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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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Use of Suglue 3 in Adhesive Mode with ADH19
·Final cementation of all-ceramic or metal Maryland bridges and 3-unit inlay/onlay bridges
·Final cementation of all-ceramic or composite veneers and occlusal veneers (tabletops)

Use of Suglue 3 in Adhesive Mode with ADH19 or in Self-Adhesive Mode

·Final cementation of all-ceramic, composite, or metal inlays and onlays, crowns, and bridges

·Final cementation of posts made of ceramic, glass fiber-reinforced composite or metal, and screws

·Final cementation of all-ceramic, composite, or metal restorations on implant abutments

Suglue 3 is a dual-curing universal cement that is used for both adhesive and self-adhesive cementation of indirect restorations and posts, whereas RelyX Unicem 2 Automix is a selfadhesive cement and RelyX Ultimate is an adhesive cement. New redox initiator system provides improved bond strength to tooth structure, especially dentin. Changed characteristics allow easier excess removal. Increased radioopacity facilitates clinicians to see the Suglue 3 in radiographs as well as tooth like fluorescence for an esthetic appearance, especially in the anterior region. Suglue 3 is used in combination with ADH19 (dental adhesive, product of 3M Deutschland GmbH) for adhesive cementation. ADH19 adhesive is self-etching. Optionally, the adhesive strength can be enhanced further through additional etching of the tooth structure with Scotchbond Universal Etchant (product of 3M Deutschland GmbH). Standard cases as well as post cementations can be solved securely and efficiently when Suglue 3 is used in selfadhesive mode.

The provided FDA 510(k) document details the clearance of a dental cement, Suglue 3. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, composition, technology, and various physical and mechanical properties.

Crucially, this document does not describe acceptance criteria, a study proving device performance against such criteria in the context of an AI/ML device, or any of the specific AI/ML related questions posed (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details).

The document is for a medical device (dental cement) and does not involve AI or machine learning. Therefore, the requested information regarding AI/ML device performance and study design elements cannot be extracted from this text.

The information from the document related to general device performance studies is as follows:

1. A table of acceptance criteria and the reported device performance:

   • The document does not provide a table of explicit acceptance criteria with specific thresholds for each performance metric. It rather states that "The results of Suglue 3 are comparable to RelyX Unicem 2 Automix, and RelyX Ultimate."
   • Reported performance (in comparison to predicate devices):
     • Excess removal forces (comparable)
     • Pull-out bond strength to endodontic post (comparable)
     • Shear bond strength to tooth structure (dentin and enamel), glass ceramic (feldspathic and lithium disilicate ceramics), zirconia, metals (gold, remanium, and titanium), and composites (comparable)
     • Film thickness (comparable)
     • Working time (comparable)
     • Flexural strength (comparable)
     • Water sorption (comparable)
     • Solubility (comparable)
     • Shade (comparable)
     • Color stability (comparable)
     • Radioopacity (comparable)
     • Compressive strength (comparable)

2. Sample size used for the test set and the data provenance:

   • Not applicable as this is a physical dental cement, not an AI/ML device using a test set of data. The document does not specify sample sizes for the in vitro tests conducted.
   • Data provenance is not mentioned beyond the tests being "in vitro."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" here would refer to the measured physical and mechanical properties of the cement, established through standardized laboratory testing, not by expert interpretation of data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This concept applies to human expert review of clinical data, not to physical property testing of a dental cement.

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 is for an AI/ML device, which Suglue 3 is not.

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

   • Not applicable. This is for an AI/ML device, which Suglue 3 is not.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the physical and mechanical properties of the dental cement, the "ground truth" is established through direct measurement and testing methods, some of which are based on ISO standards (e.g., ISO 4049:2009, ISO 9917-1:2008).

8. The sample size for the training set:

   • Not applicable. There is no AI/ML model to train for this device.

9. How the ground truth for the training set was established:

   • Not applicable. There is no AI/ML model to train for this device.

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