(153 days)
Nobel Biocare's NobelActive implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Nobel Biocare's NobelActive Wide Platform (WP) implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The NobelActive Wide Platform (WP) implants share the same basic design principles as the existing NobelActive Internal Connection Implant. The Wide Platform (WP) implants are a bigger diameter implant extending the range of the existing NobelActive platforms. The Wide Platform is made of commercial pure titanium, is 5.5 mm in diameter, and available in lengths from 6.5 mm to 12.5 mm.
Healing and temporary abutments in both titanium/vanadium alloy and PEEK and definitive abutments made of titanium/vanadium alloy are available for the new WP platform. Titanium abutments may also be designed and made individually to fit the individual requirements for each patient using NobelBiocare's NobelProcera system.
The provided text describes a 510(k) submission for the Nobel Biocare NobelActive Wide Platform (WP) implant, seeking substantial equivalence to predicate devices. The submission focuses on technological characteristics and MR conditional testing, and explicitly states that no clinical data was necessary. As such, the requested information regarding acceptance criteria, study details, and ground truth establishment for an AI/algorithm-based device is not applicable to this submission.
Therefore, many of the requested fields cannot be filled.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No clinical acceptance criteria were defined for this submission as per the risk management system. | The device was deemed substantially equivalent to predicate devices based on technological characteristics and MR conditional testing. |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. The submission explicitly states, "Nobel Biocare utilizes an ISO 14971 Risk Management System. The NobelActive Wide Platform (WP) was subjected to this system which determined that no clinical test data was necessary to support the decision of safety and effectiveness excluding the MRI Safety and compatibility."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test data was necessary.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test data was necessary.
- 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 not an AI/algorithm-based device, and no MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical test data was necessary. The determination of substantial equivalence was based on technological characteristics and MR conditional testing results.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device and no training set was used.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/algorithm-based 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.