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ZENEX Implant System Long is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

ZENEX Implants in the 20 mm length when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

ZENEX Implant System_Long is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost.

The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching).

There are 2 types of fixtures, and the dimensions are as following:

The subject devices are compatible with the following abutments made by Izenimplant Co., Ltd.

ZENEX Implant System_Long is provided sterile, and valid for 5 years.

This document describes a 510(k) premarket notification for the ZENEX Implant System Long, an endosseous dental implant. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on non-clinical testing and comparisons to predicate devices, rather than a study proving the device meets acceptance criteria in a clinical setting.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence based primarily on non-clinical testing, there isn't a direct "acceptance criterion" table in the sense of clinical performance metrics (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are the successful completion of various non-clinical tests according to established standards, demonstrating that the new device is as safe and effective as the predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of a clinical study. For non-clinical tests:
  • Fatigue Testing: The number of implant samples subjected to fatigue testing according to ISO 14801 is not specified (e.g., "n="). The standard usually specifies minimum sample sizes.
  • For other tests (Biocompatibility, Sterilization, Shelf Life, Bacterial Endotoxin, Surface Modification), the sample sizes are not provided as these were either leveraged from the predicate device or conducted per standard protocols without explicit counts in this document.
• Data Provenance: The document generally refers to "non-clinical testing data." Specific countries of origin for the non-clinical testing are not provided. The main submitter (Izenimplant Co., Ltd.) is from the Republic of Korea. The testing itself would typically be performed by accredited labs. The studies were retrospective in the sense that data from already cleared predicate devices were leveraged. The fatigue testing for the subject device was newly performed, making it prospective for that specific test on the new design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable in this context. Since this is a 510(k) submission based on non-clinical testing for substantial equivalence, there is no "ground truth" derived from expert clinical assessment of patient data (e.g., radiologists interpreting images) for a "test set" in the way it would be for an AI/CADe device. The "ground truth" for non-clinical tests is established by adhering to recognized international standards and laboratory protocols.

4. Adjudication Method for the Test Set

This information is not applicable. There was no "test set" in a clinical diagnostic sense requiring expert adjudication. Non-clinical tests typically involve objective measurements according to defined standards.

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

This information is not applicable. The device is an endosseous dental implant, not an AI or CADe diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

For non-clinical tests, the "ground truth" is defined by the established international or national standards and protocols for each test (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility). The results are compared against these benchmarks or against the performance of predicate devices tested under the same conditions.

8. The Sample Size for the Training Set

This information is not applicable. The device is an endosseous dental implant. There is no concept of a "training set" as would be used for machine learning models.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set for a machine learning model, there is no ground truth established for one.

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