(30 days)
Prism View™ provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DTI). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.
Prism View is an image processing software package for the visualization and manipulation of clinical imagery of multiple kinds. It brings sets of anatomical, physiologic and/or functional imagery into alignment and provides a variety of display and analysis options for utilizing the imagery relationships.
The provided text describes the Kyron™ Clinical Imaging Prism View™ software, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
The document is a 510(k) summary for a medical device (Prism View) that received FDA clearance. It focuses on device description, intended use, comparison to a predicate device, and regulatory classification.
Here's what can be extracted and what is missing based on your request:
Missing Information/Cannot be Determined from the provided text:
- Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document states "FDA has not established special controls or performance standards for this device," and a specific performance study with quantitative acceptance criteria and results is not detailed.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. There is no information about human readers improving with or without AI assistance.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: While the device is described as "image processing software," no standalone performance study results or methodology are provided.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Information that can be extracted from the document related to performance/validation (though not in the format requested):
7. Performance Study:
- Statement: "FDA has not established special controls or performance standards for this device. Software verification and validation was conducted to confirm proper function of the device's features."
This statement indicates that a "software verification and validation" was conducted, which is a general requirement for software medical devices. However, it does not provide details on specific acceptance criteria, study design, or results in the way you've requested for demonstrating device performance. It implies functionality was confirmed, but not necessarily clinical performance against a specific metric or clinical ground truth in a detailed study format.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and software functionality, rather than detailing a specific clinical performance study with acceptance criteria and results regarding diagnostic accuracy or similar metrics.
§ 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).