(59 days)
The Hologic DR ImagePro is a Windows-based software application acting as a Picture Archiving and Communications System (PACS). It is intended to be used by clinical professionals to view, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. It provides standard tools for image zoom, rotation, enhancement, smoothing, and sharpening. Hologic DR ImagePro also provides software tools for merging two to five DICOM image files of an individual patient together to aid visualization of large areas of interest. The software assists users in merging, or "stitching," the separate images together manually and allows users to draw lines and angles within the images to obtain measurements. The software runs on standard, off-the-shelf PC components.
The Hologic DR ImagePro is a Windows-based software application acting as a Picture Archiving and Communications System (PACS). It is intended to be used by clinical professionals to view, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. It provides standard tools for image zoom, rotation, enhancement, smoothing, and sharpening. Hologic DR ImagePro also provides software tools for merging two to five DICOM image files of an individual patient together to aid visualization of large areas of interest. The software assists users in merging, or "stitching," the separate images together manually and allows users to draw lines and angles within the images to obtain measurements. The software runs on standard, off-the-shelf PC components.
The provided text is a 510(k) Premarket Notification for the Hologic DR ImagePro, a Picture Archiving and Communications System (PACS) software. This type of document focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics of the new device itself.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical or performance validation study with quantitative metrics for accuracy, sensitivity, or specificity.
The document primarily focuses on:
- Device Description and Intended Use: Explaining what the Hologic DR ImagePro is and what it does (view, manipulate, transmit, print, store DICOM images, provide tools like zoom, rotation, enhancement, smoothing, sharpening, image stitching, line/angle measurement).
- Substantial Equivalence to a Predicate Device: Comparing its features and technical characteristics to a previously cleared device (Accuview Diagnostic Imaging Software Package with Plug-ins).
- Risk Analysis: Assessing the potential risks associated with the software, concluding a "minor" level of concern.
- Compliance with Regulations: Stating that the software was developed and validated in accordance with 21 CFR 820.
Here's what can be extracted based on the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implied by Substantial Equivalence): The primary "acceptance criterion" for this 510(k) is that the Hologic DR ImagePro software is substantially equivalent to the predicate device (Accuimage Diagnostics Corp. AccuView Diagnostic Imaging Software Package with Plugins) in terms of intended use, technological characteristics, and safety and effectiveness.
- Reported Device Performance: The document provides a detailed comparison of features between the Hologic DR ImagePro and the predicate device in a table, demonstrating that the Hologic device offers similar or enhanced functionalities without raising new questions of safety or effectiveness. For example:
- Image Processing: Both offer window/level, pan, zoom. Hologic DR ImagePro adds grayscale invert, contrast enhance, sharpen, blur, rotate, crop, side-by-side display; the predicate offers variable smooth filter, cine display.
- Image Stitching: Both merge images from the same patient/study using manual selection of common stitch points.
- Measurement Tools: Both offer line and angle measurement tools derived from DICOM header pixel size.
| Feature | Hologic DR ImagePro Performance | Implied Acceptance Criterion (Equivalence to Predicate) |
|---|---|---|
| Intended Use | View, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. Aids visualization of large areas by merging 2-5 DICOM images (stitching), allows line/angle measurements. | Equivalent to predicate's intended use of a PACS for viewing, manipulating, and managing images, and providing advanced tools like stitching and measurements. |
| Computer Platform | Standard PC, Windows XP OS, >2.0GHz processor, ≥ 512 MB RAM. | Compatible with standard PC hardware and operating systems, similar to or improved upon the predicate's requirements (Windows 95/98/NT OS, 400MHz processor, 512MB RAM). |
| Communications | TCP/IP Ethernet. | Utilizes standard network protocols like the predicate (TCP/IP Ethernet, GPIB). |
| Image Format (input) | DICOM 3.0. | Supports standard medical image formats, similar to the predicate (DICOM 3.0, ACR NEMA 2.0). |
| Image Format (output) | DICOM 3.0. | Outputs in standard medical image formats, similar to the predicate (DICOM 3.0, BMP, TIFF). |
| Storage Media | PACS/Ethernet Network, Local Disk. | Supports networked and local storage solutions, similar to the predicate (PACS/Ethernet Network, Local Disk, CD-ROM). |
| Display/Monitor Req. | > 18" Color, CRT or LCD, SXGA 1280 X 1024. | Compatible with common display standards, similar to or improved upon the predicate (Color/Grayscale, CRT or Laptop LCD, Up to 1024 X 768). |
| Image Processing Tools | Window/Level, Pan, Zoom, Grayscale Invert, Contrast Enhance, Sharpen, Blur, Rotate, Crop, Side-by-side Display. | Provides core image processing functionalities (Window/Level, Pan, Zoom), and potentially enhanced features, comparable to or exceeding the predicate's (Window/Level, Pan, Zoom, Variable Smooth Filter, Cine Display). |
| Image Stitching | Merges 2-5 images from the same patient/study using manual selection of common stitch points; software stitches user-placed common points. | Performs image merging based on user-defined stitch points, functioning equivalently to the predicate ("Manual selection of common stitch points within images. Software stitches user-placed common points or lines."). |
| Line Measurement Tool | Measures distances from user-placed points, derived from pixel size in DICOM header. | Measures distances accurately based on DICOM pixel size, equivalent to the predicate. |
| Angle Measurement Tool | Measures angles from user-placed points. | Measures angles accurately, equivalent to the predicate. |
| Risk Level (FDA) | Level of Concern: "minor." | No new risks or higher risk level than the predicate device. Ensures patient safety and device effectiveness, similar to predicate's risk profile. Software designed, developed, verified, and validated per 21 CFR 820 procedures. |
The following points cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: No information on a specific test set for performance evaluation is provided, as this is a PACS software substantial equivalence submission rather than an AI/CAD performance study.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as there's no clinical test set for diagnostic accuracy in this submission.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant or reported here.
- If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is PACS software and not a standalone diagnostic algorithm. Its function is to support human interpretation.
- The type of ground truth used: Not applicable, as there's no diagnostic accuracy study with a "ground truth." The "ground truth" for this type of device relates to its technical functionality (e.g., does it correctly display DICOM images, does the stitching work as designed given user input). The document states software was "designed, developed, verified, and validated in accordance with written procedures as required by 21 CFR 820."
- The sample size for the training set: Not applicable; this is not an AI/Machine Learning device that undergoes training.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission primarily relies on demonstrating that the Hologic DR ImagePro PACS software offers similar features and capabilities to a legally marketed predicate device, thereby meeting the "substantial equivalence" criterion for market clearance, rather than providing a detailed clinical performance study with specific acceptance criteria and performance metrics.
§ 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).