(152 days)
VistaSoft 4.0 and VisionX 4.0 imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. VisionX 4.0 / VistaSoft 4.0 runs on user provided PC compatible computers and utilize previously cleared digital image capture devices for image acquisition.
The software must only be used by authorized healthcare professionals in dental areas for the following tasks:
- Filter optimization of the display of 2D and 3D images for improved diagnosis
- Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitised 2D and 3D images and videos
- Forwarding of images and additional data to external software (third-party software)
The software is not intended for mammography use.
VisionX 4.0 / VistaSoft 4.0 imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. VisionX 4.0 / VistaSoft 4.0 runs on user provided PC compatible computers and utilize previously cleared digital image capture devices for image acquisition. Additional information: The software is intended for the viewing and diagnosis of image data in relation to dental issues. Its proper use is documented in the operating instructions of the corresponding image-generating systems. Image-generating systems that can be used with the software include optical video cameras, digital X-ray cameras, phosphor storage plate scanner, extraoral X-ray devices, intraoral scanners and TWAIN compatible image sources.
The software must only be used by authorized healthcare professionals in dental areas for the following tasks:
- Filter optimization of the display of 2D and 3D images for improved diagnosis
- Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitised 2D and 3D images and videos
- Forwarding of images and additional data to external software (third-party software)
The provided document is a 510(k) clearance letter for VistaSoft 4.0 and VisionX 4.0. It does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, specifically concerning AI performance or clinical efficacy.
The document primarily focuses on regulatory compliance, outlining:
- The device's classification and regulation.
- Its intended use and indications for use.
- Comparison with a predicate device (VisionX 3.0), highlighting new features (image filter operations, annotations, cloud interface, cybersecurity enhancements).
- Compliance with FDA recognized consensus standards and guidance documents for software development and cybersecurity (e.g., ISO 14971, IEC 62304, IEC 82304-1, IEC 81001-5-1, IEC 62366-1).
- Statement that "Software verification and validation were conducted."
However, there is no specific information presented that describes:
- Quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy).
- Details of a clinical or analytical study to demonstrate meeting these criteria.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC study results or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, expert consensus).
- How ground truth was established for training data.
The FDA 510(k) clearance process for this type of device (Medical image management and processing system, Product Code QIH) often relies on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and performance, rather than requiring extensive clinical studies with specific performance metrics like those for AI-driven diagnostic aids. The "new features" listed (filter optimization, acquisition/storage/etc., forwarding data) appear to be enhancements to image management and display, not necessarily new diagnostic algorithms that would typically necessitate rigorous performance studies with specific acceptance criteria.
Therefore, based solely on the provided text, I cannot complete the requested tables and details regarding acceptance criteria and study results, as this information is not present in the document.
If such information were available, it would typically be found in a separate section of the 510(k) submission, often within the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section in more detail than what is provided here, or in a specific performance study report referenced by the submission. The current document only states that "Software verification and validation were conducted" and lists the standards used for software development and cybersecurity, but not the outcomes of performance testing against specific acceptance criteria.
§ 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).