(78 days)
The intended use of the KinetDx system is for the acceptance, transfer, display, storage, and post-processing of digital medical images, including manipulation and quantification.
The KinetDx system is a digital image management system that includes a server. This system receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. The system has workstations that can be used to review, edit, and manipulate image data; as well as review, generate quantitative data, qualitative data, and diagnostic reports.
The provided 510(k) summary for the KinetDx system (K041029) does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K023772 and K992259). It describes the device's intended use, general characteristics, and safety aspects, but it does not detail any performance claims or the results of a specific study to validate those claims against quantifiable acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions as the required information is not present in the provided text.
The document states:
- "Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing."
- "In summary, Siemens is of the opinion that KinetDx does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices."
These statements indicate that some form of verification and validation was performed to establish safety and substantial equivalence, but the details of these tests, including specific acceptance criteria and outcome measurements, are not included in this summary.
To provide the requested information, a different section of the 510(k) submission (e.g., performance testing reports) would be needed.
§ 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).