(88 days)
The SIGNA™ Artist Evo system is a whole body magnetic resonance scanner designed to support 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, neart, 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 Evo system reflect the spatial distribution or molecular environment of nuclej exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The SIGNA™ Artist Evo 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.
The provided text is a 510(k) summary for the SIGNA™ Artist Evo magnetic resonance diagnostic device. It details how the device is considered substantially equivalent to a predicate device (SIGNA™ Artist) rather than presenting a study for meeting specific acceptance criteria itself. The document focuses on non-clinical testing for safety and performance, and the claim of "acceptable diagnostic image performance" based on sample clinical images, but does not outline a formal study with acceptance criteria for a specific AI or image perception outcome.
Therefore, I cannot fulfill all parts of your request as the provided text does not contain the acceptance criteria and the comprehensive study details you've asked for related to device performance in an AI context.
However, based on the information provided, here's what can be extracted and inferred regarding the device's substantial equivalence claim:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a magnetic resonance diagnostic device (not an AI algorithm with specific performance metrics like sensitivity/specificity for a particular disease), the "acceptance criteria" are related to substantial equivalence to a predicate device in terms of safety, technological characteristics, and image quality.
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (Summary) |
|---|---|
| Safety and Performance Standards Compliance | Compliant with: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, AAMI/ANSI 62304, applicable NEMA MS standards for MRI, NEMA PS3 (DICOM), ISO 10993. |
| Technological Characteristics | Same 1.5T LCC magnets, no changes to RF transmit/receive subsystems. Introduces new IRMW gradient coil. Key performance specifications (magnet stability, spatial homogeneity, max gradient strength) unchanged from predicate. Same software version as predicate with minor hardware accommodation changes. No changes to pulse sequences, imaging protocols, image processing. |
| Image Quality | Sample clinical images demonstrate acceptable diagnostic image performance, substantially equivalent to the predicate device. No new hazards, adverse effects, or safety/performance concerns significantly different from general MR imaging identified. |
| Risk Management | Subject to similar risk management activities as the predicate device (Risk Analysis, Requirements Reviews, Design Reviews, Unit/Module/Integration/Performance/Simulated Use Testing). |
| Indications for Use | Identical to the predicate device. |
Regarding specific study details for AI/perception performance:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states: "Sample clinical images have been included in this submission." It does not specify a test set sample size, data provenance, or whether it was retrospective or prospective. This implies a qualitative assessment rather than a structured quantitative study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The assessment of "acceptable diagnostic image performance" would inherently involve expert interpretation, but the number and qualifications of these experts are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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. The device is an MRI scanner, not an AI-assisted diagnostic tool discussed in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a medical imaging device, not an AI algorithm being evaluated for standalone performance. "The images produced...when interpreted by a trained physician yield information that may assist in diagnosis."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "acceptable diagnostic image performance," the ground truth is implicitly expert interpretation of images for diagnostic quality, likely a qualitative assessment. There's no mention of pathology or outcomes data being used to establish ground truth for this aspect.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" as this device is not an AI/machine learning algorithm undergoing a training/validation process in the context of this 510(k) summary.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided 510(k) relates to the substantial equivalence of an MRI scanner (SIGNA™ Artist Evo) to its predicate device (SIGNA™ Artist) based on non-clinical engineering and systems testing, and a qualitative assessment of sample clinical images for diagnostic performance. It is not a submission detailing the performance of an AI diagnostic algorithm, and therefore the specific criteria you've asked for related to AI-driven studies are not present in this document.
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February 11, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Healthcare (Tianjin) Company Limited % Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd. WAUKESHA WI 53188
Re: K213603
Trade/Device Name: SIGNATM Artist Evo Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: November 12, 2021 Received: November 15, 2021
Dear Glen 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 (QS) 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 mediation-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) K213603
Device Name SIGNA™ Artist Evo
Indications for Use (Describe)
The SIGNA™ Artist Evo system is a whole body magnetic resonance scanner designed to support 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, neart, 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 Evo system reflect the spatial distribution or molecular environment of nuclej exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information 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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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. There are decorative flourishes resembling water droplets or stylized leaves placed around the letters and along the inner edge of the circle. The background of the circle is a solid gray color, while the letters and decorative elements are white.
