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The GS III 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 GS III Fixture System is for single and two stage surgical procedures. It is not for immediate load.

The GS III 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.

The provided text is a 510(k) summary for the OSSTEM Implant Co., Ltd.'s GS III Fixture System. It aims to demonstrate substantial equivalence to a predicate device, the HG II Fixture System (K080744).

However, the document does not contain acceptance criteria, device performance data, details of a study (like sample sizes, ground truth establishment, or expert qualifications), or multi-reader multi-case study information. It primarily focuses on the device's description, indications for use, comparison to a predicate device, and a general statement about safety, performance, and product validations being conducted.

Based on the provided text, I can only provide the following:

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

• No specific acceptance criteria or quantitative performance measures are stated in the provided text. The submission aims to demonstrate substantial equivalence based on material, indication for use, and similar design and technological characteristics.

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

• Not provided. The text does not describe any specific clinical or performance testing studies with sample sizes or data provenance. It only states that "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations."

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 provided. The document does not describe the establishment of a ground truth for any test set, nor does it mention any experts involved in such a process.

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

• Not provided. There is no mention of an adjudication method as no test set or study details are given.

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, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case study comparing human readers with and without AI assistance is not relevant to this submission.

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

• Not applicable. As stated above, this is a dental implant, not an algorithm.

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

• Not provided. No study details are given that would involve establishing a ground truth. The submission relies on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than detailed clinical outcome data from a novel study.

8. The sample size for the training set:

• Not applicable. As this is a medical device (dental implant) and not a machine learning algorithm, there is no concept of a "training set" in the context of this 510(k) submission.

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

• Not applicable. See point 8.

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