(224 days)
Z3D Contrast Acuity (z3D) version 2.1 is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
The software displays the temporal variation in dynamic data as a surface map that enhances visualization of pixel intensity and time/intensity changes extracted from CT and MR temporal data sets. The results may be displayed as either a grayscale enhancement or a color overlay overlay over the selected image.
z3D may perform additional functions to aid in the analysis and viewing of dynamic studies, including registration of serial MR and CT acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 310. segmentation of tissues, multiplanar and oblique reformats, maximum intensity projections, image, averaging, subtraction and blinking of images acquired at different time noints to help visualize enhancement.
23D also may be used to perform post-processing analysis of multi-modality, digital images, including MR, CT, X-Ray, PET, and Nuclear Medicine images. The software analysis tools may be anplied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections.
The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of z3D analysis. The z3D software is contraindicated for automated sole interpretation of digital mammography images.
z3D Contrast acuity (z3D) Version 2.1 is a software package designed to assist the radiologist in interpretation of multi-modality, digital radiology images, including dynamic CT and MR image data sets. The software applies standard 2D and 3D image processing techniques on a pixel-bypixel basis to analyze grayscale data and perform visual enhancement of user-selected images. The software may be applied to image subtractions, reformatted images, multiplanar reformats, and Maximum Intensity Projections (MIP). Single or multi-slice data sets may be used as input.
The software consists of several modes that can be enabled or disabled depending upon the specific configuration purchased/implemented. These modes include 2D image review, 2D mass morphology, 3D mass characterization.
The results of the analysis are displayed as a surface man, parametric map, Maximum Intensity Projection (MIP), subtraction, registered subtraction, or 3D display that enhances visualization of pixel intensity data provided by the image. The results may be displayed in grayscale enhancement or as a color overlay. The software includes standard workflow tools that allow the radiologist to manipulate, rotate and fly-through images for enhanced visualization of the digital output. Additionally, the software package allows the radiologist to visually inspect time sensitive contrast agent intensity curves and to make mass measurements.
The software application consists of proprietary software developed by Clario and is a Windows 2000/XP, DICOM-compatible platform. The software is designed to be distributed as a plug-in for OEM imaging systems, PACS, workstations, or embedded in software applications cleared for use in medical imaging.
The z3D user interface is designed to follow typical workflow patterns to process, review, and analyze digital images.
The provided 510(k) summary for the z3D Contrast Acuity device does not include a detailed study proving the device meets specific acceptance criteria.
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (MedIQ/K052963 and CADstream/K043216) based on similar indications for use, technological characteristics, and performance.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.
However, I can extract information related to the device description and the claim of substantial equivalence.
Here's a breakdown of what can be inferred and what is not provided based on the input:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the z3D Contrast Acuity device itself. The primary criterion for this 510(k) submission is substantial equivalence to the predicate devices.
- Reported Device Performance: The document claims similar functionality to predicate devices. It describes what the software does (e.g., visual enhancement, 3D characterization, display of parametric maps, image manipulation tools) but does not provide quantitative performance metrics like sensitivity, specificity, accuracy, processing speed, or any clinical outcomes.
| Acceptance Criteria (Implied) | Reported Device Performance (as described for equivalence) |
|---|---|
| Substantial Equivalence to Predicate Devices (MedIQ/K052963, CADstream/K043216) in terms of: | - Assists radiologists in analysis |
- Post-processing of multi-modality digital images (dynamic CT and MR)
- Provides image display, supplemental info, visual enhancement of time/intensity changes
- Displays results as surface map, parametric map, MIP, subtraction, registered subtraction, or 3D display
- Enhances visualization of pixel intensity data
- Includes workflow tools for image manipulation, rotation, fly-through
- Allows visual inspection of time-sensitive contrast agent intensity curves
- Enables mass measurements
- Performs similar functions to MedIQ (view/manipulate images in 3D, 3D surface shading)
- Performs similar functions to CADstream (measurements on images) |
| Safety & Effectiveness | - Intended to provide supplemental information and enhanced visual analysis. - "Patient management decisions should not be made based solely on the results of z3D analysis."
- "Contraindicated for automated sole interpretation of digital mammography images." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe any specific testing with a dedicated test set in terms of patient data. The evaluation appears to be a comparison of functionalities and indications for use against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. Since a specific test set with ground truth isn't described for performance evaluation, this information is absent. The "ground truth" for the submission is the functional comparison against established predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method is described for a test set.
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, an MRMC comparative effectiveness study was not done or at least not described in this document. This submission focuses on feature equivalence and not on measuring reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not explicitly described as a formal validation study. The device is described as "post-processing, productivity software designed to assist radiologists," implying human-in-the-loop use. It is explicitly stated that "Patient management decisions should not be made based solely on the results of z3D analysis" and it is "contraindicated for automated sole interpretation of digital mammography images," which further indicates it is not a standalone diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not directly applicable for a performance study of the z3D device itself. The "ground truth" in this submission relates to the established functions and indications of the predicate devices against which z3D Contrast Acuity is being compared for substantial equivalence.
8. The sample size for the training set
- Not provided. The document describes proprietary software but does not mention any machine learning or AI models requiring a training set in the modern sense. It refers to "standard 2D and 3D image processing techniques" and "user-specified processing of algorithms."
9. How the ground truth for the training set was established
- Not applicable/Not provided. As no training set is mentioned for AI/ML development, ground truth establishment for such a set is not discussed.
§ 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).