(28 days)
The SIGNA Artist system is a whole body magnetic resonance scanner designed to support high signalto-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, 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 SIGNA Artist system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained that may assist in diagnosis.
The SIGNA Artist system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The system features a superconducting magnet. The data acquisition system accommodates up to 128 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.
This 510(k) submission is for the SIGNA Artist 1.5T MR system, and has been triggered by the addition of the AIR Recon DL software feature.
The AIR Recon DL feature has been previously cleared for use on the SIGNA Premier 3T system through K193282, which is used as a reference device for this submission.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for GE Healthcare SIGNA Artist with AIR Recon DL
The provided document describes the 510(k) submission for the GE Healthcare SIGNA Artist system with the added AIR Recon DL software feature. The study focuses on evaluating the impact of this new feature on image quality.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Image Quality | SNR (Signal-to-Noise Ratio) Improvement: Improved SNR with AIR Recon DL. | Nonclinical and clinical testing demonstrated that AIR Recon DL improves SNR. Additionally,AIR Recon DL was able to maintain image SNR for images acquired with a reduced scan time. |
| Sharpness Improvement: Improved image sharpness with AIR Recon DL. | Nonclinical and clinical testing demonstrated that AIR Recon DL improves image sharpness. Additionally,AIR Recon DL did not sacrifice sharpness for images acquired with a reduced scan time. | |
| Low Contrast Detectability: Maintenance of low contrast detectability with AIR Recon DL. | Nonclinical testing confirmed that AIR Recon DL maintains low contrast detectability. | |
| Noise Spectral Content Impact: Minimal impacts to noise spectral content with AIR Recon DL. | Nonclinical testing confirmed that AIR Recon DL has minimal impacts to noise spectral content. | |
| Average Signal Intensity Bias: No significant bias introduced that might impact quantitative measurements based on signal intensity. | Analysis was performed to confirm that the feature does not introduce significant bias that might impact quantitative measurements based on signal intensity. | |
| Motion Artifact Impact: Minimal impacts to the appearance of motion artifacts. | Nonclinical testing confirmed that AIR Recon DL has minimal impacts to the appearance of motion artifacts. | |
| Clinical Acceptability | Equivalent or Better Image Quality: Images produced with AIR Recon DL should have equivalent or better image quality compared to images without the feature as rated by radiologists. | Radiologists were asked to rate images and comment on quality; the study showed that the AIR Recon DL feature provides images with equivalent or better image quality. |
| Maintained Lesion Conspicuity: Lesion conspicuity should be maintained with AIR Recon DL. | The study showed that lesion conspicuity is maintained. | |
| Radiologist Preference: Radiologists should prefer AIR Recon DL images for clinical use. | The study showed that the radiologists preferred the AIR Recon DL images for clinical use. | |
| Scan Time | Shorter Scan Times: Ability to enable shorter scan times while maintaining SNR and image sharpness. | Nonclinical and clinical testing demonstrated that AIR Recon DL can enable shorter scan times while maintaining SNR and image sharpness. |
| Safety and Performance | No New Hazards/Adverse Effects: The feature should not introduce any new hazards, adverse effects, or safety and performance concerns significantly different from those associated with MR imaging in general. | The performance testing did not identify any new hazards, adverse effects, or safety and performance concerns that are significantly different from those associated with MR imaging in general. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for the test set used in the clinical evaluation. It mentions "sample images from clinically indicated scans."
The data provenance for the clinical evaluation is implied to be retrospective as it involves "sample images from clinically indicated scans" that were then evaluated with and without the AIR Recon DL feature. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document states that "Radiologists were asked to rate the images, and to comment on any notable aspects related to image quality." It does not specify the exact number of experts or their qualifications (e.g., years of experience, subspecialty).
