(223 days)
ZOOM Image Enhancement System is an image processing software that can be used for image enhancement in MRI images. Enhanced images will be sent to PACS server and exist in conjunction to the original images.
ZOOM Image Enhancement System is an image processing software that can be used for image enhancement in MRI images. ZOOM image enhancement software implements a noise reduction algorithm using wavelets and image guided filtering. Original images are decomposed into different wavelet sub bands and noise in each band is soft threshold. De-noised images are reconstructed from softthresholded images using inverse wavelet transform. The software, which is installed on a remote computer, receives DICOM images from MRI host computer, automatically processes the received images and sends the enhanced images to a PACS server. Enhanced images exist in conjunction to the original images.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Requirement Specification | Reported Performance |
|---|---|
| For spin echo large phantom protocol in ACR quality control 2015, the software shall increase SNR by at-least 10% in slice 7 ACR data without compromising high contrast resolution in slice 1 and low contrast resolution in slice 11 | Pass |
| For fast spin echo sequences with slice thickness in the range 2-5mm and in-plane resolution in the range 0.6-1.4 mm, the software shall increase SNR by at-least 10% in slice 7 ACR data without compromising high contrast resolution in slice 1 and low contrast resolution in slice 11 | Pass |
| For gradient echo sequences with slice thickness in the range 2-5mm and in-plane resolution in the range 0.6-1.4 mm, the software shall increase SNR by at-least 10% in slice 7 ACR data without compromising high contrast resolution in slice 1 and low contrast resolution in slice 11 | Pass |
| For spin echo small phantom protocol in ACR quality control 2015, the software shall increase SNR by at-least 10% in slice 7 ACR data without compromising high contrast resolution in slice 1 and low contrast resolution in slice 11 | Pass |
Study Information
1. Sample size used for the test set and the data provenance:
* Sample Size: A total of 64 data sets were acquired using an ACR MRI phantom.
* Data Provenance: The data was acquired using various MRI systems: GE 1.5T Excite, Siemens Avanto 1.5T, Philips Intera 1.5T, and Toshiba Titan 1.5T. The data appears to be prospectively collected as part of a validation study for the device. The country of origin is not explicitly stated, but the use of the ACR (American College of Radiology) phantom suggests a North American context.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* The document does not mention human experts or their qualifications for establishing ground truth in this performance study. The ground truth appears to be based on objective phantom measurements (Signal-to-Noise Ratio and contrast resolution) as defined by the ACR quality control protocols.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* None. The performance test relies on objective measurements from the ACR MRI phantom using defined protocols, not expert adjudication of images.
4. 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. A MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or described in this document. The study focuses solely on the objective performance of the image enhancement software itself.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Yes. The described study is a standalone performance test of the ZOOM software (algorithm only). It evaluates the software's ability to enhance SNR and maintain resolution based on phantom data, without human interaction in the evaluation process.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The ground truth is based on objective measurements derived from an ACR MRI phantom protocol. Specifically, it uses ACR quality control guidelines to measure signal-to-noise ratio (SNR) and high/low contrast resolution.
7. The sample size for the training set:
* The document does not specify the sample size used for the training set of the ZOOM software. It only describes the validation/test set.
8. How the ground truth for the training set was established:
* The document does not provide information on 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).