(154 days)
The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all "off-the-shelf" standard computer components and may be purchased independently by the end user or supplied by NIT. The NIT InSight™ software receives image files from medical scanning devices, such as CT or MRI and performs real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving.
The InSight™ Diagnostic Imaging Workstation receives image files from medical scanning devices, such as CT or MRI and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving. All of the functions are supported on standard personal computer platform for ease of cost and maintenance. The use of Microsoft Windows NT™ operating system makes the InSight™ Diagnostic Imaging Workstation easy to use and capable of being integrated with your other computer needs.
This document primarily focuses on the 510(k) submission for the Neo Imagery Technologies Inc., InSight™ Diagnostic Imaging Workstation, asserting its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a dedicated study proving the device meets specific performance criteria.
The device is being cleared based on its equivalence to existing PACS systems, which implies it operates under similar performance expectations but doesn't detail new, specific performance metrics or studies to validate them for this particular submission.
Therefore, requested information, such as specific acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set information (items 1, 2, 3, 4, 5, 6, 7, 8, 9), is not available within the provided text.
The document states:
- Device Description and Intended Use: The InSight™ Diagnostic Imaging Workstation receives image files from medical scanning devices, performs real-time viewing, image manipulation, three and four-dimensional visualization, communication, and archiving.
- Substantial Equivalence: The submission argues that the InSight™ device is substantially equivalent to K965179 (Neo Imagery Technologies Inc., InSight™ Diagnostic Imaging Workstation) and K961023 (AccuImage, AIDP).
- Software Certification: Neo Imagery Technologies Inc. certifies that the InSight™ software is designed, developed, tested, and validated according to written procedures.
- Hazard Analysis: The potential hazards are deemed "no different than those of other PACS components" and are primarily related to computer system component failure, not expected to "materially contribute to patient death or injury." The "Level of Concern" is "Minor."
In essence, the document confirms the device's regulatory pathway (510(k)) and its intended use, but it doesn't offer the detailed study information regarding acceptance criteria for device performance that you requested.
§ 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).