(125 days)
The HGIII Ultra wide 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 HGIII Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The HGIII Ultra wide Fixture System is intended to be used in the molar region.
The HGIII Ultra wide Fixture System 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 surface is RBM, Resorbable Blast Media, treated. HGIII Ultra wide Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has RBM surface.
This 510(k) premarket notification describes a dental implant system (HGIII Ultra wide Fixture System) and its substantial equivalence to a predicate device. This type of submission generally does not include studies demonstrating device performance against specific acceptance criteria in the way an AI/ML device would. Instead, substantial equivalence is established through comparison of design, materials, intended use, and performance characteristics (often non-clinical, such as fatigue testing) to a legally marketed predicate device.
Therefore, many of the requested elements for an AI/ML device study are not directly applicable or available in this document. I will extract the information that is present and indicate where certain information would not be found in this type of submission.
1. A table of acceptance criteria and the reported device performance
This document does not present "acceptance criteria" in the context of clinical performance metrics (like sensitivity, specificity, AUC) that an AI/ML device would need to meet. Instead, it establishes substantial equivalence based on a comparison of characteristics to a predicate device. The performance characteristics are primarily mechanical/material.
| Characteristic | Acceptance Criteria (Predicate Device K073465) | Reported Device Performance (HGIII Ultra wide Fixture) |
|---|---|---|
| Intended Use | Same as HGII Ultra wide Fixture System (K073465): partially or fully edentulous mandibles and maxillae, supporting various restorations; for single and two-stage surgical procedures; not for immediate load; intended for molar region. | Same as HGII Ultra wide Fixture System (K073465) |
| Structure | Single Thread, Straight body Type, Self tapping | Single Thread, Taper body Type, Self tapping |
| Connection Type | Internal hex connection | Internal hex connection |
| Diameter (D) | 6.0~7.0 | 6.0~7.0 |
| Length (mm) | 7.0~13.0 | 7.0~13.0 |
| Material of Fixture | Pure Titanium Grade 4 (ASTMF67-06) | Pure Titanium Grade 4 (ASTMF67-06) |
| Surface | RBM | RBM |
| Packaging | Polymeric Ampoule in a foil backed peel open blister pack | Polymeric Ampoule in a foil backed peel open blister pack |
| Sterilization | Radiation Sterile | Radiation Sterile |
| Shelf life | 5 years | 5 years |
| S & E (Safety & Effectiveness) | No changes in function and intended use | No changes in function and intended use |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not discuss a "test set" in the context of clinical data for performance evaluation. The primary "test" mentioned is non-clinical fatigue testing.
- Sample Size for Test Set: Not applicable for clinical performance. For fatigue testing, it's mentioned as "the worst case scenario of the GSIII Fixture(or HGIII Fixture) and an angled abutment". The exact number of samples for this test is not specified in the summary.
- Data Provenance: Not applicable for clinical performance. The fatigue testing is likely laboratory-based, performed by the manufacturer, HiOSSEN Inc. (Fairless Hills, PA, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission does not involve human readers establishing ground truth for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no multi-reader adjudication for a test set.
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
No MRMC study was done. This is a submission for a dental implant, not an AI/ML device intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not an AI/ML device, so standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device like a dental implant, "ground truth" relates to material properties, mechanical integrity, and biocompatibility.
- For material properties and dimensions: Standardized measurements and material certifications (e.g., Pure Titanium Grade 4 (ASTMF67-06)).
- For functional performance: Non-clinical bench testing (e.g., fatigue testing) against established industry standards and guidance documents ("Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment").
- For biocompatibility: Biocompatibility tests performed to comply with applicable International and US regulations.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no training set or ground truth established for it in that context.
§ 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.