(87 days)
aBSI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images acquired using nuclear medicine (NM) imaging. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including lesion marking and quantitative analysis.
The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient's skeletal disease on a bone scan, as the fraction of the total skeleton weight. The user of this product is typically a health-care professional using the software to view the patient images and analysis results.
Here's a breakdown of the acceptance criteria and study information for the aBSI device, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly define a table of "acceptance criteria" with specific performance thresholds. Instead, it refers to the device's performance through verification testing and clinical studies, demonstrating its ability to quantify the Bone Scan Index (BSI) and its association with clinical outcomes.
However, based on the performance data presented, here's an inferred table of performance aspects and reported findings:
| Performance Aspect | Reported Device Performance |
|---|---|
| BSI Calculation Linearity & Accuracy | Demonstrated during analytical validation studies. (Specific metrics not provided in the summary, but implied to be acceptable.) |
| BSI Calculation Precision | Demonstrated during analytical validation studies. (Specific metrics not provided in the summary, but implied to be acceptable.) |
| Reproducibility (different cameras) | Demonstrated during analytical validation studies. (Specific metrics not provided in the summary, but implied to be acceptable.) |
| Reproducibility (multiple images) | Demonstrated during analytical validation studies. (Specific metrics not provided in the summary, but implied to be acceptable.) |
| Reproducibility (repeated bone scans) | Demonstrated during patient study. (Specific metrics not provided in the summary, but implied to be acceptable.) |
| Hotspot Detection Algorithm Improvement | Improved algorithm from predicate. Clinical performance testing demonstrated "substantially equivalent performance" to the predicate, implying improvement while maintaining equivalence. |
| Association with Overall Survival (Study I) | Automated BSI (median=1.07; range: 0-32.60) was significantly associated with OS (HR:1.20; 95%CI:1.14-1.26; P |
§ 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).