(46 days)
VixWin PRO controls capture, display, treatment, analysis and saving of X-ray digital images from DenOptix®, Visualix®/GX-S, Orthoralix 9200 DPI and DDE digital imaging systems produced by Gendex. It can also handle other types of digital images, e.g. color images from an intraoral dental camera, such as the Gendex Concept IV series, or images acquired by digitizing film with a flat bed scanner
Vix Win is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, treatment, analysis and saving of xray digital images from DenOptix ®, Visualix ® / GX-S, KaVo Dig eXam, Orthoralix DPI & DDE series imaging systems by Gendex ®. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from an intraoral or extraoral dental camera such as the AcuCam Concept IV and eZ1 series. When properly installed in your computer, VixWin lets you:
- Control scanning and intake of x-ray images from image plates with the DenOptix . scanner (*).
- Control the direct capture of x-ray images from the intraoral sensor Visualix / GX-S, 미 KaVo Dig eXam, Orthoralix DPI & DDE series systems (*).
- View and capture color images from certain cameras, such as a dental camera, via a suitable video capture card (*).
- Export and import digital images (such as those obtained by scanning a film) in several 프 standard file formats.
- Process images with dental specific tools, to enhance their diagnostic value. 제
- 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 .. .
The provided text describes a 510(k) premarket notification for the "VixWin Pro" dental image management system. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth is not explicitly available in the provided text.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present specific performance-based acceptance criteria in the typical sense of a clinical study (e.g., sensitivity, specificity thresholds). Instead, it compares the technical specifications and functionalities of VixWin Pro to two predicate devices: DentalEye 2 (K012439) and KaVo ERGOcom®/ERGOcam® (K050744).
| Description | Predicate Device 1: DentalEye 2 (K012439) Specification | Predicate Device 2: KaVo ERGOcom®/ERGOcam® (K050744) Specification | VixWin Pro Reported Performance / Specification | Outcome (Implicit Acceptance) |
|---|---|---|---|---|
| Implementation | Software only | Hardware and Software supplied | Software only | Equivalent to DentalEye 2, addresses some functions of KaVo (software only focus) |
| Host platform | Intel or AMD based Personal Computer | PC Pentium, 1800 MHz or higher. | PC | Compatible with standard PC platforms. |
| Operating system | Windows 95, 98, ME, 2000, NT | Windows 2000, XP. And Microsoft .NET Framework. | Windows 98, 2000 and XP® | Compatible with common Windows operating systems. |
| Host RAM | 32 MB minimum | 256 MB | 32 MB | Meets or exceeds minimum requirements. |
| Host Magnetic Storage | At least 500 MB | Sufficient hard disk space to store imaging data., Usually 20 GB | 4 GB minimum, 9 GB or more recommended. | Meets or exceeds minimum requirements, with recommendations aligning with data storage needs. |
| Host Floppy Drives: | Not required | Not required | Not required | No floppy drive requirement. |
| CD ROM | Yes (for installation) | Yes (for installation) | Yes (for installation) | Standard installation method. |
| Host Processor Speed | Pentium II 233 MHz or better | PC Pentium, 1800 MHz or higher. | Pentium 133 Mhz, 300 Mhz or faster recommended | Meets or implies compatibility with a range of processors, aligning with general PC advancements. |
| Host Monitor Size | Any VGA or better PC color monitor | XGA or better, 15" or 19" Touch Display. | SVGA, XGA recommended | Compatible with standard monitor types, with recommendations for better display. |
| Display Resolution | Minimum 800 X 600 Recommended 1024 X 768 | Screen resolution 1024 X 768, with min. true color depth (32 bit). | 800 x 600 true color, 1024 x 768 true color recommended. | Meets or exceeds minimum display resolution for medical imaging. |
| User Display Preferences | Yes | Yes | Yes | Provides customization for user display. |
| USB and S Video support | NO | Yes | Yes | Aligns with modern connectivity options, similar to KaVo. |
| Receive Images from other Systems | Yes | Yes | Yes | Interoperable with other imaging systems. |
| Images Displayed | Dental X-Rays, Intraoral Images, Extraoral Images (face, etc) | Dental X-Rays, Intraoral Images, Extraoral Images (face, etc), Entertainment (TV) for patients, Instructional Video, Patient Administration. | Dental X-Rays, Intraoral Images, Extraoral Images. | Displays core dental imaging types. Omits entertainment/instructional patient administration features of KaVo. |
| Safety Standards | Not applicable. Software only supplied. | UL/CSA standards for safety met. | Not applicable. Software only supplied. | As a software-only device, hardware safety standards are not directly applicable to VixWin Pro. |
General Acceptance Criteria (Implied by 510(k) process for this device):
- Substantial Equivalence: The primary acceptance criterion for a 510(k) device like VixWin Pro is demonstrating that it is as safe and effective as a legally marketed predicate device. This is achieved by showing that it has the same intended use and the same technological characteristics as the predicate, or, if there are different technological characteristics, that the different characteristics do not raise new questions of safety and effectiveness and are shown to be at least as safe and effective as the predicate device.
- Compliance with Product Specifications: The document states, "This is based on testing to verify compliance with product specifications." This implies that internal testing was conducted to ensure the software met its defined functional and performance requirements. However, the specific product specifications and the results of this internal testing are not elaborated upon in the provided summary.
- Intended Use Compatibility: The device must effectively control capture, display, treatment, analysis, and saving of X-ray digital images as specified in its Indications for Use. The comparison table implicitly supports this by showing similar image handling capabilities to predicate devices.
2. Sample size used for the test set and the data provenance:
- Not Applicable: The provided 510(k) summary does not describe a clinical study with a "test set" of patient data in the context of diagnostic performance (e.g., for sensitivity/specificity). The testing mentioned refers to verification of compliance with product specifications, which is typically internal engineering and software testing, not patient-level data analysis. Therefore, information on sample size or data provenance is not provided for such a "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: As there's no diagnostic performance study with a "test set" of patient data described, there is no mention of experts establishing ground truth for such a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: Given the absence of a diagnostic performance study, no adjudication method for a test set is mentioned.
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: The document does not describe an MRMC comparative effectiveness study, nor does it mention AI assistance. VixWin Pro is described as a "Dental Image Management System" that processes, analyzes, and manipulates images, but there's no indication of AI algorithms for diagnostic assistance that would necessitate an MRMC study to evaluate human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No: The document describes VixWin Pro as a software system for image management, display, and processing. It is inherently a tool for human users (dentists/maxillofacial diagnosticians). There is no mention of a standalone algorithm for automated diagnosis or a standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable: Since no diagnostic performance study is described, no specific "ground truth" for patient data is mentioned in this document. If any "ground truth" was involved in the "testing to verify compliance with product specifications," it would likely relate to objective technical parameters of image quality or software functionality, rather than clinical diagnoses.
8. The sample size for the training set:
- Not Applicable: As VixWin Pro is presented as an image management and processing software without explicitly stated AI or machine learning components requiring a "training set" for model development, this information is not provided.
9. How the ground truth for the training set was established:
- Not Applicable: For the reasons stated above (no defined AI/ML training set), there's no information on how ground truth for a training set would be established.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.