(427 days)
The Biogenesis Implant System - Aticon 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 Biogenesis Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
The Biogenesis™ Implant System replaces the root of a missing tooth and is made from surgical grade titanium alloys. The Biogenesis™ Implant System is comprised of two components, implant, which is the portion that goes into the jaw bone, and the abutment, which fits into the implant and provides a solid base for a crown or a denture.
The provided document describes a 510(k) premarket notification for the "Biogenesis™ Implant System - Aticon," a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with acceptance criteria for device performance as would be seen for novel devices.
Therefore, many of the requested elements for a study proving acceptance criteria (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and specific ground truth establishment) are not applicable to this type of regulatory submission. The "study" here is primarily a non-clinical comparison and validation against established standards and predicate devices.
Here's a breakdown of the available information in relation to your request:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are not reported as quantitative performance metrics against specific benchmarks for clinical outcomes as one might expect for a new performance claim. Instead, the acceptance criteria are implicitly that the device must be "substantially equivalent" to predicate devices in terms of materials, design, function, and intended use, and must pass non-clinical safety tests.
| Acceptance Criteria (Implicit from Substantial Equivalence Basis) | Reported Device Performance (Non-Clinical Validation) |
|---|---|
| Material Composition (Surgical Grade Titanium Alloys) | Chemical Analysis: Verified material composition to be surgical grade titanium alloys, same as predicate devices. |
| Surface Treatment Cleanness | Surface Roughness Analysis and Chemical Analysis: Conducted to verify cleanness after surface treatment. The subject and predicate implants have the same surface treatments. |
| Sterilization Efficacy | Sterilization Validation Tests: Provided for both sterile and non-sterile components. |
| Biocompatibility | Biocompatibility Test (ISO 10993-5 Cytotoxicity Test): Results not explicitly stated, but completion implies compliance with this standard, indicating non-cytotoxic properties. |
| Design and Sizing Equivalence | Comparison of design features and sizing: Found to be substantially the same as predicate systems. Includes similar range of physical dimensions (diameter and length of implants, diameter and height of abutments). |
| Intended Use Equivalence | Indication for Use Statement Analysis: "The Biogenesis™ Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations... intended for delayed loading." This is stated to be the same intended use as the predicate devices. |
| Operating Principle Equivalence | Functional Comparison: Uses the same operating principle as predicate devices. |
| Safety - No Adverse Affects | "There are no significant differences between the Biogenesis™ Implant System and other systems currently being marketed which would adversely affect the use of the product." (This is a conclusion from the non-clinical testing and comparison, implying the device meets safety expectations based on its equivalence to safely marketed predicate devices). |
| Regulatory Compliance (General Controls) | The FDA's substantial equivalence determination allows the device to be marketed, subject to general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, etc.). This is an overarching "acceptance criterion" for market entry rather than a performance metric. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing (material analysis, sterility, biocompatibility) rather than a clinical "test set" of patients.
- Data Provenance: The non-clinical testing was conducted to validate the device's safety. The manufacturer, Biogenesis Co., Ltd., is located in the Republic of Korea. Therefore, the non-clinical test data likely originated from Korea or an accredited lab engaged by the manufacturer. The data would be considered prospective in the sense that these tests were performed specifically for this submission.
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. There was no clinical "test set" that required ground truth establishment by experts for performance evaluation in the context of this 510(k). The "ground truth" for the non-clinical tests is established by the relevant ISO standards and analytical methods used (e.g., ISO 10993-5 for cytotoxicity).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical "test set" requiring 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 is a dental implant system, not an AI-powered diagnostic device, and no MRMC studies were performed or are relevant to this 510(k) submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests (e.g., material analysis, cytotoxicity, sterilization), the "ground truth" is defined by the validated and recognized international standards (e.g., ISO 10993-5) and analytical methods used in laboratories to assess material properties, biocompatibility, and sterilization effectiveness. "Substantial equivalence" to predicate devices, which are already deemed safe and effective, also serves as a form of ground truth for regulatory acceptance.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set."
§ 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.