(28 days)
The HGIII 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 Fixture System is for single and two stage surgical procedures. It is not for immediate load.
The HGIII Fixture System is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
This 510(k) pertains to a dental implant system (HGIII Fixture System) and is a substantial equivalence submission, not a de novo submission. Therefore, the information provided focuses on demonstrating equivalence to a predicate device rather than presenting novel acceptance criteria or a study designed to prove the device meets specific performance criteria against pre-defined thresholds.
Here's a breakdown of why many of your requested items cannot be directly extracted from this document:
- Acceptance Criteria & Device Performance Table: The document explicitly states: "The HGIII Fixture System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." However, it does not provide specific acceptance criteria or reported device performance metrics in a tabular format because the submission is based on demonstrating substantial equivalence to a predicate device (K082213), rather than proving performance against novel criteria. The assumption is that if it's substantially equivalent, it meets the same implicit performance as the predicate.
- Sample sizes, data provenance, expert ground truth, adjudication, MRMC, standalone studies, type of ground truth, training set information: These are typically found in detailed performance studies for novel devices or when specific performance claims are being made. For a substantial equivalence claim, the focus is on comparing the new device's design, materials, and intended use to a legally marketed predicate device. The document states "The HGIII Fixture System is substantially equivalent in design, function and intended use to the HGIII Fixture System (K082213) of HiOSSEN Inc." and mentions that it "has same material and indication for use and similar design and technological characteristics as the predicate device." This indicates that the primary "study" is a comparison and justification of equivalence, not a clinical trial or performance study generating the detailed data you're asking for.
However, I can extract the information that is present in the document related to the study's nature:
Acceptance Criteria and Study for Hiossen Inc. HGIII Fixture System (K093352)
This 510(k) submission demonstrates substantial equivalence to a predicate device, rather than defining and meeting novel acceptance criteria through independent clinical or performance studies. Therefore, many standard elements of a performance study are not explicitly detailed.
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided as this is a substantial equivalence submission. The "acceptance criteria" for this type of submission are implicitly that the device is "substantially equivalent" to the predicate device (K082213) in terms of intended use, technology, materials, and performance characteristics.
| Acceptance Criteria Category | Predicate Device Performance (Implicitly Met by HGIII) | Reported HGIII Fixture System Performance |
|---|---|---|
| Intended Use | Partially/fully edentulous mandibles/maxillae; support single/multiple-unit restorations; single/two-stage surgical procedures; not for immediate load. | Meets: Same as predicate device. (Stated in Section 5) |
| Material Composition | Titanium metal. | Meets: Titanium metal. (Stated in Section 4 & 6) |
| Design Characteristics | Specific design features of K082213. | Similar: "similar design" to predicate device. (Stated in Section 6) |
| Technological Characteristics | Specific technological features of K082213. | Similar: "similar technological characteristics" to predicate device. (Stated in Section 6) |
| Safety and Biocompatibility | Complies with international/US regulations. | Meets: "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." (Stated in Section 6) |
| Performance Validations | Product validations prior to release. | Meets: "product validations prior to release." (Stated in Section 6) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/not specified. The submission is a comparison for substantial equivalence, not a clinical trial with a "test set" of patients or samples in the traditional sense for evaluating novel performance metrics.
- Data Provenance: Not applicable/not specified. The document refers to prior safety, performance, and product validations conducted by the manufacturer, but does not detail their scope, data origin, or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/not specified. Ground truth establishment by experts for a test set is typically for performance claims against a reference standard, which is not the primary focus of this substantial equivalence submission. The review process by the FDA involves their own experts, but this is an internal regulatory process, not part of the manufacturer's performance study described here.
4. Adjudication method for the test set
- Not applicable/not specified.
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 device is a dental implant, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical dental implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of a "test set" for performance evaluation. The "ground truth" for this submission is the predicate device (K082213), against which the new device (HGIII Fixture System) is compared for substantial equivalence in design, materials, and intended use.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The manufacturer conducted internal "safety, performance, and product validations" but no details on sample sizes are provided.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.