(98 days)
The ETII SA Ultra wide 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 ETIII SA Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The ETIII SA Ultra wide Fixture System is intended to be used in the molar region.
The ETⅢ SA Ultra wide Fixture is dental implant made of titanium metal intended to be used in the molar region and surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The ETM SA Ultra wide Fixture is composed of single threads with internal hex connection taper body of bone level. The surface is SA, Sandblasting and Acid etching, treated. The ET Healing Abutment is used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration.
The provided text describes the ETIII SA Ultra wide System, a dental implant, and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, or comparative effectiveness with human readers.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to pre-existing legally marketed devices rather than presenting a detailed study against specific performance acceptance criteria commonly seen for software or AI-driven medical devices.
Here's a breakdown of the information that is available in the provided text, categorized as requested, with explicit notes where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Fatigue Testing (as per "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with worst case scenario of GS III Fixture or HGII Fixture and angled abutment) | The fatigue test result of GSIII Fixture System (or HGIII Fixture System) can be used as a proof of ETIII SA Ultra Wide Fixture since ETIII SA Ultra Wide Fixture has large diameter. |
| Biocompatibility | Biocompatibility tests have been performed to ensure the devices comply with the applicable International and US regulations. |
| Material Composition (Pure Titanium Grade 4 (ASTMF67-06)) | Device is made of Pure Titanium Grade 4 (ASTMF67-06), which is the same as predicate devices. |
| Surface Treatment (SA - Sandblasting and Acid etching) | Device uses SA (Sandblasting and Acid etching), which is the same as one predicate device (ETIII SA Fixture) and analogous to another predicate device (RBM - Resorbable Blast Media for HGIII Ultra wide Fixture). |
| Sterilization (Radiation Sterile) | Device is Radiation Sterile, which is the same as predicate devices. |
| Shelf Life (5 years) | Device has a 5-year shelf life, which is the same as predicate devices. |
| Design Dimensions (Diameter and Length) | Diameters: 5.9, 5.92, 6.0 mm; 6.8, 6.82 mm. Lengths: 7.2, 8.2, 9.7, 11.2, 12.7 mm. (These match the HGIII Ultra wide Fixture predicate). |
| Intended Use | For use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations, for single and two-stage surgical procedures, not for immediate load, and intended for the molar region. This is deemed substantially equivalent to predicate devices. |
| Technological Characteristics | The device has the same material, indication for use, and technological characteristics as the predicate devices. |
| Safety and Performance Validations | The ETIII SA Ultra wide System has been subjected to safety, performance, and product validations prior to release. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "fatigue testing" and "biocompatibility tests" but does not detail the number of units or data points tested.
- Data Provenance: Not specified. The testing is reported, but the origin of any data (e.g., country) is not mentioned. It is implied to be internal testing by HiOSSEN Inc. or its contractors.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes a medical device (dental implant), not a diagnostic algorithm that relies on expert ground truth for performance evaluation. The "ground truth" here is defined by physical and mechanical properties and established medical standards.
4. Adjudication method for the test set
- Not Applicable. As above, this is a physical device, and performance assessment is based on objective measurements against standards, not subjective expert assessment requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a hardware medical device (dental implant), not an AI-assisted diagnostic or treatment planning tool. No human reader studies are mentioned or relevant for this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used
- For mechanical and material properties: Established engineering standards (e.g., ISO, ASTM F67-06 for titanium), and comparison to predicate devices' known performance.
- For biocompatibility: Applicable international and US regulations for medical device safety.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set. The "training" in this context refers to the design and manufacturing processes adhering to established standards, materials, and designs validated by predicate devices.
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved for this type of device submission. The "ground truth" for the device's development stems from existing scientific knowledge, engineering principles, and the proven safety and effectiveness of the predicate devices it claims substantial equivalence to.
§ 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.