(364 days)
The GC Aadva Implant System is a titanium alloy screw-type endosseous dental implant and endosseous dental implant abutment, which is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function. The GC Aadva Implant System is intended for immediate loading only when good primary stability is achieved and with appropriate occlusal loading.
The GC Aadva Implant System is an endosseous dental implant made of Ti-6Al-4V ELI alloy and consists of several components. Geometrically, the implant is screw-type. An abutment is connected to the implant through a tapered-joint. Implants are treated with sandblast and acid etching using scanning electron microscopy (SEM). The device functions by being surgically implanted in the bone of the upper or lower jaw arches in order to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function. With regard to the scientific concepts that form the basis for the device, root-form endosseous dental implant devices are characterized by four geometrically distinct types: basket, screw, solid cylinder, and hollow cylinder. The GC Aadva Implant System is a “screw” endosseous dental implant. With regard to the physical and performance characteristics of the GC Aadva Implant System, the design shape, engaging method, implant surface treatment and dimensions (lengths and diameters) are the same as the lawfully marketed predicate GC JNE Implant System.
The information provided is for the GC Aadva Implant System, a dental implant device, and does not involve AI or machine learning. Therefore, many of the requested fields are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance Study for the GC Aadva Implant System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Conducted | Reported Device Performance |
|---|---|---|
| Nonclinical Data | Material Characterization: |
- Solubility
- Corrosion and Electrochemical properties | - Ti-6Al-4V alloy is estimated to be a corrosion-resistant material. |
| | Biocompatibility: - Cytotoxicity | - Ti-6Al-4V alloy is estimated to be not cytotoxic. |
| | Mechanical Properties: - Fatigue | - Ti-6Al-4V ELI alloy has acceptable strength according to the fatigue test results. |
| | Packaging System Validation: - Sterilized products and non-sterile components packaging validation | - Packaging system for sterilized products and non-sterile components is the same as the predicate JNE Implant System (K072425) in constituent materials and structure, validated according to ISO 11607-1. |
| | Animal Testing (Biocompatibility): - Suitability for surgical implant use (titanium alloy) | - Results indicate that Ti-6Al-4V ELI alloy is suitable for surgical implant use. |
| | Animal Testing (Osseointegration/Compatibility): - Compatibility to bone tissue | - Results indicate that Ti-6Al-4V ELI alloy is compatible with bone tissue. |
| | Compliance with Guidance Document: - Bench testing in accordance with "Guidance for Industry and FDA Staff Class II -- Special Controls Guidance Document: Root-form Endosseous Dental Implants" | - Bench testing demonstrates that this device meets the mechanical properties recommendations by FDA. (This implies that the device performed within acceptable limits defined by the guidance). |
| Clinical Data | No clinical data was submitted. | N/A - The submission explicitly states: "No clinical test data is being submitted with this 510(k)." Substantial equivalence was based on nonclinical data and comparison to predicate devices, showing it performs "as well or better than predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as this is not a study with a test set in the conventional sense of AI models. The "tests" refer to bench and animal studies of the material and device components. The document describes several tests conducted on the Ti-6Al-4V ELI alloy and the device system. Specific sample sizes for each nonclinical test (e.g., number of implant specimens for fatigue testing, or number of animals for biocompatibility) are not provided in this summary.
- Data Provenance: The tests (solubility, corrosion, cytotoxicity, fatigue, animal testing, packaging validation) were conducted by the manufacturer (GC Corporation, Japan) and/or related testing facilities. The specific geographical origin for each test data point is not detailed beyond the manufacturer's location in Tokyo, Japan, and the sterilization facility in Gunnma, Japan. The studies are prospective insofar as they were explicitly performed to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes a traditional medical device submission based on bench and animal testing, not an AI/ML device requiring human expert annotation to establish ground truth for a test set. Ground truth for material properties and biological compatibility comes from established scientific and engineering principles, international standards (ISO, ASTM), and the results of laboratory and animal experiments.
4. Adjudication Method for the Test Set
This is not applicable as there is no "test set" in the context of human interpretation or AI output that would require an adjudication method. The evaluation of test results (e.g., whether fatigue strength is "acceptable" or material is "not cytotoxic") is based on predefined pass/fail criteria from recognized standards or established scientific norms.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable as the device is a dental implant system, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical dental implant, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the GC Aadva Implant System is established through:
- Bench Test Results: Direct measurements of physical, chemical, and mechanical properties (e.g., solubility, corrosion, fatigue strength).
- Adherence to Standards: Compliance with recognized international standards such as ISO 11607-1 for packaging and unspecified ASTM/ISO standards for material properties.
- Animal Testing Observations: Direct biological responses and integration in animal models (e.g., "suitability for surgical implant use," "compatibility to bone tissue").
- Comparison to Predicate Devices: The concept of "substantial equivalence" is based on demonstrating that the new device has the same technological characteristics, materials, and performs "as well or better" than predicate devices that are already legally marketed and established as safe and effective.
8. The Sample Size for the Training Set
This information is not applicable as this is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is not an AI/ML device.
§ 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.