(254 days)
MASS, including its option, has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular from cardiac MR data sets. The software enables the display of images for use by trained medical personnel.
Intended purposes are:
supporting clinical diagnoses about the status of the global and regional function and anatomy of the cardiac chambers;
- supporting the subsequent clinical decision making processes;
supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of interventions.
MASS, including its option, has been developed for the objective and reproducible analysis of multi-shase left and right ventricular function from cardiac MR data sets. The MASS software package can be used to semi-automatically calculate and display various parameters such as: EDV, ESV, stroke volume, ejection fraction, peak thisksping(this) = = = = ; myocardial mass; regional wall thickness, as well as wall thickening/thinning, and regional wall motion.
When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis.
MASS is a professional state-of-the-art analytical software tool designed for UNIX as well as Linux platforms. MASS facilitates the import and visualization of multi-slice, multiphase MRI data sets encompassing the cardiac chambers via CD-Rom and digital network. This MASS functionality is independent of the MRI equipment vendor. MASS provides objective and reproducible global and regional two-, three- and fourdimensional clinically relevant parameters describing left and right ventricular heart as ventricular volumes, regional wall thickness and function. such wall MASS is intended to support all clinicians, i.e. cardiologists, thickening/thinning radiologists, and referring physicians involved in the noninvasive assessment of heart function.
The provided documentation for K994283 does not contain specific acceptance criteria, detailed study results, or the other requested information for a clinical performance study. The submission primarily focuses on establishing substantial equivalence to a predicate device and discussing the safety and intended use of the MASS software.
Therefore, many of the requested fields cannot be filled. Based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document describes the device's functionality and intended use but does not present a table of specific performance metrics (e.g., accuracy, precision, repeatability) with corresponding acceptance thresholds or reported device performance values.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided document. The document mentions "Evaluations by hospitals and literature" in a general statement about supporting safety and effectiveness, but it does not specify any test set sample sizes, nor does it provide details about their origin (country, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not available in the provided document. There is no mention of specific experts or their qualifications used to establish ground truth for any test set. The document states that the "regions-of-interest will be interpreted by the operator, who can choose to accept or reject the outlines," implying human interaction in the final interpretation but not a formal ground truth establishment process for a study.
4. Adjudication Method for the Test Set
Not available in the provided document. No information is provided regarding an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available in the provided document. There is no mention of an MRMC comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is described as an analytical tool that aids trained medical personnel, but not in the context of comparative effectiveness.
6. Standalone (Algorithm Only) Performance Study
Partially available/Inferred: The document describes MASS as "stand alone software to view images" and states that "This tool calculates and displays the anatomy and function of the left and right ventricular contours and regions." This suggests that the algorithm does perform its calculations and display in a "standalone" fashion. However, there is no performance study presented to quantify its standalone accuracy, precision, sensitivity, or specificity against any ground truth. The "verification and validation tests" mentioned (Appendix E, not provided) likely cover internal software functionality rather than external clinical performance.
7. Type of Ground Truth Used
Not available in the provided document for any formal study. While the software aims to provide "objective and reproducible global and regional... parameters" for "left and right ventricular volumes, regional wall thickness and function," the basis for validating these against a "ground truth" (e.g., pathology, advanced imaging, clinical outcomes) in a formal study is not described. The document implies that a "trained physician" interprets the parameters derived by the software.
8. Sample Size for the Training Set
Not available in the provided document. There is no mention of a training set or its sample size. This suggests the device might use more traditional algorithmic approaches or was developed without a machine learning training phase in the current understanding.
9. How the Ground Truth for the Training Set Was Established
Not available in the provided document. As there is no mention of a training set, the method for establishing its ground truth is also not provided.
§ 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.