(72 days)
Prism Acquire® / Prism Process® software is used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets.
Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by Prism Process, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion.
Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, 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 central nervous system pathology and the planning and monitoring of medical treatments.
Prism Acquire provides a scripted approach to performing fMRI and other imaging studies. Prism Process performs post-processing and quality assurance of fMRI and other imaging data sets. The processed data is prepared for report generation utilizing the Prism View product, supporting the visualization and manipulation of clinical imagery of multiple kinds. It provides a flexible set of display, analysis, and export options for utilizing the imagery relationships.
These applications may communicate in the healthcare IT environment via Prism Flow®, server-based software facilitating DICOM communications, authorization/authentication, audit logging, and other infrastructure functions.
Here's a breakdown of the acceptance criteria and study information for the Prism Acquire®, Prism Process®, and Prism View® devices, based solely on the provided K122026 document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Proper function of device's features | Software verification and validation was conducted to confirm proper function of the device's features. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" with a particular sample size for performance evaluation. The study described is "Software verification and validation." The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "Performance Study" section refers only to "Software verification and validation" and does not detail any expert-driven ground truth establishment for a test set.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the document does not describe a test set or a process for establishing ground truth through expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study is mentioned in the document. The submission is for an updated version of existing software, and the "Performance Study" section focuses on verification and validation of the software's features.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document does not explicitly state whether a standalone algorithm-only performance study was conducted. The "Software verification and validation" appears to be focused on the functional correctness of the software's features.
7. The Type of Ground Truth Used
The document does not detail the type of ground truth used for any performance evaluation beyond the general "Software verification and validation." There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for a formal performance study in the context of device efficacy.
8. The Sample Size for the Training Set
A training set is not mentioned in the document, as the submission describes an update to existing software and its verification and validation, not the development or training of a de novo AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as no training set is mentioned.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.