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GS 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. GS Fixture System is for one and two stage surgical Procedures. It is not for immediate load.

The GS 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 GS Fixture 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 differences between them are shape. The surface treatment of GS Fixture System is of R.B.M (Resorbable Blasting Media).

This document is a 510(k) summary for the OSSTEM Implant Co., Ltd. "GS Fixture System," a dental implant device. It primarily serves as an FDA submission for market clearance and does not contain the detailed study information or acceptance criteria for device performance as requested.

The document states:

• "GS Fixture System has been subjected to safety, performance, and product validations prior to release."
• "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations."
• "Based on the information provided in this premarket notification Osstem concludes that the GS Fixture System is safe and effective and substantially equivalent to the predicate device as described herein."

However, it does not provide any specific acceptance criteria, reported device performance data, details on sample sizes for testing, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness study results (MRMC or standalone).

Therefore, I cannot provide the requested table and study information because the provided text only concerns the FDA 510(k) submission for substantial equivalence and does not include the underlying performance studies.

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