(59 days)
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.
| 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.
§ 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.