(215 days)
The HIOSSEN 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. ETIII SA Ultra Wide Fixture is intended to be used in the molar region.
The HIOSSEN Implant 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 HIOSSEN Implant System include length 18mm implant. The HIOSSEN Implant System is a revised product that Dimension and code(art#) are changed and added from predicate product, ETII SA Fixture, HTIII SA Fixture and ETIII SA Ultra Wide Fixture therefore there is no difference about material, indication for use and design from predicate as above. And the subject devices and the predicate devices encompass the same range of physical dimensions except length 18mm and characteristics, including implant diameter and surface treatment.
The provided document is a 510(k) premarket notification for the HIOSSEN Implant System. It does not describe a study involving algorithms, AI, or human readers, but rather demonstrates substantial equivalence to predicate devices through non-clinical testing.
Therefore, many of the requested categories related to algorithm performance, expert ground truth, and human-in-the-loop studies are not applicable to this document.
Here's a breakdown of the information that is available in the document:
1. Table of acceptance criteria and reported device performance:
The document describes the HIOSSEN Implant System as substantially equivalent to predicate devices based on various characteristics, primarily focusing on materials, indications for use, and design. The "acceptance criteria" are implied by the comparison to the predicate devices, meaning the new device should not raise new questions of safety and effectiveness regarding these characteristics.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (HIOSSEN Implant System) |
|---|---|---|
| Intended Use | 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. Intended for delayed loading. Ultra-wide Fixture System intended for molar region. | The HIOSSEN 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. ETIII SA Ultra-Wide Fixture is intended to be used in the molar region. (Same as predicate) |
| Structure | Internal Hex-connected, Submerged Fixture, Tapered body shape & Straight body shape. | Internal Hex-connected, Submerged Fixture, Tapered body shape & Straight body shape. (Similar to predicate) |
| Material of Fixture | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) (Same as predicate) |
| Surface | SA surface treatment | SA surface treatment (Same as predicate) |
| Sterilization | Radiation Sterile | Radiation Sterile (Same as predicate) |
| Shelf Life | 5 Years | 8 Years (Improved from predicate; requires justification but does not suggest non-equivalence) |
| Dimensions (Diameter) | Range provided by predicates (e.g., 3.75 - 6.82mm) | HIOSSEN Implant System includes diameters: 3.5, 3.75, 3.77, 4.2, 4.25, 4.45, 4.6, 4.63, 4.65, 4.9, 5.0, 5.05, 5.08, 5.1, 5.92, 5.95, 6, 6.8. Some diameters are modified or added compared to predicates, but stated as encompassing the same range of physical dimensions or being a revised product (e.g., "Diameter is modified," "Diameter is modified/ |
| Length 6.2mm is added," "Diameter is modified," etc.). | ||
| Dimensions (Length) | Range provided by predicates (e.g., 6.2 - 15.2mm) | HIOSSEN Implant System includes lengths: 6.2, 7.2, 8.7, 10.2, 11.7, 13.2, 15.2, 18.2. Length 18.2mm is added for several diameters, and 6.2mm is added for some ultra-wide fixtures. The document states "the subject devices and the predicate devices encompass the same range of physical |
| dimensions except length 18mm." | ||
| Performance | Static and dynamic compression-bending in worst-case scenario. | Fatigue testing in air demonstrated the subject device to the tested predicate because shape and minimum diameter of subject devices are the same with predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not applicable. The "test set" in this context refers to non-clinical testing of the physical device. The document mentions "engineering analysis, dimensional analysis, static and dynamic compression-bending testing" and "fatigue testing in air." Specific sample sizes for these tests are not provided in this summary.
- Data provenance: Not applicable. This refers to physical device testing, not data from human subjects or images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This document is for a dental implant system, not an AI/algorithm-based diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for a physical medical device submission.
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 physical dental implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical dental implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for demonstrating substantial equivalence for this device is based on established engineering standards for medical devices (e.g., ASTM F67 for material, "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" for mechanical testing). The comparison is against predicate devices that have already demonstrated safety and effectiveness.
8. The sample size for the training set:
Not applicable. There is no algorithm or AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no algorithm or AI model requiring a training set.
§ 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.