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The Internal Hex Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. For implant bodies Ø4.1 and greater, the Internal Hex Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant bodies with a diameter less than Ø4.1 are intended for immediate loading when using a minimum of 4 implants with lengths >8mm.

The subject endosseous dental implant bodies are composed of Pure Titanium Grade 4. Internal Hex Implant System has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placements. Internal Hex Implant Systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The Internal Hex Implant System has an internal connection. The surface of the implant bodies has been treated with SLA (Sandblast, Large grit Acid etched). The system consists of BLT II OS Implant Fixtures and various abutments such as Cover Screw, Healing abutment, BestDuo Abutment, BestSolid Abutment, BestOcta Abutment, BestAngled Abutment, Temporary Abutment, Octa Plastic Cylinder, Denture Abutment, Multi-Unit Abutment, Multi-unit Abutment Screw, Multi-Unit Healing Cap, Multi-Unit Temporary Cylinder, Multi-Unit Cylinder Screw and Abutment Screw.

Here's a breakdown of the acceptance criteria and study information for the EBI Inc. Internal Hex Implant System, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents describe the successful completion of various tests according to international and national standards. The acceptance criteria are implicitly that the device meets the respective standards and demonstrates substantial equivalence to predicate devices. The reported device performance is that it met these criteria.

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

The document does not explicitly state numerical sample sizes for the test sets. However, it indicates these were non-clinical tests.

• Provenance: All tests mentioned are non-clinical (laboratory/bench testing). The document does not specify country of origin for the data, but the manufacturer is based in the Republic of Korea. The data is retrospective in the sense that the tests were performed and results analyzed for this submission.

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

Not applicable. These are non-clinical engineering and biocompatibility tests against established standards. Ground truth is determined by the specific criteria outlined in the standards, not by expert consensus on interpretations of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable, as ground truth is based on objective measurements and compliance with standard specifications rather than expert interpretation.

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. This device is a dental implant system, not an AI-powered diagnostic tool. The submission focuses on the physical and biological properties of the implant and abutments.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on:

• Engineering specifications and performance limits defined in international standards (e.g., ISO 14801:2016 for fatigue).
• Biocompatibility criteria established in ISO 10993 series and USP for pyrogenicity.
• Sterilization efficacy criteria in ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79, and ISO 11137-1.2.3.
• Shelf life criteria in ASTM F1980-07.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not a machine learning model that requires a training set. The term "training set" is typically used in the context of AI/ML development.

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

Not applicable for the same reason as point 8.

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EBI Dental Implant System is intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

An endosseous dental implant is a device made of a material such as Pure Titanium Grade 4 and Titanium alloy (Ti-6A1-4V ELI). EBI Implant system has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placement. EBI Implant systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The EBI External Implant System has an external connection.

The surface of the system has been treated with RBM (Resorbable Blasted media).

The Fixture diameters are 3.25, 3.3, 3.75, 4, 4.1, 4.8, 5, 5.5, 6, 6.5, 7mm and lengths are 7, 8, 8.1, 8.5, 9, 9.6, 10, 11, 11.5, 12, 12.6, 13, 14, 14.6, 15mm in this system.

The contained various abutments and accessories in the system are cover screw, healing abutment, cemented abutment, temporary abutment, healing cap, impression coping, analog, fixture mount, Ti-screw, angled abutment, impression guide pin, gold UCLA abutment and locator.

Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.

The EBI External Implant System is a dental implant system. The provided document is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than proving specific acceptance criteria with detailed studies in the manner typically seen for novel AI/software devices. Therefore, the information typically requested for AI/software-based devices regarding acceptance criteria, ground truth, sample sizes, and expert adjudication for performance studies is not directly applicable or available in this document.

However, based on the provided text, we can glean information about the performance testing conducted and how it demonstrates "safety and effectiveness" in the context of a dental implant.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or F1-score, as would be expected for a diagnostic or AI-driven decision support system. Instead, for a dental implant, performance is assessed through bench testing demonstrating structural integrity and compliance with recognized standards.

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

The document doesn't provide specific sample sizes for the fatigue testing in terms of the number of tested devices. It only states that "Fatigue Testing was performed in accordance with ISO 14801:2007." ISO 14801 specifies test methods for dental implants, which would inherently include a defined number of samples to ensure statistical validity, but this detail is not explicitly stated in the 510(k) summary.

Data Provenance: The testing was conducted by EBI Inc., a South Korean company.

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

This question is not applicable in the context of this device and testing. The "ground truth" for a dental implant's mechanical performance is defined by adherence to engineering standards and material specifications, not expert consensus on an image or diagnosis.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in clinical performance studies, typically for diagnostic devices. Mechanical bench testing of an implant does not involve such human-based 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

Not applicable. This is a medical device (dental implant), not an AI or software-assisted diagnostic system. Therefore, MRMC studies examining human reader performance with or without AI are not relevant.

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

Not applicable. There is no algorithm. The device is a physical dental implant.

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

The "ground truth" for the performance of the EBI External Implant System is based on established engineering and material standards, specifically:

• ISO 14801:2007 for fatigue testing of dental implants.
• ASTM F67 for unalloyed titanium (CP Titanium Grade 4) used in dental implants.
• ASTM F136 for wrought titanium-6aluminum-4vanadium alloy (Ti-6Al-4V ELI) for surgical implant applications.
• General device safety and effectiveness principles outlined in FDA's Class II special controls guidance document for root-form endosseous dental implants and abutments.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a learning algorithm or AI/ML device.

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

Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.

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