(20 days)
DBSWIN and VistaEasy imaging software are intended for use by qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience. DBSWIN and VistaEasy are clinical software applications that receive images and data from various imaging sources (i.e., radiography devices and digital video capture devices) that are manufactured and distributed by DÜRR Dental and Air Techniques. It is intended to acquire, display, edit (i.e., resize, adjust contrast, etc.) and distribute images using standard PC hardware. In addition, DBSWIN enables the acquisition of still images from 3rd party TWAIN compliant imaging devices (e.g., generic image devices such as scanners) and the storage and printing of clinical exam data, while VistaEasy distributes the acquired images to 3rd party TWAIN compliant PACS systems for storage and printing.
DBSWIN and VistaEasy software are not intended for mammography use.
DBSWIN and VistaEasy imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. DBSWIN and VistaEasy software runs on user provided PC-compatible computers and utilize previously cleared digital image capture devices for image acquisition. VistaEasy is included as part of DBSWIN. It provides additional interfaces for Third Party Software. VistaEasy can also be used by itself, as a reduced feature version of DBSWIN.
The provided document is a 510(k) summary for DÜRR DENTAL SE's DBSWIN and VISTAEASY Imaging Software (K190629). This submission focuses on establishing substantial equivalence to a predicate device (K161444) rather than presenting a study to prove performance against specific acceptance criteria for a novel device. Therefore, much of the requested information about device performance and study details is not explicitly available in this document.
However, based on the information provided, here's an attempt to answer the questions:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance. Instead, it asserts substantial equivalence to a predicate device by comparing technological characteristics and functionalities. The performance is implied to be equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Identical Indications for Use | Confirmed "SAME, unchanged" |
| Identical functionality (Patient Management, Image Management, Display, Enhance, etc.) | Confirmed "YES" for all listed functionalities compared to predicate. |
| Supported Devices | Similar to predicate, with additional integrated devices (ScanX Swift View, VistaScan Nano, ScanX Classic View, CamX Triton HD Proxi, CamX Triton HD Spectra). |
| Compatible Computer Operating Systems | Updated list of supported Microsoft Windows and Server OS, removing old and adding new versions. |
| Minimum CPU Requirements | Similar to predicate (≥ Intel Pentium IV compatible, 1.4 GHz). |
| Minimum RAM Requirements | Similar to predicate (≥ 1GB, 2GB recommended). |
| Hard Disk Requirements | Similar to predicate (Workstation (without database) ≥50 GB; memory requirements of database depend on image count). |
| DICOM Compliance | Confirmed "DBSWIN is DICOM compliant." |
| Compliance with medical device software life cycle requirements (IEC 62304) | Confirmed "DBSWIN/VistaEasy was developed in compliance with the harmonized standard of IEC 62304." |
| No new issues of safety or effectiveness | Verification testing demonstrated the device continues to meet performance specifications and no new issues were raised. |
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 a separate "test set" or its sample size. The performance claims are based on "Bench testing, effectiveness, and functionality" and "Full functional software cross check testing." No information on data provenance (country of origin, retrospective/prospective) is provided, as no clinical study with patient data is mentioned.
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. The document does not describe a study involving expert-established ground truth for a test set, as it emphasizes technological equivalence and software verification/validation rather than clinical performance evaluation against a gold standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert-adjudicated test set is described.
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. This document is for imaging software that aids in acquiring, displaying, editing, and distributing images, rather than an AI diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is referred to as "clinical software applications" and a "diagnostic aide for licensed radiologists, dentists and clinicians," indicating a human-in-the-loop context. It processes and presents images, it does not perform standalone diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As no clinical study validating diagnostic accuracy is presented, there is no mention of a ground truth type. The focus is on software functionality and technical specifications.
8. The sample size for the training set
Not applicable. This device is not described as an AI/machine learning model where a training set size would be relevant. It's a general imaging software.
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
§ 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).