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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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The AnyRidge Octa 1 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 situations 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.

The AnyRidge Octa 1 Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136-13) except the CCM Abutment. The CCM Abutment is made of Cobalt Chrome Molybdenum (ASTM F1537-11). Also for the Fuse Abutment, the post is covered with provisional restoration that is made of plastic (POM). The system offers various components including the AnyRidge Octa 1 Fixture, EZ Post Abutment, Angled Abutment, Milling Abutment, Octa Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, Meg-Rhein Abutment, CCM Abutment, Cover Screw, Healing Abutment, Temporary Abutment, Fuse Abutment, Abutment Screw, and Multi-unit Abutment Screw, in various sizes.

The provided document is a 510(k) Premarket Notification from the FDA for the AnyRidge Octa 1 Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through a standalone study with acceptance thresholds.

The document discusses non-clinical testing performed to support the substantial equivalence claim. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., minimum accuracy percentages, AUC values) or corresponding device performance results in the context of clinical effectiveness or diagnostic accuracy, as it is a 510(k) submission focusing on substantial equivalence to predicate devices rather than novel performance claims.

However, it mentions that fatigue tests were performed on the subject devices in accordance with ISO 14801. The acceptance criterion for this would be that the fatigue test results of the subject device are substantially equivalent to the predicate device. The document states:

• "The fatigue testing demonstrates that the results of the subject devices are substantially equivalent to the predicate device."
  This indicates that the subject device met the implied acceptance criterion of demonstrating comparable mechanical durability to the predicate under the specified test conditions.

Other non-clinical tests mentioned also have implicit acceptance criteria:

• Sterilization validation testing (ISO 11137 and ISO 17665-1, 2): To verify a sterility assurance level (SAL) of 10^-6. The document states this was performed to verify SAL (10^-6), implying it met this standard.
• Shelf life validation testing (ASTM F1980): To validate a 5-year shelf life using accelerated aging. The document states "the test results validated 5 year shelf life," indicating the criterion was met.
• Surface Morphology (EDS), Surface Roughness, GC/LC Analysis, IC Analysis: These tests were done to evaluate SLA treatment. The implicit acceptance would be that the characteristics are consistent with acceptable dental implants and/or comparable to the predicate device's surface treatment.
• Endotoxin testing (USP 39 ): The testing limit is below 0.5 EU/mL. This will be conducted on every batch, implying this is the ongoing acceptance criterion for endotoxin levels.

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

The document does not describe a "test set" in the context of patient data or a clinical study for performance evaluation. The "tests" performed are non-clinical, laboratory-based tests on the device itself. Therefore, information on sample size for patient data or data provenance (country of origin, retrospective/prospective) is not applicable or provided.

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

Not applicable. This is a non-clinical 510(k) submission, not a clinical study requiring expert ground truth for a test set.

4. Adjudication Method

Not applicable. This is a non-clinical 510(k) submission.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a non-clinical 510(k) submission for a dental implant system, not a diagnostic device typically evaluated with MRMC studies with human readers and AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This product is a physical medical device (dental implant system), not an algorithm or AI system.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" refers to established scientific standards and regulatory guidelines.

• Mechanical Fatigue: ISO 14801, and comparison to the performance of legally marketed predicate devices.
• Sterilization: ISO 11137 and ISO 17665-1, 2.
• Shelf Life: ASTM F1980.
• Biocompatibility: Likely established through previous 510(k) submissions for the predicate devices using similar materials.
• Endotoxin: USP 39 .

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/algorithm-based product that requires a training set.

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

Not applicable.

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