(91 days)
Xelis Cardiac™ is intended for the manipulation, displaying, and distribution of medical images. It can display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
The device is used by physicians when doing preoperative planning and post-operative follow-up. Device functions are initiated manually by the user and are not performed automatically or semi-automatically by the software. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not by the software.
Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists).
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Xelis Cardiac™ is a software device intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities.
Xelis Cardiac™ is a software device that consists of INFINITT Server (Database), and the software application which supports the DICOM standard with such functions as advanced DICOM viewing.
The subject device allows users to take advantage of the images from various modalities in order to view data and images and the web based solution distributes images and relevant information to internal and external users at anytime. Remote diagnostic software configuration enables fast information delivery in a low bandwidth network environment and centralized management module enables automatic update.
Xelis Cardiac™ supports interoperability between IHE approved workstations (Integrating the Healthcare Enterprise) with security functions.
Xelis Cardiac™ does not perform computer aided diagnosis and does not include anv automated or semi-automated processes for the detection of nodules or other diseases and is not intended for use with or for the primary diagnostic interpretation of Mammography images.
The software does not provide diagnostic assistance to the physician. Any diagnostic determination or treatment is solely made by a physician and not the software.
The provided document describes XELIS Cardiac™, a software device for viewing and manipulating medical images. Based on the content, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met." And "If the device is installed by INFINITT CO., LTD, integration and installations verification tests are conducted against acceptance criteria prior to release to the client."
However, the specific "predetermined acceptance criteria" themselves (e.g., performance metrics, thresholds) are not detailed in the provided text. The document broadly states that the device "passed all in-house testing criteria" and "demonstrated that the predetermined acceptance criteria were met."
Therefore, a table of specific acceptance criteria and reported performance cannot be provided from this text. The study primarily focuses on demonstrating functional equivalence and safety (non-inferiority) to predicate devices rather than specific quantitative performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for any specific test set related to image data or patient cases. It mentions "The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria."
The data provenance (e.g., country of origin, retrospective or prospective) for any image data used in testing is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document states that the software "does not provide diagnostic assistance to the physician. Any diagnostic determination or treatment is solely made by a physician and not the software." It also mentions "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."
However, there is no information provided regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set (e.g., for diagnostic accuracy or image interpretation performance). The study appears to be primarily focused on the functional performance and reliability of the software as an image viewing and manipulation tool, rather than its diagnostic accuracy comparative to human experts.
4. Adjudication Method for the Test Set
Since no specific test set involving human interpretation or ground truth establishment based on expert consensus is described, there is no information provided on any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in the provided text. The document explicitly states that the software "does not perform computer aided diagnosis and does not include any automated or semi-automated processes for the detection of nodules or other diseases" and "does not provide any diagnostic assistance to the physician." Therefore, a study comparing human readers with and without AI assistance is not relevant to this device's intended use.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study of the algorithm without human-in-the-loop performance, in the context of diagnostic performance, was not conducted or reported. The device's primary function is as a PACS system for image viewing and manipulation, where the "human-in-the-loop" (the physician) is always the ultimate interpreter. The non-clinical testing focused on system functional performance and validation.
7. Type of Ground Truth Used
The document does not describe the use of any ground truth (e.g., expert consensus, pathology, outcomes data) in the context of evaluating diagnostic accuracy or similar performance metrics. The testing focused on validating the software's functional capabilities (input, output, actions) against internal criteria.
8. Sample Size for the Training Set
Since the device "does not perform computer aided diagnosis" and does not employ AI/ML algorithms that would typically require a training set for diagnostic tasks, there is no information provided regarding a training set sample size.
9. How Ground Truth for the Training Set Was Established
As no training set is described for diagnostic AI/ML algorithms, there is no information provided on how ground truth would have been established for such a set.
§ 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).