(135 days)
The OsseoFuse Dental 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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading.
The OsseoFuse Dental Implant system includes Hexa-Plus fixture, Hexa-Plus abutment, and Lab components. This system made of Titanium intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. It 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 surface of this system has been treated with R.B.M.
Hex-Plus Fixture is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). Surface of part to be implanted into bone is treated by RBM (Resorbable Blast Media) method to increase junction strength by increasing the area of bone-implant interface.
The tight and precisely fitting implant-abutment relation of the internal hexagon with internal bevel design makes abutment connection a quick and simple procedure.
Here's an analysis of the acceptance criteria and study information for the OsseoFuse Dental Implant System, based on the provided 510(k) summary:
The provided document describes a 510(k) premarket notification for the OsseoFuse Dental Implant System. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than conducting new clinical trials to establish de novo safety and effectiveness. Therefore, the "acceptance criteria" and "study" described are primarily focused on mechanical performance and comparison to predicate devices, not clinical outcomes or human reader performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | "The OsseoFuse Dental Implant System possess mechanical strength at least equivalent to the predicate devices." (Implied acceptance: >= predicate strength) | "mechanical testing of the implants demonstrated that the OsseoFuse Dental Implant System possess mechanical strength at least equivalent to the predicate devices." (Specific values are not provided, but equivalence is asserted). |
| Fatigue Performance | "this system meets its predefined acceptance criteria and performs in accordance with its intended use." (Implied acceptance: Equivalent to predicate fatigue performance and no failure under specified fatigue conditions). | "fatigue testing demonstrated that there is substantial equivalence in the performance, safety and effectiveness between the OsseoFuse Dental Implant System and the referenced predicate devices. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use." |
| Substantial Equivalence (General) | * Same intended use as predicate devices. * Same technological characteristics as predicate devices. * As safe and effective as predicate devices. * Does not raise different questions regarding safety and effectiveness. | * The device is stated to have the same intended use. * The device is stated to have similar technology, materials (Ti 6Al 4V ELI, RBM surface treatment, Gamma sterilization), and design features as the predicates (internal hex, bone-level, tapered, neck design). * The conclusion asserts the device is "as safe and effective as the predicate devices and therefore is determined to be substantially equivalent." |
Detailed Study Information (Based on 510(k) Content):
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests. For mechanical and fatigue testing, a sufficient number of samples would have been tested per device configuration (e.g., different diameters/lengths) to ensure statistical validity, but the exact numbers are not provided in this summary.
- Data Provenance: The studies were likely conducted internally by the manufacturer (KJ Meditech Co., Ltd. for the subject device) or a contracted lab. The document does not specify the country of origin of the data beyond the manufacturer's location (Korea, based on the manufacturer name). These were likely prospective bench tests performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable in the context of this 510(k) submission. The "ground truth" for mechanical and fatigue testing is based on engineering standards and test methodology (e.g., ASTM standards for dental implant testing). It does not involve human expert consensus or clinical evaluation in the same way a diagnostic AI device would. The "truth" is objective, measurable mechanical properties.
4. Adjudication Method for the Test Set
- Not applicable. As the "test set" refers to mechanical and fatigue properties, there is no human adjudication process involved. Results are typically compared against pre-defined engineering specifications or relative to predicate device performance.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where AI assists human readers. The OsseoFuse Dental Implant System is a physical medical device (implant) and does not involve AI for interpretation or human reader assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or AI system, but a physical implant. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- For mechanical and fatigue testing, the "ground truth" is established through objective physical measurements conducted according to recognized engineering standards (e.g., ISO, ASTM for dental implants). The comparison to predicate devices also serves as a benchmark for "ground truth" performance in a regulatory context.
- For the overall substantial equivalence, the "ground truth" is also the intended use, technological characteristics, and safety/effectiveness profile of the legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. Since this is not an AI/ML device, there is no "training set" in the computational sense. The design and manufacturing processes are informed by existing biomechanical knowledge, engineering principles, and the characteristics of successful predicate devices.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set in the AI sense. Design choices are based on established engineering principles for dental implants, materials science for biocompatibility and strength (e.g., Ti 6Al 4V ELI, RBM surface treatment), and the successful history of predicate devices. The "ground truth" here is the accumulated scientific and clinical knowledge in the field of dental implantology.
§ 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.