(234 days)
The ETII SA 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
The ETII SA Fixture System is 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. ETII SA Fixture is composed of single threads with internal hex connection straight body of bone level for two stage surgery. It has SA surface. The ETII SA Fixture System is for single and two stage surgical procedures. ETII SA Fixture System is compatibly used with abutment in the ET/SS Implant System (K120847). The ETII SA Fixture 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 ETII SA Fixture is available in various lengths and diameters according to the anatomical situation.
This document describes a 510(k) premarket notification for the Hiossen ETII SA Fixture System, a dental implant. The purpose of the submission is to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated through a declaration of substantial equivalence based on material, indication for use, and similar design/technological characteristics to predicate devices. The primary "acceptance" is the FDA's determination of substantial equivalence.
| Aspect of Equivalence | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material | Must be the same as predicate device (Pure Titanium Grade 4). | The ETII SA Fixture System uses Pure Titanium Grade 4 (ASTMF67-06), which is the same as the predicate devices (ET III SA Fixture System, HGII Fixture system, HG II Short Fixture System). |
| Indication for Use | Must be the same as predicate devices. | The ETII SA Fixture System's indication for use is identical to the predicate devices: "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." |
| Design & Technological Characteristics | Must be similar to predicate devices, with no significant differences altering safety or effectiveness. | The ETII SA Fixture System has a straight body type, self-tapping, submerged fixture, and internal hex connection, similar to the HGII Fixture system. The surface is SA treated, similar to the ET III SA Fixture System. The document states there are "no big differences between design of ETII SA Fixture System and predicate device, especially ETII SA Fixture System is almost the same with HGII Fixture system except thread shape of the top." |
| Fatigue Testing | Must demonstrate comparable or superior resistance to fatigue as predicate device, considering worst-case scenarios. | Fatigue testing was conducted according to FDA guidance using a worst-case scenario (HGII Fixture with an angled abutment). The report states that the "fatigue test result of HGII Fixture can be used as a proof of ETII SA Fixture System" because the ETII SA Fixture System has the same material and similar design as the HGII Fixture. |
| Biocompatibility | Must comply with applicable international and US regulations. | Biocompatibility tests have been performed to ensure compliance with applicable regulations. |
2. Sample Size Used for the Test Set and Data Provenance
This submission is for a medical device (dental implant) and does not involve an AI algorithm with a 'test set' in the traditional sense of evaluating diagnostic or predictive performance on a dataset. The "test" in this context refers to non-clinical bench testing (fatigue testing, biocompatibility).
- Sample Size for Non-Clinical Testing: The specific number of devices tested for fatigue or biocompatibility is not provided in this summary. It only indicates that "fatigue testing was considered" and "biocompatibility have been performed."
- Data Provenance: The data provenance for the non-clinical tests (fatigue, biocompatibility) would be from the manufacturer's internal testing. The submission does not specify the country of origin of this testing, but Hiossen Inc. is located in Fairless Hills, PA, USA. The testing is prospective in the sense that it was performed specifically for this submission to demonstrate substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI diagnostic device that requires expert-established ground truth on a test set of medical images or patient data. The "ground truth" for a dental implant's performance is established through material standards, engineering specifications, and biological compatibility, verified by laboratory testing as opposed to expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable, as there is no 'test set' requiring expert adjudication for ground truth establishment.
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 device is a physical dental implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.
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
For this type of device, the "ground truth" is defined by:
- Material Specifications: Adherence to standards like ASTM F67-06 for Pure Titanium Grade 4.
- Engineering Standards: Meeting performance criteria for mechanical properties, particularly fatigue resistance, often guided by industry standards and FDA guidance documents (e.g., "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment").
- Biocompatibility Standards: Compliance with ISO or FDA standards for biological evaluation of medical devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical dental implant.
§ 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.