The GE Omni Legend is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages.

Omni Legend is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning. therapy quidance and monitoring. and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion).

When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the raw and image data is an aid in; detection, localization, diagnosis, staging, restaging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology.

Examples of which are: Cardiology:

· Cardiovascular disease
· Myocardial perfusion
· Myocardial viability
· Cardiac inflammation
· Coronary artery disease

Neurology:

· Epilepsy
· Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia

· Movement disorders, such as Parkinson's and Huntington's disease

· Tumors
· Inflammation
· Cerebrovascular disease such as acute stroke, chronic and acute ischemia
· Traumatic Brain Injury (TBI)
Oncology/Cancer:
· Non-Small Cell Lung Cancer
· Small Cell Lung Cancer
· Breast Cancer
· Prostate Cancer
· Hodgkin disease
· Non-Hodgkin lymphoma
· Colorectal Cancer
· Melanoma

Omni Legend is also intended for stand-alone, diagnostic CT imaging in accordance with the standalone CT system's cleared indications for use.

Device Description

GE HealthCare's subject Omni Legend device, same as the unmodified predicate device, is a hybrid digital PET/CT diagnostic imaging system combining a GEHC Positron Emission Tomography (PET) System and a current production diagnostic GEHC Computed Tomography (CT) System. The proposed Omni Legend is a conventional, general-purpose PET/CT system using existing technological characteristics with identical Intended Use and Indications for Use as its predicate.

Omni Legend is made available with a "6 Ring", "4 Ring" configuration of its PET detector that correspondent provide an AFOV of 32 cm, 21cm, 16 cm. Omni Legend's major components include PET gantry / detector, GEHC commercially available Revolution Maxima CT system (K192686), patient table, operator console / workspace, computing hardware, power distribution unit, system software, and image reconstruction software. The operator console and system software control image acquisition and reconstruction, image display and post processing analysis, protocol and patient management, CT dose display, networking, filming, etc.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the GE Omni Legend device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantifiable, pass/fail format for the clinical reader study. However, it does specify types of evaluations and the general outcome.

Acceptance Criteria Category	Details of Evaluation	Reported Device Performance
Clinical Reader Study - Diagnostic Image Quality	Assessment of overall diagnostic image quality using a Likert Scale.	"All of the physicians attested that their assessments demonstrated acceptable diagnostic results."
Clinical Reader Study - Artifact Correction	Evaluation of the ability of the "Enhanced AC" option to correct attenuation artifacts.	The study's results "support the determination of substantial equivalence" and the clinical experts' assessments "demonstrated acceptable diagnostic results," implying successful artifact correction.
Non-Clinical Testing (Bench Testing)	* System Sensitivity * Noise Equivalent Count Rate (NECR) * Contrast Recovery and Contrast to Noise Ratio * Spatial Resolution * Quantitation * Dose / Time Reduction (Acquisition and Image Quality) * Design for Scalability * Verification of PET Digital Gating cleared performance claims * Qualitative and quantitative evaluation of PET images corrected with Enhanced AC, including demonstration of improvement in lesion quantitation.	"All testing and results did not raise new or different questions of safety and effectiveness than associated with predicate device. GE believes the proposed Omni Legend is of comparable type and substantially equivalent to our currently marketed system Omni Legend (K221932)." This implies successful completion of all bench tests with results comparable to the predicate.

2. Sample Size for Test Set and Data Provenance

Sample Size: The document states that the clinical reader study used "a clinically representative sample for evaluating the performance of Omni Legend's Enhanced AC option." However, the specific number of cases or patient exams in this test set is not provided.
Data Provenance: Not explicitly stated. The document refers to "PET/CT exams acquired on Omni Legend," implying prospective acquisition on the device, but does not specify the country of origin. It also doesn't explicitly state whether the data was retrospective or prospective, though "acquired on Omni Legend" suggests prospective collection for the study.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: The clinical reader study involved "NM physicians." The specific number of physicians is not provided.
Qualifications of Experts: The experts were identified as "NM physicians" (Nuclear Medicine physicians). No further details on their years of experience or board certifications are given.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the clinical reader study. It states that "Each image was read by NM physicians who provided an assessment of overall diagnostic image quality... as well as the ability of Enhanced AC to correct artifacts." This suggests individual assessments rather than a consensus or adjudicated ground truth process involving the readers themselves.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document describes a clinical reader study but does not explicitly state that it was an MRMC comparative effectiveness study comparing human readers with AI vs. without AI assistance. The study primarily focused on evaluating the "Enhanced AC" software option, with readers assessing diagnostic image quality and artifact correction.
Effect Size: As it wasn't explicitly an MRMC study designed to measure human improvement with AI assistance, no effect size of human readers improving with AI vs. without AI assistance is reported. The study's conclusion is about the acceptability of the device's enhanced features.

