(51 days)
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Straumann Narrow Neck CrossFit Cementable Abutments are indicated for cement-retained single tooth and bridge restorations.
Straumann Narrow Neck CrossFit (NNC) Cementable Abutments are permanent abutments intended for placement onto the Straumann Narrow Neck CrossFit (NNC) tissue level Implants with the diameter of 3.3mm. The abutments are made of Titanium Grade 4 with a corresponding basal screw made of Titanium Alloy. The abutments are available in straight and 15° angled configurations.
Here's a breakdown of the acceptance criteria and the study information for the NNC Cementable Abutments, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study that Proves Acceptance |
|---|---|---|---|
| Performance Testing | Fatigue Performance | "function as intended and met the pre-determined acceptance criteria." | Fatigue Testing in accordance to FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." |
| Overall Equivalence | Substantial Equivalence to Predicate Device | "are substantially equivalent to the named predicate device and is safe and effective for its intended use." | Performance bench testing and risk analysis. |
| Intended Functionality | Function as Intended | "function as intended" | Performance bench testing and risk analysis, as well as the above fatigue testing. |
Missing Information: It's important to note that the document states that the device met pre-determined acceptance criteria for fatigue testing and overall performance. However, it does not quantify these acceptance criteria (e.g., "must withstand X cycles at Y load" or "fracture strength must be Z MPa"). Similarly, it doesn't provide specific numerical results of the device performance against these criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document refers to "Performance Testing" which included fatigue testing, but the number of devices tested is not mentioned.
- Data Provenance: Not specified. The company is Straumann USA, but the location where the testing was conducted is not stated. The study is prospective in the sense that newly manufactured abutments were tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This type of information (experts establishing ground truth for a test set) is typically relevant for studies involving diagnostic tools or image analysis where human interpretation is the "gold standard." For a mechanical device like a dental abutment, the "ground truth" is established through engineering and material science standards (e.g., ASTM, ISO, or FDA guidance documents for mechanical testing), not expert consensus in the diagnostic sense.
4. Adjudication Method for the Test Set
- Not Applicable. See explanation above. Mechanical test results are objective measurements against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic imaging or interpretation tasks where human readers make assessments. This is a mechanical device performance study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This question is typically asked for AI/ML-based diagnostic devices. This is a mechanical device, so there is no "algorithm only" performance in that context. The "standalone" performance here refers to the device itself (the abutment) without human interaction influencing its mechanical integrity during the test.
7. The type of ground truth used
- The ground truth for the performance testing was based on "FDA guidance document 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.'" This guidance document likely defines the mechanical testing protocols and performance thresholds (e.g., minimum fatigue life, maximum deformation) that dental abutments must meet to be considered safe and effective.
8. The sample size for the training set
- Not Applicable. This question is relevant for AI/ML models that require a training set. This is a mechanical device, not an AI/ML system.
9. How the ground truth for the training set was established
- Not Applicable. See explanation above.
§ 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.)