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The HIOSSEN Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ETIII SA Ultra Wide Fixture is intended to be used in the molar region.

The HIOSSEN Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The HIOSSEN Implant System include length 18mm implant. The HIOSSEN Implant System is a revised product that Dimension and code(art#) are changed and added from predicate product, ETII SA Fixture, HTIII SA Fixture and ETIII SA Ultra Wide Fixture therefore there is no difference about material, indication for use and design from predicate as above. And the subject devices and the predicate devices encompass the same range of physical dimensions except length 18mm and characteristics, including implant diameter and surface treatment.

The provided document is a 510(k) premarket notification for the HIOSSEN Implant System. It does not describe a study involving algorithms, AI, or human readers, but rather demonstrates substantial equivalence to predicate devices through non-clinical testing.

Therefore, many of the requested categories related to algorithm performance, expert ground truth, and human-in-the-loop studies are not applicable to this document.

Here's a breakdown of the information that is available in the document:

1. Table of acceptance criteria and reported device performance:

The document describes the HIOSSEN Implant System as substantially equivalent to predicate devices based on various characteristics, primarily focusing on materials, indications for use, and design. The "acceptance criteria" are implied by the comparison to the predicate devices, meaning the new device should not raise new questions of safety and effectiveness regarding these characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample size: Not applicable. The "test set" in this context refers to non-clinical testing of the physical device. The document mentions "engineering analysis, dimensional analysis, static and dynamic compression-bending testing" and "fatigue testing in air." Specific sample sizes for these tests are not provided in this summary.
• Data provenance: Not applicable. This refers to physical device testing, not data from human subjects or images.

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

Not applicable. This document is for a dental implant system, not an AI/algorithm-based diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for a physical medical device submission.

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 physical dental implant, not an AI-assisted diagnostic device.

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

Not applicable. This is a physical dental implant.

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

The "ground truth" for demonstrating substantial equivalence for this device is based on established engineering standards for medical devices (e.g., ASTM F67 for material, "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" for mechanical testing). The comparison is against predicate devices that have already demonstrated safety and effectiveness.

8. The sample size for the training set:

Not applicable. There is no algorithm or AI model requiring a training set.

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

Not applicable. There is no algorithm or AI model requiring a training set.

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