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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.

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.

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.

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.

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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, 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 guidance 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, evaluation, diagnosis, staging, 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, 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 stand-alone CT system's cleared indications for use.

GE's Omni Legend is a hybrid digital PET/CT diagnostic imaging system combining a GE Positron Emission Tomography System and the commercially available GE Revolution Maxima CT System, for excellent, best-in-class imaging performance. Omni Legend 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. It is also intended for stand-alone, diagnostic CT imaging.

Omni Legend's major components include the PET system, Revolution Maxima CT system, patient table, operator console, computing hardware, power distribution unit (PDU), system software, and reconstruction software.

The PET System uses the same design elements used in the predicate Discovery MI Gen2, including use of digital detection (SiPMs). The most significant difference is that the digital detection on Omni Legend uses BGO as a scintillator instead of the Lutetium-based scintillator (LYSO/LGSO) used on Discovery MI Gen2. Omni Legend's digital BGO-based detection achieves the very high sensitivity desired. The Discovery IQ reference device also uses BGO as the scintillator material for its analogic detection. Omni Legend's PET system offers scalable ring configurations (3-ring and 6-ring) to have scalable Axial Field of Views (AFOV) of 16 and 32 cm respectively, with corresponding imaging performances.

The CT System is GE's commercially available 64 detector row Revolution Maxima, which may also be used for standalone, diagnostic CT imaging.

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. The software carries over functionalities available on the Discovery MI Gen2 product line and is updated to support the changes introduced with Omni Legend and to bring enhancement, including ACQC, RadRx 2.0, and Express Mode.

The Patient Table and PDU are identical to those of the predicate Discovery MI Gen2.

The provided text describes the GE Omni Legend PET/CT system and its submission for FDA 510(k) clearance, asserting its substantial equivalence to a predicate device. However, the document does not contain a detailed table of specific acceptance criteria or quantitative performance metrics for the device, nor does it provide a comprehensive report of a study that directly proves the device meets specific, pre-defined acceptance criteria with numerical outcomes.

Instead, it describes the types of tests performed and the general conclusions, focusing on demonstrating equivalence to a predicate device rather than meeting absolute performance thresholds.

Therefore, for the specific request:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values. It generally states that performance testing compliant with NEMA NU 2-2018 was conducted for various parameters.

General Performance Evaluation (as inferred from the text):

Note: The document only mentions that these tests were performed and that the results "support substantial equivalence" or "demonstrated acceptable diagnostic results," but it does not provide the specific numerical acceptance thresholds or the actual measured performance values for these metrics.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated. The document mentions "a clinically representative sample for evaluation of Omni Legend's performance."
• Data Provenance: Not explicitly stated regarding country of origin. The study was a "clinical reader study using PET/CT exams acquired on Omni Legend," implying prospective acquisition for the purpose of the study, though the specific recruitment method (e.g., patient volunteers vs. retrospective scans) is not detailed. It is highly likely, given GE's global presence and the setting of the submission (FDA), that the data was collected under ethical guidelines in a clinical setting relevant to the product development, but the specific origins are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not precisely stated. The document says "Each image was read by NM physicians." This implies multiple physicians, but the exact number is not provided.
• Qualifications of Experts: "NM physicians" (Nuclear Medicine physicians). No specific experience level (e.g., "10 years of experience") is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Adjudication Method: Not explicitly mentioned. The statement "Each image was read by NM physicians who provided an assessment of overall diagnostic image quality using a Likert Scale. All of the physicians attested that their assessments demonstrated acceptable diagnostic results" suggests independent reads followed by a collective attestation of acceptability, rather than a formal adjudication process (like 2+1 or 3+1 for discordance resolution).

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 clinical reader study was conducted. However, the description states it was to evaluate "Omni Legend's performance" and for "assessment of overall diagnostic image quality."
• This study does not appear to be an MRMC comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance. The document indicates the study was to evaluate the image quality of the system itself, not the impact of an AI algorithm on human reading performance.
• Therefore, no effect size for human readers improving with AI vs. without AI assistance is reported because that was not the stated purpose or design of the clinical reader study described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• The document describes the Omni Legend as a "PET/CT system" and mentions its components and functionalities. It does not describe a specific standalone "algorithm" being assessed independently of the system's image acquisition and reconstruction. The performance testing (NEMA NU 2-2018 tests) are for the entire imaging system (e.g., sensitivity, resolution), not a separate diagnostic algorithm.
• Thus, a standalone algorithm-only performance study, as typically understood in AI/CADx submissions, is not detailed or implied for a distinct diagnostic algorithm component. The testing described is for the device as an image-generating system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth for the clinical reader study appears to be expert assessment/consensus based on the NM physicians' evaluations of "overall diagnostic image quality." There is no mention of pathology, long-term outcomes, or other objective data used as ground truth for the diagnostic image quality assessment. The physicians attested to acceptable diagnostic results.

8. The sample size for the training set:

• The document makes no mention of a training set sample size. This is because the submission is for a PET/CT imaging system, not an AI/ML algorithm that typically requires a large training set. While the system may incorporate advanced processing, the submission focuses on the hardware's performance (digital BGO detector, CT system) and its ability to produce diagnostic images, rather than a trainable AI model used for diagnosis.

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

• Since no training set is mentioned or implied for a trainable AI/ML algorithm in this submission, the establishment of ground truth for a training set is not applicable to the information provided. The "ground truth" discussed is related to the evaluation of the final image quality and diagnostic acceptability by physicians, not for training a model.

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