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The HG II Fixture 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 terminal or intermediate abutment support for fixed bridgework. The HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load.

The HG II Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

This document is a 510(k) summary for the Hiossen HG II Fixture System, a dental implant. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated study proving performance against general acceptance criteria for such a device.

Therefore, many of the requested categories of information are not present in this type of regulatory submission. The document explicitly states: "The HG II Fixture System is substantially equivalent in design, function and intended use to the HG II Fixture System (K080744) of Osstem Implant Co., Ltd."

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

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

This document does not define specific "acceptance criteria" for the device's performance in a quantitative or qualitative manner that would typically be found in a study or a validation report outlining specific metrics (e.g., strength, biocompatibility thresholds). Instead, it states the device has undergone general safety and performance validations.

Note: The "acceptance criteria" here are inferred from the statements made for regulatory clearance, rather than explicit, quantifiable metrics.

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

Not provided in the document. The document refers to "safety, performance, and product validations" but does not detail the sample sizes, study design (retrospective/prospective), or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a 510(k) summary for device clearance, not a study evaluating human or AI performance against a ground truth established by experts.

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

Not applicable. This is a 510(k) summary for device clearance, not a study involving expert 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 document is for a dental implant system. There is no mention of AI assistance or human reader studies.

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

Not applicable. This document is for a physical medical device (dental implant), not a software algorithm.

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

Not applicable. The document relies on demonstrating substantial equivalence to a predicate device, supported by safety and performance validations, rather than establishing a new ground truth for a diagnostic task. The "ground truth" for regulatory clearance is that the device meets safety and effectiveness requirements and is substantially equivalent to a legally marketed predicate.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model, so there is no concept of a "training set."

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

Not applicable. This is a physical device, not an AI model.

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