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InterActive/SwishActive Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate SMARTBase support for fixed bridgework. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment.

Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

• Narrow Diameter (3.2. 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

The InterActive SMARTBase abutments system is a line extension of the previously cleared Implant Direct device, 2014 InterActive/SwishActive Implant System. The InterActive SMARTBase abutments are comprised of engaging abutments, non-engaging abutments, modified zirconia engaging abutments, modified zirconia non-engaging multiunit bridges, and fixation screws that are intended to function as an extension of the implant. The proposed SMARTBase Abutment is a two-piece abutment consisting of titanium base and zirconia top components. To fabricate the zirconia top component that fits the titanium base, there are three workflow options: (1) using a press-ceramic material that is formed by conventional wax-up technique by the end user, (2) the zirconia top component is designed and milled by Implant Direct in stock sizes and provided to the end user to be placed on the titanium base for forming two-piece abutment, and (3) digital workflow using 3Shape where CAD design and milling of the zirconia top component is done at the end user's dental laboratory/office to be placed on the titanium base. The CAD design requires loading of Implant Direct abutment design library to the 3Shape Software to design the zirconia top component within the established design limitations and specifications.

The provided document describes the FDA's 510(k) clearance for the InterActive SMARTBase Abutments, which is a dental implant component. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might find for a novel AI device.

Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone performance is not applicable or not present in this regulatory submission for a dental abutment. The submission primarily relies on non-clinical testing to demonstrate that the changes from the predicate device do not negatively impact safety or effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific numerical acceptance criteria and corresponding performance metrics for the SMARTBase abutments in a typical AI/software validation format. Instead, it describes general testing categories and their successful completion.

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

• Test Set Sample Size: Not explicitly stated for each test beyond "worst-case configuration" for mechanical fatigue and "worst case drivers" for screw torque.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The testing appears to be primarily laboratory-based non-clinical testing.

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

• Not Applicable. This type of information is typically for devices involving human interpretation of data (e.g., imaging diagnosis). The current device is a physical dental implant abutment, and its "ground truth" is established through engineering and material testing standards.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of cases, typically in diagnostic or screening AI applications.

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

• No. This type of study is for evaluating human performance with and without AI assistance in diagnostic tasks. The InterActive SMARTBase Abutments are physical devices, not an AI software meant to assist human readers.

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

• Not Applicable in the traditional sense of an AI algorithm. While software is mentioned (3Shape Abutment Designer™ Software), its role is in designing the physical component, not in making a standalone medical decision. The software itself underwent "verification and validation testing" to ensure it adheres to design rules and limitations for the physical device. The device itself (the abutment) does not operate as a standalone algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for this device revolves around engineering specifications, material properties, and established international standards (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility, ISO 17665 for sterilization). The successful completion of these standardized tests serves as the evidence of meeting the necessary performance and safety benchmarks. There is no "expert consensus," "pathology," or "outcomes data" ground truth as would be relevant for a diagnostic or predictive device.

8. The Sample Size for the Training Set:

• Not Applicable. This refers to training data for machine learning models. This device is a physical implant component, not an AI model that requires a training set. The "abutment design library" is an engineering dataset, not a machine learning training set.

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

• Not Applicable. See point 8. The "ground truth" for the design library (if one were to interpret "training set" very loosely for a design context) would be established through engineering design principles, material science, and prior validated designs, ensuring the resulting physical abutments meet functional and safety requirements.

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