(120 days)
IDEAL IQ is a software option intended for use on GE MR systems. IDEAL IQ is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, breast, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the abdomen, breast, spine, joints, and extremities.
IDEAL IQ is an acquisition and reconstruction technique that simultaneously obtains independent images of hydrogen nuclei that resonate at different frequencies to provide separation of water and triglyceride fat. IDEAL IQ generates images of separated water and triglyceride fat, relative triglyceride fat fraction map, and tissue transverse magnetization relaxation. In the liver, the relative triglyceride fat fraction map is quantitative; it reflects the proton density (number of protons per unit volume) of triglyceride fat, divided by the sum of the proton density of triglyceride fat and the proton density of water, on a voxel-by-voxel basis.
When interpreted by a trained physician, these images provide information that can aid in diagnosis.
IDEAL IQ is a software application offered as an option for GE MR scanners. The IDEAL IQ imaging technique (IDEAL: Iterative Decomposition of water and fat with Echo Asymmetry and Least-squares estimation) is a triglyceride fat and water separation technique that acquires multiple images of the anatomy at separate echo times to calculate the phase differences and determine triglyceride fat and water content per pixel. It exploits the resonance frequency differences between triglyceride fat and water, measured as phase differences in multiple echoes, to resolve triglyceride fat and water. It provides reliable and uniform water-fat separation in the presence of B0 field inhomogeneity and improves the accuracy of water-fat separation by estimating and correcting for T2* decay between echoes and by more accurately modeling triglyceride fat's spectral profile as multiple peaks rather than a single peak. It produces images showing the separated water and triglyceride fat signals, and the tissue transverse magnetization relaxation. Finally, IDEAL IO processes decomposed water and triglyceride fat images to generate a relative triglyceride fat-fraction map. Such a representation of a proton density triglyceride fat fraction is intrinsically insensitive to B1 and coil-sensitivity heterogeneity. The IDEAL IO method uses a low flip angle excitation to reduce any TI bias in the relative triglyceride fat fraction map images caused by differences in the TI of triglyceride fat and water. With the confounding effects of T2*, multiple spectral peaks of triglyceride fat, and T1 differences reduced, the images from IDEAL IQ reflect the spatial distribution of relative concentration of triglyceride fat in a voxel.
The provided text describes the "IDEAL IQ Software Option" for GE MR scanners. However, the document does not contain a table of acceptance criteria or a detailed study that explicitly proves the device meets specific performance criteria through a clinical trial with reported outcomes against predefined metrics.
The submission focuses on establishing substantial equivalence to a predicate device (IDEAL Software Option, K072998) and outlining non-clinical tests for safety and internal quality assurance.
Here's an attempt to answer your questions based on the available information, noting where information is not present:
1. A table of acceptance criteria and the reported device performance
Not provided in the document. The submission states: "Clinical image comparisons demonstrate that the IDEAL IQ software option maintains the same imaging performance results as the predicate software option IDEAL." This implies the acceptance criterion was "maintaining the same performance as the predicate device," but no specific metrics or reported performance values are given.
2. Sample size used for the test set and the data provenance
Not explicitly provided. The document mentions "several in vivo human studies showing correlation to MR Spectroscopy" for quantification in the liver. It also refers to "clinical image comparisons." However, no specific sample sizes for these studies or their data provenance (e.g., country of origin, retrospective/prospective) are detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly provided. The document mentions "When interpreted by a trained physician, these images provide information that can aid in diagnosis." This implies expert interpretation, but the number or qualifications of these experts are not specified for any studies mentioned.
4. Adjudication method for the test set
Not provided.
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
No MRMC comparative effectiveness study is described for this device. The IDEAL IQ is described as a software option for acquisition and reconstruction to generate specific image types (separated water and fat images, fat-fraction maps). It is not presented as an AI-powered diagnostic aid that improves human reader performance. Its purpose is to provide quantitative information (e.g., relative triglyceride fat-fraction map) that aids diagnosis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the device has standalone performance. The IDEAL IQ software itself generates the separated water and fat images, the relative triglyceride fat-fraction map, and tissue transverse magnetization relaxation maps. The "quantification in the liver" is shown through "correlation to MR Spectroscopy," suggesting a direct comparison of the algorithm's output (fat-fraction map) to a reference standard (MR Spectroscopy). The key output, the "relative triglyceride fat-fraction map," is inherently quantitative, reflecting the proton density of triglyceride fat per voxel.
7. The type of ground truth used
For quantification in the liver (fat-fraction map), the ground truth used was MR Spectroscopy.
For the general "clinical image comparisons" to demonstrate "same imaging performance results as the predicate software option IDEAL," the nature of the ground truth is not specified but would likely involve expert visual assessment and comparison for image quality and diagnostic utility, though this is inferred.
8. The sample size for the training set
The document describes IDEAL IQ as a software option for image acquisition and reconstruction that exploits physical phenomena (resonance frequency differences between fat and water). It is not a machine learning or AI algorithm that typically has a "training set" in the conventional sense. Therefore, a training set size is not applicable or provided.
9. How the ground truth for the training set was established
As there is no traditional "training set" for this type of image reconstruction algorithm, this question is not applicable. The algorithm's principles are based on established physics and signal processing.
