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The AnyOne External Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose 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. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

AnyOne External 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 External 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. Dental prosthesis is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is made of Ti-6A1-4V ELI, Gold alloy, CCM alloy and intended to be placed on the fixture allows single & multiple prosthetic restore a patient's chewing function.

Here's a breakdown of the acceptance criteria and study information for the AnyOne External Implant System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission details the equivalence to predicate devices rather than explicit, stand-alone acceptance criteria with specific numerical thresholds for each component. However, the core acceptance criteria revolve around demonstrating substantial equivalence to existing, legally marketed devices (predicates and reference devices). The reported performance across all components is that they met the pre-set criteria for the conducted tests.

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

The document does not explicitly state the numerical sample size for the test set used in the performance bench tests (static compression-strength and fatigue tests). It mentions "test was performed on the subject device and predicate device" and "representative specimen".

• Sample Size (Test Set): Not explicitly stated as a numerical value for each test (e.g., how many implants were tested for fatigue). It generally refers to "the subject device and predicate device" and "representative specimen" in singular form, implying at least one of each worst-case scenario. However, for a regulatory submission of this nature, multiple samples would typically be tested to establish statistical confidence, even if not explicitly detailed in this summary.
• Data Provenance: The study is non-clinical bench testing. The country of origin of the data is not specified, but the applicant and correspondent are located in the Republic of Korea. The tests are prospective as they were conducted specifically for this submission to demonstrate substantial equivalence.

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

This is not applicable as the studies are non-clinical bench tests (physical properties, biocompatibility, sterilization, etc.). Ground truth in this context is established by adherence to recognized international standards (ISO, ASTM, USP) and FDA guidance documents. There is no mention of human experts interpreting test results for "ground truth" in the way it might apply to a clinical study involving medical image analysis, for example.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical bench testing. Passing or failing criteria are determined by adherence to established engineering and material science standards (e.g., force applied, number of cycles, endotoxin concentration limits).

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

No. This is a submission for a dental implant system involving physical components. MRMC studies are typically performed for AI/CAD systems that assist human readers in tasks like medical image interpretation.

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

No. As above, this is for a physical medical device. There is no algorithm involved.

7. Type of Ground Truth Used

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

• Standardized Test Methods: Adherence to international standards such as ISO 14801 for mechanical testing, ISO 10993-1 for biocompatibility, ISO 11137 and ISO 17665-1, 2 for sterilization, ASTM F1980 for shelf life, and USP 39 for endotoxin testing.
• Predicate Device Comparison: Substantial equivalence is established by demonstrating that the subject device's performance, materials, and design are comparable to legally marketed predicate and reference devices. The predicate devices themselves serve as a form of "ground truth" for acceptable performance and safety within their intended use.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.

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

Not applicable. See point 8.

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