(42 days)
Quentry Dose Review is a web based software for medical professionals that provides doctors, physicists and physicians with tools for secure online image (DICOM and DICOM RT) review including measurement and RT specific functions, such as display of dose distribution information, isodose lines, and dose volume histograms (DVH).
It is not intended for the review of mammographic images, detailed treatment planning, plan approval or treatment of patients. It is also not intended to be used on mobile systems.
For radiotherapy treatment plan approval, it is required to use the hospital specific workflows, tools and record&verify systems.
Quentry Dose Review is part of the online collaboration platform Quentry to share, discuss and transfer medical image data. The viewer provides capabilities to visualize medical images (DICOM and DICOM RT) and dose information.
Quentry is a software platform consisting of a set of server-based components providing functions for transfer and storage of medical data, as well as user access via a web-based portal for data management, sharing, and download. The platform is integrated with desktop and server-based applications for upload and download of medical data from workstations and network-based image archive servers. The platform also provides interfaces for integration of third-party systems and applications. Quentry platform is an FDA class I product.
Here's a breakdown of the acceptance criteria and study information for the Quentry Dose Review device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantifiable acceptance criteria such as performance metrics (e.g., sensitivity, specificity, accuracy) or error rates that the device was tested against. Instead, the validation section focuses on demonstrating that the "design specifications are met" and that "all test reports were finally rated as successful according to their acceptance criteria."
Therefore, I can infer the "acceptance criteria" were qualitative, relating to functional compliance and usability.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Summary from text) |
|---|---|
| Functional Compliance | - All design specifications were met through thorough verification at top and subsystem levels. |
- Successfully loads and imports DICOM images.
- Successfully views DICOM images (converted to PNG).
- Provides adjustment functionalities (pan, zoom, window, color scheme).
- Supports reconstruction from different orientations.
- Enables distance and point measurements (gray level, dose value).
- Reviews imported DICOM objects and fused images.
- Supports cine loop playing for multiframe DICOM.
- Loads, displays, compares, and analyzes RT plan information (isodose lines, DVH, dose distribution, dose analysis, manual normalization). |
| Usability | - Usability tests performed to ensure useful workflow and user interface. - All usability test reports rated as successful.
- Workflow included patient selection as an interface between Quentry.com Portal and Quentry Dose Review. |
| Substantial Equivalence | - Demonstrated similar functionality, intended use, technological characteristics, and typical users compared to predicate devices (Advanced Viewer and iPlan RT). - No new issues concerning safety and effectiveness were introduced. |
| Technical Environment Compatibility | - Verified compatibility with specified operating systems (Windows XP+, Mac OS X 10+). - Verified compatibility with specified browsers (IE 8+, FireFox 3.x+, Chrome 10+, Safari 5+).
- Requires Microsoft® Silverlight® plugin.
- Hardware recommendations met (2GB RAM+, 1024x768 screen+, mouse).
- Network requirements met (2 Mbit/sec+ stable internet, open outbound port 80/443). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: The document does not specify the sample size of the test set used for verification and validation. It mentions "All test reports" without providing a number of cases or datasets.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It only mentions the device allows for "secure online image (DICOM and DICOM RT) review," implying diverse data sources, but no specifics are provided for the testing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions the intended users are "Physicians, Radiologists, Radio oncologists or their assistants" and that "usability tests" were conducted, suggesting clinical input, but no details on ground truth establishment are provided.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth or resolving discrepancies in the test set evaluation.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. The device, "Quentry Dose Review," is a viewing and review software, not an AI-assisted diagnostic tool designed to improve human reader performance in the sense of a standalone AI algorithm. Its purpose is to facilitate review and collaboration for medical professionals.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a form of "standalone" evaluation was done in the sense of functional verification and non-clinical validation of the software itself. The verification ensures the software meets its design specifications, and the non-clinical validation (usability tests) ensures the interface is useful. However, this is not a standalone diagnostic performance study typical for AI algorithms; it's a validation of software functionality and usability. The device is a "viewer" and "review" tool, not an AI for interpretation.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. Given that it's a software for viewing and reviewing DICOM and DICOM RT images, the "ground truth" for its functional verification would likely be the accuracy of rendering the provided medical data and the correctness of its measurements and display features against known input data (e.g., a DICOM image with known dimensions, a DICOM RT plan with calculated dose distributions and DVH data). For usability, the ground truth would be user feedback and adherence to usability best practices.
8. The Sample Size for the Training Set
The document does not mention a training set because Quentry Dose Review is not described as a machine learning or AI algorithm that requires training data. It is a software application for displaying and interacting with medical images and RT plans based on predetermined functionalities.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this type of device, the method for establishing its ground truth is not applicable.
§ 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).