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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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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 internediate abutment support for fixed bridgework. GS System is for one stage surgical procedures. It is not intended for immediate load.

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

The GS 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 the SS System is R.B.M. (Resorbable Blasting Media) and that of GS system is R.B.M. or CellNest.

The GS System is substantially equivalent in design, function and intended use to the SS System of Osstem Implant Co., Ltd.

This document does not contain the information required to populate the fields of the table provided. The 510(k) submission describes a dental implant system (GS System) and argues for its substantial equivalence to a predicate device (SS System) based on similar materials, indications for use, design, and technological characteristics.

The document states that "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations," and that the device "has been subjected to safety, performance, and product validations prior to release." However, it does not provide specific acceptance criteria, performance metrics, or details of any studies demonstrating that the device meets those criteria.

Therefore, I cannot extract the requested information about acceptance criteria, reported device performance, sample sizes, data provenance, ground truth establishment, MRMC studies, or standalone algorithm performance.

Ask a specific question about this device