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. The text only mentions that "Radiologists were asked to rate the images, and to comment on any notable aspects related to image quality." This suggests an individual review process, but it doesn't detail how discrepancies or consensus building was handled if multiple radiologists reviewed the same case. It doesn't mention methods like 2+1, 3+1, or majority vote.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated as the primary methodology. The clinical evaluation described involves radiologists rating images "both with and without the AIR Recon DL feature" and stating their preference. While this provides comparative feedback, it does not quantify human reader improvement in terms of diagnostic accuracy or a specific effect size. The study concludes that radiologists "preferred the AIR Recon DL images for clinical use" and that lesion conspicuity was maintained, indicating a subjective improvement, but not a measurable effect size of diagnostic performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done as part of the "Nonclinical Tests." These tests were designed to evaluate the AIR Recon DL feature "and its impact on image quality, including SNR, sharpness, low contrast detectability, and noise spectral content. Analysis was performed to confirm that the feature does not introduce significant bias that might impact quantitative measurements based on signal intensity. The influence of motion during image acquisition on the performance of AIR Recon DL was also evaluated." These are objective, quantitative measurements of the algorithm's output without human interpretation being the primary endpoint.
7. The Type of Ground Truth Used
For the nonclinical tests, the ground truth appears to be based on objective image quality metrics, physical phantoms, and simulated conditions. For instance, evaluating SNR, sharpness, noise spectral content, a lack of signal intensity bias, and motion artifact influence against established benchmarks or predefined ideal conditions.
For the clinical tests, the ground truth for "equivalent or better image quality" and "maintained lesion conspicuity" was established by expert consensus/opinion from radiologists.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set used for the AIR Recon DL algorithm. It only mentions that the AIR Recon DL feature "has been previously cleared for use on the SIGNA Premier 3T system through K193282, which is used as a reference device for this submission." This implies the training was done prior to this specific submission for the SIGNA Artist.
9. How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set was established for the AIR Recon DL algorithm. While it mentions the algorithm was previously cleared for another device, it does not elaborate on the specific data used for its initial training and ground truth annotation.
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September 4, 2020
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GE Healthcare (Tianjin) Company Limited % Mr. Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical System, LLC) 3200 N Grandview Blvd. WAUKESHA WI 53188
Re: K202238
Trade/Device Name: SIGNA Artist Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: August 6, 2020 Received: August 7, 2020
Dear Mr. Sabin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202238
Device Name SIGNA Artist
Indications for Use (Describe)
The SIGNA Artist system is a whole body magnetic resonance scanner designed to support high signalto-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, 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 SIGNA Artist system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained that may assist in diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Premarket Notification Submission SIGNA Artist
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | August 06, 2020 |
|---|---|
| Submitter: | GE Healthcare (GE Healthcare (Tianjin) Company Limited)No. 266 Jingsan Road,Tianjin Airport Economic AreaTianjin, China 300308 |
| Primary ContactPerson: | Qiang DingRegulatory Affairs LeaderPhone: +86 13311385163Email: Ding.Qiang@ge.com |
| Secondary ContactPerson: | Glen SabinRegulatory Affairs DirectorPhone: 262-894-4968Email: Glen.Sabin@ge.com |
| Device Trade Name: | SIGNA Artist |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | Magnetic Resonance Diagnostic Device |
| Regulation Number: | 21 CFR 892.1000 |
| Primary Product Code: | LNH |
| Secondary Product Code: | LNI, MOS |
| Predicate Device: | SIGNA Artist (K163331) |
| Device Description: | The SIGNA Artist system is a whole body magnetic resonance scannerdesigned to support high resolution, high signal-to-noise ratio, and short scantimes. The system features a superconducting magnet. The data acquisitionsystem accommodates up to 128 independent receive channels in variousincrements and multiple independent coil elements per channel during asingle acquisition series. The system uses a combination of time varyingmagnetic fields (gradients) and RF transmissions to obtain informationregarding the density and position of elements exhibiting magneticresonance. The system can image in the sagittal, coronal, axial, oblique, anddouble oblique planes, using various pulse sequences and reconstructionalgorithms.This 510(k) submission is for the SIGNA Artist 1.5T MR system, and hasbeen triggered by the addition of the AIR Recon DL software feature. |
