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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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True Enhance DL is a deep learning-based image processing method trained to estimate monochromatic, 50 keV GSI images. The algorithm is intended to improve the contrast of 120 kVp, single energy images of the body.

This device is intended to provide non-quantitative, adjunct information and should not be interpreted without the original 120 kVp image.

True Enhance DL may be used for patients of all ages.

True Enhance DL is a deep learning-based image processing method for contrast enhanced images of the body obtained using the Revolution Ascend Family (K213938), which consists of multiple commercial configurations: Revolution Ascend Elite, Revolution Ascend Plus, and Revolution Ascend Select. True Enhance DL is intended to post-process single energy, 120 kVp images to output nonquantitative, adjunctive information with better contrast than single energy input data.

True Enhance DL brings four deep leaning models that the user can choose depending on different contrast enhancement phases. These four models are CT Angiography, Arterial, Portal/Venous, and Delayed True Enhance DL.

True Enhance DL is not intended to replace hardware based Monochromatic Imaging by Gemstone Spectral Imaging (GSI) technology or replicate GSI dual energy acquisitions. The device was trained to estimate monochromatic, 50 keV GSI images, and only enhances images from 120 kVp acquisitions on non-GSI Revolution Ascend systems.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a number of cases. The text mentions "sample clinical data" and "Additional representative clinical cases and anthropomorphic phantom cases."
• Data Provenance: Retrospective. The study used "retrospectively collected representative clinical cases." The country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Number of Experts: Four.
• Qualifications of Experts: "Four board certified radiologists." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set:

• The text does not explicitly state a formal adjudication method (e.g., 2+1, 3+1). It indicates that the four radiologists each provided a comparative assessment of image quality related to diagnostic use. This suggests individual reader assessment rather than a consensus-building adjudication process for ground truth. However, they were asked to "rate the contrast enhancement in the True Enhance DL series vs the native image series," which implies a comparative evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• A MRMC-like study was done, as "four board certified radiologists" read the images.
• Effect Size: The text states, "the readers were asked to rate the contrast enhancement in the True Enhance DL series vs the native image series" and "validated that True Enhance DL software provides additional benefit by improving contrast." However, a quantitative effect size of human readers' improvement with AI vs. without AI assistance is not provided in this summary. The focus was on the software's ability to improve contrast rather than a comparative effectiveness of human performance with and without the tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, a standalone evaluation was conducted to assess image characteristics. The text mentions "Additional representative clinical cases and anthropomorphic phantom cases from a GSI system generating both single energy 120 kVp and 50 keV monochromatic images were evaluated for CT number in various anatomical regions to study image characteristics for different materials of the device output compared to 50 keV and 120 kVp reference images." This assesses the algorithm's output properties directly against a reference, which constitutes a standalone performance aspect.

7. The Type of Ground Truth Used:

• Expert Consensus / Reader Assessment: For the image quality and contrast improvement aspects, the subjective assessment of "four board certified radiologists" served as the ground truth.
• Reference Images / Clinical Data: For the standalone evaluation, "50 keV and 120 kVp reference images" (likely derived from GSI systems with known energy characteristics) were used to study the algorithm's output. Clinical cases with "disease/pathology" were used, implying the presence of known conditions, although how these conditions served as "ground truth" for the AI's performance beyond simply being present in the data is not fully detailed.

8. The Sample Size for the Training Set:

• The sample size for the training set is not provided in this document. The text only states, "The device was trained to estimate monochromatic, 50 keV GSI images."

9. How the Ground Truth for the Training Set Was Established:

• The document implies that the training was based on "to estimate monochromatic, 50 keV GSI images." This suggests that 50 keV monochromatic GSI images (likely acquired from dual-energy CT scans, which serve as a form of ground truth for spectral decomposition) were used as the target output for the deep learning model during training. The process of generating these reference 50 keV GSI images themselves would involve the CT system's physics and reconstruction algorithms.

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