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The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following stuations and with the clinical protocols:

-Delayed loading.

-Immediate loading when good

primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.

AnyOne Onestage Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance.

AnyOne Onestage Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the . surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. The fixtures have Octa connection, and various cuff height with consideration for soft tissue level (gingival height). These fixtures can be used the one-stage and two-stage surgical procedure. This device is a tissue level implant.

Dental prosthesis is an abutment of a dental implant system and connecting elements between the dental implant and the restoration. The abutment is fixed to the implant and is permanently or temporary in contact with the gum in the surgical cavity. These abutments are made of alloy and POM, and intended to be placed on the fixture allows single & multiple prosthetic restorations to restore a patient's chewing function.

The proposed AnyOne Onestage Implant System is consisted of the following components: Fixture Products (AnyOne Onestage Fixture), Closing Screw & Cover Screw & Healing Abutment (Closing Screw, Cover Screw, Healing Abutment), Fixture Level Prosthesis (Multi Post, Multi Post Cap, EZ Post Abutment, Angled Abutment, Gold Abutment, CCM Abutment, Multi Post Screw, Abutment Screw), Abutment Level Prosthesis (Solid Abutment, Solid Cap, Solid Post Abutment, Solid Post Cap, Octa Abutment, Healing Cap, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder, Abutment Screw), Overdenture Prosthesis (Meg-Loc Abutment, Meg-Ball Abutment, Meg-Magnet Abutment, Magnet, Meg-Rhein Abutment).

The provided text does not describe an AI/ML device but rather a dental implant system. Therefore, details regarding AI/ML device performance, such as acceptance criteria, test set sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or training set specifics, are not applicable and not present in the document.

The document focuses on demonstrating the substantial equivalence of the "AnyOne Onestage Implant System" to predicate devices, primarily through comparison of design, materials, indications for use, and mechanical performance testing (biocompatibility, surface treatment, endotoxin, sterilization, and static/fatigue tests).

Acceptance Criteria and Device Performance (Not Applicable for AI/ML):

Since this is a non-AI/ML device, the concept of "acceptance criteria" as it relates to algorithm performance (e.g., sensitivity, specificity, AUC) and "reported device performance" in that context is not relevant. Instead, the document demonstrates that the new device meets established standards and is equivalent to legally marketed predicate devices through various non-clinical tests.

However, if we interpret "acceptance criteria" as the criteria for demonstrating substantial equivalence for this medical device (dental implant system) and "reported device performance" as the results of the non-clinical tests, we can extract details regarding the physical property tests performed. The acceptance criterion for these tests is that the device must meet "pre-set criteria" according to ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment," and the reported performance is simply that the test results "met the pre-set criteria."

Summary of Non-Clinical Testing Performance for Dental Implant System:

Further details as requested (adapted for a non-AI/ML device):

2. Sample size used for the test set and the data provenance:
   The document focuses on non-clinical (bench) testing. For the physical properties (static compression-strength and fatigue tests), representative specimens were selected "under the consideration of worst case." The exact number of samples tested for each component is not explicitly stated in this summary, but it would have been part of the full testing report. The provenance of the "data" would be the internal testing laboratories of MegaGen Implant Co., Ltd. (Republic of Korea). The tests are prospective in the sense that they are specifically conducted to support this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical tests is established by standardized testing protocols (e.g., ISO 14801) and engineering measurements, not human expert consensus.

4. Adjudication method for the test set: Not applicable for physical property testing. Test results are objectively measured against predefined standards.

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, as this is a dental implant system (physical device), not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used:
   For physical properties (static compression-strength and fatigue), the "ground truth" is based on the performance requirements specified in international standards (ISO 14801) and FDA guidance documents ("Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment"). For biocompatibility and sterilization, it's adherence to ISO standards (ISO 10993-1, ISO 11137, ISO 17665-1, 2) and ASTM standards (ASTM F1980), as well as USP for endotoxin.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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