(15 days)
The Q LAB Quantification software is a Windows 2000/Windows XP software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
The O LAB software provides a means of opening and displaying image files. The O LAB software provides a means of creating AVI and BMP files from the image data displayed by the software. The Q LAB software provides a means of quantifying the image data using a plugin module designed to operate with the core engine of the software. The O LAB software provides a means for performing an automatic distance measurement of the intima media thickness of an artery represented in the image file data. The Q LAB software provides a means of creating region of interest figures overlaid on the image data displayed by the software. The Q LAB software provides a means of analyzing the content of the image data contained within the ROI figure. The Q LAB software provides a means of presenting the ROI data in an XY graphic format. The O LAB software provides a means to perform a curve fit operation on a data set generated by the ROI analysis software. The O LAB software provides a means of exporting the data generated by the plugin modules in a form accessible to the end user.
The provided K021966 510(k) summary does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study data. This submission is for Q LAB Quantification Software, which is described as a Picture Archiving and Communications Systems (PACS) Workstation with quantification capabilities.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics for the Q LAB Quantification Software, beyond general statements about safety and effectiveness. The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to software development processes.
2. Sample Size Used for the Test Set and Data Provenance:
The 510(k) summary does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The document describes software verification and validation but doesn't provide details on the data used for these activities.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The 510(k) summary does not provide information on the number of experts, their qualifications, or how ground truth was established for any test set.
4. Adjudication Method for the Test Set:
Given the absence of information on a test set and ground truth establishment, the 510(k) summary does not describe any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The 510(k) summary does not mention any MRMC comparative effectiveness study. The focus is on the software's functionality and its substantial equivalence to predicate devices for image viewing and quantification. There is no discussion of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
While the device is a software application and performs quantification, the 510(k) summary does not present a formal standalone performance study with specific metrics (e.g., sensitivity, specificity, accuracy) for its algorithms. It describes the software's capabilities (e.g., automatic distance measurement of intima media thickness, ROI analysis) but without quantified performance data.
7. Type of Ground Truth Used:
The 510(k) summary does not specify the type of ground truth used for any evaluations, as detailed performance studies are not described.
8. Sample Size for the Training Set:
The 510(k) summary does not provide any information regarding the sample size used for a training set. This filing appears to be for a software product that, while performing "quantification," is primarily described in terms of its ability to display, analyze, and export data, rather than a novel AI/ML algorithm requiring extensive training data.
9. How Ground Truth for the Training Set Was Established:
Given the absence of information on a training set, the 510(k) summary does not describe how ground truth for a training set was established.
Summary of Available Information:
The K021966 510(k) summary describes a software device (Q LAB Quantification Software) that provides image viewing, creation of AVI/BMP files, quantification using plug-in modules, automatic intima media thickness measurement, region of interest (ROI) creation and analysis, graphic presentation of ROI data, curve fitting, and data export.
The submission focuses heavily on:
- Substantial Equivalence: Comparing the Q LAB software's image viewing capabilities to the MedLink Workstation and its ROI quantification capabilities to the Hewlett Packard Acoustic Densitometry Option.
- Software Design Controls: Stating that software development follows documented processes for design, verification, and validation testing, and that a risk assessment was completed.
- Compliance with Standards: Mentioning compliance with Microsoft Developer's Network (MSDN) and ISO Joint Photographic Experts Group (JPEG) standards.
In conclusion, this 510(k) filing provides a high-level overview of the software's functionalities and its adherence to regulatory processes, but it does not contain the specific, quantitative performance data or detailed study descriptions that your request specifies for demonstrating acceptance criteria. This level of detail is often not included in the public 510(k) summaries for devices cleared under substantial equivalence, especially for software applications of this nature from this era. Device performance data, if collected, would typically be part of the full 510(k) submission reviewed by the FDA but often not made public in the summary.
§ 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).