(117 days)
QPlaque MR is a post-processing software application that is intended to assist trained cardiologists and radiologists in the assessment of atherosclerosis. The software is intended in particular to aid in assessing vessel wall thickness and remodeling in the carotid arteries I OPlaque MR post-processes multi-spectral MR images to semi-automatically determine the boundaries of the lumen and outer vessel wall, and provides editing tools for manual drawing of plaque components. The software enables area and volume measurements of the vessel wall as well as quantification of user-indicated areas.
QPlaque MR results can be used to support the decision-making process in clinical practice and to support conclusions in clinical trials.
QPlaque MR is able to read DICOM MR images from all major MR vendors. Vessel analysis data, generated by semi-automatic segmentation, detected stenosis and quantitative results can be saved in separate files enabling the comparison of results from different users.
Radiologists, cardiologists and technicians use the QPlaque MR analytical software package to obtain objective and reproducible results. The obtained results may be used to support the interpretation of MR data, or they are used in the evaluation of follow-up studies and the effectiveness of treatment.
In clinical practice QPlaque MR is used on workstations in review rooms or integrated in a PACS environment.
This document does not contain the detailed information necessary to answer all parts of your request. It is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of a device's performance against specific acceptance criteria.
Here's what can be extracted from the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The 510(k) summary focuses on the device's indications for use and substantial equivalence to existing devices, not on a performance study with defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document.
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)
This information is not present in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided document.
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
This information is not present in the provided document. The device is described as an "auxiliary tool" to "support the interpretation" and "support the decision-making process," which implies human-in-the-loop, but no MRMC study or effectiveness data is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly stated as a standalone performance study. The device is intended to "assist trained cardiologists and radiologists" and its results "may be used to support the decision-making process." This indicates it's designed to be used with a human in the loop, rather than operating in a fully standalone capacity.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not present in the provided document.
8. The sample size for the training set
This information is not present in the provided document.
9. How the ground truth for the training set was established
This information is not present in the provided document.
In summary, the provided document is a 510(k) substantial equivalence submission, which typically does not include the detailed study design, acceptance criteria, and performance results that would be found in a full clinical or technical validation report. The focus here is on demonstrating that the new device is as safe and effective as previously cleared devices, largely by having similar technology and intended use.
§ 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.