(58 days)
XVWeb 3D is a Picture Archiving and Communications System (PACS) that enables dental facilities to query and access digitally stored hard and soft tissue intraoral radiological images using an internet/web browser.
A web-based interface provides users the needed functionality to display patient images and studies in commercially available web browsers. Patient images/studies can be accessed by users locally within the system or across a wide-area network at distributed locations.
Acquisition can be included via integration with a DICOM-compatible Imaging and/or PACS system configured to forward images to the XVWeb 3D database. XVWeb 3D is compatible with programs that run on standard "offthe-shelf" personal computers, business computers, and servers running standard operating systems.
The system allows users to: manipulate (e.g. rotate, flip, etc.); enhance (e.g. increase brightness/contrast, gamma correction); add labels (e.g. measurements, lines, arrows, etc.), annotations to patient images/studies and other relevant operations for diagnostic purposes.
XVWeb 3D is designed for medium to large dental practices and is intended for trained dental professionals and technicians to access, manipulate, and enhance dental images for diagnostic purposes only.
XVWeb 3D is an add-on software module for XVWeb (K132342) that enables dental practices to query and access digitally stored, 3D hard- and soft-tissue cone beam CT images using an internet/web browser. XVWeb 3D uses the web-based interface provided by XVWeb to display patient 3D images and studies.
XVWeb 3D allows users to manipulate 3D images an infinite number of ways, allowing the dental anatomy to be viewed from every possible perspective, providing the information needed to plan efficient treatments. XVWeb 3D also allows users to enhance images (e.q., increase or decrease brightness/contrast, gamma correction), and add measurement labels to 3D patient images/studies for diagnostic purposes, and view the image's DICOM information entities.
XVWeb 3D is designed for medium to large dental practices and is intended for trained dental professionals and technicians to access, manipulate, and enhance dental cone beam CT images of the teeth, jaw, and lower skull area for diagnostic purposes only. The patient population are those who have had a dental cone beam CT examination.
XVWeb 3D does not function by itself (i.e., it is not standalone software that can be launched and ran), it is integrated with XVWeb to query/access/view/ patient 3D images. XVWeb 3D is not required for XVWeb, it is an extra-cost option available to those who wish to add 3D-imaging capability to their existing XVWeb workflow. XVWeb 3D does not perform any radiographic image acquisition.
The provided document describes the XVWeb 3D software, which is an add-on module for the XVWeb Picture Archiving and Communications System (PACS) for dental applications. It allows dental facilities to query, access, manipulate, and enhance digitally stored 3D hard and soft tissue cone beam CT images for diagnostic purposes.
Here's an analysis of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a table format. The submission focuses on demonstrating substantial equivalence to a predicate device (XVWeb, K132342) based on functional similarities and extended capabilities for 3D images.
The primary "performance" discussed relates to its functionality in viewing, manipulating, and enhancing 3D dental cone beam CT images, mirroring the capabilities of the predicate device for 2D images.
Implied Acceptance Criteria (based on device description and comparison):
| Acceptance Criteria Category | Description | Reported/Implied Performance |
|---|---|---|
| Functional Equivalence | The device must perform the same core functions for 3D images as the predicate device (XVWeb) does for 2D images. This includes: |
- Querying and viewing patient images
- Manipulating images (e.g., rotate, flip, view from different perspectives, zoom in/out)
- Enhancing images (e.g., increase/decrease brightness/contrast, gamma correction)
- Adding measurement labels
- Viewing DICOM information entities
- Exporting a copy of images | XVWeb 3D is described as extending the cloud capability of XVWeb to include cone beam CT datasets, applying these same characteristics to 3D images. It states, "XVWeb 3D allows users to manipulate 3D images an infinite number of ways... allowing the dental anatomy to be viewed from every possible perspective," and "allows users to enhance images (e.q., increase or decrease brightness/contrast, gamma correction), and add measurement labels to 3D patient images/studies for diagnostic purposes." |
| Image Processing | The device must correctly process DICOM files with rescale type HU from cone beam CT systems, converting raw images/CT frames into a web-viewable format for display. This involves: - Computing spacing between CT frames
- Computing min/max pixel values
- Downscaling/merging frames for web optimization
- Normalizing each CT frame
- Storing as JPEG files
- Rendering orthogonal MPR slices (axial, sagittal, coronal), 3D volume view, and curved MPR slices (including cross-sectional slices). | The "How it works" section details a multi-step preprocessing procedure for DICOM files, including computation of frame spacing, min/max pixel values, optimization for web browser bandwidth, normalization, and storage as JPEG files. It also explicitly states that XVWeb 3D "renders the orthogonal MPR slices (the axial, sagittal, and coronal plane views) and the 3D volume view" and "renders the curved MPR slice (including cross-sectional slices)". The successful rendering of these views implies that the processing criteria are met. |
| Interoperability | Integration with DICOM-compatible imaging and/or PACS systems. Compatibility with standard "off-the-shelf" personal computers, business computers, and servers running standard operating systems. | "Acquisition can be included via integration with a DICOM-compatible Imaging and/or PACS system configured to forward images to the XVWeb 3D database." "XVWeb 3D is compatible with programs that run on standard 'off-the-shelf' personal computers, business computers, and servers running standard operating systems." The device explicitly uses the DICOM file format standard. |
| Safety and Reliability | The software should not introduce new or increased risks compared to the predicate device. The "Level of Concern" for the software is considered Moderate. | "Apteryx believes the XVWeb 3D Level of Concern to be Moderate, since a latent design flaw could result in an erroneous diagnosis that would likely lead to minor injury." This suggests that the verification and validation (V&V) testing aimed to ensure the software's safety and reliability commensurate with this level of concern. The successful 510(k) clearance implies the FDA agreed with this assessment and that the V&V was adequate. |
| Intended Use Adherence | The device must only be used by trained dental professionals and technicians for diagnostic purposes, specifically for enhancing and manipulating dental cone beam CT images for diagnosis. | The Indications for Use and Device Description clearly state this, e.g., "XVWeb 3D is designed for medium to large dental practices and is intended for trained dental professionals and technicians to access, manipulate, and enhance dental images for diagnostic purposes only." The study (software V&V) implicitly validates that device functionality supports this use without unintended consequences. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "No clinical testing was performed." Therefore, there is no mention of a specific test set of patient data, its size, or provenance. The evaluation was done through software verification and validation testing, not clinical studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical testing or studies with patient data were performed, there was no "test set" in the sense of a dataset requiring expert ground truth establishment for diagnostic accuracy evaluation. The evaluation focused on software functionality rather than diagnostic performance against a ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring ground truth establishment or adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. The document explicitly states, "No clinical testing was performed." Therefore, there is no discussion of human readers improving with or without AI assistance. This device is a PACS system designed to display and manipulate images, not diagnose automatically or provide AI-assisted interpretations.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study was conducted in the sense of an algorithm making a diagnosis. The device itself is a software tool for human professionals to use for diagnostic purposes. Its "standalone" function is to correctly process, store, and display images, which was addressed through software verification and validation. It does not perform automated diagnostic algorithms.
7. Type of Ground Truth Used
No ground truth from expert consensus, pathology, or outcomes data was used for evaluating diagnostic performance, as no clinical testing was performed. The "ground truth" for the software's functionality would have been adherence to technical specifications, DICOM standards, and the correct rendering/manipulation of images as intended by the software design.
8. Sample Size for the Training Set
Not applicable. The document describes a PACS software system that displays and manipulates images, not an AI/ML model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/ML model.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).