(143 days)
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
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fatigue Testing | Compliance with ISO 14801 and "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst-case scenario. | Results were in compliance and similar to previously cleared predicate devices. |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.