(259 days)
The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® Bone Level abutments and prosthetic parts.
Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.
Abutments can be used in single tooth replacements and multiple tooth restorations. The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm.
The Oktagon Bone Level System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
The Bone Level Implant is an addition to the currently distributed OKTAGON® dental implant system.
The root-form designed implant is made of commercially pure Titanium Grade 4 conforming to ASTM Standard Specification F67. The surface is micro-structured in the endosteal section and the implant shoulder is polished. The implant surface has been blasted with high-grade corundum and afterwards acid-etched.
The prosthetic connection is achieved with the help of an inner cone with an additional octagonal anti-rotation device.
A sterile locking screw is enclosed with the implant so that an immediate occlusion of the internal thread is allowed after successful insertion.
The endosseous dental implants are available in a range of endosseous diameters and lengths.
The abutments are available in different versions including the corresponding screws. The abutments are made of Titanium Grade 4, Titanium Alloy or POM; the connection to the implants is achieved by an internal octagon/nut construction and a metric thread.
The following types of abutments will be available:
- . Cover screw
- Healing abutment
- Straight abutment ●
- Alligator abutment
The provided document is a 510(k) summary for a medical device called "Dental Implant System OKTAGON® Bone Level." It establishes substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way an AI/ML device would.
Therefore, many of the requested fields (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for a physical medical device.
However, I can extract information related to performance testing that serves as the basis for demonstrating safety and effectiveness relative to established standards.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
For this physical medical device, the "acceptance criteria" are the requirements outlined in the referenced international and national standards. The "reported device performance" is a statement of successful adherence to these standards.
| Acceptance Criteria (Standard Requirements) | Reported Device Performance |
|---|---|
| ISO 14801: Fatigue testing requirements for dental implants. | Performance tests (fatigue tests) have been conducted, fulfilling the requirements of ISO 14801. |
| FDA's "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments": Specific guidance for this device type. | Performance tests have been conducted, fulfilling the requirements of the FDA's "Guidance..." |
| ISO 7405: Dental Materials - Evaluation of biocompatibility of medical devices used in dentistry. | Followed. |
| ISO 10993-1: Biological evaluation of medical devices (Part 1: Evaluation and testing within a risk management process). | Followed. |
| ISO 5832-2: Implants for surgery - Metallic materials - Part 2: Unalloyed titanium. | Followed (material: commercially pure Titanium Grade 4 conforming to ASTM F67). |
| ASTM F67: Standard Specification for Unalloyed Titanium for Surgical Implant Applications. | Followed (material: commercially pure Titanium Grade 4 conforming to ASTM F67). |
| ISO 11137-1, ISO 11137-2: Sterilization of health care products - Radiation (Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Part 2: Establishing the sterilization dose). | Followed. |
| ISO 14971: Medical devices - Application of risk management to medical devices. | Followed. |
| ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. | Followed. |
| ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities. | Followed for sterilization validation of accessories. |
| ISO 11607-1:2009: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. | Followed. |
| ASTM F88/F88M-09: Standard Test Method for Seal Strength of Flexible Barrier Materials. | Followed. |
| ASTM F1929-98 (2004): Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. | Followed. |
| ISO 5832-3: Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy. | Followed. |
| ASTM F136: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. | Followed. |
| ISO 17665-1, ISO 17665-2: Sterilization of health care products - Moist heat (Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices; Part 2: Guidance on the application of ISO 17665-1). | Followed for sterilization validation for accessories. |
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: Not specified in the document. The performance tests (fatigue tests) are likely conducted on a sample of devices according to the requirements of the specified standards (e.g., ISO 14801).
- Data Provenance: Not specified. Standard performance testing is typically conducted in a laboratory setting, often by the manufacturer or a third-party testing facility. This is not "clinical data" in the sense of patient data.
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. "Ground truth" in this context would refer to the established performance requirements outlined in the engineering and material standards. These are not established by clinical experts in the same way an AI/ML diagnostic output needs ground truth. Compliance to these standards is verified by testing engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to resolving discrepancies in expert interpretations, primarily relevant for image-based diagnostic AI/ML. For a physical device, performance is measured against objective engineering metrics.
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 physical dental implant system, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is the adherence to the engineering and material specifications defined by international standards (e.g., ISO 14801 for fatigue, ASTM F67 for material composition). These standards establish objective, measurable criteria for safety and performance.
8. The sample size for the training set
- Not applicable. This device does not use machine learning, so there is no training set. Design validation and verification are based on engineering principles and regulatory standards.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
§ 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.