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Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants 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 by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

The proposed Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Roxolid (TiZr) Dental Implants utilize the Straumann Titanium Zirconium material, Roxolid, to the currently cleared Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Titanium dental implants.

The proposed devices are Tissue Level Roxolid dental implants with apical diameters of 4.1 mm and 4.8 mm, and coronal diameters of 4.8 mm and 6.5 mm. The implants will be available in varying lengths of 6.0.to 16mm.

The body of the proposed implants has a threaded implant body design made of Straumann's Titanium Zirconium (TiZr) Alloy material with Straumann's SLActive surface treatment. The proposed changes are a material change only. There are no changes to the surface treatment, indications for use, fundamental operating principles, or sterilization processes or procedures as a result of the proposed change. No new surgical instruments are being introduced as placement of the proposed implants will follow the established surgical protocols of the currently cleared Straumann Dental Implant Systems.

The provided document describes the acceptance criteria and the study that proves the device meets them for the "Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Roxolid Dental Implants".

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for the fatigue testing.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). This type of bench testing typically does not involve human subjects or retrospective/prospective data collection in the clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This was a physical bench test (fatigue testing) and did not involve expert review or ground truth establishment in the context of clinical images or diagnostic performance.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication was involved for a bench test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. This submission is for a material change to an existing dental implant and relies on bench testing to demonstrate substantial equivalence, not a clinical effectiveness study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device (dental implant), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is defined by the ISO 14801.2007(E) standard for dynamic fatigue testing of endosseous dental implants. The device's ability to withstand the forces defined by this standard serves as the "ground truth" for its mechanical performance.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no concept of a "training set" as would be used for an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device and testing.

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