(78 days)
etkon_visual is a software device intended to import patient-specific data from a scanner for CAD (computer aided design) design of individual dental restorations like crowns, bridges, inlays, onlays, veneers and abutments.
etkon_visual also facilitates the transfer of 3D data from a dental lab to a remote milling center by internet connection and serves as an order management tool.
etkon™ visual is a software package by Institut Straumann AG which allows for digital design of customized abutments. etkon™ visual is also the operating software that controls Straumann's scanner etkon™ es 1. The scanner etkon™ es 1 together with the application software etkon™ visual fall under the definition of 21CFR872.3661, Optical Impression Systems for CAD/CAM. Such systems are defined as class II devices which are exempt from 510(k) requirements. This 510(k) premarket notification submission describes etkon™_visual's dental abutment design functionality. For designing a dental abutment, the etkon™ es 1 scanner collects data from a dental plaster model with a scan body attached intended to provide for the correct positioning of the abutment. The scanning is done extraorally. The scan data is used by the etkon™_visual software design tools to virtually design the shape and size of the dental abutment. Once the design process is finished, the digital dataset is sent to Straumann by internet connection for CAM manufacturing from milling blanks.
The provided document is a 510(k) summary for the etkon™ visual software, which is used for the digital design of customized dental abutments. It outlines the device's functionality, its substantial equivalence to a predicate device, and the FDA's clearance. However, it does not contain a detailed study report with specific acceptance criteria and device performance results in the format requested.
Therefore, most of the requested information cannot be extracted from this document. The document primarily focuses on establishing substantial equivalence to a predicate device (Nobel Biocare's Procera® Software) and confirming that the manufactured abutments meet the properties and specifications of Straumann's already 510(k)-cleared individual abutments ("CARES").
Here's what can be gathered:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the provided text. The document mentions "Verification and validation efforts of etkon™ visual provides evidence that design parameters for the individual abutments are met and that dental abutments meeting design specifications are manufactured by Straumann," but it does not specify what those design parameters or specifications are, nor does it provide a table of performance against them.
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The text does not describe a specific test set or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document.
4. Adjudication method for the test set:
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
This information is not provided in the document. The document focuses on the standalone performance of the software in designing abutments, not on its impact on human readers' effectiveness.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Based on the description, the functionality outlined for "etkon™ visual" and "etkon™ es 1" is for the standalone (algorithm only) design of dental abutments. The software imports scan data and provides tools to virtually design the abutment, which is then sent for CAM manufacturing. There's no mention of a human "reading" or interpreting the software's output to make a diagnosis; rather, the software generates the design.
7. The type of ground truth used:
The "ground truth" implicitly referred to is the design specifications and properties of Straumann's already 510(k)-cleared individual abutments ("CARES"). The document states, "The individual abutments that are finally manufactured at Straumann from zirconium dioxide and titanium blanks meet all properties and specifications of Straumann's already 510(k)-cleared individual abutments ('CARES')." This suggests that the effectiveness of the etkon™ visual software is measured by its ability to produce designs that result in physical abutments conforming to these established standards.
8. The sample size for the training set:
This information is not provided in the document.
9. How the ground truth for the training set was established:
This information is not provided in the document.
In summary:
This 510(k) summary focuses on demonstrating substantial equivalence and the device's adherence to known manufacturing specifications rather than presenting a detailed clinical study with explicit acceptance criteria, performance metrics, and ground truth establishment like those typically found for AI/ML diagnostic devices. The acceptance criteria are implicitly tied to the ability to produce abutment designs that, when manufactured, meet the established properties and specifications of previously cleared devices.
§ 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.)