(317 days)
The Kerator is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The Kerator is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by other manufactures.
Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and supporting studies:
Assessment of Acceptance Criteria and Study Details for Kerator
Based on the provided 510(k) summary for the "Kerator" device (K112787), the primary acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to predicate devices, rather than establishing novel safety and effectiveness through clinical trials with specific performance metrics. This is typical for Class II medical devices seeking 510(k) clearance.
The summary emphasizes design, material, function, and intended use equivalence. The key non-clinical tests performed relate to the physical characteristics and functional compatibility of the device.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for an abutment, the "acceptance criteria" are predominantly related to matching the design, materials, and functional characteristics of the predicate device, or meeting established engineering standards for such components. The performance is assessed against these equivalences.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Design and Sizing Compatibility (Geometric Equivalence) | • Reverse Engineering Analysis Conducted: Verified that Kerator has the "same sizes and the tolerance" as the predicate device and other marketed compatible fixtures. This implies the new device fits and functions mechanically like existing, cleared devices. |
| Material Composition Equivalence | • Titanium 6Al 4V ELI alloy ASTM F136: Same material as the predicate device's abutment. |
| • DuPont Zytel 101L NC-10 Nylon / Low Density Polyethylene 993: Same materials as the predicate device's male socket. | |
| Functional Equivalence (Retention Strength) | • Retention Test Carried Out: Confirmed the ability of the abutments to "resist pullout from the male cap / male housing assemblies." While no specific numerical acceptance threshold is provided in this summary, the implication is that the retention is adequate and comparable to the predicate. |
| Intended Use Equivalence | • Indicated for the "same intended uses" as predicate devices: "use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla." |
| Surface Treatment Equivalence | • TiN coating only for the head part of the abutment: Same as predicate. |
| Recommended Sterilization Method Equivalence | • Autoclave: Same as predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a number of physical units tested. The documentation mentions that a "reverse engineering analysis was conducted" and "the retention test has been carried out." These imply a limited number of samples were tested to demonstrate equivalence, but the precise count is not provided.
- Data Provenance: The studies are non-clinical, involving laboratory testing of the device itself.
- Country of Origin: The manufacturer is in South Korea (KJ Meditech Co., Ltd.), so the tests were likely conducted in South Korea or by a contracted lab.
- Retrospective or Prospective: These non-clinical tests were conducted prospectively as part of the 510(k) submission process to assess the newly manufactured Kerator devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This is a non-clinical 510(k) for an implant abutment. There is no ground truth, expert consensus, or human interpretation involved in the engineering performance tests (reverse engineering for size/tolerance, or retention strength). The "ground truth" is established by direct physical measurement and engineering principles compared against established specifications of the predicate devices.
4. Adjudication Method for the Test Set
N/A. As mentioned above, there's no human interpretation or ground truth to adjudicate. The "adjudication" is essentially the comparison of physical measurements and test results against the specifications of the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for AI-driven diagnostic or medical image analysis devices to evaluate how human performance (e.g., diagnostic accuracy) is affected by AI assistance. The Kerator is a physical dental implant abutment, not a diagnostic or AI-enabled device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is N/A. The Kerator is a physical medical device (an abutment), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
The "ground truth" in this context is the engineering specifications and demonstrated performance characteristics of the legally marketed predicate devices.
- For design and sizing, the ground truth is the established dimensions and tolerances of the predicate devices and compatible fixtures.
- For material equivalence, the ground truth is the specified ASTM standards and material compositions of the predicate devices.
- For retention performance, the ground truth is the expected or established retention ability of commercially available, similar abutment systems, against which the Kerator's performance is implicitly (or explicitly, if thresholds were defined internally) compared.
8. The Sample Size for the Training Set
N/A. This is a physical device, not an AI or machine learning model. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. There is no training set or ground truth for a training set for this type of device.
§ 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.)