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The Aurora system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures.

· NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT), Imaging modes include single photon, multi-isotope, and multi-peak, with data stored in frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

· CT System: produces Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications.

· NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping (localization, registration, and fusion).

The Aurora system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.

GEHC's Aurora is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available Revolution Ascend system. It is intended for general purpose Nuclear Medicine imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. Aurora does not introduce any new Intended Use.

Aurora consists of two back-to-back gantries (i.e. one for the NM sub-system and another for the CT subsystem), patient table, power distribution unit (PDU), operator console with a computer for both the NM acquisition and SmartConsole software and another for the CT software, interconnecting cables, and associated accessories (e.g. NM collimator carts, cardiac trigger monitor, head holder). The CT sub-system main components include the CT gantry, PDU, and CT operator console. All components are from the commercially available GEHC Revolution Ascend CT system. The CT gantry has been adapted for use with predicate device's NM portion. CT PDU, CT Console Keyboard and CT operator console are the same as in Revolution Ascend Plus.

The provided document does not contain details about specific acceptance criteria, a study proving device performance against those criteria, or the various methodological details requested regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

The document is a 510(k) summary for the Aurora system, indicating that it is a modification of a predicate device (Discovery NM/CT 670) and incorporates components from other cleared devices. The filing emphasizes that, due to the nature of these modifications (primarily replacing a 16-slice CT with a 64-slice CT and other workflow enhancements, while the NM system is largely carried over), clinical testing was deemed unnecessary to demonstrate substantial equivalence.

The document states:

• "Because the changes associated with Aurora do not change the Indications for Use from the predicate and reference devices, and represent equivalent technological characteristics, this type of change supports using scientific, established / standardized, engineering / physics-based performance testing, without inclusion of clinical images for determining substantial equivalence."
• "Given the above information and the type and scope of changes, particularly that the NM imaging component is identical to the predicate, and the CT component is the commercially available Revolution Ascend CT system, clinical images are not included in this submission. Clinical images are not needed to demonstrate substantial equivalence."

Instead of a clinical study, the submission relies on:

• Design control testing per their quality system (21CFR 820 and ISO 13485): including 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).
• Conformance to standards: IEC 60601-1 and its applicable Collateral and Particular Standards (IEC 60601-1-2, 60601-1-3, 60601-2-44), as well as performance testing per NEMA NU-1.
• Additional engineering bench testing (non-clinical testing): This was performed to support substantial equivalence, demonstrate performance, and substantiate product claims. Evaluated areas included applicability of cleared lesion detectability and dose/time reduction claims, quantitation accuracy, IQ performance with low dose CT for attenuation correction, and workflow.

Therefore, the requested information cannot be extracted from this document as a clinical validation study demonstrating performance against specific acceptance criteria with human-in-the-loop or standalone performance was not part of the submission for substantial equivalence.

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Clarify DL is a deep learning-based image reconstruction method intended to reduce noise and improve image quality of Nuclear Medicine bone SPECT scintigraphy images. Clarify DL may be used for patients of all ages.

Clarify DL is a software-only device for the reconstruction of NM bone SPECT scintigraphy images obtained using supported GE HealthCare SPECT and SPECT-CT systems. Clarify DL is designed to reduce image noise while maintaining contrast to enable increased Contrast-to-Noise Ratio (CNR) and Contrast Recovery Coefficient (CRC). Clarify DL is deployed within the software of the predicate Xeleris V Processing and Review System and StarGuide devices.

The provided text describes the acceptance criteria and the study conducted for Clarify DL, a deep learning-based image reconstruction method for Nuclear Medicine bone SPECT scintigraphy images.

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for Clarify DL revolve around its ability to reduce image noise while maintaining contrast, thereby improving image quality. The specific metrics assessed are:

The text explicitly states that "All readers attested that their assessments of Clarify DL demonstrated acceptable diagnostic results" for overall image quality, image resolution, and noise level. Furthermore, the additional engineering bench testing "substantiated all performance claims," including improvement in CNR and CRC.

