(14 days)
InstaRad™ is a software device (DICOM Gateway Application, InstaRad Enterprise Server, and Workstation) used for viewing and manipulating medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaRad™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
InstaRad™ is an application used for viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. When viewing images, users can perform adjustments of window width and level, annotation, and various image manipulations. In addition, InstaRad™ can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study of the System), providing seamless access to reports for fully-integrated electronic patient records.
InstaRad™ allows multiple centers or hospitals to send their images to a central server where Radiologists can view images over Web. It consists of following components:
- DICOM Gateway Application is deployed at all remote centre or . hospitals. It receives images from modalities over LAN and uploads them to central server.
- Central Server runs the Web Server and Image Server and provide . study and image data to doctors.
- . WorkStation - Doctor at client side access the study list in the browser. They can select the patient and download the images.
The provided text describes InstaRad™, a Picture Archiving Communications System (PACS), and its 510(k) summary for regulatory approval. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment related to the device itself as a medical image processing system.
The text focuses on establishing substantial equivalence to a predicate device (VISAGE PACS/CS, RELEASE VERSION 4.1, K062490) based on its technological characteristics, intended use, and general safety and effectiveness.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given information because that data is absent from the document. The subsequent points regarding studies are also not addressable for the same reason.
Here's a breakdown of what the document does provide and why the requested information is missing:
- Device Description: InstaRad™ is an application for viewing, manipulating, processing, storing, and communicating digital medical images from various sources (CT, MR, US, RF, etc.) across computer networks. It can be integrated with HIS/RIS.
- Intended Use: Viewing and manipulating medical images, including mammography (with specific caveats regarding lossy compression and monitor requirements).
- Technological Characteristics: It's a software product handling digital medical images, not contacting the patient, and not controlling life-sustaining devices. Human intervention is expected for interpretation.
- Predicate Device: VISAGE PACS/CS, RELEASE VERSION 4.1 (K062490).
- Conclusion: The submission contains adequate information to determine substantial equivalence to the predicate device.
Missing Information:
- Acceptance criteria and reported device performance: Not specified. This type of detail is often found in performance testing reports, which are not included in this 510(k) summary.
- Sample sizes used for the test set and data provenance: No performance test data is mentioned.
- Number of experts used to establish ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm-only) performance: Not mentioned, as this device functions as a PACS, not an AI algorithm performing a diagnostic task.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not applicable for this type of PACS device, as it doesn't appear to use machine learning for diagnostic tasks that would require a "training set."
- How the ground truth for the training set was established: Not applicable.
The 510(k) process for a PACS system like InstaRad™ typically focuses on functional equivalence, compliance with DICOM standards, security, data integrity, and display capabilities compared to an existing predicate. It's not usually about diagnostic accuracy studies with ground truth in the same way an AI diagnostic algorithm would be evaluated.
§ 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).