Search Results

Dexis Webview is a web-based software used for general dental and maxillofacial diagnostic image review that allows users alternate access to image data using a common web-browser. It provides the ability to view, enhance, annotate, compare, and export images by accessing an existing image database available in a distributed environment.

Dexis Webview is indicated for use only by prescription and by a trained and qualified dentist or dental technician.

Dexis Webview is a web browser-based accessory software application that allows users to access preexisting imaging data remotely. Users are able to view, enhance, annotate, compare, and export preexisting images using the Dexis Core database using a web-browser. The intended use of the device is to allow dentists to be able to diagnose remotely using a traditional web-browser running on a desktop PC or Apple Mac.

The Dexis Webview Software is a software program for general dental and maxillofacial diagnostic imaging. It provides the ability to view, enhance, annotate, compare, and export images by accessing an existing image database available in a distributed environment. It allows remote access to x-ray digital images acquired from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flatbed scanner, or color images from intraoral dental cameras as long as they are stored in an accessible database.

The provided text is a 510(k) summary for the Dexis Webview device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Dexis Software K140445). However, it does not contain the information requested regarding acceptance criteria, a specific study demonstrating performance against criteria, sample sizes, ground truth establishment, or human reader effectiveness studies.

The document discusses "Performance Data" in a general sense, focusing on verification and validation testing, conformance to a risk management standard (ISO 14971), and a claim that the Dexis Webview performs equivalently in functionality to the predicate device for viewing, enhancing, annotating, comparing, and exporting images. It explicitly states: "The safety and effectiveness of the Dexis Webview web-browser software was evaluated via bench testing. verification and validation testing, and conformance to international conformance standards." This is a general statement about software development practices, not a detailed description of a clinical or analytical performance study demonstrating specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be inferred or stated as unavailable:

1. Table of acceptance criteria and reported device performance:

• Not available. The document states "Performance data (Verification and Validation) demonstrate that Dexis Webview web-browser software functions equivalently to the Dexis Software predicate device," but does not list specific acceptance criteria or quantitative performance metrics against them.

2. Sample size used for the test set and data provenance:

• Not available. The document mentions "bench testing, verification and validation testing" but does not provide details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature of data).

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Not available. As no specific performance study with a test set and ground truth is described, this information is absent.

4. Adjudication method for the test set:

• Not available. For the same reasons as above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• Not done/Not described. The document focuses on demonstrating substantial equivalence based on technological characteristics and functional equivalence to the predicate device. It does not mention any MRMC study comparing human readers with or without AI assistance. The device is described as an image review software, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable/Not described. The Dexis Webview is a viewing and processing tool for human operators, not an autonomous algorithm that provides diagnostic outputs. Its "performance" would be related to display quality, functionality of tools, and data integrity, rather than standalone diagnostic accuracy.

7. The type of ground truth used:

• Not available. No specific ground truth establishment is described as there is no detailed performance study presented.

8. The sample size for the training set:

• Not applicable/Not available. The Dexis Webview is described as software for viewing, enhancing, annotating, comparing, and exporting images. It is not an AI/ML device that would typically involve a "training set" for model development. Its development would involve software engineering and testing against functional requirements.

9. How the ground truth for the training set was established:

• Not applicable/Not available. For the same reasons as above.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on functional and technological characteristics, rather than reporting on a detailed clinical or analytical performance study with specific acceptance criteria and outcome metrics.

Ask a specific question about this device