(74 days)
The HG II 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 HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load.
The HG II Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
This document is a 510(k) summary for the Hiossen HG II Fixture System, a dental implant. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated study proving performance against general acceptance criteria for such a device.
Therefore, many of the requested categories of information are not present in this type of regulatory submission. The document explicitly states: "The HG II Fixture System is substantially equivalent in design, function and intended use to the HG II Fixture System (K080744) of Osstem Implant Co., Ltd."
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:
1. A table of acceptance criteria and the reported device performance
This document does not define specific "acceptance criteria" for the device's performance in a quantitative or qualitative manner that would typically be found in a study or a validation report outlining specific metrics (e.g., strength, biocompatibility thresholds). Instead, it states the device has undergone general safety and performance validations.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety and Performance | "The HG II 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." |
| Material Composition | "same material as the predicate device" |
| Indication for Use | "same indication for use as the predicate device" |
| Design and Technological Characteristics | "similar design and technological characteristics as the predicate device" |
| Substantial Equivalence | "safe and effective and substantially equivalent to the predicate device as described herein" |
Note: The "acceptance criteria" here are inferred from the statements made for regulatory clearance, rather than explicit, quantifiable metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document. The document refers to "safety, performance, and product validations" but does not detail the sample sizes, study design (retrospective/prospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a 510(k) summary for device clearance, not a study evaluating human or AI performance against a ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a 510(k) summary for device clearance, not a study involving expert 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 document is for a dental implant system. There is no mention of AI assistance or human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a physical medical device (dental implant), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document relies on demonstrating substantial equivalence to a predicate device, supported by safety and performance validations, rather than establishing a new ground truth for a diagnostic task. The "ground truth" for regulatory clearance is that the device meets safety and effectiveness requirements and is substantially equivalent to a legally marketed predicate.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
§ 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.