(15 days)
QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
QLAB version 3.0 adds a Cardiac 3DQ Plug-in (3D viewer with 3D measurements), G1 3D viewer Plug-in and an MVI Plug-in to the cleared QLAB version 2.0.
The Cardiac 3DQ plug-in provides a means of opening. displaying, manipulating and measuring 3D inage files from currently cleared Plilips Ultrasound systems The 3DQ plug-in also allows distance, area, volume and mass measurements from MultiPlanar Reconstruction (MPR) images derived the 3D data sets. The software also provides a means of exporting the data generated by the plug in module in a form accessible to the end user.
Gl (General Imaging) ND Viewer Plug-in reads DICOM compliant liles generated by currently cleared Philips Ultrasound systems. It contains tools for changing 3D volume rendering parameters. The volume rendering is done using the rendering engine shipping with the Boris Platform and Philips HDI 5000. Therefore the main volume rendering controls are the same as on the imaging system.
MVI (Microvascular Imaging) Plug-in reads DICOM compliant files generated by the Philips Boris Platform and the Philips HDI 5000 Platforms. It performs a Maximum Intensity Projection convolution of the cine' information and allows viewing of the processed information. It provides tools for export of the resulting information in a standard AVI tile formal for use in presentations. The processing is accomplished exactly as in the Predicate device (HDI 5000) with the exception that there are no user selectable processing changes possible.
The provided text is a 510(k) Summary for the QLAB Quantification software, which focuses on device description, predicate devices, and general safety and effectiveness concerns. It explicitly states that "No performance standards for PACS systems or components have been issued under the authority of Section 14" and that the software "has been designed to comply with the following voluntary standards: MSDN Microsoft Developer's Network October 2001 and ISO Joint Photographic Experts Group (JPEG) Image Compression Standard."
Crucially, the document does not contain information about specific performance acceptance criteria or a study proving that the device meets such criteria. It mentions "software design, verification and validation testing" and a "risk assessment" but provides no details on the methodologies, results, or ground truth used for these internal processes.
Therefore, I cannot fully answer your request based on the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify any quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity, measurement tolerances) or reported device performance metrics against such criteria. It only references compliance with general software development and image compression standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention the sample size of any test set used, nor does it specify the provenance, type (retrospective/prospective), or origin of any data used for testing.
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)
- Cannot be provided. The document does not refer to the use of experts for establishing ground truth, nor does it describe their number or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. There is no mention of an adjudication method as no test set details are provided.
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
- Cannot be provided. The document does not mention any MRMC comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. This device is described as a quantification and viewing software, not specifically an AI-assisted diagnostic tool in the sense of predictive or interpretive algorithms.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be determined from the text. While the device performs "quantification" and "volume rendering," which are algorithmic tasks, the document does not distinguish between testing done in a standalone manner versus with a human in the loop. The device is fundamentally a workstation for human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. The document does not specify the type of ground truth used for any testing.
8. The sample size for the training set
- Cannot be provided. The document does not mention a training set or its sample size.
9. How the ground truth for the training set was established
- Cannot be provided. As no training set is mentioned, information on how its ground truth was established is absent.
§ 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).