6. Standalone Performance Study (Algorithm Only)

The document does not explicitly describe a standalone (algorithm only, without human-in-the-loop) performance study for the "Enhanced AC" option. The clinical study involved human readers assessing the images produced by the system (which includes the Enhanced AC), but it wasn't an isolated evaluation of the algorithm's output without human interpretation. The non-clinical testing included "qualitative and quantitative evaluation of PET images corrected with Enhanced AC, including demonstration of improvement in lesion quantitation," which could be considered a form of standalone evaluation, but it's not a clinical performance study.

7. Type of Ground Truth Used

For the clinical reader study, the ground truth was based on the expert assessment/consensus of NM physicians regarding the "overall diagnostic image quality" and the "ability of Enhanced AC to correct artifacts" and whether these assessments demonstrated "acceptable diagnostic results." It is not explicitly stated if pathology, outcomes data, or another objective measure was used to establish ground truth for this specific reader study. For the non-clinical testing, the "ground truth" would be established by physical measurements and phantom studies comparing results against known values as per NEMA standards.

8. Sample Size for Training Set

The document does not provide any information regarding the sample size used for training the algorithms (e.g., "Enhanced AC" or "Precision DL").

9. How Ground Truth for Training Set Was Established

The document does not provide any information on how the ground truth for any training set was established.

Summary

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August 8th, 2024

Image /page/0/Picture/1 description: The image contains 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 Medical Systems Israel, Functional Imaging Alexandra Lifshits Sr. Program Manager, Regulatory Affairs (GE Healthcare) 4 Hayozma Street Tirat HaCarmel, WI 30200 Israel

Re: K241665

Trade/Device Name: Omni Legend Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: June 10, 2024 Received: June 10, 2024

Dear Alexandra Lifshits:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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,

Ningzhi Li-S

for Daniel Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K241665

Device Name

Omni Legend

Indications for Use (Describe)

Examples of which are: Cardiology:

· Cardiovascular disease
· Myocardial perfusion
· Myocardial viability
· Cardiac inflammation
· Coronary artery disease

Neurology:

· Epilepsy
· Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia

· Movement disorders, such as Parkinson's and Huntington's disease

· Tumors
· Inflammation
· Cerebrovascular disease such as acute stroke, chronic and acute ischemia
· Traumatic Brain Injury (TBI)
Oncology/Cancer:
· Non-Small Cell Lung Cancer
· Small Cell Lung Cancer
· Breast Cancer
· Prostate Cancer
· Hodgkin disease
· Non-Hodgkin lymphoma
· Colorectal Cancer
· Melanoma

Omni Legend is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-

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alone CT system's cleared indications for use. 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/4/Picture/1 description: The image contains the logo for GE HealthCare. The logo consists of the GE monogram in a circle on the left, followed by the text "GE HealthCare" on the right. The color of the logo is a shade of purple.

510(k) SUMMARY OF SAFETY AND EFFECTIVNESS

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h):

Date:	June 10, 2024
Submitter:	GE Medical Systems Israel, Functional Imaging (GE Healthcare
	4 Hayozma Street
	Tirat Hacarmel, 30200, Israel
Primary Contact:	Alexandra Lifshits
	Sr. Regulatory Affairs Program Manager
	GE Medical Systems Israel, Functional Imaging
	Tel: +972-4-8563666
	Fax: +972-4-8577662
	email: Alexandra.Lifshits@gehealthcare.com
Secondary Contacts:	John Jaeckle
	Chief Regulatory Affairs Engineer and Strategist
	GE Healthcare
	Tel: 262-424-9547
	Email: John.Jaeckle@gehealthcare.com
Device Trade Name:	Omni Legend
Device Classification	Class II
Regulation number:	21CFR 892.1200 and 21CFR 892.1750
Product Code	KPS and JAK