| The AIR Recon DL feature has been previously cleared for use on theSIGNA Premier 3T system through K193282, which is used as a referencedevice for this submission. | |
| Indications for Use: | The Indications for Use statement for the proposed device is identical tothat of the predicate device: |
| The SIGNA Artist system is a whole body magnetic resonancescanner designed to support high resolution, high signal-to-noiseratio, and short scan times. It is indicated for use as a diagnosticimaging device to produce axial, sagittal, coronal, and obliqueimages, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entirebody, including, but not limited to, head, neck, TMJ, spine, breast,heart, abdomen, pelvis, joints, prostate, blood vessels, andmusculoskeletal regions of the body. Depending on the region ofinterest being imaged, contrast agents may be used. | |
| The images produced by the SIGNA Artist system reflect thespatial distribution or molecular environment of nuclei exhibitingmagnetic resonance. These images and/or spectra wheninterpreted by a trained physician yield information that may assistin diagnosis. | |
| The addition of the AIR Recon DL feature does not impact the intendeduse of the SIGNA Artist system. | |
| TechnologyCharacteristics: | Many of the technological characteristics of the proposed SIGNA Artistsystem are unchanged from the predicate device. The SIGNA Artistsystem has been introduced an additional configuration with IPM magnet.There are no changes to gradient, and RF subsystems compared to thepredicate K163331. Key performance specifications (such as magnetstability, maximum gradient strength and slew rate, etc.) for the systemare also unchanged. |
| The software used on the proposed SIGNA Artist system has beenmodified to include the AIR Recon DL feature. The User interfaceprovides operators of the system with new options for selecting AIRRecon DL and adjusting the associated level of image noise reduction.The resulting images can have higher SNR and improved sharpnesscompared to images reconstructed without AIR Recon DL. | |
| AIR Recon DL has been previously cleared for use with GE Healthcare's3T SIGNA Premier system through K193282. Due to the technicalsimilarities, SIGNA Premier (K193282) is used as a reference device forthis submission. | |
| Determination of | Summary of Non-Clinical Tests: |
| SubstantialEquivalence: | The AIR Recon DL feature has undergone the performance testing.These tests were designed to evaluate the AIR Recon DL feature and itsimpact on image quality, including SNR, sharpness, low contrastdetectability, and noise spectral content. Analysis was performed toconfirm that the feature does not introduce significant bias that mightimpact quantitative measurements based on signal intensity. Theinfluence of motion during image acquisition on the performance of AIRRecon DL was also evaluated.The nonclinical testing demonstrated that AIR Recon DL does improve |
| SNR and image sharpness while maintaining low contrast detectabilityand having minimal impacts to noise spectral content, average signalintensity, or the appearance of motion artifacts. AIR Recon DL was alsoable to maintain image SNR and did not sacrifice sharpness for imagesacquired with a reduced scan time. The nonclinical testing passed thedefined acceptance criteria, and did not identify any adverse impacts toimage quality or other concerns related to safety and performance. | |
| Summary of Clinical Tests:Objective measures of in vivo images were analyzed to confirm that AIRRecon DL improves SNR and image sharpness for typical clinical use | |
| cases. | |
| Additionally, sample images from clinically indicated scans wereevaluated both with and without the AIR Recon DL feature. Thesesamples included images using exogenous contrast and images involvingpathology spanning a variety of anatomies and pulse sequences.Radiologists were asked to rate the images, and to comment on anynotable aspects related to image quality. This study showed that the AIRRecon DL feature provides images with equivalent or better imagequality, lesion conspicuity is maintained, and that the radiologistspreferred the AIR Recon DL images for clinical use. | |
| Conclusion Drawn fromPerformance Testing: | The nonclinical and clinical testing demonstrated that AIR Recon DLsatisfies the product claims of improved SNR and image sharpness, andcan enable shorter scan times while maintaining SNR and imagesharpness. |
| The proposed SIGNA Artist system with AIR Recon DL has beendeveloped under GE Healthcare's quality system and is at least as safeand effective as the legally marketed predicate. The performance testingdid not identify any new hazards, adverse effects, or safety andperformance. | |
| performance concerns that are significantly different from those. | |
| associated with MR imaging in general.Therefore, GE Healthcare believes that SIGNA Artist with AIR Recon DLis substantially equivalent to the predicate device, and is safe andeffective for its intended use. |
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510(k) Premarket Notification Submission SIGNA Artist
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510(k) Premarket Notification Submission SIGNA Artist
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510(k) Premarket Notification Submission SIGNA Artist
§ 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.