(56 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.
Narrow Neck CrossFit Solid Abutments are indicated for cement-retained single tooth and bridge restorations.
Temporary Copings made from PEEK (polyether etherketone) are intended to serve as a base for temporary restorations for up to 180 days.
Temporary Copings made from PMMA (polymethyl methacrylate) are intended to serve as a base for temporary restorations for up to 30 days.
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Straumann Narrow Neck CrossFit (NNC) Solid Abutments are permanent abutments intended for placement onto the Straumann Narrow Neck CrossFit (NNC) tissue level Implants with the diameter of 3.3mm, K111357. The abutments are made of Titanium Grade 4. The abutments are available in straight configurations only. Temporary abutments, copings and protective caps are indicated for temporary usage of up to 180 days (Ti, TAN, PEEK). Temporary copings made from PMMA are intended for temporary usage up to 30 days.
The provided document describes the acceptance criteria and performance testing for the Straumann Narrow Neck CrossFit (NNC) Solid Abutments, Temporary Copings, and Protective Caps.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Component | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| NNC Solid Abutments | Function as intended; modifications do not impact performance. | "results from the testing conducted demonstrated that the Straumann Narrow Neck CrossFit (NNC) Solid Abutments... function as intended and met the pre-determined acceptance criteria." The device was found to be "substantially equivalent to the named predicate devices and are safe and effective for their intended use." This was specifically achieved through fatigue testing in accordance with FDA guidance. |
| NNC Temporary Copings | Function as intended; modifications do not impact performance. | "results from the testing conducted demonstrated that the Straumann Narrow Neck CrossFit (NNC) Temporary Copings... function as intended and met the pre-determined acceptance criteria." The device was found to be "substantially equivalent to the named predicate devices and are safe and effective for their intended use." This was achieved through functional inspection and dimensional inspections. |
| NNC Protective Caps | Function as intended; modifications do not impact performance. | "results from the testing conducted demonstrated that the Straumann Narrow Neck CrossFit (NNC) Protective Caps... function as intended and met the pre-determined acceptance criteria." The device was found to be "substantially equivalent to the named predicate devices and are safe and effective for their intended use." This was achieved through functional inspection and dimensional inspections. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for the performance tests (fatigue testing, functional inspection, dimensional inspections). It only states that "Verification and validation testing were performed." There is also no information provided regarding the data provenance (country of origin, retrospective/prospective). This type of detail is typically found in the full test reports, which are not included in this summary document.
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 available in the provided document. The performance testing described (fatigue testing, functional and dimensional inspections) are bench tests and do not typically involve human experts establishing ground truth in the way a clinical study or image interpretation study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not available in the provided document. Adjudication methods are relevant for studies where a panel of experts evaluates data (e.g., medical images) to establish a consensus ground truth. The tests performed here are mechanical and dimensional, not involving human interpretation or expert adjudication.
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
There was no MRMC comparative effectiveness study done. This device is a dental implant component, not an AI-powered diagnostic or assistive tool. The performance testing focuses on the mechanical and functional integrity of the physical components.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device (dental implant components), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the NNC Solid Abutments, the ground truth for performance was established by compliance with FDA guidance documents for fatigue testing. This guidance dictates specific testing methodologies and acceptance criteria for mechanical endurance.
For the NNC Temporary Copings and NNC Protective Caps, the ground truth was established through functional inspection and dimensional inspections. This means the ground truth was based on pre-defined specifications and expected functional behavior for the physical properties of the device.
In essence, the "ground truth" for these physical devices is their adherence to established engineering standards, material properties, and functional requirements.
8. The sample size for the training set
This information is not applicable and not available. This device is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set for a physical medical device, the establishment of its ground truth is irrelevant.
§ 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.)