(52 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, bridges and overdentures.
Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridge Restoration is a permanent abutment intended for placement on the Straumann Narrow Neck CrossFit (NNC) tissue level Implant with a diameter : of 3,3mm. The abutment is made of a non-oxiding gold alloy.
Here's an analysis of the provided text regarding the Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridges, focusing on acceptance criteria and supporting studies:
It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter. These documents typically summarize the results of testing rather than providing the full study reports. Therefore, some details you requested may not be explicitly stated.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly detailed in terms of specific numeric thresholds within the public 510(k) summary. However, the document states that the device was evaluated against the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance document would define the performance requirements, including fatigue testing parameters.
The reported device performance is a general statement that the device "met the pre-determined acceptance criteria" and "functions as intended." This implies that the device successfully passed the fatigue testing outlined in the FDA guidance.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" for fatigue testing. | "Met the pre-determined acceptance criteria." |
| Device functions as intended. | "Functions as intended." |
| Substantial equivalence to predicate device (Straumann Narrow Neck CrossFit (NNC) Gold Abutment for crown restoration). | "Substantially equivalent to the Straumann Narrow Neck CrossFit (NNC) Gold Abutment for crown restoration." |
Study Details:
-
Sample size used for the test set and the data provenance:
- Sample size: The specific number of abutments used for fatigue testing is not provided in this summary. The FDA guidance typically specifies the number of samples required for such tests (e.g., a certain number of devices for specific load levels).
- Data provenance: The document indicates that the testing was performed by Straumann US (on behalf of Institut Straumann AG), suggesting internal testing. The country of origin of the data is not specified beyond "Straumann US." It is a prospective study in the sense that the testing was planned and executed for the purpose of demonstrating device performance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and study. The "ground truth" for mechanical performance tests like fatigue testing is established by the physical testing itself and the engineering specifications/standards, not by human expert consensus or clinical assessment.
-
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment (e.g., image interpretation). Mechanical testing does not involve human adjudication in this manner; the pass/fail criteria are based on objective measurements from the testing equipment.
-
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 study is for a dental abutment, a passive mechanical component, not an AI-powered diagnostic device or a system that involves human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical component, not an algorithm.
-
The type of ground truth used:
- The "ground truth" for this performance testing is the objective measurement of mechanical properties (e.g., resistance to fatigue failure) as defined by the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance provides the scientific basis and methodology for determining acceptable performance. It's essentially a set of engineering standards and test protocols.
-
The sample size for the training set:
- Not applicable. There is no "training set" for this type of mechanical device performance testing. Training sets are relevant for machine learning algorithms.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
Summary of what is known from the provided text:
- The device underwent fatigue testing as per FDA guidance.
- The testing demonstrated the device met predetermined acceptance criteria and functions as intended.
- The device was deemed substantially equivalent to a predicate device (NNC Gold Abutment for crown restoration).
- The study was a bench test evaluating mechanical performance.
- Many of the requested details (e.g., sample sizes, expert qualifications, MRMC studies, AI performance) are not applicable or not provided in this specific 510(k) summary, as they relate to different types of medical devices or study designs (e.g., diagnostic AI, clinical trials).
§ 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.)