(79 days)
AVANA Dental Implant Systems are designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium fixture when surgically implanted under controlled conditions, as per well known clinical studies. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
The Avana SS-II Implant is a threaded, root form endosseous implant comprised of an internal octa, one-stage 8° morse tapered device manufactured from commercially pure titanium. The implant's external threaded surfaces are roughened to facilitate tissue and bone integration. The implant's self-tapping feature may be used with or without pre-tapping the bone. System components for restorative purposes include: screw-on and cemented abutments, healing abutments, and angled abutments. Surgical accessories include drills, depth gages, drivers, torque wrenches, taps, reamers and fixture mount removal tool.
This document describes the acceptance criteria and study proving the device meets those criteria for the AVANA Dental Implant System.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. | Biocompatibility of the AVANA Dental Implant System was verified in accordance with ISO 10993-1. |
| Surface Treatment Performance | Animal studies conducted to determine the performance of the surface treatment. | Animal studies were conducted to determine the performance of the surface treatment. |
| Device Durability | In-vitro performance tests conducted to establish device durability (e.g., compression and fatigue tests). | In-vitro performance tests were conducted to establish device durability, including compression and fatigue tests. |
| Material Characterization | In-vitro performance tests conducted to characterize the implant surface treatment and purity (e.g., spectroscopic studies). | In-vitro performance tests were conducted to characterize the implant surface treatment and purity, including spectroscopic studies. |
| Substantial Equivalence | Device is substantially equivalent to predicate devices in construction, intended use, and principles of operation. | The AVANA Dental Implant System is substantially equivalent to the predicate devices in its construction, intended use, and principles of operation. |
2. Sample Size and Data Provenance
The provided text does not specify the exact sample sizes used for the biocompatibility animal studies or the in-vitro performance tests. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth
The provided information does not indicate the number of experts used to establish ground truth for any specific test set, nor does it state their qualifications. The studies mentioned (biocompatibility, animal studies, in-vitro performance) are laboratory or animal model-based, not involving human expert interpretation of data in the way a clinical diagnostic device might.
4. Adjudication Method
The provided information does not describe any adjudication method as it pertains to human interpretation of data. The types of studies cited (biocompatibility, animal, in-vitro) do not typically involve human adjudication in the context of establishing ground truth for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. This device is an endosseous implant, a physical medical device, not a diagnostic imaging or AI-assisted system that typically undergoes MRMC studies to evaluate human reader improvement.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study (i.e., algorithm only without human-in-the-loop performance) was done. This is not an algorithmic or AI device.
7. Type of Ground Truth Used
The ground truth for this device is based on:
- Established standards and methodologies: For biocompatibility, it's ISO 10993-1.
- Biological responses: For surface treatment performance, it's likely based on physiological reactions in animal models.
- Engineering and material science measurements: For device durability and material characterization, it's based on objective physical measurements from laboratory tests (e.g., compression, fatigue, spectroscopy).
8. Sample Size for Training Set
This device is a physical medical implant, not a machine learning model, therefore, there is no concept of a "training set" as understood in the context of AI or algorithms.
9. How Ground Truth for Training Set Was Established
As there is no training set for this type of device, this question is 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.