, 13.0, 15.0, 18.0mm |
| Attachments | Various abutments and components | Various abutments and components |
| Product Code | DZE | DZE |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a 510(k) submission, not a clinical trial report with a defined test set of patient data for performance evaluation. The "test" mentioned refers to laboratory testing for functionality and conformance to design requirements, not clinical data.
The document states, "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." No details regarding the sample size or provenance of data from this laboratory testing are provided in the summary.
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. Ground truth for clinical performance is not established or discussed in this 510(k) summary as it is not a clinical efficacy study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 device is a physical dental implant, not an AI or imaging diagnostic tool.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. Ground truth in the context of clinical outcomes or diagnostic accuracy is not established or discussed. The "ground truth" here would be adherence to engineering specifications and performance in mechanical tests.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" in the context of this device's regulatory submission.
9. How the ground truth for the training set was established:
Not applicable.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)