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Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches and for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. lmplants can be placed with immediate function on single-tooth and/or multiple-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

The Straumann® Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, healing abutments, closure screws and surgical and prosthetic parts and instruments. The Straumann® Dental Implant System includes various dental implants with different sizes and surfaces (SLActive® and Roxolid®). Straumann® Dental implants are solid screw implants manufactured from titaniumzirconium alloy (Roxolid®) or titanium Grade 4. The implant surface is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a NaCI solution.

The provided text describes a 510(k) Pre-Market Notification for the Straumann® Dental Implant System. It does not contain information about the acceptance criteria or a study designed to prove the device meets specific performance criteria. Instead, it details a change to the Instructions for Use (IFU) by removing Type II Diabetes and patients previously irradiated in the head and neck from the Cautions/Precautions.

The document discusses performance data but it is a review of published literature to support the change in IFU, not a study performing specific tests against acceptance criteria for the device itself.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used for a test set.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided document indicates that:

• Bench and animal performance testing was previously submitted in support of referenced predicate devices and deemed representative of the subject devices (Section 5.7). This implies that past studies covered the initial performance metrics, but the details of those studies and their acceptance criteria are not in this document.
• Performance data (for the IFU change): A review and summarization of published literature was conducted regarding dental implant treatment in patients with Diabetes Mellitus (DM) and patients previously irradiated in the head and neck area to justify removing these conditions from "Cautions/Precautions." This involved survival rates and adverse events from existing literature.

While the document references "performance data," it is not structured as an acceptance criteria study report for the device's functional attributes but rather a clinical literature review to justify a labeling change.

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