(78 days)
The AtheroEdge™ software is a Window's-based application program used on a personal computer for an automatic measurement of the Intima-Media Thickness (IMT) of the carotid artery from images obtained from ultrasound systems.
AtheroEdge™ is a software package that runs on a stand-alone computer running a Microsoft Windows™ XP or Microsoft Windows™ 7.0 Operating System. There is no dedicated medical equipment required for operation of this software application except for an ultrasound machine that is the source of images of the carotid artery. These images are digitally transferred from the ultrasound machine to the computer containing the software application. AtheroEdge™ software provides a means of opening and displaying images in DICOM, ISO Joint Photographic Experts Group (JPEG) Image Compression Standard and Microsoft Windows's BMP formats. AtheroEdge™ then uses proprietary techniques and algorithms to automatically measure the Intima-Media Thickness (IMT) and its variability of the distal (far) wall of the carotid artery in ultrasound image. AtheroEdge™ software provides a means for creating a region of interest on the distal (far) wall image and display by the software. AtheroEdge™ software provides a means of analyzing the content of the image data contained within the region of interest (ROI) and compute the IMT and its variability. AtheroEdge™ can generate, view and print a report indicating what the patient's IMT and its variability values. This information is used adjunctively with other medical data by a physician to help assess the cardiovascular health of a patient. AtheroEdge™ is also capable of storing patient measurement values in the database management system along with the images for future reference.
Acceptance Criteria and Study for AtheroEdge™
This response summarizes the acceptance criteria and the study conducted to demonstrate that the AtheroEdge™ device meets those criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device performance within 5% tolerance of the mean manual caliper measurements of IMT values. | AtheroEdge™ software performed within 5% tolerance of the mean manual caliper measurements of IMT values taken from a commercially available ultrasound system. |
| Device performance within 5% tolerance of the mean expert reader's measurement of IMT values. | AtheroEdge™ software performed within 5% tolerance of the mean expert reader's measurements of IMT values taken from two radiological expert ultrasound tracers. |
Note: The acceptance criteria were implicitly defined by the chosen benchmarking methods and the 'within 5% tolerance' goal stated for the performance.
2. Sample Size and Data Provenance
- Sample Size for Test Set: 200 carotid ultrasound images from 50 subjects.
- Data Provenance: Retrospective, from a longitudinal study. The specific country of origin is not mentioned, but the ultrasound scanner used was a Sonoline Antares from Siemens, USA. The images were "laboratory tested off-line."
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Two radiological expert ultrasound tracers.
- Qualifications of Experts: Described as "radiological expert ultrasound tracers." Specific experience levels (e.g., years of experience) are not provided.
4. Adjudication Method for the Test Set
The adjudication method involved "taking its average" of the measurements from the two radiological expert ultrasound tracers. This implies a simple averaging method, rather than a formal consensus or 2+1/3+1 approach.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on benchmarking the device's performance against two forms of ground truth (manual caliper and averaged expert readings), not on how human readers improve with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The AtheroEdge™ algorithm's performance (without human-in-the-loop assistance) was evaluated by comparing its IMT measurements to:
* Manual caliper measurements.
* Averaged measurements from two expert readers.
7. Type of Ground Truth Used
Two types of ground truth were used:
- Manual Caliper Measurements: Taken from a commercially available ultrasound system.
- Expert Consensus (Averaged): Mean measurements from two radiological expert ultrasound tracers.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. It only describes the validation study (test set).
9. How the Ground Truth for the Training Set Was Established
Since the training set size and details are not provided, information on how its ground truth was established is also not available in the provided text.
§ 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).