(101 days)
Straumann Temporary Abutments VITA CAD-Temp are indicated for use with Straumann Bone Level and Tissue Level implants for temporary crown and bridge restorations, and to maintain, stabilize and shape the soft tissue during the healing phase for up to six months, and should be placed out of occlusion.
Straumann Temporary Abutments VITA CAD-Temp are temporary abutments intended for placement on Straumann Bone Level and Straumann Tissue Level implants of corresponding diameter. The temporary abutments are made of polymethyl methacrylate (PMMA), with a Titanium Alloy inlay.
The manufacturer performed fatigue testing and sterilization validation to ensure that the device functions as intended and meets predetermined acceptance criteria.
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fatigue Testing | Based on the performance of predicate devices as outlined in the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | The proposed devices met or surpassed the acceptance criteria. |
| Sterilization Validation | In accordance with ISO 17665-1 and ISO 17665-2 for moist heat sterilization (overkill method, partial cycle). | Requirements were met, and there were no deviations to the applicable standards. |
2. Sample size(s) used for the test set and the data provenance:
- Fatigue Testing: The specific sample size for fatigue testing is not explicitly stated in the provided text.
- Sterilization Validation: The specific sample size for sterilization validation is not explicitly stated in the provided text.
- Data Provenance: Not specified, but generally, such tests are conducted in a controlled laboratory environment by the manufacturer or a third-party testing facility. The document does not indicate country of origin for 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):
This information is not applicable to the described testing. The described tests (fatigue and sterilization) are bench tests and do not involve expert interpretation or ground truth establishment in the clinical sense. The ground truth for fatigue testing is the mechanical integrity of the device under stress, determined by engineering principles and comparison to predicate devices. For sterilization, it's the successful elimination of microorganisms.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable to the described bench tests. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments.
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 document describes the premarket notification for a dental implant abutment, which is a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document describes the premarket notification for a physical medical device. There is no algorithm involved in the function of the Straumann Temporary Abutments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Fatigue Testing: The "ground truth" for fatigue testing is the mechanical performance and integrity of the device under specified loading conditions, with acceptance criteria based on the demonstrated performance of legally marketed predicate devices. This is an engineering/bench test "ground truth."
- Sterilization Validation: The "ground truth" for sterilization validation is the sterility assurance level achieved, demonstrating the elimination of microorganisms according to established international standards (ISO 17665-1 and ISO 17665-2). This is a microbiological/bench test "ground truth."
8. The sample size for the training set:
Not applicable. This device is a physical medical device and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for this device, a ground truth for it was not established.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)