(37 days)
MedicColon I is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the colon derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of polyps, cancers and other lesions. The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting a seed point followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images
MedicColon™ 1 is a software tool designed to assist radiologists and other clinicians in the evaluation of polyps, cancers and other lesions in the colon. The software allows the user to select Regions of Interest either manually or by selecting a single or double seed point, followed by semi-automatic detection of the ROI boundary. It provides 2D and 3D visualisation of polyps and other lesions, and measurement of polyp characteristics such as size and volume.
The provided document does not contain acceptance criteria or a study proving the device meets them. This 510(k) Summary of Safety and Effectiveness document instead focuses on establishing substantial equivalence to predicate devices for the MedicColon™ Release 1 software.
Here's what the document does provide:
- Device Description: MedicColon™ 1 is a software tool to assist radiologists in evaluating polyps, cancers, and other lesions in the colon from CT scans. It offers 2D and 3D visualization, semi-automatic ROI selection, and measurement of polyp characteristics.
- Intended Use: PC-based, stand-alone, non-invasive image analysis software for display and visualization of 2D and 3D CT colon data to assist clinicians in evaluating polyps, cancers, and other lesions.
- Predicate Devices: VOXAR VC, MODEL 1.0 (K012072) and SIEMENS SYNGO COLONOGRAPHY SOFTWARE PRODUCT (K030982).
- Conclusion of Substantial Equivalence: MedicColon 1 is considered substantially equivalent to the predicate devices with respect to safety and effectiveness, and does not raise new safety risks. Test data were provided to validate performance and substantial equivalence.
Therefore, it is impossible to answer the requested questions about acceptance criteria and study details based on the provided text. The document states that "Test data are provided to validate the performance of the system and its substantial equivalence to the predicate devices," but does not describe the nature of this test data, the studies conducted, or any specific performance metrics or acceptance criteria.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.