Predicate Device Information
Device Name	Omni Legend
Manufacturer	GE Medical Systems Israel, Functional Imaging
510(k) number	K221932
Regulation number	21CFR 892.1200 and 21CFR 892.1750
Product Code	KPS and JAK

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Image /page/5/Picture/0 description: The image contains the GE Healthcare logo. The logo consists of a purple circular emblem with intertwined letters inside. To the right of the emblem, the text "GE HealthCare" is written in purple. The text is aligned horizontally with the emblem.

GE Healthcare 510(k) Premarket Notification Submission

Reference Device Information
Device Name	Precision DL
Manufacturer	GE Medical Systems Israel, Functional Imaging
510(k) number	K223212
Regulation Number	21CFR 892.1200
Product Code	KPS

Reference Device Information
Device Name	Discovery MI
Manufacturer	GE Medical System, L.L.C.
510(k) number	K161574
Regulation number	21CFR 892.1200 and 21CFR 892.1750
Product Code	KPS and JAK

Marketed Devices

GE HealthCare's (GEHC) proposed Omni Legend device is a modification of the predicate Omni Legend device (K221932). The modification adds a new intermediate "4 Ring" 21 cm Axial Field of View (AFOV) system configuration to the predicate's "3 Ring" 16 cm and "6 Ring" 32 cm AFOV system configurations, as well as adds the "Enhanced AC" software option for the correction of image attenuation artifacts resulting from natural respiratory motion. The PET portion of the proposed Omni Legend uses the same design elements that are used in its predicate device. The software of the proposed Omni Legend is also developed from that of the predicate.

Device Description

Omni Legend is made available with a "6 Ring", "4 Ring" configuration of its PET detector that correspondently provide an AFOV of 32 cm, 21cm, 16 cm. Omni Legend's major components include PET gantry / detector, GEHC commercially available Revolution Maxima CT system (K192686), patient table, operator console / workspace, computing hardware, power distribution unit, system software, and image reconstruction software. The operator console and system software control

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Image /page/6/Picture/1 description: The image contains the logo for GE Healthcare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized, circular design in purple. The text "GE HealthCare" is also in purple and is written in a clean, sans-serif font.

image acquisition and reconstruction, image display and post processing analysis, protocol and patient management, CT dose display, networking, filming, etc.

Intended Use

The Omni Legend PET/CT system is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. It is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The system is also intended for stand-alone, diagnostic CT imaging.

Indications for Use

Omni Legend is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy quidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion).

When used with radiopharmaceuticals approved by the regulatory in the country of use, the raw and image data is an aid in; detection, localization, diagnosis, staging, restaging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, and neurology. Examples of which are:

Cardiology:

Cardiovascular disease
Myocardial perfusion
· Myocardial viability
Cardiac inflammation
Coronary artery disease

Neurology:

· Epilepsy
Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia
Movement disorders, such as Parkinson's and Huntington's disease
Tumors
Inflammation
Cerebrovascular disease such as acute stroke, chronic and acute ischemia
Traumatic Brain Injury (TBI)

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Image /page/7/Picture/1 description: The image contains the GE Healthcare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the text "GE HealthCare" is written in a simple, sans-serif font, also in purple. The overall design is clean and corporate, representing the brand identity of GE Healthcare.

Oncoloqy/Cancer:

Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Breast Cancer
Prostate Cancer
Hodgkin's disease
Non-Hodgkin's lymphoma
Colorectal Cancer
Melanoma

Omni Legend is also intended for stand-alone, diagnostic CT imaging in accordance with the standalone CT system's cleared indications for use.

Technological Characteristics

The proposed Omni Legend employs the same basic operating principles and fundamental technologies as the predicate Omni Legend device. The table below summarizes the substantive feature / technological differences between the predicate and proposed devices.

