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The ET/SS Implant 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.

The ET/SS Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. Its surfaces are partially Tin coated and uncoated.

This 510(k) premarket notification for the ET/SS Implant System does not contain the level of detail typically found in a study describing acceptance criteria and device performance for AI/ML-based medical devices. The submission focuses on demonstrating substantial equivalence to predicate dental implants through a comparison of physical characteristics, intended use, and a summary of nonclinical testing (fatigue testing).

Therefore, I cannot directly extract the specific information requested in your prompt regarding acceptance criteria, study details, ground truth, sample sizes, or MRMC studies, as the document is for a traditional medical device (dental implant) and not an AI/ML device.

However, I can extract the information provided about the nonclinical testing for this device and present it in a similar structure:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable as this is a nonclinical, component-level fatigue test, not a performance study on a test set of data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for fatigue testing is established by engineering standards and measurement.

4. Adjudication Method

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, this type of study was not done. The device is a physical dental implant, not an AI system that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The "device" is a physical implant. The fatigue testing is a standalone test of the implant's physical properties.

7. The Type of Ground Truth Used

Engineering standards and measurements for fatigue life.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for physical fatigue testing of a dental implant in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Device Information from the Provided Document:

• Device Name: ET/SS Implant System
• Manufacturer: OSSTEM Implant Co., Ltd.
• Device Type: Endosseous Dental Implant
• Classification: Class II
• Key Feature: Made of pure titanium metal, SA (Sandblasting and Acid etching) treated surface.
• Intended Use: For use in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations (cemented, screw-retained, or overdenture), and for final or temporary abutment support for fixed bridgework. Intended for delayed loading.
• Nonclinical Testing: Fatigue testing performed according to ISO 14801 and relevant FDA guidance.
• Clinical Testing: No clinical studies were submitted.
• Basis for Equivalence: Substantial equivalence was claimed based on material, indication for use, and similar design and technological characteristics to predicate devices, supported by nonclinical testing results.

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