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Ti Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with Ti Link Abutment are intended to be manufactured at a Izenimplant validated milling center.

The Ti Link Abutment is a two-piece abutment intended to provide support for restorations such as crowns and bridges. The two pieces which compose the final abutment consist of the pre-manufactured titanium base component composed of titanium alloy conforming to ASTM F136, and the CAD/CAM patient matched mesostructure composed of zirconia (K091096). The diameters of the premanufactured titanium base component are 4.0/4.5mm. The final two-piece abutment is fixed to the implant with an abutment screw composed of titanium alloy conforming to ASTM F136. Ti Link Abutment is provided non-sterile, therefore must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component.

The abutments are compatible with the implants cleared under K211090.

The CAD/CAM patient matched mesostructure that is added to the pre-manufactured titanium base component to create the final abutment design should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the Ti Link Abutment. The coping would be manufactured by Izenimplant only with design input using CAD/CAM Software from and by Izenimplant milling center.

CAD/CAM patient matched mesostructure is made from NaturaZ (K091096) and is cemented to the pre-manufactured titanium base component using RelyX cement (K110508) to complete the final finished abutment.

This document, a 510(k) Premarket Notification from the FDA, concerns the "Ti Link Abutment" device, an endosseous dental implant abutment. It aims to demonstrate the device's substantial equivalence to previously cleared predicate devices.

Crucially, this document does NOT describe the acceptance criteria and study proving a device meets those criteria for software or AI-based medical devices. This is a hardware dental implant abutment, and the "testing" performed is for mechanical and biocompatibility properties, not algorithmic performance.

Therefore, many of the requested points related to AI/software study design (sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific FDA submission document.

However, I can extract and present the information that is relevant to the document regarding the device's acceptance criteria and the studies performed:

Acceptance Criteria and Study for Ti Link Abutment (Hardware Device)

Since this is a hardware device (dental implant abutment) and not an AI/software device, the concept of "acceptance criteria" and "performance" is based on mechanical, material, and biocompatibility standards rather than algorithmic metrics like accuracy, sensitivity, or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of number of manufactured units tested for the fatigue, sterilization, and cytotoxicity tests. These types of tests typically follow specific ISO/ASTM standards that dictate sample sizes based on statistical methods or industry practice, but the exact numbers are not detailed in this summary.
• Data Provenance: The tests were conducted for the subject device. Biocompatibility test data was "leveraged" from a predicate device (K211090), which is owned by the applicant. This implies in-house or contracted lab testing for the subject device-specific tests, and prior testing data for the predicate. No information about country of origin for the data is provided, but it's likely originating from the manufacturer's region (Republic of Korea, as per submitter address) or contract laboratories they engaged.
• Retrospective/Prospective: The testing described (Fatigue, Sterilization, Cytotoxicity, Biocompatibility) are prospective tests specifically conducted to support this 510(k) submission.

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

• Not Applicable. This document pertains to the physical and material properties of a dental device, not an AI or software device requiring human expert annotation for ground truth. Ground truth for these tests is established by objective measurements against engineering standards (e.g., force applied, temperature, cell viability, chemical composition).

4. Adjudication Method for the Test Set:

• Not Applicable. As there are no human expert reviewers establishing observational data, there is no need for an adjudication method. Test results are typically objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is relevant to AI/software performance with human users. It is not applicable to a hardware dental abutment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a hardware device; there is no standalone algorithm to evaluate.

7. The Type of Ground Truth Used:

• For mechanical, sterilization, and cytotoxicity tests: The ground truth is defined by the acceptance criteria of the relevant ISO, ASTM, and ANSI/AAMI standards. For example, the fatigue test ground truth is whether the device withstands a specified number of cycles at a specific load without failure, as per ISO 14801. Cytotoxicity is measured against living cell responses.
• For material composition: Ground truth is established by material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI).
• For biocompatibility: Ground truth is established by the safety profiles defined in the ISO 10993 series for medical device biological evaluation.

8. The Sample Size for the Training Set:

• Not Applicable. This is a hardware device; there is no AI/ML model with a "training set." The CAD/CAM design process does not involve machine learning in this context; it refers to computer-aided design and manufacturing.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. No training set exists for this hardware device.

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