(30 days)
The Eigen DSA 2000 product is used in vascular imaging applications. During X-ray exposures, the DSA 2000 is used to acquire video images from the video display chain provided by the X-ray manufacturer's system. The images are stored in the DSA 2000 solid state memory, and written to the hard disk medium. Images are processed in real-time to provide increased image usability. The processing is primarily subtraction, but also includes window and level adjustments, as well as optional noise reduction, landscaping, and pixel shifting. The Eigen DSA 2000 device is used in X-ray cardiology and radiology labs to enhance diagnostic capabilities of radiologists and cardiologists, with minimal intervention required by users to perform basic capture, playback, and archiving functions.
The Eigen Digital Subtraction Angiography® (DSA) is a real-time video acquisition device that can be added to an existing standard line-rate X-ray system and provides creation of photos and real-time digital subtraction taken from a mask image. The DSA acquires and transmits data to a DICOM workstation or PAC system. The data will then be available for display. The DSA output conforms to the DICOM 3.0XA Standard for lossless images. The Eigen DSA is assembled on a Hewlett Packard (HP)/Intel platform and uses the Microsoft Windows XP® operating system.
The Eigen Digital Subtraction Angiography (DSA) 2000 is an image processing system used in vascular imaging applications. The information provided outlines its intended use and a general conclusion of its performance rather than specific quantitative acceptance criteria or a detailed study plan.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device (Digital 8) with modifications. | "Actual device performance as tested internally conforms to the system requirements." |
| "The test results support the conclusion that the DSA 2000 is substantially equivalent to its predicate device, D8." | |
| Maintenance of Intended Use and Fundamental Scientific Technology. | "The modifications made to the DSA 2000 do not alter the intended use or the fundamental scientific technology of the device." |
| Real-time video acquisition and image processing. | The device "acquires video images from the video display chain," "Images are processed in real-time to provide increased image usability." |
| Specific Processing Functions (Subtraction, Window/Level, Noise Reduction, Landscaping, Pixel Shifting). | "The processing is primarily subtraction, but also includes window and level adjustments, as well as optional noise reduction, landscaping, and pixel Shifting." |
| Image Storage and Archiving. | "Images are stored in the DSA 2000 solid state memory, and written to the hard disk medium." |
| "Data Archiving" is listed as a function. | |
| DICOM 3.0XA Standard Conformance for Lossless Images. | "The DSA output conforms to the DICOM 3.0XA Standard for lossless images." |
| Enhance diagnostic capabilities for radiologists and cardiologists with minimal user intervention. | "The Eigen DSA 2000 device is used in X-ray cardiology and radiology labs to enhance diagnostic capabilities of radiologists and cardiologists, with minimal intervention required by users to perform basic capture, playback, and archiving functions." |
2. Sample size used for the test set and the data provenance
The document states: "Testing was performed at the module and system level according to written test protocols established before the testing was conducted." However, it does not provide any specific sample size for the test set (e.g., number of images, patients, or cases). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be internal (hence "tested internally").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions that "Test results were reviewed by designated technical professionals before release of the software." However, it does not specify the number of experts used or their qualifications. It also does not explicitly state that these "technical professionals" established ground truth for a test set in a clinical context; their role appears to be reviewing the internal technical test results.
4. Adjudication method for the test set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for a clinical test set. The review mentioned seems to be technical verification of internal test results.
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 MRMC comparative effectiveness study was mentioned in the provided text. The device is presented as a tool to enhance diagnostic capabilities, but no study comparing human readers with and without the device's assistance is described, nor is an effect size provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document describes the device as an "image processing system" that "enhances diagnostic capabilities of radiologists and cardiologists." This implies it is a human-in-the-loop system. No standalone algorithm performance study is indicated. The "Test Discussion" section refers to "module and system level" testing, which likely refers to the functional performance of the software and hardware components rather than a standalone clinical performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the type of ground truth used for any clinical evaluation as it focuses on functional equivalence and internal system requirements rather than a clinical performance study with established ground truth.
8. The sample size for the training set
The device described is an "image processing system" and not explicitly an AI/ML device that requires a training set in the contemporary sense. It performs fixed algorithms (e.g., subtraction, window/level, noise reduction). Therefore, no training set is mentioned or applicable in the context of this device's description.
9. How the ground truth for the training set was established
As there is no training set mentioned or applicable for this type of image processing system, the method for establishing its ground truth is not relevant and therefore not provided.
§ 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).