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510(k) Data Aggregation
(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.
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(124 days)
The nCommand Lite system allows remote access for viewing/review of images as well as the ability to remotely provide real-time quidance to the licensed technologist operating a compatible MRI, CT, and PET-CT scanner. This access must be granted by the local licensed technologist operating the system. The remote access is only available for systems supporting remote connectivity capability. Images reviewed remotely are not for diagnostic use.
The nCommand Lite system is a SaMD (Software as Medical Device) that is customer-facing and provides remote access through a web application for viewing images as well as the ability to remotely provide real-time guidance to the near-patient licensed technologist (local users) operating the medical imaging devices in the context of training, procedure assessment, for MN, CT, and PET-CT scanner.
Remote users are licensed technologists and are able to access an imaging medical device from a computer that meets the minimum required specifications anywhere, using a secure software connection that streams video and mouse access. This allows remote users to assist local users with both remote and resoonsibilities being subject to local requlations where the imaging occurs. This access must by the local user using the system, and it can also be revoled at any time by the local user, thus allowing him/her to maintain complete control of the session at all times. Also, each remote session is controlled via a secure credential that is managed by the local user. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use. n Command Lite is an IT hardware and software-based installation solution that supports multisesson, allowing remote technologists to view multiple medical imaging devices as needed. However, access is restricted to one medical imaging device at any given time, as only one keyboard and one mouse are provided.
Scanners that are compatible with nCommand Lite system comply with a common protocol, allowing for scanning parameter management and remote scanning.
The provided text describes the nCommand Lite System, a Software as a Medical Device (SaMD) that facilitates remote access for viewing medical images and providing real-time guidance to technologists operating MRI, CT, and PET-CT scanners.
However, the submission primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and non-clinical testing, rather than presenting performance metrics against specific acceptance criteria for diagnostic accuracy or clinical outcomes. The device explicitly states that "Images reviewed remotely are not for diagnostic use." This significantly changes the type of acceptance criteria and supporting studies expected.
Therefore, the response will focus on the acceptance criteria implied by the non-clinical tests and the general safety and effectiveness claims.
Acceptance Criteria and Study Details for nCommand Lite System
Given that the nCommand Lite system is explicitly "not for diagnostic use" and assists in providing "real-time guidance" during scanner operation, the acceptance criteria are focused on safety, functionality, usability, and cybersecurity rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC). The provided submission details the non-clinical tests performed to demonstrate substantial equivalence to predicate devices in these areas.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from submission) | Reported Device Performance (Inferred from submission) |
|---|---|---|
| Software Functionality & Reliability | The software operates as intended, reliably facilitating remote access, image viewing, and real-time guidance. | Non-clinical software testing was performed following FDA guidance (e.g., "Content of Premarket Submissions for Device Software Functions," "General Principles of Software Validation Guidance") and recognized standards (e.g., IEC 62304, ANSI/AAMI SW91). The conclusion is that the device is "as safe, as effective, and performs equivalently" to predicates. |
| Cybersecurity | The system is secure against unauthorized access, data breaches, and other cyber threats. | Cybersecurity testing was performed following FDA guidance ("Cybersecurity in Medical Devices") and recognized standards (e.g., NIST Cybersecurity Framework, IEC 81001-5-1, ANS/ISA 62443-4-1, AAM TIR57). The conclusion states the device is "as safe, as effective, and performs equivalently" to predicates. |
| Usability & Human Factors | The system is safe and effective for its intended users (remote and local technologists) in its intended use environment, without causing undue use errors. | Usability engineering/human factors testing was performed following FDA guidance ("Applying Human Factors and Usability Engineering to Medical Devices") and recognized standards (e.g., IEC 62366-1). The conclusion states the device is "as safe, as effective, and performs equivalently" to predicates. |
| Electrical Safety & Electromagnetic Compatibility (EMC) | The device meets electrical safety and EMC requirements to ensure safe operation without interfering with other equipment. | Adherence to recognized standards: IEC 60601-1 (medical electrical equipment basic safety and essential performance) and IEC 60601-1-2 (collateral standard for electromagnetic disturbances). The conclusion states the device is "as safe, as effective, and performs equivalently" to predicates. |
| Risk Management | All identified risks associated with the device's use are appropriately managed and mitigated. | Application of risk management processes following ISO 14971:2019. The conclusion states the device is "as safe, as effective, and performs equivalently" to predicates. |
2. Sample Size for Test Set and Data Provenance
The submission primarily discusses non-clinical testing (software, cybersecurity, usability, electrical safety) rather than clinical studies with patient data. Therefore, there isn't a "test set" in the traditional sense of medical images or patient cases to determine diagnostic accuracy.
- Sample Size: Not applicable in the context of patient data. The "test set" would refer to the scenarios, use cases, and testing environments used for the non-clinical evaluations. Specific numbers for these scenarios are not provided in the summary.
- Data Provenance: Not applicable as no patient data or images were used to demonstrate performance against diagnostic acceptance criteria. The provenance relates to the simulated environments, test data, and user interactions during the non-clinical tests.
3. Number of Experts and Qualifications for Ground Truth
Given the non-diagnostic, assistance-based nature of the device and the focus on non-clinical testing, the concept of "ground truth" established by medical experts (e.g., radiologists) for a test set is not directly relevant in the way it would be for a diagnostic AI device.
- Number of Experts: Not specified or applicable for a ground truth derived from clinical diagnostic labels.
- Qualifications of Experts: For usability testing and software validation, "experts" would typically refer to software engineers, human factors engineers, cybersecurity specialists, and potentially experienced medical technologists who participated in user acceptance testing or usability evaluations. Their specific qualifications are not detailed in the provided summary.
4. Adjudication Method for Test Set
Not applicable, as there is no mention of a test set requiring adjudication by medical experts to establish ground truth for diagnostic purposes. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements in expert opinions for diagnostic labels.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study was not performed.
- Effect size of human readers with AI vs. without AI assistance: Not applicable, as this device is not designed to provide AI assistance for diagnostic interpretation of medical images. Its purpose is to provide remote guidance and access to operating medical imaging equipment.
6. Standalone Performance (Algorithm only without Human-in-the-loop)
- Was a standalone performance study done? Yes, in a sense, the non-clinical testing (software, cybersecurity, compliance with standards) evaluates the device's functionality and safety characteristics in a standalone manner, separate from human operation during actual clinical scenarios. For example, software unit tests, integration tests, and system tests would evaluate the algorithm's performance on its own, ensuring it can connect, stream video, and process input/output as designed. However, this is not a clinical standalone performance in terms of diagnostic accuracy.
7. Type of Ground Truth Used
The concept of "ground truth" in this submission relates to:
- Functional Specifications: The ground truth for software testing is that the software performs its specified functions correctly and reliably.
- Cybersecurity Standards: The ground truth for cybersecurity is adherence to established security protocols and standards.
- Usability Requirements: The ground truth for usability is that the device can be used effectively and safely by its intended users.
- Regulatory Standards: The ground truth is compliance with the recognized electrical safety and EMC standards.
There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for a clinical assessment of the device, as its intended use is not diagnostic.
8. Sample Size for the Training Set
Not applicable. The nCommand Lite system is a software device that provides remote access and guidance. It is not described as an AI/ML model that requires a "training set" of medical images or other data to learn and make predictions or classifications. Its functionality is based on established software engineering principles and protocols for remote connectivity.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML model.
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