The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/ or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

Device Description

The GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. The system is designed for whole body oncology, neurology and cardiology examinations. The SIGNA PET/MR system provides simultaneous acquisition of high-resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a patient table and both the acquisition and processing workstations with associated software. The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil and body coil. The system includes dual drive capabilities. The SIGNA PET detectors are integrated into the MR bore. This allows for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The SIGNA PET/MR software is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

AI/ML Overview

Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving device performance for the SIGNA PET/MR system (K163619).

Important Note: The provided document is a 510(k) premarket notification summary for a modification to an existing device (SIGNA PET/MR, K142098). Therefore, the information primarily focuses on demonstrating substantial equivalence of the modified features (MR Attenuation Correction) rather than a complete de novo study of the entire PET/MR system. As such, some specific details typically found in studies for novel devices, such as comprehensive stand-alone performance or MRMC studies for improved human reading, are not explicitly provided or may not be applicable in the same way.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Defined for Modified Software Features)	Reported Device Performance (Summary from Non-Clinical and Clinical Tests)
Compliance with AAMI/ANSI 62304 (Medical Device Software - Software lifecycle processes)	Software features comply with AAMI/ANSI 62304
Compliance with AAMI/ANSI ES60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)	Software features comply with AAMI/ANSI ES60601-1
Compliance with IEC 60601-2-33 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis)	Software features comply with IEC 60601-2-33
Passing results for detailed Pass/Fail criteria defined in test cases for:	Testing completed with passing results per defined criteria for:
- Risk Analysis	- Risk Analysis (applied during development)
- Requirements Reviews	- Requirements Reviews (applied during development)
- Design Reviews	- Design Reviews (applied during development)
- Unit-level testing (Module verification)	- Testing on unit level (Module verification)
- Integration testing (System verification)	- Integration testing (System verification)
- Safety testing (Verification)	- Safety testing (Verification)
- Simulated use testing (Validation)	- Simulated use testing (Validation)
Substantial equivalence of modified MR Attenuation Correction to predicate MR Attenuation Correction technology regarding clinical images, qualitative, and quantitative comparisons.	Sample clinical images, qualitative and quantitative comparisons confirm substantial equivalence of modified features to predicate MR Attenuation Correction technology.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document mentions "Sample clinical images" were used for qualitative and quantitative comparisons. However, a specific numerical sample size for this test set is not explicitly stated in the provided text.
Data Provenance: Not explicitly stated. The document refers to "clinical images," but does not specify the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) for a medical device company, it's generally assumed to be clinical data relevant to human use, potentially from multiple sites.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not explicitly stated. The document does not detail how ground truth was established for the "sample clinical images" used for comparison, nor does it mention the number or qualifications of experts involved in this specific aspect of the testing for the modified features.

4. Adjudication Method for the Test Set

Not explicitly stated. The document focuses on demonstrating compliance with quality assurance measures and comparative testing. It does not mention an adjudication method for a test set in the context of expert review or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned. The submission describes "clinical tests" involving "sample clinical images, qualitative and quantitative comparisons compared to the predicate MR Attenuation Correction technology." This implies a comparison against the existing technology, but not necessarily an MRMC study with human readers assessing improvement with human-AI assistance. The focus is on the performance of the attenuation correction modification itself.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Yes, implicitly. The reported performance relates to the "software-only features" and their engineering verification and validation ("Testing on unit level," "Integration testing," "Safety testing," "Simulated use testing"). The "qualitative and quantitative comparisons" of the modified MR Attenuation Correction also refer to the algorithmic performance in generating these corrections, independent of a human interpreting the final images. The comparative aspects focus on the technical output of the algorithm.

7. The type of ground truth used

Regarding the "clinical tests" for the modified MR Attenuation Correction, the "ground truth" seems to be established through comparison to the predicate device's MR Attenuation Correction technology. The document states, "Sample clinical images, qualitative and quantitative comparisons compared to the predicate MR Attenuation Correction technology are included in this submission to support substantial equivalence of the modified features." This indicates the predicate's performance serves as the reference point for evaluating the new system's attenuation correction. It does not explicitly mention pathology or direct outcomes data being used as ground truth for this specific software modification.

8. The sample size for the training set

Not explicitly stated. The document describes a software modification to an existing device. It discusses the development process using "Risk Analysis," "Requirements Reviews," and "Design Reviews" and then verification and validation testing. There is no mention of a separate "training set" in the context of machine learning model development. The focus is on demonstrating that the modified software behaves as intended and is substantially equivalent to the predicate.

9. How the ground truth for the training set was established

N/A. As no explicit "training set" for a machine learning model is mentioned, there is no information on how its ground truth was established. The document describes a development and testing process for software features, not the training of an AI model in the typical sense with labeled data.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 14, 2017

GE Medical Systems, LLC % Ms. Janice Sich Regulatory Affairs Manager 3200 N. Grandview Blvd. Waukesha WI 53188

Re: K163619

Trade/Device Name: SIGNA PET/MR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: OUO Dated: December 21, 2016 Received: December 22, 2016

Dear Ms. Sich:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name SIGNA PET/MR

Indications for Use (Describe)
The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality ofthe MR and PET devices, allowing for single modality MR and / or PET imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection. localization, and diagnosis of disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles.

