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The GE Discovery MI Gen2 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.

Discovery MI Gen2 is intended to image the whole body, head, heart, 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's disease
• Non-Hodgkin's lymphoma
• Colorectal Cancer
• Melanoma

Discovery MI Gen2 is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-alone CT system's cleared indications for use.

GE's Discovery MI (DMI) Gen2, same as the unmodified predicate device, is a hybrid digital PET/CT diagnostic imaging system combining a GE Positron Emission Tomography (PET) System and a GE Computed Tomography (CT) System. The DMI Gen2 is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. lt 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.

GE has modified the cleared Discovery MI (K161574) within our design controls to include a 6ring configuration that provides 30 cm Axial Field of View (AFOV) coverage. DMI Gen2 employs the same detector design architecture and manufacturing process as in the predicate to offer scalable ring configurations (3-ring, 4-ring, 5-ring and 6-ring) to have scalable AFOV coverage (15cm, 20cm, 25cm and 30cm) and corresponding imaging performances.

The provided text is a 510(k) Summary of Safety and Effectiveness for the GE Discovery MI Gen2 PET/CT system. It does not include a description of acceptance criteria or a detailed study proving the device meets specific performance metrics in a clinical setting. Instead, it states that clinical testing was not required due to the nature of the changes to the device and the use of established engineering and physics-based performance testing.

Therefore, many of the requested items related to clinical study design and ground truth are explicitly stated as not applicable or not performed in this submission.

Here's a breakdown based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

• Absent. The document does not provide specific acceptance criteria or reported performance metrics in a tabular format for clinical outcomes. It focuses on engineering and image performance evaluation testing, but no specific values or acceptance thresholds are given. The mention of "better detectability of small lesions" and "higher AFOV coverage... allows a patient to be scanned using fewer field of views" are general claims of improvement, not specific performance metrics against an acceptance criterion.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This was a non-clinical study. The summary states: "Clinical Testing: Discovery MI Gen2 is designed and built entirely from existing and cleared systems, subsystems, components, and technologies of its Predicate Device (Discovery MI). This type of change in Discovery MI Gen 2 is supported using scientific, established/standardized, engineering/physics-based performance testing, without inclusion of clinical images, to demonstrate that the device is as safe and as effective as the predicate devices. Given the above information and the type and scope of the changes, particularly the addition of the 30 cm, 6-ring, AFOV configuration, clinical testing is not required to demonstrate that the Discovery MI Gen 2 is as safe and as effective as the legally marketed predicate device."
• "Image Performance evaluation testing used a variety of test methods and phantoms covering a broad base of relevant imaging performance and image quality test cases..." This indicates the test set consisted of phantoms, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No human experts were used for ground truth because the testing was non-clinical, using phantoms, and relied on "mathematical and physics analysis" and "scientific methods that are standardized (e.g. NEMA, FDA Guidance), well established, and/or reviewed in previous GE's PETCT or Nuclear Medicine clearances."

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

• Not applicable. No human review or adjudication was performed as it was a non-clinical performance study.

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. An MRMC study was not performed as clinical testing with human readers was not part of this 510(k) submission. No AI component is mentioned.

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

• Partially applicable, but not for a clinical algorithm. The testing was "algorithm only" in the sense that it assessed the device's performance using phantoms and engineering methods, independent of human interpretation in a clinical setting. However, it's a PET/CT system, not an AI algorithm in the context of diagnostic assistance. The document refers to "Deep Learning Image Reconstruction (DLIR) K193170" for the CT System component, suggesting an AI component is involved in image generation, but this submission focuses on the full PET/CT system and does not detail performance data specific to DLIR.

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

• Engineering/Physics-based Standards and Phantoms. The ground truth was established through "scientific methods that are standardized (e.g. NEMA, FDA Guidance)" and "phandoms" [sic] with known properties, along with "mathematical and physics analysis."

8. The sample size for the training set

• Not applicable / Not explicitly stated. This document describes the clearance of a medical imaging device (PET/CT system), not a new AI algorithm that requires a separate training set. While the CT component mentions "Deep Learning Image Reconstruction (DLIR)," the training data and methods for DLIR (K193170) are outside the scope of this specific 510(k) summary. For the overall PET/CT system, there isn't a "training set" in the sense of a machine learning model, but rather a design and development process based on existing technologies.

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

• Not applicable / Not explicitly stated. As above, no training set for a new AI algorithm specific to this 510(k) is discussed. For the DLIR component (from K193170, mentioned as part of the CT system), the ground truth for its training would have been established in its own separate clearance, likely through high-quality, low-noise CT scans.

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The GE Discovery MI 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.

