Search Results

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.

Ask a specific question about this device

The HS II Short 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 HS II Short Fixture System is for single and two stage surgical procedures. It is not for immediate load.

The HS II Short 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.

This report describes a 510(k) premarket notification for the "HS II Short Fixture System," a dental implant device. The provided text mainly focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study specifically designed to assess its performance against predefined acceptance criteria for a new AI/medical device.

Therefore, the requested information regarding acceptance criteria and performance against those criteria, especially in the context of an AI device, cannot be extracted from this document. The document confirms the device's material, indications for use, and technological characteristics are similar to the predicate devices, leading to a conclusion of substantial equivalence.

However, based on the provided text, here's a breakdown of what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable in this context. The document is a 510(k) summary for a legacy medical device (dental implant). It does not present acceptance criteria or reported performance metrics in the way an AI/software device would, such as sensitivity, specificity, accuracy, or AUC. The "performance" assessment here is focused on demonstrating that the new device is "substantially equivalent" to existing, legally marketed predicate devices.

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

Not applicable. This document describes a dental implant, not an AI or software device that would typically use test sets of data for performance evaluation. Product testing for a device like this would involve mechanical, biological, and material properties testing, not data-driven performance assessments against a ground truth dataset.

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

Not applicable. As above, there is no "test set" in the context of AI or diagnostic imaging for this device. The regulatory submission relies on comparison to predicate devices and established standards for dental implants.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication is discussed in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This document pertains to a physical dental implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to readers improving with AI assistance is not relevant or described.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable. No "ground truth" (in the sense of a definitive diagnosis or outcome for data evaluation) is discussed here. The "truth" for this device's approval lies in its material composition, design, and functional equivalence to legally marketed predicates.

8. The Sample Size for the Training Set:

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided 510(k) summary for the "HS II Short Fixture System" is exclusively focused on demonstrating substantial equivalence to predicate dental implants through a comparison of their materials, design, indications for use, and technological characteristics. It is not a study about an AI/software device and therefore does not contain information about acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, or human-AI interaction studies typically associated with such devices.

Ask a specific question about this device