(123 days)
The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital images from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.
The DEXIS Software is a software program for general dental and maxillo-facial diagnostic imaging. It controls capture, display, enhancement and saving of x-ray digital images from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intraoral or extraoral dental cameras. DEXIS Software allows the following functionality:
- Control scanning and intake of x-ray images from imaging plates with the DenOptix scanner.
- Control the direct capture of x-ray images from the intraoral sensor Visualix / GX-S. KaVo Dig eXam, Orthoralix DPI & DDE series systems.
- View and capture color images from certain cameras, such as dental camera, via a suitable video capture card.
- Export and import digital images (such as those obtained by scanning a film) in several standard file formats.
- Process images with dental specific tools, to enhance their diagnostic value.
- Analyze and manipulate images in order to gather additional diagnostic information which may not be immediately apparent on initial visual inspection.
- Create a database of patients and easily store images in patient folders.
This document is a 510(k) summary for the DEXIS Software, dated February 4, 2009. It describes the software's functionality and its intended use as a dental imaging device. The submission claims substantial equivalence to two predicate devices: DEXIS Model 601 (K962631) and Gendex Dental Systems, VixWin Pro (K060178).
Based on the provided text, there is no specific study that proves the device meets acceptance criteria in the traditional sense of a clinical trial or performance study with defined metrics. This 510(k) submission is for a software update to an already cleared device, focusing on technical changes (rewritten in 32-bit code for newer Windows versions) rather than a novel diagnostic algorithm. The acceptance criteria and "device performance" in this context are related to demonstrating that the modified software maintains the same intended use and technical characteristics as the predicate devices and the original cleared version of DEXIS Software.
Here's an attempt to extract the requested information, noting where details are not present in the provided document:
Acceptance Criteria and Device Performance for DEXIS Software (K090431)
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission as a software update and re-affirmation of substantial equivalence, the "acceptance criteria" are implied by the claim of maintaining the same intended use and technical characteristics as predicate devices. The "reported device performance" is the statement that these characteristics have been retained despite the software rewrite.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The modified software performs the | "There will be no change to the intended use..." |
| same functions for general dental and maxillofacial diagnostic | "The DEXIS Software is substantially equivalent in |
| imaging as the predicate devices. This includes controlling | intended use...as the VixWin Pro software..." |
| capture, display, enhancement, and saving of X-ray digital images, | |
| and handling other image types. | |
| Technical Characteristic Equivalence: The modified software | "...no change to the technical characteristics." |
| maintains the core functionalities related to image acquisition, | "The DEXIS Software is substantially equivalent in |
| processing, analysis, manipulation, and database management | ...technical characteristics as the VixWin Pro software." |
| as the predicate devices. | |
| Backward Compatibility: The modified software retains | "The modified device also retains 'backward |
| compatibility with earlier versions. | compatibility' with earlier versions including |
| Windows® 98, NT and non-upgrade versions of ME." | |
| Operating System Compatibility: The software is compatible | "The modified DEXIS Software has been rewritten in |
| with specified operating systems. | 32-bit code and will now run in 'native' format with |
| Microsoft® Windows XP® (home or professional) and | |
| Windows® 2000." |
2. Sample size used for the test set and the data provenance
The document does not specify a test set sample size or data provenance for any performance evaluation directly related to this 510(k) submission. As this is a software update for an already cleared device, the submission focuses on compatibility and equivalence rather than new performance data from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention using experts to establish ground truth for a test set, as no specific performance study is detailed.
4. Adjudication method for the test set
The document does not mention any adjudication method, as no specific performance study is detailed with a test set.
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
No MRMC comparative effectiveness study was done or reported in this 510(k) submission. The DEXIS Software, as described, is a dental imaging management system, not an AI-assisted diagnostic tool providing interpretations that would typically be evaluated in an MRMC study comparing human performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned or reported. The software's function is to control, display, enhance, and save images for human interpretation, not to provide independent diagnostic outputs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the use of ground truth data for performance evaluation in this 510(k) submission. The basis for clearance is substantial equivalence to legally marketed predicate devices, implying that their prior clearance (which would have involved demonstrating performance appropriate for their intended use) serves as the "ground truth" for the current device's capabilities.
8. The sample size for the training set
The document does not mention a training set sample size. As this primarily describes an update to an existing imaging software, not a machine learning or AI algorithm development, a "training set" in that context would not be applicable.
9. How the ground truth for the training set was established
Not applicable, as no training set (in the context of machine learning/AI) is mentioned.
Summary of Filing Focus:
This 510(k) submission (K090431) for the DEXIS Software primarily serves as an update to an already cleared medical device (K962631). The key points for its clearance are:
- The software has been rewritten into 32-bit code for compatibility with newer operating systems (Windows XP, 2000).
- It retains "backward compatibility" with earlier Windows versions.
- Critically, it asserts "no change to the intended use or technical characteristics" compared to its previously cleared version and the identified predicate devices (DEXIS Model 601 and Gendex VixWin Pro).
The FDA's review and clearance of this 510(k) is based on the claim of substantial equivalence, meaning the updated software is as safe and effective as the predicate devices, without requiring new clinical or performance studies that would typically involve specific acceptance criteria, test sets, experts, or ground truth establishment for novel diagnostic claims.
§ 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).