(255 days)
SERV MEDICAL CDSS is an image processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians. The software runs on standard "off-the-shelf" hardware and can be used to perform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices. SERV MEDICAL CDSS provides viewing and analysis capabilities for imaging datasets acquired with DSA (Digital Subtraction Angiography). SERV MEDICAL CDSS is not intended for mobile diagnostic use.
SERV MEDICAL CDSS is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. SERV MEDICAL CDSS allows for the visualization, analysis and post-processing of DICOM compliant DSA images which, when interpreted by a trained physician or medical technician, may yield information useful in clinical decision making. SERV MEDICAL CDSS provides a wide range of basic image viewing, processing and manipulation functions, through multiple output formats. The software is used to visualize large vessels from DSA imaging. SERV MEDICAL CDSS can connect with other DICOM-compliant devices, for example to transfer DSA scans from a Picture Archiving and Communication System (PACS) to SERV MEDICAL CDSS software for processing.
The provided FDA 510(k) summary for Serv Medical Pte. Ltd.'s SERV MEDICAL CDSS does not contain the detailed information required to answer the questions about acceptance criteria and study particulars.
The document states:
- "Performance data supports that the device is safe and as effective as the predicate device for its intended use." (Page 6)
- And under "7. Performance Data": "The following performance data are provided in support of the substantial equivalence determination. 1) Software Verification and Validation. Software documentation consistent with basic documentation level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels." (Page 8)
This means that performance data was submitted, and the software verification and validation activities were conducted and found successful. However, the details of these performance data, including specific acceptance criteria, reported device performance metrics, study design, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness, are not included in this public summary.
Therefore, I cannot provide a detailed answer to your request based solely on the provided text. The summary only confirms that such data exists and was presented to the FDA to support substantial equivalence.
To answer your questions, one would need access to the full 510(k) submission, which is typically not publicly available in its entirety.
§ 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).