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | November 12, 2021 |
| Submitter: | GE Healthcare (GE Healthcare (Tianjin) Company Limited)No. 266 Jingsan Road, Tianjin Airport Economic AreaTianjin, China 300308 |
| PrimaryContactPerson: | Qiang DingRegulatory Affairs Program ManagerPhone: +86 13311385163Email: Ding.Qiang@ge.com |
| SecondaryContactPerson: | Glen SabinRegulatory Affairs DirectorPhone: 262-894-4968Email: Glen.Sabin@ge.com |
| Device TradeName: | SIGNA TM Artist Evo |
| Common/UsualName: | Magnetic Resonance Diagnostic Device |
| ClassificationNames: | Magnetic Resonance Diagnostic Device |
| RegulationNumber: | 21 CFR 892.1000 |
| PrimaryProduct Code: | LNH |
| SecondaryProduct Code: | LNI, MOS |
| PredicateDevice: | SIGNA TM Artist (K202238) |
| ReferenceDevice | SIGNA Architect (K202966) |
| DeviceDescription: | The SIGNA TM Artist Evo system is a whole body magnetic resonancescanner designed to support high resolution, high signal-to-noiseratio, and short scan times. The system features a superconductingmagnet. The data acquisition system accommodates up to 128independent receive channels in various increments and multipleindependent coil elements per channel during a single acquisitionseries. The system uses a combination of time varying magnetic fields(gradients) and RF transmissions to obtain information regarding thedensity and position of elements exhibiting magnetic resonance. Thesystem can image in the sagittal, coronal, axial, oblique, and double |
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|--|
| oblique planes, using various pulse sequences and reconstructionalgorithms. | |
|---|---|
| Indications forUse: | The Indications for Use statement for the proposed device isidentical to that of the predicate device:The SIGNA™ Artist Evo system is a whole-body magneticresonance scanner designed to support high resolution, highsignal-to-noise ratio, and short scan times. It is indicated for use asa diagnostic imaging device to produce axial, sagittal, coronal, andoblique images, spectroscopic images, parametric maps, and/orspectra, dynamic images of the structures and/or functions of theentire body, 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 Evo 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. |
| TechnologyCharacteristics: | Many of the technological characteristics of the proposed SIGNA™Artist Evo system are unchanged from the predicate device. TheSIGNA™ Artist Evo system reuses GE Healthcare 1.5T LCCmagnets in the installed base, and introduces the new IRMWgradient coil. There are no changes to the RF transmit and receivesubsystems compared to the predicate K202238. Key performancespecifications (such as magnet stability and spatial homogeneity,maximum gradient strength, etc.) for the system are alsounchanged.The SIGNA™ Artist Evo system also uses the same versionsoftware as the predicate device with some minor changes toaccommodate the hardware differences. There are no changes tothe pulse sequences, imaging protocols and image processing. |
| DeterminationofSubstantialEquivalence: | Summary of Non-Clinical Tests:The SIGNA™ Artist Evo and the predicate device were subject tosimilar risk management activities and performance testing todemonstrate substantial equivalence of safety and performance.Testing included compliance to the following voluntary standards:AAMI/ANSI ES60601-1 IEC 60601-1-2 IEC 60601-2-33 AAMI/ANSI 62304 |
| In addition, the SIGNA™ Artist Evo was tested in accordance withapplicable NEMA MS standards for MRI, and complies with theNEMA PS3 standard for DICOM, as does the predicate device.Both the SIGNA™ Artist Evo and the predicate device arecompliant with ISO 10993.The following quality assurance measures were applied to thedevelopment of the subject device, as they were for the predicatedevice: | |
| Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Simulated use testing (Validation) | |
| Summary of Clinical Tests:The subject of this premarket submission, the SIGNAT™ Artist Evo,did not require clinical studies to support substantial equivalence.Sample clinical images have been included in this submission. Thesample clinical images demonstrate acceptable diagnostic imageperformance of the SIGNA™ Artist Evo in accordance with the FDAGuidance "Submission of Premarket Notifications for MagneticResonance Diagnostic Devices" issued on November 18, 2016.The image quality of the SIGNA™ Artist Evo is substantiallyequivalent to that of the predicate device. | |
| Substantial Equivalence Conclusion:The indications for use of the proposed device are comparable tothe claimed predicate device. The SIGNA™ Artist Evo employsequivalent technology to the claimed predicate device. Additionally,the results from the above non-clinical tests demonstrate that thedevice performs as intended. Therefore, the SIGNA™ Artist Evo issubstantially equivalent to the predicate device to which it has beencompared. | |
| ConclusionDrawn fromPerformanceTesting: | The proposed SIGNA™ Artist Evo system has been developedunder GE Healthcare's quality system and is at least as safe andeffective as the legally marketed predicate. The performance testingdid not identify any new hazards, adverse effects, or safety orperformance concerns that are significantly different from thoseassociated with MR imaging in general.Therefore, GE Healthcare believes that SIGNAT™ Artist Evo issubstantially equivalent to the predicate device, and is safe andeffective for its intended use. |
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Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are four decorative flourishes or droplets evenly spaced around the outer edge of the circle. The logo is presented in a grayscale color scheme.
§ 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.