(46 days)
Visia™ Dynamic Review is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. Visia™ Dynamic Review supports evaluation of dynamic MR data.
Visia™ Dynamic Review automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics (parametric image maps). Furthermore, it performs other user-defined post-processing functions such as image subtractions; multi-planar reformats and maximum intensity projections. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. Visia™ Dynamic Review can also be used to provide measurements for diameters, areas and volumes. Furthermore, Visia™ Dynamic Review can evaluate the uptake characteristics of segmented tissues.
Visia™ Dynamic Review also displays images from a number of other imaging modalities; however, these images must not be used for primary diagnostic interpretation.
When interpreted by a skilled physician, Visia™ Dynamic Review provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of Visia™ Dynamic Review analysis.
Visia™ Dynamic Review is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. Visia™ Dynamic Review supports evaluation of dynamic MR data.
Visia™ Dynamic Review integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard offthe-shelf personal computer (PC) and can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network.
Visia™ Dynamic Review automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics (parametric image maps). Furthermore, it performs other user-defined post-processing functions such as image subtractions; multi-planar reformats and maximum intensity projections.
The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source images can also be displayed based on physician preferences using configurable viewing options or hanging protocols.
Visia™ Dynamic Review provides the clinician with a broad set of viewing and analysis tools to annotate, measure, and output selected image views or user defined reports. Furthermore, Visia™ Dynamic Review can evaluate the uptake characteristics of segmented tissues.
Visia™ Dynamic Review also displays images from a number of other imaging modalities; however, these images must not be used for primary diagnostic interpretation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Visia™ Dynamic Review device, structured according to your requested information:
1. A table of acceptance criteria and the reported device performance
Based on the provided K113337 510(k) Summary, specific quantitative acceptance criteria and corresponding reported device performance values are not explicitly detailed. The document focuses on the regulatory submission process and general affirmations of safety and effectiveness through nonclinical testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in the provided document. The document states: "The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the software in each operational mode and followed the process documented in the Validation Test Plan." And "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification activities and that the results demonstrated that the predetermined acceptance criteria were met." | No specific quantitative performance metrics are provided. The document states: "The complete system configuration has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria." And "Nonclinical tests demonstrate that the device is safe, effective, and is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided K113337 510(k) Summary does not specify the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It only mentions "in-house testing criteria" and "Validation Test Plan."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The provided K113337 510(k) Summary does not provide information on the number or qualifications of experts used to establish ground truth for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided K113337 510(k) Summary does not describe any adjudication method used for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not described or performed in the provided K113337 510(k) Summary. The device is software for viewing and analyzing MRI studies, and the document explicitly states, "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians." There is no mention of AI assistance or human reader improvement with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The K113337 510(k) Summary does not explicitly describe a standalone performance study in terms of quantitative metrics. It states that the "complete system configuration has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria." However, it clarifies that the software's role is to provide information for a skilled physician's interpretation, rather than performing diagnosis independently: "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians." and "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The provided K113337 510(k) Summary does not specify the type of ground truth used for its internal testing or validation studies.
8. The sample size for the training set
The provided K113337 510(k) Summary does not mention a training set sample size. This is consistent with the nature of the device, which is described as "Medical Image Processing Software" that performs functions like motion registration, parametric image mapping, subtractions, and multi-planar reformats. These are generally rule-based or algorithmic image processing tasks rather than machine learning models that require explicit training sets in the typical sense.
9. How the ground truth for the training set was established
As no training set is mentioned or implied for the core functionalities of the device, the document does not describe how ground truth for a training set was established.
§ 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.