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The Kerator fixture is intended for use in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations. The Kerator abutments are intended use with overdentures or partial dentures. Kerator AO type is compatible with Kerator fixture and the following types are compatible with the fixtures made by other manufacturers as indicated below.

The Kerator is a dental implant system 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. There are one fixture model and three abutment models in the Kerator. Among three abutment model is compatible with the Kerator fixture, and the other two abutment models are compatible with the fixtures made by other manufacturers. The implant 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 fixture has been treated with R.B.M (Resorbable Blast Media) and the head part of the abutment has TiN coating over it. The Kerator abutment is placed into the dental implant to provide support for a prosthetic restoration.

The Kerator system is a dental implant system. The provided text describes the device and its equivalence to predicate devices, but it does not contain any information about a study with acceptance criteria and reported device performance in relation to AI or any advanced analytical methods.

Therefore, I cannot provide the requested information in the format of the table or other points, as the document focuses on regulatory approval based on substantial equivalence to existing devices, primarily through material and design comparisons and standard non-clinical testing (sterilization, shelf life, chemical analysis). It does not involve AI or algorithms, nor does it present clinical performance data against specific acceptance criteria in the manner described in your prompt.

The document indicates "Non-Clinical Testing" for sterilization, shelf life, and chemical/SEM analysis, which are standard safety and manufacturing validations, not performance against clinical or analytical acceptance criteria.

If the prompt were referring to a different type of device or study that typically involves such criteria, the answer would differ. However, based solely on the provided text, there is no such study or acceptance criteria information to extract.

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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.

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.

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