(85 days)
VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.
VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.
VixWin Platinum Software has the following functionality which compares with the functionality provided for VixWin PRO predicate cleared under K060178. The functionality has been updated to remove legacy hardware no longer supported by the VixWin Platinum Software.
- Controls scanning and intake of x-ray images from imaging plates with the Photo-Stimulable ● Phosphor (PSP) scanners.
- Controls the direct capture of x-ray images from intra-oral sensors and extra-oral systems. ●
- Allows View and capture color images from intra-oral and extra-oral cameras. ●
- . Export and import digital images (such as those obtained by scanning a film).
- . Process images with dental specific tools to enhance their diagnostic value.
- . Analyze and enhance images to gather additional diagnostic information which may not be immediately apparent on initial visual inspection.
- Obtaining and storing patient data pertaining to those images
- Both the viewing of the images and storage of the images and their associated data. ●
- Managing (locally and remotely) a database of patients and related data.
- Allows the update of existing patient information and the creation and storage of new patient information in a database over the network.
- . Allows access to patient files from multiple workstations via network connectivity.
- . Allows printing images and image related information over the network.
VixWin Platinum can be utilized either locally or over a networked environment. If VixWin Platinum is installed on several computers, the patient and image database can be shared among them and used from different workstations.
The provided text describes a 510(k) premarket notification for the device "VixWin Platinum." This document is a regulatory submission for a medical device that aims to demonstrate its substantial equivalence to a legally marketed predicate device, not typically a study proving performance against acceptance criteria for an AI/ML device in the sense of accuracy, specificity, or sensitivity. Therefore, much of the requested information (sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not present in this type of regulatory submission.
The document primarily focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than a quantitative performance study.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
There are no specific quantitative "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, AUC) or reported performance metrics against such criteria in this document. The "performance" described relates to the functionality of the software.
| Acceptance Criteria (Implied) | Reported Device Performance (as described in the document) |
|---|---|
| Functional Equivalence to Predicate | VixWin Platinum performs equivalently in functionality to the cleared VixWin PRO (K060178). All internal verification and validation has been completed, demonstrating functional equivalence. |
| Compatibility with updated software/hardware environments | VixWin Platinum operates on newer Windows operating systems (Windows 8, 7, Vista, XP) and server environments (2003, 2008), with higher RAM and storage requirements appropriate for modern systems. |
| Maintenance of core imaging functionalities | Controls capture, display, enhancement, and saving of digital images; processes images with dental-specific tools; analyzes and enhances images; obtains and stores patient data; manages patient and image database; allows printing. |
| Support for varied imaging modalities | Controls scanning and intake of x-ray images from PSP scanners; controls direct capture of x-ray images from intra-oral sensors and extra-oral systems; allows view and capture color images from intra-oral and extra-oral cameras; exports/imports digital images (e.g., scanned film). |
| No New Safety or Effectiveness Concerns | The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is safe and effective. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document states that "All internal verification and validation has been completed," but does not detail a specific test set, its size, or data provenance for proving diagnostic performance equivalence. The comparison is primarily structural and functional.
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)
- Not applicable / Not provided. Ground truth establishment is not mentioned as part of this type of regulatory submission for a Picture Archiving and Communication System (PACS) software primarily focused on processing and displaying images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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
- Not applicable / Not provided. This device is a PACS software, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is a PACS software, not an autonomous algorithm for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. The "performance data" refers to functional verification and validation that the software operates as intended and equivalently to its predicate, not against a clinical ground truth for diagnostic accuracy.
8. The sample size for the training set
- Not applicable / Not provided. This software is not an AI/ML model that would require a distinct training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
§ 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).