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MAR 2 2 2011
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GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | March 21, 2011 |
| Submitter: | GE Healthcare (GE Medical Systems, LLC)3200 N. Grandview Blvd.Waukesha, WI 53188USA |
| Primary Contact Person: | Tracey FoxRegulatory Affairs ManagerGE Healthcare (GE Medical Systems, LLC)(262) 521-6079(414) 918-8349 fax |
| Secondary Contact Person: | Glen SabinRegulatory Affairs DirectorGE Healthcare (GE Medical Systems, LLC)(262) 521-6848(262) 521-6439 fax |
| Device: | IDEAL IQ Software Option |
| Trade Name: | IDEAL IQ Software Option |
| Common/Usual Name: | Software Option for Magnetic Resonance Imaging System |
| Classification Names: | 21 C.F.R. 892.1000Magnetic Resonance Diagnostic Device |
| Product Code: | LNH |
| Predicate Device(s): | IDEAL Software Option, K072998 |
| Device Description: | IDEAL IQ is a software application offered as an option for GEMR scanners. The IDEAL IQ imaging technique (IDEAL:Iterative Decomposition of water and fat with Echo Asymmetr |
and Least-squares estimation) is a triglyceride fat and water separation technique that acquires multiple images of the anatomy at separate echo times to calculate the phase differences and determine triglyceride fat and water content per pixel. It exploits the resonance frequency differences between triglyceride fat and water, measured as phase differences in multiple echoes, to resolve triglyceride fat and water. It provides reliable and
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GE Healthcare
510(k) Premarket Notification Submission
uniform water-fat separation in the presence of B0 field inhomogeneity and improves the accuracy of water-fat separation by estimating and correcting for T2* decay between echoes and by more accurately modeling triglyceride fat's spectral profile as multiple peaks rather than a single peak. It produces images showing the separated water and triglyceride fat signals, and the tissue transverse magnetization relaxation. Finally, IDEAL IO processes decomposed water and triglyceride fat images to generate a relative triglyceride fat-fraction map. Such a representation of a proton density triglyceride fat fraction is intrinsically insensitive to B1 and coil-sensitivity heterogeneity. The IDEAL IO method uses a low flip angle excitation to reduce any TI bias in the relative triglyceride fat fraction map images caused by differences in the TI of triglyceride fat and water. With the confounding effects of T2*, multiple spectral peaks of triglyceride fat, and T1 differences reduced, the images from IDEAL IQ reflect the spatial distribution of relative concentration of triglyceride fat in a voxel.
IDEAL IQ is a software option intended for use on GE MR Intended Use: systems. IDEAL IO is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, breast. abdominal, and neurological systems. Specific anatomical regions that may be imaged include the abdomen, breast, spine, joints, and extremities.
IDEAL IO is an acquisition and reconstruction technique that simultaneously obtains independent images of hydrogen nuclei that resonate at different frequencies to provide separation of water and triglyceride fat. IDEAL IQ generates images of separated water and triglyceride fat, relative triglyceride fat fraction map, and tissue transverse magnetization relaxation. In the liver, the relative triglyceride fat fraction map is quantitative; it reflects the proton density (number of protons per unit volume) of triglyceride fat, divided by the sum of the proton density of triglyceride fat and the proton density of water, on a voxel-byvoxel basis.
When interpreted by a trained physician, these images provide information that can aid in diagnosis.
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P 3/3
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GE Healthcare
510(k) Premarket Notification Submission
Technology: The IDEAL IQ acquisition uses a fast 3D SPGR sequence in one or more repetitions. IDEAL IQ exploits the resonant frequency difference between triglyceride fat and water, measured as phase differences in multiple echoes. The IDEAL IQ software option employs the same fundamental scientific technology as its predicate device.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The IDEAL IO software option complies with voluntary standards as detailed in Section 9, 11, 16 and 18 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- . Requirements Reviews
- . Design Reviews
- . Design Verification
- . Safety Testing
The following safety parameters were measured:
- Acoustic Noise ●
- . dB/dt
- . SAR
The non-clinical tests outlined above have been executed with acceptable results. Refer to Sections 9, 16, and 18 of this submission for testing results.
Summary of Clinical Tests:
Clinical image comparisons demonstrate that the IDEAL IQ software option maintains the same imaging performance results as the predicate software option IDEAL. Quantification in the liver is shown through included studies of animal models, and several in vivo human studies showing correlation to MR Spectroscopy.
- GE Healthcare considers the IDEAL IQ software option to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Tracey Fox Regulatory Affairs Manager GE Medical Systems 3200 N Grandview Blvd W-827 WAUKESHA, WISCONSIN 53188
MAR 2 2 2011
Re: K103411
Trade/Device Name: IDEAL IQ Software Option Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: February 23, 2011 Received: February 24, 2011
Dear Ms. Fox,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5 00%) remarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerelv Yours.
Mary Pastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known): K103411 Device Name:
IDEAL IQ Software Option
Indications for Use
IDEAL IQ is a software option intended for use on GE MR systems. IDEAL IQ is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, breast, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the abdomen, breast, spine, joints, and extremities.
IDEAL IQ is an acquisition and reconstruction technique that simultaneously obtains independent images of hydrogen nuclei that resonate at different frequencies to provide separation of water and triglyceride fat. IDEAL IQ generates images of separated water and triglyceride fat, relative triglyceride fat fraction map, and tissue transverse magnetization relaxation. In the liver, the relative triglyceride fat fraction map is quantitative; it reflects the proton density (number of protons per unit volume) of triglyceride fat, divided by the sum of the proton density of triglyceride fat and the proton density of water, on a voxel-by-voxel basis.
When interpreted by a trained physician, these images provide information that can aid in diagnosis.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Pastel
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)
Page I of
§ 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.