Specification /Attribute	Predicate Device:Omni Legend (K221932)	Proposed Device:Omni Legend
PET Gantry	Multiple detector ring configurations(16, 32 cm axial FOV).70 cm bore.	Multiple detector ring configurations(16, 21 , 32 cm axial FOV).70 cm bore
Detector Unit	SiPM-based light sensor with ASIC	SiPM-based light sensor with ASIC
	BGO scintillator crystals	BGO scintillator crystals
CT System	Revolution Maxima (K192686)	Revolution Maxima (K192686)
Image Reconstruction/ Processing	Iterative Image Reconstruction,including Precision DL (K223212)	Iterative Image Reconstruction,including Precision DL (K223212).PET Digital Gating (DDG) also knownas MotionFree (K180318)Enhanced AC option


StandardsConformance	IEC 60601-1 and applicable Collateraland Particular Standards.	IEC 60601-1 and applicable Collateraland Particular Standards.

Omni Legend's technological characteristics do not create new questions of safety or effectiveness, and did not introduce any new risks/hazards, warnings, or limitations.

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Image /page/8/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the text "GE HealthCare" is written in a simple, sans-serif font, also in purple. The logo is clean and modern, representing the company's brand identity.

Determination of Substantial Equivalence

Summary of Non-Clinical, Design Control Testing

Omni Legend has successfully completed the design control testing per our quality system. No additional hazards were identified, and no unexpected test results were observed. Omni Legend was designed and is manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. GE believes that the extensive bench testing and the physician evaluations performed are sufficient for FDA's substantial equivalence determination.

Omni Legend has been independently tested and conforms with IEC 60601-1 and its applicable Collateral and Particular Standards including IEC 60601-1-2, 60601-2-44, as well as performance testing per NEMA NU 2-2018.

The following quality assurance measures were applied to the development of the system:

Risk Analysis
· Required Reviews
Design Reviews
Testing on unit level (Module verification)
· Integration testing (System verification)
· Performance testing (Verification)
· Safety testing (Verification)
· Simulated use testing (Validation)

Additional Non-Clinical Testing

Additional engineering bench testing was performed to support substantial equivalence, demonstrate performance, and substantiate the product claims. Where applicable the testing was conducted according to NEMA NU-2-2018. This included testing for:

= System Sensitivity
Noise Equivalent Count Rate (NECR)
Contrast Recovery and Contrast to Noise Ratio
Spatial Resolution
Quantitation
Dose / Time Reduction (Acquisition and Image Quality)
= Design for Scalability

Testing of PET Digital Gating (K180318) verified use with Omni Legend and included substantiation of PET Digital Gating cleared performance claims. Testing of Enhanced AC included qualitative and quantitative evaluation of PET images corrected with Enhanced AC, including demonstration of improvement in lesion quantitation.

All testing and results did not raise new or different questions of safety and effectiveness than associated with predicate device. GE believes the proposed Omni Legend is of comparable type and substantially equivalent to our currently marketed system Omni Legend (K221932).

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Image /page/9/Picture/1 description: The image contains the GE Healthcare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized version of the letters "GE" intertwined within a circle. The text is in a simple, sans-serif font and is colored in the same shade of purple as the emblem.

Clinical Testing

A clinical reader study using PET/CT exams acquired on Omni Legend was conducted. The exams constituted a clinically representative sample for evaluating the performance of Omni Legend's Enhanced AC option. The results of the study support the determination of substantial equivalence. Each image was read by NM physicians who provided an assessment of overall diagnostic image quality using a Likert Scale as well as the ability of Enhanced AC to correct artifacts. All of the physicians attested that their assessments demonstrated acceptable diagnostic results.

Substantial Equivalence Conclusion:

The modifications associated with proposed Omni Legend do not create a new Intended Use or Indications for Use and represent equivalent technological characteristics, with no changes to the control mechanisms, operating principle, and energy type. GEHC's quality system's design verification, and risk management processes did not identify any new questions of safety or effectiveness, hazards, unexpected results, or adverse effects stemming from the changes to the predicate.

Based on development under GEHC's quality system, the successful system and software verification and validation testing, conformance to standards, the additional engineering bench testing, and the clinical reader study demonstrates that the proposed Omni Legend is substantially equivalent to, and hence as safe and as effective for its Intended Use, as the legally marketed predicate device.

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.