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The 3i orthodontic abutment with 3i's endosseous dental implant system is (are) indicated for use in orthodontic procedures, in which prior edentulism permits implantation of a root form implant into jaw arches (alveolar bone), as an anchor for fixation and abutment (support) of an orthodontic appliance.

Upon completion of orthodontic treatment, the orthodontic abutment may be removed and replaced with a conventional 3i restorative abutment device.

The 3i orthodontic abutment is a commercially pure titanium abutment cylinder and screw, very similar in design to 3i's "Standard" or "Two Piece Temporary Healing Abutment". The 3i orthodontic abutment" is designed specifically for cement (epoxy) retention of an orthodontic bracket or appliance and has a 360 degree portion of the abutment cylinder plasma sprayed (TPS) with commercially pure titanium, applied by the same means and to similar specifications as 3i's TPS cvlinder implants.

The 3i orthodontic abutment will be distributed cleaned but non-sterile and will be packaged in an autoclavable, heat-sealed pouch (as other 3i abutment and restorative components.

The 3i orthodontic abutment" eliminates need for modification of other types of abutments, and provides a consistent abutment design for orthodontic treatment. It is simply screwed into the integrated implant, without further preparation (with exception of sterilization by dry heat or autoclave). The pre-roughened (Titanium Plasma Sprayed) surface provides an optimum surface for epoxy adhesion attachment of orthodontic brackets.3i's orthodontic abutment may be used with any 3i endosseous dental implant of corresponding diameter and size.

The 31 implant and implant systems do not change in any form for orthodontic application or use of the orthodontic abutment.

This 510(k) submission for the 3i Orthodontic Abutment focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, device performance, and study methodology are not explicitly provided in this document.

However, based on the provided text, we can infer some information relevant to your request, particularly regarding the comparison to a predicate and the nature of the evaluation.

Here's a breakdown of the available information and what's not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of acceptance criteria with corresponding performance results. The submission is based on demonstrating substantial equivalence to a predicate device already on the market, rather than meeting specific pre-defined performance thresholds through a new study.

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

Not applicable. There is no specific "test set" in the context of an effectiveness study for this submission. The evaluation is based on comparing the design, materials, and intended use to an existing predicate device.

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

Not applicable. There is no expert-established ground truth for a test set in this substantial equivalence submission. The regulatory review process itself involves expert review by the FDA.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring an adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No. An MRMC comparative effectiveness study was not conducted or reported in this 510(k) submission. The focus is on the device's design and material equivalence.

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

Not applicable. This is a physical medical device (orthodontic abutment), not an algorithm or AI system. Therefore, standalone performance in that context is not relevant.

7. The Type of Ground Truth Used

The "ground truth" in this submission is the established safety and efficacy of the predicate device (3i's two-piece, temporary healing abutments, K934126), against which the new device is compared for substantial equivalence. The argument is that because the new device is substantially equivalent in design and materials, and its differences are well-understood and do not raise new questions of safety or effectiveness, it shares the same "ground truth" of acceptability as the predicate.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or algorithm-based device.

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

Not applicable. As there's no training set, there's no ground truth establishment for it.

Summary of Device Comparison and Justification for Equivalence (as substitute for acceptance criteria and study):

The submission for the 3i Orthodontic Abutment ("Orthobutment") aims to demonstrate substantial equivalence to the existing 3i's two-piece, temporary healing abutments (K934126).

Key points of the comparison and justification:

• Design and Materials: The 3i orthodontic abutment is described as "very similar in design and materials" to the predicate. It is a commercially pure titanium abutment cylinder and screw.
• Key Difference: The primary difference is the incorporation of a Titanium Plasma Sprayed (TPS) surface on a 360-degree portion of the abutment cylinder.
• Purpose of Difference: The TPS surface is added "to provide roughness for improved cement (epoxy) retention" of orthodontic brackets. The material application method and specifications are the same as 3i's TPS cylinder implants.
• Implication of Difference: The manufacturer argues this modification simplifies the procedure by eliminating the need for clinicians to surface-roughen other abutments, providing a consistent design.
• Indications for Use (Key Change): While the predicate is for temporary placement to form gingival tissues, the Orthodontic Abutment is specifically "designed for cemented orthodontic appliances, to move or realign natural dentition." After orthodontic treatment, it is removed and replaced with a permanent abutment.
• Safety and Effectiveness Argument: The submitter certifies that a search for adverse safety or effectiveness reports with endosseous dental implants and/or abutments used in orthodontic applications revealed "No specific reports were found." Known general risks associated with dental implants are acknowledged, but no new concerns specific to this modified abutment are raised. The design change (TPS surface) is presented as a functional improvement without introducing new risks not already associated with the predicate or the general use of implants in orthodontics.

Conclusion by FDA:

The FDA reviewed the 510(k) notification and determined that the device is substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. This determination implies that the FDA found the differences in design and indications of use were not significant enough to raise new questions of safety or effectiveness, based on the comparison to the predicate device and existing knowledge. Therefore, the "study" demonstrating this involves an engineering and materials comparison, along with a literature review rather than a prospective clinical trial with specific performance metrics.

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