(127 days)
The Discovery MR750w 3.0T is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The Discovery MR750w 3.0T features a superconducting magnet operating at 3.0 Tesla. The data acquisition system accommodates up to 32 independent receive channels in various increments, and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The Discovery MR750w 3.0T uses multi-drive RF transmit for imaging of the head and body regions. The Discovery MR750w 3.0T is designed to conform to NEMA DICOM standards.
The provided document is a 510(k) Premarket Notification Submission for a Magnetic Resonance Imaging (MRI) system, the GE Healthcare Discovery MR750w 3.0T. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about an AI/algorithm-based device and its performance against specific acceptance criteria in the manner requested.
Therefore, I cannot extract the following information:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- Whether a standalone (algorithm only) performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Key takeaway from the document regarding "acceptance criteria" and "study":
The document details the device's compliance with various voluntary standards (IEC and NEMA) and quality assurance measures applied during its development. It also states that non-clinical tests were conducted and summarized in verification testing, with passing results based on defined pass/fail criteria.
Crucially, under "Summary of Clinical Tests," it explicitly states:
"The subject of this premarket submission, Discovery MR750w 3.0T, did not require clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality. The clinical results demonstrated that the Discovery MR750w 3.0T maintains the same imaging performance results as its predicate device, the Discovery MR750w 3.0T (K103327)."
This indicates that the device's enhanced features (specifically, multi-drive RF transmit for head scanning, which is a software change) were validated through internal non-clinical tests and internal scans for workflow and image quality, rather than formal clinical studies with a predefined set of acceptance criteria based on diagnostic performance that would typically be associated with AI/algorithm efficacy. The primary "acceptance criteria" here is demonstrated equivalence to the predicate device through these internal tests and compliance with recognized standards.
§ 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.