(40 days)
The CTC Workstation system is intended for use by a qualified physician to direct the storage, display, enhancement, and viewing of ultrasound images.
Under the direction of the physician the device stores, displays, and enhances ultrasound images. The image enhancement is performed by assigning pixels numeric values. The system is comprised of a software package running on off-the-shelf hardware.
The provided text does not contain detailed acceptance criteria for the CTC Workstation or a study proving that the device meets specific performance criteria. Instead, it describes a 510(k) submission for the CTC Workstation, focusing on its substantial equivalence to predicate devices, its intended use, and general product description.
The relevant sections state:
- "The CTC Workstation has completed design verification and validation tests for conformance with specifications." However, no specific performance metrics, acceptance criteria, or results of these tests are provided.
- "CTC Workstation provides functionality that is substantially equivalent to the cited predicate devices." This is a regulatory statement relying on a comparison to existing devices, not a direct demonstration of meeting quantitative performance criteria.
- "The main technological difference is that the MDT device uses a different set of known algorithms to perform enhancement and assign numeric values to pixels." This highlights a difference but does not quantify performance.
Therefore, the requested information regarding acceptance criteria and performance study details cannot be extracted from the provided text. The document primarily serves as a regulatory clearance (510(k)) decision, affirming substantial equivalence rather than detailing a direct performance study to 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).