(146 days)
The syngo.CT Lung CAD device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid (part-solid and ground glass) pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may otherwise be overlooked.
The syngo. CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist or as second reader after the radiologist has completed his/her initial read.
The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface.
Siemens Healthcare GmbH intends to market the syngo.CT Lung CAD which is a medical device that is designed to perform CAD processing in thoracic CT examinations for the detection of solid pulmonary nodules (between 3.0 mm and 30.0mm) and subsolid (partsolid and ground glass) nodules (between 5.0 mm and 30.0mm) in average diameter. The device processes images acquired with multi-detector CT scanners with 16 or more detector rows.
The syngo.CT Lung CAD device supports the full range of nodule locations (central, peripheral) and contours (round, irregular).
The syngo.CT Lung CAD sends a list of nodule candidate locations to a visualization application, such as syngo MM Oncology, or a visualization rendering component, which generates output images series with the CAD marks superimposed on the input thoracic CT images to enable the radiologist's review. syngo MM Oncology (FDA clearance K191309) is deployed on the syngo.via platform (FDA clearance K191040), which provides a common framework for various other applications implementing specific clinical workflows (but are not part of this clearance) to display the CAD marks. The syngo.CT Lung CAD device may be used either as a concurrent first reader, followed by a review of the case, or as a second reader only after the initial read is completed
The subject device and predicate device have the same basic technical characteristics. This does not introduce new types of safety or effectiveness concerns as demonstrated by the statistical analyses and results of the reader study and additional evaluations results documented in the Statistical Analysis.
Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating the improvement of the new VD20 version over the predicate VC30, rather than explicitly listing fixed "acceptance criteria" with numerical targets in a single table. However, based on the statistical analysis summary and the comparison tables, we can infer the performance goals and the reported outcomes:
| Feature/Metric | Acceptance Criteria (Inferred) | Reported Device Performance (VD20) |
|---|---|---|
| Detection Target | Extension to subsolid (part-solid and ground glass) pulmonary nodules, in addition to solid nodules. | Device successfully assists in detecting solid and subsolid (part-solid and ground glass) pulmonary nodules. |
| Nodule Size Range | Solid: Up to 30mm; Subsolid: Up to 30mm | Solid: ≥ 3mm and ≤ 30mm; Subsolid: ≥ 5mm and ≤ 30mm. |
| Reader Workflow | Support for concurrent first reader workflow in addition to second reader. | Device supports both concurrent first reader and second reader workflows. |
| Multi-vendor Compatibility | Support for multi-vendor CT scanners. | Supports Siemens, GE, Philips, and Toshiba MDCT scanners. |
| Detector Rows | Recommended 16 or more detector rows. | Recommendation to use 16 or more detector rows included, matching FDA recommendation. |
| Voltage | Expanded range (implied). | 100-140 kVp. |
| Slice Thickness | Up to 2.5mm, with recommendation for ≤ 1.25mm for smaller nodules. | Up to and including 2.5mm; recommended that ≤ 1.25mm be used for detection of smaller nodules (e.g., 3.0mm). |
| Slice Overlap | 0-50% | 0-50%. |
| Kernels | Expanded range of supported kernels. | Consistent with thoracic CT protocols and patient safety guidelines. Typical kernels: Smooth, Medium, Sharp groups validated. |
| Dose | Consistent with diagnostic and screening protocols. | CTDIvol |
§ 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).