(86 days)
Clarity Reveal is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning. Clarity Reveal is designed for use by healthcare professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Clarity Reveal is a software-only device that allows clinicians to review CT and MR image data in three-dimensional (3D) format and/or stereoscopic 3D format (commonly known as virtual reality, or VR). The 3D and VR images are accessible through the Clarity Reveal mobile application which is used by clinicians for preoperative planning.
Clarity Reveal includes two main software-based user interface components, the Processing Interface and Viewer Interface. The Processing Interface is hosted on a cloud-based, virtual workstation and only accessed by authorized personnel, such as an imaging technician. The Processing Interface contains a graphical user interface where an imaging technician can select DICOM-compatible medical images, segment such images, and initiate processing into a 3D format. The Viewer Interface is a mobile application that is accessible via a compatible, touchscreen enabled, off-the-shelf mobile device to allow for clinicians to review the medical images in 3D and/or VR formats. Only when the compatible mobile device is used in conjunction with a compatible off-the-shelf VR headset can the surgeon view medical images in the VR format.
The product is intended to be used by trained medical professionals, including imaging technicians and clinicians/surgeons, and is used to assist in clinical decision making.
This document describes the Ceevra Clarity Reveal device, a software-only medical imaging system. The provided text is a 510(k) summary submitted to the FDA, detailing the device's intended use, description, and comparison to a predicate device. However, it does not contain specific acceptance criteria or the study data proving the device meets those criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance details
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document only states the following regarding performance:
- Performance Data (Section 7): "Safety and performance of Clarity Reveal has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2008- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and 'Content of Premarket Submission for Management of Cybersecurity in Medical Devices.'"
This statement indicates that verification and validation were performed to ensure the device met software specifications and applicable performance standards, and that the process followed relevant international standards and FDA guidance. However, it does not disclose the specific performance metrics, acceptance criteria, or the results of those tests.
The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (EchoPixel True3D Viewer K142107) based on intended use, technological characteristics, and general safety/performance verification, rather than providing detailed clinical study results or quantitative performance 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).