The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

The combined system utilizes the MR for radiation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

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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K163619

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is blue and has a vintage look.

GE Healthcare 510(k) Premarket Notification Submission

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	December 21, 2016
Primary Contact Person:	Janice M SichRegulatory Affairs Manager, MRGE Healthcare, (GE Medical Systems, LLC)Phone: 262-521-6312Fax: 414-908-9585
Secondary ContactPerson:	Glen SabinRegulatory Affairs Director, MRGE Healthcare, (GE Medical Systems, LLC)Phone: 262-521-6848Fax: 414-908-9585
Device Trade Name:	SIGNA PET/MR
Common/Usual Name:	Magnetic Resonance Diagnostic Device / Positron EmissionTomography (PET) System
Classification Names:	Emission Computed Tomography System per 21 CFR 892.1200
Product Code:	OUO
Predicate Device:	SIGNA PET/MR (K142098)
Device Description:	The GE SIGNA PET/MR system is a combined MagneticResonance Diagnostic Device (MRDD) and Positron EmissionTomography (PET) scanner. The system is designed for whole bodyoncology, neurology and cardiology examinations. The SIGNAPET/MR system provides simultaneous acquisition of high-resolution metabolic and anatomic information from the two majorcomponents of each system (MR and PET). Additional componentsof the system include: a patient table and both the acquisition andprocessing workstations with associated software.The SIGNA PET/MR includes a 3.0T superconducting magnet,gradient coil and body coil. The system includes dual drivecapabilities. The SIGNA PET detectors are integrated into the MRbore. This allows for simultaneous, precisely aligned whole bodyMR and PET acquisition. The PET subsystem supports Time ofFlight (ToF). The SIGNA PET/MR software is used for patientmanagement, data management, scan control, image reconstructionand image archival and evaluation. All images conform to DICOMimaging format requirements.
Indications for Use:	The SIGNA PET/MR system combines magnetic resonancediagnostic devices (MRDD) and Positron Emission Tomography(PET) scanners that provide registration and fusion of highresolution physiologic and anatomic information, acquiredsimultaneously and isocentrically. The combined system maintainsindependent functionality of the MR and PET devices, allowing forsingle modality MR and / or PET imaging. These systems areintended to be utilized by appropriately trained health careprofessionals to aid in the detection, localization, and diagnosis ofdiseases and disorders. MR is intended to produce transverse,sagittal, coronal and oblique cross-sectional MR images,spectroscopic images and/ or spectra, and displays the internalstructure and/or function of the human body. Other physicalparameters derived from the images and/or spectra may also beproduced. Depending on the region of interest, approved contrastagents may be used, as described in their labeling. This system mayalso be used for imaging during interventional procedures whenperformed with MR compatible devices, such as MR safe biopsyneedles. PET images and measures the distribution of PETradiopharmaceuticals in humans to aid the physician in determiningvarious metabolic (molecular) and physiologic functions within thehuman body for evaluation of diseases and disorders such as, but notlimited to, cardiovascular disease, neurological disorders and cancer.The combined system utilizes the MR for radiation-free attenuationcorrection maps for PET studies. The system provides inherentanatomical reference for the fused PET and MR images due toprecisely aligned MR and PET image coordinate systems.
Comparison of IntendedUse	The proposed modifications do not impact the indications for use ofthe device, therefore the intended use has not changed compared tothe predicate.The modifications outlined within this submission have the sameintended use as the predicate device in accordance with the FDA'sguidance document "The 510(k) Program: Evaluating SubstantialEquivalence in Premarket Notifications [510(k)]", dated 28 July2014.
Technology:	The SIGNA PET/MR with the proposed software modificationsemploys the same fundamental scientific technology as the predicatedevice. This subject of this premarket notification includesmodifications to MR Attenuation Correction compared to thepredicate device.
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:The features that are the subject of this premarket notification aresoftware only features that comply with the following voluntary
standards:AAMI/ANSI 62304 AAMI/ANSI ES60601-1 IEC 60601-2-33 The following quality assurance measures were applied to the development of subject features: Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Safety testing (Verification) Simulated use testing (Validation) Non-clinical tests have been summarized in the verification and validation testing. The testing was completed with passing results per the pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicate because the software features were developed under quality assurance Design Controls.Summary of Clinical Tests:Sample clinical images, qualitative and quantitative comparisons compared to the predicate MR Attenuation Correction technology are included in this submission to support substantial equivalence of the modified features.
Conclusion:GE Healthcare considers the SIGNA PET/MR with the modified software to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle. The logo is simple and recognizable, representing the multinational conglomerate corporation.

GE Healthcare 510(k) Premarket Notification Submission

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a circular emblem with the letters 'GE' intertwined in the center. The letters are stylized and have a flowing, cursive appearance. The logo is blue and has a white background.

GE Healthcare

510(k) Premarket Notification Submission

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.