(15 days)
Rapid DeltaFuse is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.
The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images.
Data and images are acquired through DICOM compliant imaging devices.
Rapid DeltaFuse provides both viewing and analysis capabilities for imaging datasets acquired with Non-Contrast CT (NCCT) images.
The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue including overlays of time differentiated scans of the same patient.
Rapid DeltaFuse is intended for use for adults.
Rapid DeltaFuse (DF) is a Software as a Medical Device (SaMD) image processing module and is part of the Rapid Platform. It provides visualization of time differentiated neuro hyperdense and hypodense tissue from Non-Contrast CT (NCCT) images.
Rapid DF is integrated into the Rapid Platform which provides common functions and services to support image processing modules such as DICOM filtering and job and interface management along with external facing cyber security controls. The Integrated Module and Platform can be installed on-premises within customer's infrastructure behind their firewall or in a hybrid on-premises/cloud configuration. The Rapid Platform accepts DICOM images and, upon processing, returns the processed DICOM images to the source imaging modality or PACS.
The provided FDA 510(k) clearance letter for Rapid DeltaFuse describes the acceptance criteria and the study that proves the device meets those criteria, though some details are absent.
Here's a breakdown of the information found in the document, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantified manner as a target. Instead, the document describes the type of performance evaluated and the result obtained.
| Acceptance Criteria (Implied/Description of Test) | Reported Device Performance |
|---|---|
| Co-registration accuracy for slice overlays | DICE coefficient of 0.94 (Lower Bound 0.93) |
| Software performance meeting design requirements and specifications | "Software performance testing demonstrated that the device performance met all design requirements and specifications." |
| Reliability of processing and analysis of NCCT medical images for visualization of change | "Verification and validation testing confirms the software reliably processes and supports analysis of NCCT medical images for visualization of change." |
| Performance of Hyperdensity and Hypodensity display with image overlay | "The Rapid DF performance has been validated with a 0.95 DICE coefficient for the overlay addition to validate the overlay performance..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 14 cases were used for the co-registration analysis. The sample size for other verification and validation testing is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The document refers to "performance validation testing" and "software verification and validation testing" but does not detail the involvement of human experts or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was reported. The document focuses on the software's performance (e.g., DICE coefficient for co-registration) rather than its impact on human reader performance.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done. The reported DICE coefficients (0.94 and 0.95) are measures of the algorithm's performance in co-registration and overlay addition, independent of human interaction.
7. Type of Ground Truth Used
- The document implies that the ground truth for co-registration and overlay performance was likely established through a reference standard based on accurate image alignment and feature identification, against which the algorithm's output (DICOM images with overlays) was compared. The exact method of establishing this reference standard (e.g., manual expert annotation, a different validated algorithm output) is not explicitly stated.
8. Sample Size for the Training Set
- The document does not specify the sample size used for training the Rapid DeltaFuse algorithm.
9. How Ground Truth for the Training Set Was Established
- The document does not specify how the ground truth for the training set was established.
§ 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).