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The US/SS/GS 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 US/SS/GS Fixture System is for one and two stage surgical procedures. It is not for immediate load.

The US/SS/GS 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 510(k) submission (K073247) for the OSSTEM Implant Co., Ltd. US/SS/GS System is for an endosseous dental implant. This document is a summary of the 510(k) submission and primarily focuses on establishing substantial equivalence to previously cleared predicate devices. It does not contain the details of a study with specific acceptance criteria and performance data in the format requested.

Therefore, I cannot populate the table and answer the specific questions about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth methodologies, as this information is not present within the provided text.

The document states:

• "The US/SS/GS 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."

However, it does not provide the details of these validations or tests, nor does it specify numerical acceptance criteria or the reported performance against them.

In a 510(k) submission for a device like a dental implant, substantial equivalence is often demonstrated through:

• Comparison of materials, design, indications for use, and technological characteristics to predicate devices.
• Results from mechanical testing (e.g., fatigue strength, static strength) to ensure the device meets recognized standards.
• Biocompatibility testing.
• Dimensional and tolerance analysis.

The provided text only asserts that these tests and validations were done and that the device is substantially equivalent to predicate devices (K062030, K062051, K063861). It does not provide the numerical data, study design, or expert review details that would allow me to fill in the requested information.

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