(8 days)
IDEAL is a software option intended for use on GE Signa MR systems. It is indicated for magnetic resonance imaging of the musculoskeletal, breast, abdominal, and neurological systems of the human body.
IDEAL is an acquisition and reconstruction method that simultaneously obtains independent images of nuclei that resonate at different frequencies. IDEAL provides uniform tissue separation, reduces chemical shift artifacts, and minimizes the effects of magnetic field inhomogeneities. The IDEAL method provides higher image quality relative to chemically selective fat saturation techniques and STIR. Specific tissue for separation may include water and fat.
When used with a GE Signa MR system, IDEAL is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the cervical-spine, joints, and extremities. The independent images produced from IDEAL may be added or subtracted for tissue delineation.
The images reflect the spatial distribution of nuclei exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, molecular environment, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The IDEAL Software Option is a software only product for use on GE Signa MR scanners.
To improve the separation between fat and water, the IDEAL technique acquires three measurements of IDEAL echoes to resolve fat, water and the magnetic field variations. The IDEAL processing produces four images from the IDEAL echoes: a water image, a fat image, a combined water plus fat image, and a combined water minus fat image. This process helps achieve uniform fat suppression and reduce chemical shift artifacts.
The provided text makes a general statement about the device's performance relative to predicate devices but does not include specific acceptance criteria or a study detailing numerical performance results.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states that IDEAL provides "higher image quality relative to chemically selective fat saturation techniques and STIR" but does not quantify this improvement with specific metrics or acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not available in the provided text. The document states that images should be "interpreted by a trained physician," but this refers to the intended use of the device, not the validation process.
4. Adjudication Method for the Test Set
Not available in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not mentioned in the provided text.
6. Standalone Performance Study
Not mentioned in the provided text. The device is described as "IDEAL is a software option for use on GE Signa MR systems," indicating it functions as an integrated component, not a standalone algorithm in isolation.
7. Type of Ground Truth Used
Not available in the provided text.
8. Sample Size for the Training Set
Not available in the provided text.
9. How the Ground Truth for the Training Set Was Established
Not available in the provided text.
Summary of the Study Discussed in the Document:
The provided document, K072998, is a 510(k) summary of safety and effectiveness for the IDEAL Software Option for GE Signa MR Scanners. It is focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance metrics from a specific clinical study with acceptance criteria.
The conclusion states: "This premarket notification submission demonstrates that the IDEAL software option is substantially equivalent to the analogous feature in the cleared GE 1.5T and 3.0T Signa HDx MR Systems because it has the same intended use and differences in methodology do not raise new questions of safety and efficacy."
This indicates that the "study" proving the device meets its "acceptance criteria" (which in this context is primarily substantial equivalence) is the comparison to the predicate device, K052293. The acceptance criterion appears to be that the IDEAL software option has the same intended use and its methodological differences do not raise new questions of safety and efficacy compared to the predicate. No specific performance numbers or detailed study methodology (like expert reads, sample sizes, or ground truth establishment) are provided in this regulatory summary.
§ 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.