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The Dentis Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

The Dentis Dental Implant System consists of three system, i-Clean System, s-Clean System, and e-Clean System. The purpose of this submission is to add various fixtures and abutment to the previously cleared device, K073486. Also, various set packing codes have been changed and it applies to the subject submission. Each system in the submission includes:

1. i-Clean System: Fixture (i-Clean Tapered Fixture/ i-Clean Straight Fixture / i-Clean Tapered II Fixture / i-Clean SAVE Fixture / i-Clean SAVE II Fixture), Abutment (i-Clean Cover Screw, i-Clean Closing Screw, i-Clean Solid Abutment, i-Clean Excellent Solid Abutment, i-Clean Healing Abutment, i-Clean Octa Abutment, i-Clean SynOcta Abutment, i-Clean InOcta Abutment, i-Clean Free Abutment, i-Clean Octa Healing Cap, i-Clean Gold UCLA, i-Clean Temporary Abutment, i-Clean Solid Healing Cap, i-Clean O-ring Abutment)
2. s-Clean System: Fixture (s-Clean Tapered Fixture/ s-Clean Straight Fixture / s-Clean SAVE Fixture / s-Clean SAVE II Fixture), Abutment (s-Clean Cover Screw, s-Clean Healing Abutment, s-Clean Free Healing Abutment, s-Clean Couple Abutment, s-Clean Free Abutment, s-Clean Sole Abutment, s-Clean Sub-Octa Abutment, s-Clean Gold UCLA Abutment, s-Clean Temporary Abutment, s-Clean Sole Healing cap, s-Clean O-Ring Abutment, s-Clean Abutment screw, s-Clean CCM UCLA Abutment)
3. e-Clean System: Fixture (e-Clean Tapered Fixture/ e-Clean Tapered II Fixture), Abutment (e-Clean Cover Screw, e-Clean Abutment Screw, e-Clean Mount Screw, e-Clean Healing Abutment ,e-Clean Cemented Abutment, e-Clean Gold UCLA Abutment, e-Clean Temporary Abutment(Ti), e-Clean O-Ring Abutment)
   The surface of the fixture has been treated with RBM (Resorbable Blasted media).

This document discusses the Dentis Dental Implant System and its substantial equivalence to previously cleared predicate devices. Since this is an unassisted device (a dental implant system), the concepts of "acceptance criteria for device performance," "test set," "training set," "experts for ground truth," "adjudication method," and "MRMC study" are not directly applicable in the way they would be for an AI/ML-driven device.

Instead, the "acceptance criteria" here relate to demonstrating that the new device (Dentis Dental Implant System with added fixtures and abutments) is as safe and effective as existing legally marketed devices. This is typically achieved through comparison to predicate devices and non-clinical testing.

Here's an interpretation of the requested information in the context of this unassisted medical device:

1. Table of Acceptance Criteria and the Reported Device Performance

For an unassisted device like this, "acceptance criteria" are not performance metrics in the sense of accuracy, sensitivity, or specificity. Instead, they are the criteria used to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance. These typically involve demonstrating equivalence in:

• Intended Use: The purpose for which the device is used.
• Technological Characteristics: How the device achieves its intended purpose (e.g., design, materials, surface treatment, sterilization, packaging, shelf life).
• Performance Data: Non-clinical tests to confirm the device meets safety and functional requirements.

The reported device "performance" is therefore its adherence to these characteristics, demonstrating it is as safe and effective as the predicate.

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

• Sample Size: Not applicable in the context of an AI/ML device. For this unassisted medical device, "testing" refers to non-clinical bench testing (e.g., LAL, sterilization validation, shelf-life validation, biocompatibility) rather than a dataset for evaluating an algorithm's performance. The document doesn't specify the number of units or samples used for these non-clinical tests.
• Data Provenance: The non-clinical tests were performed by Dentis Co., Ltd. (South Korea) or leveraged from prior submissions for their predicate devices. The tests adhere to international standards (e.g., ISO, ASTM, USP). The country of origin for the device is South Korea.

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

• This concept is not applicable for this type of unassisted medical device. "Ground truth" established by experts is relevant for AI/ML diagnostic or prognostic devices where human experts define the correct diagnosis or outcome. For a dental implant system, the "ground truth" is typically defined by engineering specifications, material standards, and biological compatibility standards, evaluated through physical and chemical testing.

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

• This concept is not applicable as there is no test set in the AI/ML sense, and no human interpretation requiring adjudication.

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

• No MRMC study was done. This device is an implant system, not an AI-assisted diagnostic or interpretative tool that would involve human "readers."

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

• This is not applicable as this is not an algorithm or AI device.

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

• For this device, the "ground truth" is defined by established engineering and material standards, biological compatibility requirements (ISO 10993 series), and manufacturing process controls. The tests (e.g., LAL, sterilization, shelf life, biocompatibility) confirm that the device meets these pre-defined standards. There is no "ground truth" derived from expert consensus on medical images or patient outcomes data in the way an AI/ML device would use it.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth established for it.

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