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The UV Active Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function.

The narrow (Ø3.0, Ø3.3) implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

The Regular (Ø3.8 ~ Ø5.5) 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 is achieved with appropriate occlusal loading.

The Wide (Ø5.9 ~ Ø6.4) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

The UV Active Implant System includes UV Active Fixture, Abutments (Multi- unit abutment, Cemented abutment, Angled abutment, Solid abutment and Mill abutment), Cylinders (Temporary cylinder, Cemented cylinder, CCM Cylinder) and screws (Abutment screw, Cylinder screw). The UV Active Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well-known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

The UV Active Fixture is made of pure titanium grade 4(ASTM F67) and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-atched). The fixtures have the diameter (3.06.4mm) and length (7.013.0mm).

The multi-unit abutment have the diameter of 4.8mm and the angle has straight, 20° and 30°. It is made from titanium alloy conforming to ASTM F136.

The Cemented abutment, Angled abutment, Solid abutment and Mill abutment has same diameter when comparing to each primary predicate device. The subject device and the predicate device are the same except for surface treatment change from machined surface to TiN Coated surface. The Cemented abutment, Solid abutment and Mill abutment made from titanium alloy confirming to ASTM F67. The Abutment screw and Cylinder screw are made of titanium alloy confirming to ASTM F136 and no surface treatment for these components.

The Fixtures are supplied gamma sterilization. The abutments, screws and cylinders are provided nonsterile, these should be user steam sterilized before use.

The provided text describes a 510(k) submission for the UV Active Implant System, which is an endosseous dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study design for acceptance criteria based on performance metrics such as sensitivity, specificity, and AUC. The "acceptance criteria" discussed are related to meeting standards for medical devices and demonstrating substantial equivalence.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not in the format of sensitivity/specificity/AUC, but rather conformance to established medical device standards and demonstrated substantial equivalence to predicate devices.

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

The document does not describe a "test set" in the context of a clinical performance study with human subjects, nor does it refer to data provenance in terms of country of origin or retrospective/prospective collection for an AI/CAD-like device. The testing described is non-clinical testing on the device itself (e.g., sterilization, fatigue, biocompatibility). Therefore, there is no mention of sample size for human subjects or data provenance.

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

Not applicable. This device is not an AI/CAD system evaluated by experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable.

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. No AI/CAD functionality is described in this submission.

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

Not applicable. No AI/CAD functionality is described in this submission.

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

The "ground truth" in this context is the fulfillment of established engineering, material, and biological standards through laboratory testing. For example:

• Sterilization: Measured sterility assurance level (SAL).
• Fatigue: Measured force resistance and cycles to failure against ISO 14801:2007.
• Biocompatibility: In vitro cytotoxicity assays and general biological evaluation against ISO 10993 series.
• Dimensional/Material: Conformance to specified dimensions and material properties (e.g., CP Ti Gr4 (ASTM F67), Ti-6Al-4V ELI (ASTM F136)).

8. The Sample size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/CAD device.

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

Not applicable.

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