Study Details

The evaluation of Clarify DL involved both non-clinical (bench) testing and clinical reader evaluation.

Clinical Reader Evaluation (Test Set):

1. Sample size used for the test set: The text mentions "clinical bone SPECT and SPECT-CT exams obtained using supported SPECT CT systems" from "11 hospitals." The exact number of exams (cases) used for the test set is not specified.
2. Data provenance: The clinical exams came from "11 hospitals, including 5 US hospitals from 4 different states (i.e Ohio, Kansas, Rhode Island, and California) and 6 non-US hospitals from Europe and Asia." This indicates a prospective or retrospective collection of real-world clinical data from a diverse geographical range. The studies are described as "clinical bone SPECT and SPECT-CT exams."
3. Number of experts used to establish the ground truth for the test set and their qualifications: The clinical reader evaluation involved "expert NM physicians" but the number of experts is not specified. Their qualifications are given as "expert NM physicians." No specific years of experience are provided.
4. Adjudication method for the test set: The text states, "The clinical reader evaluation included review by expert NM physicians to assess overall Image Quality, Image Resolution, and Noise Level. The results of the clinical reader evaluation support the determination of substantial equivalence. All readers attested that their assessments of Clarify DL demonstrated acceptable diagnostic results." This implies a consensus or individual assessment model, but a specific adjudication method (e.g., 2+1, 3+1) is not explicitly mentioned. Given that "all readers attested," it suggests a strong agreement or individual positive assessments were sufficient.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: The text does not explicitly state that an MRMC comparative effectiveness study was done to compare human readers with and without AI assistance. The clinical reader evaluation assessed the Clarify DL images directly.
6. Standalone (algorithm-only without human-in-the-loop performance): Yes, standalone performance was evaluated through "additional engineering bench testing". This included image-level metrics (SSIM, MSE, PSNR) and lesion-level metrics (CNR, CRC) to quantitatively assess the algorithm's performance independent of human interpretation.
7. Type of ground truth used: For the clinical reader evaluation, the ground truth was expert consensus/interpretation by "expert NM physicians" regarding image quality, resolution, and noise level. For the bench testing, the "ground truth" implicitly referred to a reference image or quantitative metric against which the performance improvements (e.g., noise reduction, contrast enhancement) of Clarify DL were measured.
8. Sample size for the training set: The text does not specify the sample size for the training set used for the deep learning model.
9. How the ground truth for the training set was established: The text does not explicitly describe how the ground truth for the training set was established. It only states that Clarify DL uses an "OSEM-based Iterative Image Reconstruction with integrated deep learning model trained to reduce noise."

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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 Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population). The Discovery NM 750b Gamma Camera is indicated for planar and dynamic planar scintigraphy in the energy range 80-200keV for the detection and display of radioisotope tracer uptake in patients of all ages.

The Discovery NM 750b is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. The device may include signal analysis and display equipment, patient and equipment supports, and accessories. The Discovery NM 750b is a high performance and compact planar nuclear imaging system, available in a dual head configuration or a single head configuration. This system is intended to measure and image the distribution of selected single photon emission radioisotopes in the breast and other small body parts in order to aid in the evaluation of lesions.

This 510(k) summary explicitly states that no clinical studies were submitted to support the substantial equivalence determination for the Discovery NM 750b. Therefore, there is no information about acceptance criteria or a study proving the device meets them in the provided text.

Specifically, the document states:

"Clinical Tests Submitted The 510(k) application does not contain information from GEHC sponsored clinical studies as provided for under 21CFR 54.2(e), and therefore does not require Clinical trials data."

Instead, substantial equivalence was determined based on:
"The proposed device has undergone bench testing that was designed to simulate clinical factors."

As such, I cannot provide the requested information from the provided text.

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