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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

Study Details

1. 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."
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test data was necessary.
4. 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.
5. 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.
6. 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.
7. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device and no training set was used.
8. How the ground truth for the training set was established: Not applicable, as this is not an AI/algorithm-based device.

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