(15 days)
LungCARE CT is a self-contained image analysis software package for evaluating CT volume data sets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (eg. nodules) in addition to evaluation, documentation and follow-up of any such lesions using standard or low-dose spiral CT scanning. The LungCare CT Software Package with extended functionality contains modifications which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Nodule enhanced Viewing).
This visualization tool allows for volumetric analysis of pulmonary nodule or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape and position.
This premarket notification covers Siemens LungCARE CT software package with extended functionality. It is based on Siemens syngo software platform.
This premarket notification covers Siemens LungCARE CT - Software package with extended functionality. LungCARE CT is a self-contained image analysis software package for evaluating CT volume data sets. Combining enhanced commercially available digital image processing tools (MIP, MPR SSD, VRT), evaluation tools (volumetric estimation using consistent standardised measurement protocol, comparator tool for lesion matching by synchronisation of two datasets, classification of lesions using configurable descriptors) and reporting tools (targeted presets, saved lesion location) with optimised workflow palette. The LungCare CT Software Package with extended functionality contains modifications which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Nodule enhanced Viewing).
This software package is designed to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. lesions) in addition to evaluation, documentation and follow-up of any such lesions using standard or lowdose spiral CT scanning. This visualisation tool allows for volumetric analysis of pulmonary lesion or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.
The enhanced part of the LungCARE CT software package provides an extended evaluation of segmentation by displaying all connected voxels above a certain HU ( Hounsfield-Unit ) threshold. The system will now indicate the voxels of equivalent signal level and calculate the contours of the suspicious lesion/lesion.
The provided text describes a 510(k) submission for the Siemens LungCare CT Software Package with extended functionality but does not contain the specific details of a study that proves the device meets acceptance criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria. It mentions verification and validation testing as part of risk management but doesn't provide the results or methodology for such tests.
Therefore, I cannot provide the requested table or detailed answers to the study-specific questions based on the given input. The document explicitly states: "Siemens is of the opinion that LungCARE CT software package with extended functionality does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate software components and the predicate device." This indicates the primary method of clearance was substantial equivalence rather than a new performance study against defined acceptance criteria.
§ 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).