(27 days)
BodyViz is a software device that receives digital images and data from various sources (i.e. CT scanner, MRI scanners). Data must be in DICOM format. Images and data are parsed, stored, processed, and displayed within the system as 3D representations. Image tools are available such as translation, rotation, scaling, clipping, and coloring. A data tool is available to window the displayed representation to certain tissue types based on tissue density (e.g., muscle, bone, or skin). Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals.
BodyViz is a software based application for creating 3D models of patient data from 2D scan slices. Users have the ability input, display, color, and manipulate the 2D scan slices via a 3D representation. BodyViz is a visualization environment that allows surgeons to plan various types of surgery on their patient data in 3D. BodyViz works with any, DICOM formatted 2D image scan slices. Data can be accessed from internal and external data storage devices, as well as network and CD/DVD data sources. The software runs on any modern Windows based computer (i.e. laptop or desktop) with a 3D graphics card that meets minimum requirements, eliminating the need for specialized hardware. BodyViz is a medical device image software that is used with computer hardware in a typical hospital or clinic networked computer environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing sufficient opportunity for competent human intervention, interprets images and information being displayed.
The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document is a 510(k) summary for the BodyViz Picture Archiving Communications System, which is a software device for creating 3D models from 2D scan slices.
The relevant sections discuss:
- Device Description: The software's function to input, display, color, and manipulate 2D scan slices into 3D representations for surgical planning.
- Indications for Use: Emphasizes that "Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals." This indicates the device is a visualization tool, not a diagnostic aid that would require performance metrics for accuracy or sensitivity/specificity.
- Technological Characteristics: States it's medical device image software used with computer hardware in a PACS environment.
- Testing: Only mentions "BodyViz software has been tested to DICOM media storage application profiles." This generally refers to technical standards compliance for image handling, not clinical performance.
- Conclusion: Declares substantial equivalence to predicate devices.
Therefore, I cannot provide the requested table and study details because the provided text does not include:
- Acceptance Criteria and Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, processing time) are mentioned, nor are any thresholds for acceptance.
- Sample size for the test set or data provenance: No clinical study or test set is described beyond DICOM compliance.
- Number and qualifications of experts for ground truth: Not applicable as no clinical ground truth assessment is mentioned.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No such study is mentioned or implied.
- Standalone performance study: No study evaluating the algorithm's performance on its own is described.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable as no AI/Machine Learning model requiring a training set is explicitly described beyond basic image processing.
- How ground truth for the training set was established: Not applicable.
The device, as described, is a visualization tool. Its "performance" would likely be assessed through its ability to accurately render 3D models from 2D DICOM data, rather than diagnostic accuracy. The testing mentioned only addresses DICOM compliance, which is a technical interoperability standard, not a clinical performance standard.
§ 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).