Discovery MI 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 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

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

The Discovery MI system is a PET/CT diagnostic imaging system combining a GE Positron Emission Tomography (PET) System and a GE Computed Tomography (CT) System.

The PET portion of the system uses a Lutetium-based Scintillator (LBS) detector. Scintillator crystal arrays are attached to Silicon Photo Multipliers (SiPM) to form detector units. The detector units are inherited from the reference device Signa PET/MR. Detector units are attached on a common support to form detector modules. The detector modules are arranged in a ring around the patient positioned inside of the PET gantry for detection of gamma rays generated as a result of PET radiopharmaceuticals injected into the patient.

The PET/CT system uses the full-featured multi-slice diagnostic CT subsystem with PET/CT post processing software to generate a map of the non-uniform attenuation in the patient. This attenuation map is then used for attenuation correction of the PET data. The CT image is also used for localization of the PET image in the patient anatomy by means of fusing the PET and CT images.

The Discovery MI system's major components are the PET gantry/detector, Revolution EVO CT system, patient table, operator console/workspace, computing hardware, power distribution unit, system software, and reconstruction software. The operator console and software provide control of the imaging (i.e. setting and confirming conditions of operation), image acquisition, dose display, reconstruction, viewing, post processing analysis, patient management, networking, and filmina. The system may include respiratory and cardiac gating capabilities, signal analysis and display equipment, patient and equipment supports, components and accessories. In addition to being installed as a complete PET/CT system, the Discovery MI may result from an upgrade to a Revolution EVO- based Discovery PET/CT 710.

The Discovery MI system provides scalable axial coverage for the PET detector. All configurations offer reference adult and pediatric protocols for both hybrid PET/CT and CT applications. The PET 3D data acquisition modes include Static, Gated, Dynamic, and Whole Body scanning. All of which can be acquired with List mode data. The system includes standard PET iterative reconstruction alqorithms. Q.Clear full-convergence, reqularized reconstruction is optionally available. Time of Flight (ToF) may be used for all PET reconstruction types.

The CT system is the commercially available 64-detector row Revolution Evo, which may also be used for stand-alone, diagnostic CT imaging. The CT system's acquisition modes include Axial, Cine, Helical (Volumetric), Cardiac, and Gated, for head, whole body, trauma, cardiac and vascular applications.

This document describes the Discovery MI, a PET/CT diagnostic imaging system. No specific acceptance criteria table or a detailed study proving the device meets acceptance criteria in the sense of a clinical trial for diagnostic performance are provided in the extracted text. The document focuses on demonstrating substantial equivalence to a predicate device, as required for a 510(k) premarket notification.

However, the text does mention non-clinical testing to substantiate product performance and claims, which effectively serve as internal performance criteria:

1. Table of Performance Claims Tested (Non-Clinical) and Device Performance (Implicitly Met):

2. Sample Size and Data Provenance for Test Set:

• Test Set (Non-Clinical): "a variety of test methods and phantoms appropriate for the performance metric/claim to be tested and evaluated." No specific sample size (e.g., number of phantoms) is provided, and the data is generated through physics and engineering analysis, not from human subjects.
• Data Provenance: Non-clinical (phantom-based, mathematical, and physics analysis). Not applicable for country of origin or retrospective/prospective as it's not human data.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

• Not applicable as the "ground truth" for the non-clinical performance evaluations (sensitivity, NECR, resolution, lesion detectability) would be based on the known physical properties of the phantoms and the expected performance of the system as designed and measured, rather than expert consensus on clinical images.

4. Adjudication Method for Test Set:

• Not applicable, as this was non-clinical phantom testing.

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

• No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned. The document explicitly states: "Given the above information and the type and scope of the changes, particularly that the new system uses PET detector modules from the cleared Signa PET/MR, and that its 510k included numerous clinical images, clinical testing is not required to demonstrate that the Discovery MI is as safe and as effective as the legally marketed predicate and reference devices."

6. Standalone (Algorithm Only) Performance Study:

• The "lesion detectability evaluation included a model observer study." This implies a standalone computational assessment of lesion detection performance, without human readers. No specific metrics (e.g., AUC, sensitivity, specificity) or detailed results from this model observer study are provided.

7. Type of Ground Truth Used (for Non-Clinical Tests):

• For non-clinical performance evaluation, the ground truth was based on the known physical properties of the phantoms and the expected performance derived from mathematical and physics analysis.

8. Sample Size for Training Set:

• Not applicable. The document does not describe the development of an AI algorithm that would typically require a training set. The "model observer study" mentioned for lesion detectability is unlikely to refer to a machine learning training set in this context but rather a computational model used to assess detectability in phantoms.

9. How Ground Truth for Training Set Was Established:

• Not applicable, as there is no mention of a machine learning training set for an AI algorithm.

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